Hyoscyamine/

Methenamine/

Methylene Blue/

Phenyl Salicylate/

Sodium Biphosphate Delayed-Release Tablets

Generic Name: Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Biphosphate (hye-oh-SYE-a-meen/meth-EN-a-meen/METH-i-leen/FEN-ill sa-LI-si-late/SOE-dee-um bye-FOS-fate)
Brand Name: Urimax and Utira

Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Biphosphate Delayed-Release Tablets are used for:

Treating painful and irritating symptoms of the urinary tract due to urinary tract infections or diagnostic procedures.

Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Biphosphate Delayed-Release Tablets are a urinary antiseptic, urinary acidifier, analgesic, and anticholinergic combination. It works by helping to kill bacteria in the urine, decreasing pain and inflammation, and reducing muscle spasms in the urinary tract. These actions work together to help relieve discomfort while urinating.

Do NOT use Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Biphosphate Delayed-Release Tablets if:

• you are allergic to any ingredient in Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Biphosphate Delayed-Release Tablets
• you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to aspirin, other salicylate medicines, or a nonsteroidal anti-inflammatory drug (NSAID) (eg, ibuprofen, naproxen, celecoxib)
• you have angle-closure glaucoma, problems with your esophagus, bowel motility problems, a blockage of your bladder or bowel, severe intestinal problems (eg, ulcerative colitis), severe bleeding, flu or chickenpox, myasthenia gravis, severe kidney problems, or you are severely dehydrated
• you are taking a sulfonamide (eg, sulfamethoxazole)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Biphosphate Delayed-Release Tablets:

Some medical conditions may interact with Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Biphosphate Delayed-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have constipation, diarrhea, an infection of the stomach or bowel, a hiatal hernia, or stomach ulcers
• if you have nervous system problems, glucose-6-phosphate dehydrogenase (G-6-PD) deficiency, gout, influenza, Kawasaki syndrome, rheumatic disease, open-angle glaucoma, risk factors for angle-closure glaucoma, kidney or liver problems, an enlarged prostate, bladder problems, or you are unable to urinate
• if you have a history of stroke or brain blood vessel problems (eg, aneurysm), an irregular heartbeat, heart blood vessel problems, congestive heart failure, heart valve problems, or other heart problems
• if you are on a low-salt diet

Some MEDICINES MAY INTERACT with Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Biphosphate Delayed-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Anticholinergics (eg, benztropine) because they may increase the risk of Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Biphosphate Delayed-Release Tablets’s side effects.
• Ketoconazole because it may decrease Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Biphosphate Delayed-Release Tablets’s effectiveness.
• Monoamine oxidase inhibitors (MAOIs) or narcotic pain medicine (eg, codeine) because the risk of serious side effects may be increased
• Medicine for myasthenia gravis (eg, ambenonium), phenothiazines (eg, chlorpromazine), sulfonamides (eg, sulfamethoxazole), thiazide diuretics (eg, hydrochlorothiazide), or urinary alkalinizers (eg, sodium bicarbonate) because their effectiveness may be decreased by Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Biphosphate Delayed-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Biphosphate Delayed-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Biphosphate Delayed-Release Tablets:

Use Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Biphosphate Delayed-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Biphosphate Delayed-Release Tablets by mouth with or without food.
• Swallow Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Biphosphate Delayed-Release Tablets whole. Do not break, crush, or chew before swallowing.
• Do not take antacids or antidiarrheal medicines that has loperamide within 1 hour before or 2 hours after you take Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Biphosphate Delayed-Release Tablets.
• Drinking extra fluids while you are taking Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Biphosphate Delayed-Release Tablets are recommended. Check with your doctor for instructions.
• If you miss a dose of Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Biphosphate Delayed-Release Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Biphosphate Delayed-Release Tablets.

Important safety information:

• Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Biphosphate Delayed-Release Tablets may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Biphosphate Delayed-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do NOT take more than the recommended dose or use for more often than prescribed without checking with your doctor.
• Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Biphosphate Delayed-Release Tablets may discolor the urine or stools a blue-green color. This is normal and not a cause for concern.
• Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Biphosphate Delayed-Release Tablets contains salicylate. Salicylates have been linked to a serious illness called Reye syndrome. Do not give Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Biphosphate Delayed-Release Tablets to a child or teenager who has the flu, chickenpox, or a viral infection. Contact your doctor with any questions or concerns.
• Use Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Biphosphate Delayed-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially excitement, agitation, drowsiness, and confusion.
• Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Biphosphate Delayed-Release Tablets should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Biphosphate Delayed-Release Tablets while you are pregnant. Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Biphosphate Delayed-Release Tablets are found in breast milk. If you are or will be breast-feeding while you use Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Biphosphate Delayed-Release Tablets, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Biphosphate Delayed-Release Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dry mouth; flushing; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; difficulty urinating; dizziness; fast or irregular heartbeat.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.

Proper storage of Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Biphosphate Delayed-Release Tablets:

Store Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Biphosphate Delayed-Release Tablets between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Biphosphate Delayed-Release Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Biphosphate Delayed-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
• Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Biphosphate Delayed-Release Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Biphosphate Delayed-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Hyoscyamine/

Methenamine/

Methylene Blue/

Phenyl Salicylate/

Sodium Phosphate

Generic Name: Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Phosphate (hye-oh-SYE-a-meen/meth-EN-a-meen/METH-i-leen/FEN-ill sa-LI-si-late/SOE-dee-um FOS-fate)
Brand Name: Examples include Uta and Uretron D/S

Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Phosphate is used for:

Treating painful and irritating symptoms of the urinary tract due to urinary tract infections or diagnostic procedures.

Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Phosphate is a urinary antiseptic, urinary acidifier, analgesic, and anticholinergic combination. It works by helping to kill bacteria in the urine, decreasing pain and inflammation, and reducing muscle spasms in the urinary tract. These actions work together to help relieve discomfort while urinating.

Do NOT use Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Phosphate if:

• you are allergic to any ingredient in Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Phosphate
• you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to aspirin, other salicylate medicines, or a nonsteroidal anti-inflammatory drug (NSAID) (eg, ibuprofen, naproxen, celecoxib)
• you have angle-closure glaucoma, problems with your esophagus, bowel motility problems, a blockage of your bladder or bowel, severe intestinal problems (eg, ulcerative colitis), severe bleeding, flu or chickenpox, myasthenia gravis, severe kidney problems, or you are severely dehydrated
• you are taking a sulfonamide (eg, sulfamethoxazole)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Phosphate:

Some medical conditions may interact with Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Phosphate. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have constipation, diarrhea, an infection of the stomach or bowel, a hiatal hernia, or stomach ulcers
• if you have nervous system problems, glucose-6-phosphate dehydrogenase (G-6-PD) deficiency, gout, influenza, Kawasaki syndrome, rheumatic disease, open-angle glaucoma, risk factors for angle-closure glaucoma, kidney or liver problems, an enlarged prostate, bladder problems, or you are unable to urinate
• if you have a history of stroke or brain blood vessel problems (eg, aneurysm), an irregular heartbeat, heart blood vessel problems, congestive heart failure, heart valve problems, or other heart problems
• if you are on a low-salt diet

