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Hyoscyamine Controlled-Release Tablets 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 or runny nose. It may also be used for other conditions as determined by your doctor.

Hyoscyamine Controlled-Release Tablets 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 Controlled-Release Tablets if:

• you are allergic to any ingredient in Hyoscyamine Controlled-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 Controlled-Release Tablets:

Some medical conditions may interact with Hyoscyamine Controlled-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, 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 Controlled-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 Controlled-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 Controlled-Release Tablets
• Metoclopramide because its effectiveness may be decreased by Hyoscyamine Controlled-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Hyoscyamine Controlled-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 Controlled-Release Tablets:

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

• Hyoscyamine Controlled-Release Tablets is usually taken 30 to 60 minutes before a meal. Follow your doctor's specific instructions for taking Hyoscyamine Controlled-Release Tablets.
• Swallow Hyoscyamine Controlled-Release Tablets whole. Do not break, crush, or chew before swallowing.
• If you also take antacids, ask your doctor or pharmacist how to take them with Hyoscyamine Controlled-Release Tablets.
• If you miss a dose of Hyoscyamine Controlled-Release Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose. 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 Controlled-Release Tablets.

Important safety information:

• Hyoscyamine Controlled-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 Controlled-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Hyoscyamine Controlled-Release Tablets will add to the effects of alcohol and other medicines that may cause drowsiness (eg, sleep aids, muscle relaxers). Ask your pharmacist if you have any 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.
• Proper dental care is important while you are taking Hyoscyamine Controlled-Release Tablets. Brush and floss your teeth and visit the dentist regularly.
• Hyoscyamine Controlled-Release Tablets may make your eyes more sensitive to sunlight. It may help to wear sunglasses.
• You may notice undissolved parts of Hyoscyamine Controlled-Release Tablets in your stool. This is normal and not a cause for concern.
• Use Hyoscyamine Controlled-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially constipation, trouble urinating, drowsiness, agitation, confusion, or excitement.
• Caution is advised when using Hyoscyamine Controlled-Release Tablets in CHILDREN; they may be more sensitive to its effects.
• Hyoscyamine Controlled-Release Tablets should not be used 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 Controlled-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 Controlled-Release Tablets while you are pregnant. Hyoscyamine Controlled-Release Tablets is found in breast milk. Do not breast-feed while you are taking Hyoscyamine Controlled-Release Tablets.

Possible side effects of Hyoscyamine Controlled-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; excitement; headache; nausea; nervousness; trouble sleeping; weakness.

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; 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 or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or 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/findyour.htm), 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, headache, dizziness, nausea, or vomiting; trouble breathing or swallowing.

Store Hyoscyamine Controlled-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 Controlled-Release Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Hyoscyamine Controlled-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
• Hyoscyamine Controlled-Release Tablets 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 Controlled-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.