Some MEDICINES MAY INTERACT with Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Phosphate. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Anticholinergics (eg, benztropine) because they may increase the risk of Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Phosphate’s side effects
• Ketoconazole because it may decrease Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Phosphate’s effectiveness
• Monoamine oxidase inhibitors (MAOIs) or narcotic pain medicine (eg, codeine) because the risk of serious side effects may be increased
• Medicine for myasthenia gravis (eg, ambenonium), phenothiazines (eg, chlorpromazine), sulfonamides (eg, sulfamethoxazole), thiazide diuretics (eg, hydrochlorothiazide), or urinary alkalinizers (eg, sodium bicarbonate) because their effectiveness may be decreased by Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Phosphate

This may not be a complete list of all interactions that may occur. Ask your health care provider if Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Phosphate may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Phosphate:

Use Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Phosphate as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Phosphate by mouth with or without food.
• Do not take antacids or antidiarrheal medicines that has loperamide) within 1 hour before or 2 hours after you take Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Phosphate.
• Drinking extra fluids while you are taking Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Phosphate is recommended. Check with your doctor for instructions.
• If you miss a dose of Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Phosphate, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Phosphate.

Important safety information:

• Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Phosphate may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Phosphate with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do NOT take more than the recommended dose or use more often than prescribed without checking with your doctor.
• Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Phosphate may discolor the urine or stool a blue-green color. This is normal and not a cause for concern.
• Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Phosphate contains salicylate. Salicylates have been linked to a serious illness called Reye syndrome. Do not give Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Phosphate to a child or teenager who has the flu, chickenpox, or a viral infection. Contact your doctor with any questions or concerns.
• Use Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Phosphate with caution in the ELDERLY; they may be more sensitive to its effects, especially excitement, agitation, drowsiness, and confusion.
• Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Phosphate is not recommended for use in CHILDREN younger than 6 years old; safety and effectiveness in this age group have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Phosphate while you are pregnant. Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Phosphate is found in breast milk. If you are or will be breast-feeding while you use Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Phosphate, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Phosphate:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dry mouth; flushing; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; difficulty urinating; dizziness; fast or irregular heartbeat.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.

Proper storage of Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Phosphate:

Store Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Phosphate between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Phosphate out of the reach of children and away from pets.

General information:

• If you have any questions about Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Phosphate, please talk with your doctor, pharmacist, or other health care provider.
• Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Phosphate is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Hyoscyamine/Methenamine/Methylene Blue/Phenyl Salicylate/Sodium Phosphate. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Hyoscyamine/

Phenyltoloxamine

Generic Name: Hyoscyamine/Phenyltoloxamine (HYE-oh-SYE-a-meen/FEN-il-tole-OX-a-meen)
Brand Name: Digex NF

Hyoscyamine/Phenyltoloxamine is used for:

Relieving symptoms of indigestion (eg, feeling of fullness, gas, bloating). It is also used to treat certain stomach and intestinal conditions, including spasms and cramps. It may also be used for other conditions as determined by your doctor.

Hyoscyamine/Phenyltoloxamine is an anticholinergic and antihistamine combination. It works by decreasing the motion of muscles in the stomach, intestines, and bladder. It also decreases the production of stomach acid.

Do NOT use Hyoscyamine/Phenyltoloxamine if:

• you are allergic to any ingredient in Hyoscyamine/Phenyltoloxamine
• you have severe esophagus problems (eg, irritation, narrowing); a blockage of the stomach, bowel, or bladder; bowel motility problems; or severe bowel problems (eg, severe ulcerative colitis, toxic megacolon)
• you have glaucoma, myasthenia gravis, or heart problems caused by severe bleeding
• you are taking sodium oxybate (GHB)
• you are taking potassium chloride capsules or tablets

Contact your doctor or health care provider right away if any of these apply to you.

Before using Hyoscyamine/Phenyltoloxamine:

Some medical conditions may interact with Hyoscyamine/Phenyltoloxamine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have lung or breathing problems (eg, asthma), nerve problems, prostate problems, esophagus problems (eg, reflux), stomach or bowel problems, heart or blood vessel problems (eg, fast or irregular heartbeat, heart failure, coronary heart disease), hiatal hernia, kidney problems, an overactive thyroid, high blood pressure, urinary problems, paralysis, or brain damage, or if you are at risk for glaucoma
• if you have diarrhea or fever, have trouble urinating, have been very ill, or are in poor health

Some MEDICINES MAY INTERACT with Hyoscyamine/Phenyltoloxamine. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Potassium tablets or capsules because they may not be able to move through the stomach and bowel as well when taken with Hyoscyamine/Phenyltoloxamine; this may increase the risk of their side effects
• Narcotic pain medicines (eg, codeine) because the risk of their side effects may be increased by Hyoscyamine/Phenyltoloxamine
• Amantadine, antihistamines (eg, diphenhydramine), haloperidol, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), other anticholinergics (eg, scopolamine), phenothiazines (eg, thioridazine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Hyoscyamine/Phenyltoloxamine’s side effects
• Ketoconazole or metoclopramide because their effectiveness may be decreased by Hyoscyamine/Phenyltoloxamine

This may not be a complete list of all interactions that may occur. Ask your health care provider if Hyoscyamine/Phenyltoloxamine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Hyoscyamine/Phenyltoloxamine:

Use Hyoscyamine/Phenyltoloxamine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Hyoscyamine/Phenyltoloxamine by mouth with food as directed by your doctor.
• If you also take antacids, take Hyoscyamine/Phenyltoloxamine before meals and the antacid after meals, unless directed otherwise by your doctor.
• If you open the capsule, do not breathe in the powder. Some patients may experience an allergic reaction (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue) from breathing in the powder.
• If you miss a dose of Hyoscyamine/Phenyltoloxamine, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Hyoscyamine/Phenyltoloxamine.

Important safety information:

• Hyoscyamine/Phenyltoloxamine may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Hyoscyamine/Phenyltoloxamine with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Hyoscyamine/Phenyltoloxamine; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
• Do not become overheated or dehydrated in hot weather or while you are being active; heatstroke may occur.
• Drink plenty of fluids, maintain good oral hygiene, and suck on sugarless hard candy to relieve dry mouth.
• Proper dental care is important while you are taking Hyoscyamine/Phenyltoloxamine. Brush and floss your teeth and visit the dentist regularly.
• Hyoscyamine/Phenyltoloxamine may make your eyes more sensitive to sunlight. It may help to wear sunglasses.
• Tell your doctor or dentist that you take Hyoscyamine/Phenyltoloxamine before you receive any medical or dental care, emergency care, or surgery.
• Use Hyoscyamine/Phenyltoloxamine with caution in the ELDERLY; they may be more sensitive to its effects, especially constipation, trouble urinating, dry mouth, drowsiness, agitation, confusion, excitability, or memory problems.
• Caution is advised when using Hyoscyamine/Phenyltoloxamine in CHILDREN; they may be more sensitive to its effects, including excitability.
• PREGNANCY and BREAST-FEEDING: It is not known if Hyoscyamine/Phenyltoloxamine can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Hyoscyamine/Phenyltoloxamine while you are pregnant. Hyoscyamine/Phenyltoloxamine is found in breast milk. If you are or will be breast-feeding while taking Hyoscyamine/Phenyltoloxamine, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Hyoscyamine/Phenyltoloxamine:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Bloated feeling; blurred vision; constipation; decreased sweating; dizziness; drowsiness; dry mouth; enlarged pupils; excitability; headache; nausea; nervousness; trouble sleeping; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; behavior changes; confusion; decreased sexual ability; diarrhea; difficulty focusing eyes; disorientation; exaggerated sense of well-being; fast or irregular heartbeat; fever; hallucinations; loss of consciousness; loss of coordination; memory loss; mental or mood changes; severe or persistent trouble sleeping; speech changes; taste changes or loss; trouble urinating; unusual tiredness or weakness; vision changes; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include disorientation; excessive thirst or excitability; fever; hot, dry skin; seizures; severe dry mouth; severe or persistent blurred vision, dizziness, headache, nausea, or vomiting; trouble breathing or swallowing.

Proper storage of Hyoscyamine/Phenyltoloxamine:

Store Hyoscyamine/Phenyltoloxamine at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Hyoscyamine/Phenyltoloxamine out of the reach of children and away from pets.

General information:

• If you have any questions about Hyoscyamine/Phenyltoloxamine, please talk with your doctor, pharmacist, or other health care provider.
• Hyoscyamine/Phenyltoloxamine is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Hyoscyamine/Phenyltoloxamine. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Generic Name: Belladonna Alkaloids/Phenobarbital (bell-a-DON-a/fee-noe-BAR-bih-tal)
Brand Name: Examples include Donnatal and Hyosophen

Hyosophen is used for:

Treating irritable bowel syndrome and intestinal inflammation in combination with other medicines. It may also be used along with other medicines to treat intestinal ulcers. It may also be used for other conditions as determined by your doctor.

Hyosophen is an anticholinergic and barbiturate combination. It works by decreasing the motion of the muscles in the stomach and intestine and providing mild sedation.

Do NOT use Hyosophen if:

• you are allergic to any ingredient in Hyosophen
• you have previously experienced restlessness or excitement after taking phenobarbital
• you have glaucoma; severe irritation of the esophagus or other serious problems with the esophagus (eg, esophageal achalasia); a blockage of the stomach, bowel, or bladder; bowel motility problems; severe bowel inflammation (eg, ulcerative colitis); certain muscle problems (eg, myasthenia gravis); or heart problems with severe bleeding
• you have a history of the blood disorder porphyria
• you have a history of alcohol or substance abuse or dependence or may be at risk for an addiction
• you are taking methoxyflurane, sodium oxybate (GHB), or voriconazole

Contact your doctor or health care provider right away if any of these apply to you.

Before using Hyosophen:

Some medical conditions may interact with Hyosophen. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have nerve problems, prostate problems, heart or blood vessel problems (eg, fast or irregular heartbeat, heart failure, coronary heart disease), hiatal hernia, diarrhea, fever, risk factors for glaucoma, kidney or liver problems, gallbladder problems, lung or breathing problems, an overactive thyroid, high blood pressure, difficulty urinating, or ulcer
• if you have depression, pain, a history of suicidal thoughts or attempts, or are in shock
• if you have been very ill or severely weakened
• if you regularly consume alcohol

Some MEDICINES MAY INTERACT with Hyosophen. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Amantadine, antihistamines (eg, diphenhydramine), haloperidol, monoamine oxidase (MAO) inhibitors (eg, phenelzine), phenothiazines (eg, thioridazine), quinine, stiripentol, tricyclic antidepressants (eg, amitriptyline), valproic acid, or other anticholinergics (eg, scopolamine) because they may increase the risk of Hyosophen’s side effects
• Methoxyflurane orsodium oxybate (GHB) because the risk of their side effects may be increased by Hyosophen
• Anticoagulants (eg, warfarin), beta-blockers (eg, propranolol), clozapine, corticosteroids (eg, hydrocortisone), cyclosporine, doxorubicin, doxycycline, erlotinib, estrogens (eg, estradiol), imatinib, metronidazole, quinidine, steroidal contraceptives (eg, birth control pills), theophylline, or voriconazole because their effectiveness may be decreased by Hyosophen
• Halothane because Hyosophen may mask the symptoms of halothane toxicity.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Hyosophen may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Hyosophen:

Use Hyosophen as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Hyosophen by mouth with or without food.
• If you miss a dose of Hyosophen, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Hyosophen.

Important safety information:

• Hyosophen may cause dizziness, drowsiness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Hyosophen with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Hyosophen; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Do not become overheated in hot weather or while you are being active; heatstroke may occur.
• Drink plenty of fluids, maintain good oral hygiene, and suck on sugarless hard candy to relieve dry mouth.
• Hyosophen may make your eyes more sensitive to sunlight. It may help to wear sunglasses.
• Use Hyosophen with caution in the ELDERLY; they may be more sensitive to its effects, especially excitement, agitation, or drowsiness.
• Hyosophen should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
• Hormonal birth control (eg, birth control pills) may not work as well while you are using Hyosophen. To prevent pregnancy, use an extra form of birth control (eg, condoms).
• PREGNANCY and BREAST-FEEDING: Hyosophen has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Hyosophen while you are pregnant. Hyosophen is found in breast milk. If you are or will be breast-feeding while you use Hyosophen, check with your doctor. Discuss any possible risks to your baby.

When used for long periods of time or at high doses, Hyosophen may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Hyosophen stops working well. Do not take more than prescribed.

Some people who use Hyosophen for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you stop taking Hyosophen suddenly, you may have WITHDRAWAL symptoms. These may include anxiety, nausea, sleeplessness, body aches, seizures, and delirium.

Possible side effects of Hyosophen:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Bloated feeling; blurred vision; clumsiness; constipation; decreased sweating; dizziness; drowsiness; dry mouth; excessive daytime drowsiness (“hangover effect”); feeling of a whirling motion; headache; lightheadedness; nausea; nervousness; tired feeling; trouble sleeping.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; confusion; diarrhea; difficulty focusing eyes; disorientation; exaggerated feeling of well-being; excitement; fainting; fast or irregular heartbeat; hallucinations; loss of coordination; loss of taste; memory loss; muscle pain; pounding in the chest; severe or persistent trouble sleeping; trouble urinating; unusual weakness; very slow breathing; vision changes; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include change in size of pupil; deep sleep; hot, dry skin; loss of consciousness; severe dry mouth; severe or persistent headache or nausea; slowed or fast breathing; trouble swallowing; vomiting.

Proper storage of Hyosophen:

Store Hyosophen at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Hyosophen out of the reach of children and away from pets.

General information:

• If you have any questions about Hyosophen, please talk with your doctor, pharmacist, or other health care provider.
• Hyosophen is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Hyosophen. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Generic Name: hyoscyamine (hye oh SYE a meen)
Brand Names: Anaspaz, Cystospaz, Hyospaz, Hyosyne, Levbid, Levsin, Levsin SL, Levsinex SR, Symax Duotab, Symax SL, Symax SR

What is Hyospaz (hyoscyamine)?

Hyoscyamine produces many effects in the body, including relief from muscle spasms.

Hyoscyamine also reduces the fluid secretions of many organs and glands in the body, such as the stomach, pancreas, lungs, saliva glands, sweat glands, and nasal passages.

Hyoscyamine is used to treat many different stomach and intestinal disorders, including peptic ulcer and irritable bowel syndrome. It is also used to control muscle spasms in the bladder, kidneys, or digestive tract, and to reduce stomach acid. Hyoscyamine is sometimes used to reduce tremors and rigid muscles in people with symptoms of Parkinson’s disease.

Hyoscyamine is also used as a drying agent to control excessive salivation, runny nose, or excessive sweating.

Hyoscyamine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Hyospaz (hyoscyamine)?

Do not take hyoscyamine if you are allergic to it, or if you have kidney disease, a bladder or intestinal obstruction, severe ulcerative colitis, toxic megacolon, glaucoma, or myasthenia gravis.

Before taking hyoscyamine, tell your doctor if you have heart disease, congestive heart failure, a heart rhythm disorder, high blood pressure, overactive thyroid, or hiatal hernia with gastroesophageal reflux disease.

Avoid taking antacids at the same time you take hyoscyamine. Antacids can make it harder for your body to absorb hyoscyamine. If you use an antacid, take it after you have taken hyoscyamine and eaten a meal.

Hyoscyamine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase drowsiness and dizziness while you are taking hyoscyamine.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Hyoscyamine can decrease sweating and you may be more prone to heat stroke.

What should I discuss with my healthcare provider before taking Hyospaz (hyoscyamine)?

Do not take hyoscyamine if you are allergic to it, or if you have:

• kidney disease;

• an enlarged prostate or problems with urination;

• intestinal blockage;

• severe ulcerative colitis, or toxic megacolon;

• glaucoma; or

• myasthenia gravis.

If you have any of these other conditions, you may need a hyoscyamine dose adjustment or special tests:

• heart disease, congestive heart failure;

• a heart rhythm disorder;

• high blood pressure;

• overactive thyroid; or

• hiatal hernia with GERD (gastroesophageal reflux disease).

FDA pregnancy category C. It is not known whether hyoscyamine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Hyoscyamine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Hyospaz (hyoscyamine)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your medication may come with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Do not crush, chew, or open an extended-release tablet or capsule. It is specially made to release medicine slowly in the body. Breaking or crushing the pill would cause too much of the drug to be released at one time. Your doctor may want you to break an extended-release tablet and take only half of it. Follow your doctor’s instructions.

Measure the oral liquid form of hyoscyamine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

The sublingual tablet form of this medication must be placed under the tongue, where it will dissolve. Do not swallow the sublingual tablet whole or wash it down with water. You may drink water after the pill has completely dissolved in your mouth.

Before using hyoscyamine oral spray for the first time, you must prime the spray pump. To do this, spray 3 test sprays into the air and away from your face. Prime the spray pump at least 1 test spray any time you have not used the oral spray for longer than 2 days. Spray until a fine mist appears.

After using the oral spray, try not to swallow right away. Do not rinse your mouth or spit for 5 to 10 minutes after using the oral spray.

Hyoscyamine is usually taken before a meal. Follow your doctor’s instructions.

Store this medication at room temperature away from moisture and heat.

Do not use hyoscyamine oral spray for more than 30 sprays, even if there is medicine still left in the bottle.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include headache, dizziness, dry mouth, trouble swallowing, nausea, vomiting, blurred vision, hot dry skin, and feeling restless or nervous.

What should I avoid while taking Hyospaz (hyoscyamine)?

Avoid taking antacids at the same time you take hyoscyamine. Antacids can make it harder for your body to absorb hyoscyamine. If you use an antacid, take it after you have taken hyoscyamine and eaten a meal.

Hyoscyamine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase drowsiness and dizziness while you are taking hyoscyamine.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Hyoscyamine can decrease sweating and you may be more prone to heat stroke.

Hyospaz (hyoscyamine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using hyoscyamine and call your doctor at once if you have any of these serious side effects:

• diarrhea;

• confusion, hallucinations;

• unusual thoughts or behavior;

• fast, pounding, or uneven heart rate;

• rash or flushing (warmth, redness, or tingly feeling); or

• eye pain.

Less serious side effects may include:

• dizziness, drowsiness, feeling nervous;

• blurred vision, headache;

• sleep problems (insomnia);

• nausea, vomiting, bloating, heartburn, or constipation;

• changes in taste;

• problems with urination;

• decreased sweating;

• dry mouth; or

• impotence, loss of interest in sex, or trouble having an orgasm.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Hyospaz (hyoscyamine)?

Tell your doctor about all other medicines you use, especially:

• amantadine (Symmetrel);

• haloperidol (Haldol);

• an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate);

• phenothiazines such as chlorpromazine (Thorazine), fluphenazine (Permitil, Prolixin), perphenazine (Trilafon), prochlorperazine (Compazine, Compro), promethazine (Pentazine, Phenergan, Anergan, Antinaus), thioridazine (Mellaril), or trifluoperazine (Stelazine); or

• an antidepressant such as amitriptyline (Elavil, Vanatrip), doxepin (Sinequan), desipramine (Norpramin), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others.

This list is not complete and other drugs may interact with hyoscyamine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about hyoscyamine.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 3.01. Revision Date: 04/05/2010 8:25:00 AM.

Generic Name: hyoscyamine (hye oh SYE a meen)
Brand Names: Anaspaz, Cystospaz, Hyospaz, Hyosyne, Levbid, Levsin, Levsin SL, Levsinex SR, Symax Duotab, Symax SL, Symax SR

What is Hyosyne (hyoscyamine)?

Hyoscyamine produces many effects in the body, including relief from muscle spasms.

Hyoscyamine also reduces the fluid secretions of many organs and glands in the body, such as the stomach, pancreas, lungs, saliva glands, sweat glands, and nasal passages.

Hyoscyamine is used to treat many different stomach and intestinal disorders, including peptic ulcer and irritable bowel syndrome. It is also used to control muscle spasms in the bladder, kidneys, or digestive tract, and to reduce stomach acid. Hyoscyamine is sometimes used to reduce tremors and rigid muscles in people with symptoms of Parkinson’s disease.

Hyoscyamine is also used as a drying agent to control excessive salivation, runny nose, or excessive sweating.

Hyoscyamine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Hyosyne (hyoscyamine)?

Do not take hyoscyamine if you are allergic to it, or if you have kidney disease, a bladder or intestinal obstruction, severe ulcerative colitis, toxic megacolon, glaucoma, or myasthenia gravis.

Before taking hyoscyamine, tell your doctor if you have heart disease, congestive heart failure, a heart rhythm disorder, high blood pressure, overactive thyroid, or hiatal hernia with gastroesophageal reflux disease.

Avoid taking antacids at the same time you take hyoscyamine. Antacids can make it harder for your body to absorb hyoscyamine. If you use an antacid, take it after you have taken hyoscyamine and eaten a meal.

Hyoscyamine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase drowsiness and dizziness while you are taking hyoscyamine.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Hyoscyamine can decrease sweating and you may be more prone to heat stroke.

What should I discuss with my healthcare provider before taking Hyosyne (hyoscyamine)?

Do not take hyoscyamine if you are allergic to it, or if you have:

• kidney disease;

• an enlarged prostate or problems with urination;

• intestinal blockage;

• severe ulcerative colitis, or toxic megacolon;

• glaucoma; or

• myasthenia gravis.

If you have any of these other conditions, you may need a hyoscyamine dose adjustment or special tests:

• heart disease, congestive heart failure;

• a heart rhythm disorder;

• high blood pressure;

• overactive thyroid; or

• hiatal hernia with GERD (gastroesophageal reflux disease).

FDA pregnancy category C. It is not known whether hyoscyamine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Hyoscyamine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Hyosyne (hyoscyamine)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your medication may come with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Do not crush, chew, or open an extended-release tablet or capsule. It is specially made to release medicine slowly in the body. Breaking or crushing the pill would cause too much of the drug to be released at one time. Your doctor may want you to break an extended-release tablet and take only half of it. Follow your doctor’s instructions.

Measure the oral liquid form of hyoscyamine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

The sublingual tablet form of this medication must be placed under the tongue, where it will dissolve. Do not swallow the sublingual tablet whole or wash it down with water. You may drink water after the pill has completely dissolved in your mouth.

Before using hyoscyamine oral spray for the first time, you must prime the spray pump. To do this, spray 3 test sprays into the air and away from your face. Prime the spray pump at least 1 test spray any time you have not used the oral spray for longer than 2 days. Spray until a fine mist appears.

After using the oral spray, try not to swallow right away. Do not rinse your mouth or spit for 5 to 10 minutes after using the oral spray.

Hyoscyamine is usually taken before a meal. Follow your doctor’s instructions.

Store this medication at room temperature away from moisture and heat.

Do not use hyoscyamine oral spray for more than 30 sprays, even if there is medicine still left in the bottle.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include headache, dizziness, dry mouth, trouble swallowing, nausea, vomiting, blurred vision, hot dry skin, and feeling restless or nervous.

What should I avoid while taking Hyosyne (hyoscyamine)?

Avoid taking antacids at the same time you take hyoscyamine. Antacids can make it harder for your body to absorb hyoscyamine. If you use an antacid, take it after you have taken hyoscyamine and eaten a meal.

Hyoscyamine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase drowsiness and dizziness while you are taking hyoscyamine.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Hyoscyamine can decrease sweating and you may be more prone to heat stroke.

Hyosyne (hyoscyamine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using hyoscyamine and call your doctor at once if you have any of these serious side effects:

• diarrhea;

• confusion, hallucinations;

• unusual thoughts or behavior;

• fast, pounding, or uneven heart rate;

• rash or flushing (warmth, redness, or tingly feeling); or

• eye pain.

Less serious side effects may include:

• dizziness, drowsiness, feeling nervous;

• blurred vision, headache;

• sleep problems (insomnia);

• nausea, vomiting, bloating, heartburn, or constipation;

• changes in taste;

• problems with urination;

• decreased sweating;

• dry mouth; or

• impotence, loss of interest in sex, or trouble having an orgasm.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Hyosyne (hyoscyamine)?

Tell your doctor about all other medicines you use, especially:

• amantadine (Symmetrel);

• haloperidol (Haldol);

• an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate);

• phenothiazines such as chlorpromazine (Thorazine), fluphenazine (Permitil, Prolixin), perphenazine (Trilafon), prochlorperazine (Compazine, Compro), promethazine (Pentazine, Phenergan, Anergan, Antinaus), thioridazine (Mellaril), or trifluoperazine (Stelazine); or

• an antidepressant such as amitriptyline (Elavil, Vanatrip), doxepin (Sinequan), desipramine (Norpramin), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others.

This list is not complete and other drugs may interact with hyoscyamine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about hyoscyamine.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 3.01. Revision Date: 04/05/2010 8:25:00 AM.

Generic Name: Hyoscyamine (HYE-oh-SYE-a-meen)
Brand Name: Examples include NuLev and Symax FasTabs

Hyoscyamine Orally Disintegrating Tablets are used for:

Treating certain stomach, intestinal, and bladder conditions, including spasms. It is also used to control stomach secretions and cramps. It is also used to relieve the symptoms of colic, runny nose, and Parkinson-like problems. It is also used to treat excessive sweating or saliva production. It may also be used for other conditions as determined by your doctor.

Hyoscyamine Orally Disintegrating Tablets are an anticholinergic agent. It works by decreasing the motion of muscles in the stomach, intestines, and bladder. It also decreases the production of stomach acid.

Do NOT use Hyoscyamine Orally Disintegrating Tablets if:

• you are allergic to any ingredient in Hyoscyamine Orally Disintegrating Tablets
• you have severe esophagus problems (eg, irritation, narrowing); a blockage of the stomach, bowel, or bladder; bowel motility problems; or severe bowel problems (eg, severe ulcerative colitis, toxic megacolon)
• you have glaucoma, myasthenia gravis, or certain severe heart problems (eg, decreased blood flow to the heart)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Hyoscyamine Orally Disintegrating Tablets:

Some medical conditions may interact with Hyoscyamine Orally Disintegrating Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have nerve problems, prostate problems, esophagus problems (eg, reflux), stomach or bowel problems, heart or blood vessel problems (eg, fast or irregular heartbeat, heart failure, coronary heart disease), hiatal hernia, kidney problems, an overactive thyroid, high blood pressure, urinary problems, paralysis, or brain damage, or you are at risk for glaucoma
• if you have diarrhea or fever, have been very ill, or are in poor health
• if you have phenylketonuria

Some MEDICINES MAY INTERACT with Hyoscyamine Orally Disintegrating Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Amantadine, other anticholinergics (eg, scopolamine), antihistamines (eg, diphenhydramine), haloperidol, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), phenothiazines (eg, thioridazine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Hyoscyamine Orally Disintegrating Tablets’s side effects
• Narcotic pain medicines (eg, codeine) or potassium chloride because the risk of their side effects may be increased by Hyoscyamine Orally Disintegrating Tablets
• Ketoconazole or metoclopramide because their effectiveness may be decreased by Hyoscyamine Orally Disintegrating Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Hyoscyamine Orally Disintegrating Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Hyoscyamine Orally Disintegrating Tablets:

Use Hyoscyamine Orally Disintegrating Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Hyoscyamine Orally Disintegrating Tablets are usually taken 30 to 60 minutes before a meal. Follow your doctor’s specific instructions for taking Hyoscyamine Orally Disintegrating Tablets.
• Place the tablet on the tongue and allow it to dissolve and then swallow. Some brands of Hyoscyamine Orally Disintegrating Tablets may also be chewed. Ask your pharmacist if your brand may be chewed.
• Hyoscyamine Orally Disintegrating Tablets may be taken with or without water.
• If you also take antacids, take Hyoscyamine Orally Disintegrating Tablets before meals and the antacid after meals, unless directed otherwise by your doctor.
• If you miss a dose of Hyoscyamine Orally Disintegrating Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Hyoscyamine Orally Disintegrating Tablets.

Important safety information:

• Hyoscyamine Orally Disintegrating Tablets may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Hyoscyamine Orally Disintegrating Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Hyoscyamine Orally Disintegrating Tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
• Do not become overheated or dehydrated in hot weather or while you are being active; heatstroke may occur.
• Drink plenty of fluids, maintain good oral hygiene, and suck on sugarless hard candy to relieve dry mouth.
• Proper dental care is important while you are taking Hyoscyamine Orally Disintegrating Tablets. Brush and floss your teeth and visit the dentist regularly.
• Hyoscyamine Orally Disintegrating Tablets may make your eyes more sensitive to sunlight. It may help to wear sunglasses.
• Some of these products contain phenylalanine. If you must have a diet that is low in phenylalanine, ask your pharmacist if it is in your product.
• Tell your doctor or dentist that you take Hyoscyamine Orally Disintegrating Tablets before you receive any medical or dental care, emergency care, or surgery.
• Use Hyoscyamine Orally Disintegrating Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially constipation, trouble urinating, dry mouth, drowsiness, agitation, confusion, excitability, or memory problems.
• Caution is advised when using Hyoscyamine Orally Disintegrating Tablets in CHILDREN; they may be more sensitive to its effects, including excitability.
• Some of these products should not be used in CHILDREN younger than 6 years old. Ask your pharmacist if your brand may be used in children younger than 6 years old. Check with your doctor if you have questions about giving Hyoscyamine Orally Disintegrating Tablets to your child.
• Hyoscyamine Orally Disintegrating Tablets should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: It is not known if Hyoscyamine Orally Disintegrating Tablets can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Hyoscyamine Orally Disintegrating Tablets while you are pregnant. Hyoscyamine Orally Disintegrating Tablets are found in breast milk. If you are or will be breast-feeding while taking Hyoscyamine Orally Disintegrating Tablets, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Hyoscyamine Orally Disintegrating Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Bloated feeling; blurred vision; constipation; decreased sweating; dizziness; drowsiness; dry mouth; enlarged pupils; excitability; headache; nausea; nervousness; trouble sleeping; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; behavior changes; confusion; decreased sexual ability; diarrhea; difficulty focusing eyes; disorientation; exaggerated sense of well-being; fast or irregular heartbeat; hallucinations; loss of consciousness; loss of coordination; memory loss; mental or mood changes; severe or persistent trouble sleeping; speech changes; taste changes or loss; trouble urinating; unusual tiredness or weakness; vision changes; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include disorientation; excessive thirst or excitability; fever; hot, dry skin; seizures; severe dry mouth; severe or persistent blurred vision, dizziness, headache, nausea, or vomiting; trouble breathing or swallowing.

Proper storage of Hyoscyamine Orally Disintegrating Tablets:

Store Hyoscyamine Orally Disintegrating Tablets at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Hyoscyamine Orally Disintegrating Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Hyoscyamine Orally Disintegrating Tablets, please talk with your doctor, pharmacist, or other health care provider.
• Hyoscyamine Orally Disintegrating Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Hyoscyamine Orally Disintegrating Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Generic Name: Hyoscyamine (HYE-oh-SYE-a-meen)
Brand Name: IB-Stat

Hyoscyamine Spray is used for:

Treating certain stomach, intestinal, and bladder conditions, including spasms. It is used to control stomach secretions and cramps. It is used to relieve the symptoms of colic, runny nose, and Parkinson-like problems. It is used to treat excessive sweating or saliva production. It may also be used for other conditions as determined by your doctor.

Hyoscyamine Spray is an anticholinergic agent. It works by decreasing the motion of muscles in the stomach, intestines, and bladder. It also decreases the production of stomach acid.

Do NOT use Hyoscyamine Spray if:

• you are allergic to any ingredient in Hyoscyamine Spray
• you have severe esophagus problems (eg, irritation, narrowing); a blockage of the stomach, bowel, or bladder; bowel motility problems; or severe bowel problems (eg, severe ulcerative colitis, toxic megacolon)
• you have glaucoma, myasthenia gravis, or heart problems caused by severe bleeding

Contact your doctor or health care provider right away if any of these apply to you.

Before using Hyoscyamine Spray:

Some medical conditions may interact with Hyoscyamine Spray. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have nerve problems, prostate problems, esophagus problems (eg, reflux), stomach or bowel problems, heart or blood vessel problems (eg, fast or irregular heartbeat, heart failure, coronary heart disease), hiatal hernia, kidney problems, an overactive thyroid, high blood pressure, urinary problems, paralysis, or brain damage, or if you are at risk for glaucoma
• if you have diarrhea or fever, have been very ill, or are in poor health

Some MEDICINES MAY INTERACT with Hyoscyamine Spray. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Amantadine, antihistamines (eg, diphenhydramine), haloperidol, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), other anticholinergics (eg, scopolamine), phenothiazines (eg, thioridazine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Hyoscyamine Spray’s side effects
• Narcotic pain medicines (eg, codeine) or potassium chloride because the risk of their side effects may be increased by Hyoscyamine Spray
• Ketoconazole or metoclopramide because their effectiveness may be decreased by Hyoscyamine Spray

This may not be a complete list of all interactions that may occur. Ask your health care provider if Hyoscyamine Spray may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Hyoscyamine Spray:

Use Hyoscyamine Spray as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Hyoscyamine Spray. Talk to your pharmacist if you have questions about this information.
• Hyoscyamine Spray is usually taken 30 to 60 minutes before a meal. Follow your doctor’s instructions for taking Hyoscyamine Spray.
• The spray pump must be primed before you use the first dose of Hyoscyamine Spray. Remove the plastic cover and point the opening away from yourself and others. Press down firmly and quickly until a fine mist appears (at least 3 sprays).
• To use Hyoscyamine Spray, hold the container upright. Open your mouth and bring the container as close as possible. Press down firmly and close your mouth. If necessary, repeat as directed by your doctor.
• Do not swallow immediately after you use the spray. Do not spit or rinse your mouth for 5 to 10 minutes after you use Hyoscyamine Spray.
• If you have not used the spray pump for 2 days or more, reprime before using it. Point the opening away from yourself and others and spray 1 time to reprime.
• Wipe the spray tip with a clean tissue and replace the cover.
• Do not use this bottle for more than 30 sprays even if it looks like it still contains medicine. The pump may not deliver the correct amount of medicine after 30 sprays.
• Do not take extra doses or stop using Hyoscyamine Spray without first checking with your doctor.
• If you also take antacids, take Hyoscyamine Spray before meals and the antacid after meals, unless directed otherwise by your doctor.
• If you miss a dose of Hyoscyamine Spray, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Hyoscyamine Spray.

Important safety information:

• Hyoscyamine Spray may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Hyoscyamine Spray with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Hyoscyamine Spray; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
• Do not become overheated or dehydrated in hot weather or while you are being active; heatstroke may occur.
• Drink plenty of fluids, maintain good oral hygiene, and suck on sugarless hard candy to relieve dry mouth.
• Proper dental care is important while you are taking Hyoscyamine Spray. Brush and floss your teeth and visit the dentist regularly.
• Hyoscyamine Spray may make your eyes more sensitive to sunlight. It may help to wear sunglasses.
• Tell your doctor or dentist that you take Hyoscyamine Spray before you receive any medical or dental care, emergency care, or surgery.
• Use Hyoscyamine Spray with caution in the ELDERLY; they may be more sensitive to its effects, especially constipation, trouble urinating, dry mouth, drowsiness, agitation, confusion, excitability, or memory problems.
• Caution is advised when using Hyoscyamine Spray in CHILDREN; they may be more sensitive to its effects, including excitability.
• Hyoscyamine Spray should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: It is not known if Hyoscyamine Spray can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Hyoscyamine Spray while you are pregnant. Hyoscyamine Spray is found in breast milk. If you are or will be breast-feeding while taking Hyoscyamine Spray, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Hyoscyamine Spray:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Bloated feeling; blurred vision; constipation; decreased sweating; dizziness; drowsiness; dry mouth; enlarged pupils; excitability; headache; nausea; nervousness; trouble sleeping; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; behavior changes; confusion; decreased sexual ability; diarrhea; difficulty focusing eyes; disorientation; exaggerated sense of well-being; fast or irregular heartbeat; hallucinations; loss of consciousness; loss of coordination; memory loss; mental or mood changes; severe or persistent trouble sleeping; speech changes; taste changes or loss; trouble urinating; unusual tiredness or weakness; vision changes; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include disorientation; excessive thirst or excitability; fever; hot, dry skin; seizures; severe dry mouth; severe or persistent blurred vision, dizziness, headache, nausea, or vomiting; trouble breathing or swallowing.

Proper storage of Hyoscyamine Spray:

Store Hyoscyamine Spray at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Hyoscyamine Spray out of the reach of children and away from pets.

General information:

• If you have any questions about Hyoscyamine Spray, please talk with your doctor, pharmacist, or other health care provider.
• Hyoscyamine Spray is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Hyoscyamine Spray. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Generic Name: Hyoscyamine (HYE-oh-SYE-a-meen)
Brand Name: Examples include Levbid and Symax SR

Hyoscyamine Extended-Release Tablets are used for:

Treating certain stomach, intestinal, and bladder conditions, including spasms. It is used to control stomach secretions and cramps. It is used to relieve the symptoms of colic, runny nose, and Parkinson-like problems. It is used to treat excessive sweating or saliva production. It may also be used for other conditions as determined by your doctor.

Hyoscyamine Extended-Release Tablets are an anticholinergic agent. It works by decreasing the motion of muscles in the stomach, intestines, and bladder. It also decreases the production of stomach acid.

Do NOT use Hyoscyamine Extended-Release Tablets if:

• you are allergic to any ingredient in Hyoscyamine Extended-Release Tablets
• you have severe esophagus problems (eg, irritation, narrowing); a blockage of the stomach, bowel, or bladder; bowel motility problems; or severe bowel problems (eg, severe ulcerative colitis, toxic megacolon)
• you have glaucoma, myasthenia gravis, or heart problems caused by severe bleeding

Contact your doctor or health care provider right away if any of these apply to you.

Before using Hyoscyamine Extended-Release Tablets:

Some medical conditions may interact with Hyoscyamine Extended-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have nerve problems, prostate problems, esophagus problems (eg, reflux), stomach or bowel problems, heart or blood vessel problems (eg, fast or irregular heartbeat, heart failure, coronary heart disease), hiatal hernia, kidney problems, an overactive thyroid, high blood pressure, urinary problems, paralysis, or brain damage, or if you are at risk for glaucoma
• if you have diarrhea or fever, have been very ill, or are in poor health

Some MEDICINES MAY INTERACT with Hyoscyamine Extended-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Amantadine, antihistamines (eg, diphenhydramine), haloperidol, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), other anticholinergics (eg, scopolamine), phenothiazines (eg, thioridazine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Hyoscyamine Extended-Release Tablets’s side effects
• Narcotic pain medicines (eg, codeine) or potassium chloride because the risk of their side effects may be increased by Hyoscyamine Extended-Release Tablets
• Ketoconazole or metoclopramide because their effectiveness may be decreased by Hyoscyamine Extended-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Hyoscyamine Extended-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Hyoscyamine Extended-Release Tablets:

Use Hyoscyamine Extended-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Hyoscyamine Extended-Release Tablets are usually taken 30 to 60 minutes before a meal. Follow your doctor’s instructions for taking Hyoscyamine Extended-Release Tablets.
• Swallow Hyoscyamine Extended-Release Tablets whole. Do not break, crush, or chew before swallowing. Some brands of Hyoscyamine Extended-Release Tablets may be broken in half before taking. If you have trouble swallowing the whole tablet, ask your pharmacist if your brand of medicine may be broken in half.
• If you also take antacids, ask your doctor or pharmacist how to take them with Hyoscyamine Extended-Release Tablets.
• If you miss a dose of Hyoscyamine Extended-Release Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Hyoscyamine Extended-Release Tablets.

Important safety information:

• Hyoscyamine Extended-Release Tablets may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Hyoscyamine Extended-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Hyoscyamine Extended-Release Tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
• Do not become overheated or dehydrated in hot weather or while you are being active; heatstroke may occur.
• Drink plenty of fluids, maintain good oral hygiene, and suck on sugarless hard candy to relieve dry mouth.
• Proper dental care is important while you are taking Hyoscyamine Extended-Release Tablets. Brush and floss your teeth and visit the dentist regularly.
• Hyoscyamine Extended-Release Tablets may make your eyes more sensitive to sunlight. It may help to wear sunglasses.
• Tell your doctor or dentist that you take Hyoscyamine Extended-Release Tablets before you receive any medical or dental care, emergency care, or surgery.
• Use Hyoscyamine Extended-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially constipation, trouble urinating, dry mouth, drowsiness, agitation, confusion, excitability, or memory problems.
• Caution is advised when using Hyoscyamine Extended-Release Tablets in CHILDREN; they may be more sensitive to its effects, including excitability.
• Hyoscyamine Extended-Release Tablets should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: It is not known if Hyoscyamine Extended-Release Tablets can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Hyoscyamine Extended-Release Tablets while you are pregnant. Hyoscyamine Extended-Release Tablets are found in breast milk. If you are or will be breast-feeding while taking Hyoscyamine Extended-Release Tablets, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Hyoscyamine Extended-Release Tablets:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Bloated feeling; blurred vision; constipation; decreased sweating; dizziness; drowsiness; dry mouth; enlarged pupils; excitability; headache; nausea; nervousness; trouble sleeping; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; behavior changes; confusion; decreased sexual ability; diarrhea; difficulty focusing eyes; disorientation; exaggerated sense of well-being; fast or irregular heartbeat; hallucinations; loss of consciousness; loss of coordination; memory loss; mental or mood changes; severe or persistent trouble sleeping; speech changes; taste changes or loss; trouble urinating; unusual tiredness or weakness; vision changes; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include disorientation; excessive thirst or excitability; fever; hot, dry skin; seizures; severe dry mouth; severe or persistent blurred vision, dizziness, headache, nausea, or vomiting; trouble breathing or swallowing.

Proper storage of Hyoscyamine Extended-Release Tablets:

Store Hyoscyamine Extended-Release Tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Hyoscyamine Extended-Release Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Hyoscyamine Extended-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
• Hyoscyamine Extended-Release Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Hyoscyamine Extended-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Generic Name: Hyoscyamine (HYE-oh-SYE-a-meen)
Brand Name: Examples include Hyosyne and Colidrops

Hyoscyamine Drops are used for:

Treating certain stomach, intestinal, and bladder conditions, including spasms. It is used to control stomach secretions and cramps. It is used to relieve the symptoms of colic, runny nose, and Parkinson-like problems. It is used to treat excessive sweating or saliva production. It may also be used for other conditions as determined by your doctor.

Hyoscyamine Drops are an anticholinergic agent. It works by decreasing the motion of muscles in the stomach, intestines, and bladder. It also decreases the production of stomach acid.

Do NOT use Hyoscyamine Drops if:

• you are allergic to any ingredient in Hyoscyamine Drops
• you have severe esophagus problems (eg, irritation, narrowing); a blockage of the stomach, bowel, or bladder; bowel motility problems; or severe bowel problems (eg, severe ulcerative colitis, toxic megacolon)
• you have glaucoma, myasthenia gravis, or heart problems caused by severe bleeding

Contact your doctor or health care provider right away if any of these apply to you.

Before using Hyoscyamine Drops:

Some medical conditions may interact with Hyoscyamine Drops. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have nerve problems, prostate problems, esophagus problems (eg, reflux), stomach or bowel problems, heart or blood vessel problems (eg, fast or irregular heartbeat, heart failure, coronary heart disease), hiatal hernia, kidney problems, an overactive thyroid, high blood pressure, urinary problems, paralysis, or brain damage, or if you are at risk for glaucoma
• if you have diarrhea or fever, have been very ill, or are in poor health

Some MEDICINES MAY INTERACT with Hyoscyamine Drops. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Amantadine, antihistamines (eg, diphenhydramine), haloperidol, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), other anticholinergics (eg, scopolamine), phenothiazines (eg, thioridazine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Hyoscyamine Drops’s side effects
• Narcotic pain medicines (eg, codeine) or potassium chloride because the risk of their side effects may be increased by Hyoscyamine Drops
• Ketoconazole or metoclopramide because their effectiveness may be decreased by Hyoscyamine Drops

This may not be a complete list of all interactions that may occur. Ask your health care provider if Hyoscyamine Drops may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Hyoscyamine Drops:

Use Hyoscyamine Drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Hyoscyamine Drops are usually taken 30 to 60 minutes before a meal. Follow your doctor’s instructions for taking Hyoscyamine Drops.
• Use the dropper that comes with Hyoscyamine Drops to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.
• If you also take antacids, take Hyoscyamine Drops before meals and the antacid after meals, unless directed otherwise by your doctor.
• If you miss a dose of Hyoscyamine Drops, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Hyoscyamine Drops.

Important safety information:

• Hyoscyamine Drops may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Hyoscyamine Drops with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Hyoscyamine Drops; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
• Do not become overheated or dehydrated in hot weather or while you are being active; heatstroke may occur.
• Drink plenty of fluids, maintain good oral hygiene, and suck on sugarless hard candy to relieve dry mouth.
• Proper dental care is important while you are taking Hyoscyamine Drops. Brush and floss your teeth and visit the dentist regularly.
• Hyoscyamine Drops may make your eyes more sensitive to sunlight. It may help to wear sunglasses.
• Tell your doctor or dentist that you take Hyoscyamine Drops before you receive any medical or dental care, emergency care, or surgery.
• Use Hyoscyamine Drops with caution in the ELDERLY; they may be more sensitive to its effects, especially constipation, trouble urinating, dry mouth, drowsiness, agitation, confusion, excitability, or memory problems.
• Caution is advised when using Hyoscyamine Drops in CHILDREN; they may be more sensitive to its effects, including excitability.
• Hyoscyamine Drops should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.
• Hyoscyamine Drops should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: It is not known if Hyoscyamine Drops can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Hyoscyamine Drops while you are pregnant. Hyoscyamine Drops are found in breast milk. If you are or will be breast-feeding while taking Hyoscyamine Drops, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Hyoscyamine Drops:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Bloated feeling; blurred vision; constipation; decreased sweating; dizziness; drowsiness; dry mouth; enlarged pupils; excitability; headache; nausea; nervousness; trouble sleeping; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; behavior changes; confusion; decreased sexual ability; diarrhea; difficulty focusing eyes; disorientation; exaggerated sense of well-being; fast or irregular heartbeat; hallucinations; loss of consciousness; loss of coordination; memory loss; mental or mood changes; severe or persistent trouble sleeping; speech changes; taste changes or loss; trouble urinating; unusual tiredness or weakness; vision changes; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include disorientation; excessive thirst or excitability; fever; hot, dry skin; seizures; severe dry mouth; severe or persistent blurred vision, dizziness, headache, nausea, or vomiting; trouble breathing or swallowing.

Proper storage of Hyoscyamine Drops:

Store Hyoscyamine Drops at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Hyoscyamine Drops out of the reach of children and away from pets.

General information:

• If you have any questions about Hyoscyamine Drops, please talk with your doctor, pharmacist, or other health care provider.
• Hyoscyamine Drops are to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Hyoscyamine Drops. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.