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|Ditropan XL Extended-Release Tablets

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Ditropan XL Extended-Release Tablets

Generic Name: Oxybutynin Extended-Release Tablets (OX-i-BYOO-ti-nin)
Brand Name: Ditropan XL

Ditropan XL Extended-Release Tablets is used for:

Relieving symptoms of bladder problems (urinary urgency, frequency, or leakage; loss of bladder control; and painful urination) in certain patients. It may also be used in certain children with overactive bladder muscle (detrusor) caused by certain conditions (eg, spina bifida). It may also be used for other conditions as determined by your doctor.

Ditropan XL Extended-Release Tablets is an anticholinergic. It works by relaxing muscles in the bladder.

Do NOT use Ditropan XL Extended-Release Tablets if:

you are allergic to any ingredient in Ditropan XL Extended-Release Tablets
you have bladder blockage or are unable to urinate
you have certain stomach or bowel problems (eg, blockage, decreased muscle movement) or tightening of the esophagus
you have uncontrolled narrow-angle glaucoma
you have heart problems caused by severe bleeding
you cannot swallow the tablet whole

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

Before using Ditropan XL Extended-Release Tablets:

Some medical conditions may interact with Ditropan XL 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 trouble urinating or have very poor health
if you have a history of heart problems (eg, heart failure, fast or irregular heartbeat), high blood pressure, nervous system problems, esophagus problems (eg, reflux disease, inflammation), stomach or bowel problems (eg, colitis, inflammation, narrowing), or hiatal hernia
if you have a history of liver or kidney problems, myasthenia gravis, an enlarged prostate, an overactive thyroid, or glaucoma, or if you are at risk for glaucoma

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

Anticholinergics (eg, scopolamine), azole antifungals (eg, ketoconazole), or macrolide antibiotics (eg, erythromycin) because they may increase the risk of Ditropan XL Extended-Release Tablets"s side effects
Bisphosphonates (eg, alendronate) because the risk of irritation of the esophagus may be increased
Phenothiazines (eg, chlorpromazine) because their effectiveness may be decreased by Ditropan XL Extended-Release Tablets and they may increase the risk of Ditropan XL Extended-Release Tablets"s side effects

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

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

Take Ditropan XL Extended-Release Tablets by mouth with or without food.
Swallow Ditropan XL Extended-Release Tablets whole. Do not break, crush, or chew before swallowing.
Take Ditropan XL Extended-Release Tablets with a full glass of water (8 oz/240 mL).
Take Ditropan XL Extended-Release Tablets on a regular schedule to get the most benefit from it. Ditropan XL Extended-Release Tablets works best if it is taken at the same time each day.
Continue to take Ditropan XL Extended-Release Tablets event if you feel well. Do not miss any doses.
If you miss a dose of Ditropan XL 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 Ditropan XL Extended-Release Tablets.

Important safety information:

Ditropan XL Extended-Release Tablets may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Ditropan XL Extended-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Ditropan XL Extended-Release Tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
Ditropan XL Extended-Release Tablets may cause decreased sweating. Do not become overheated in hot weather or while you are being active; heatstroke may occur. Contact your doctor if you have been exposed to high temperatures and you develop fever; flushing; hot, dry skin; severe or persistent headache; dizziness; sudden fatigue; fast heartbeat; seizures; or fainting.
Ditropan XL Extended-Release Tablets may cause dry mouth. To hep relieve dry mouth, suck on sugarless hard candy or ice chips, chew sugarless gum, drink water, or use a saliva substitute. Ask your doctor or pharmacist if you have any questions.
You may notice the tablet shell in your stool. This is normal and not a cause for concern.
Use Ditropan XL Extended-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects.
Ditropan XL Extended-Release Tablets should be used with extreme caution in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.
PREGNANCY and BREAST-FEEDING: It is not known if Ditropan XL 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 Ditropan XL Extended-Release Tablets while you are pregnant. It is not known if Ditropan XL Extended-Release Tablets is found in breast milk. If you are or will be breast-feeding while you use Ditropan XL Extended-Release Tablets, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Ditropan XL 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:

Blurred vision; constipation; diarrhea; dizziness; drowsiness; dry eyes, nose, skin, or mouth; headache; indigestion; nausea; runny nose; stomach pain or upset; 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); confusion; difficult or painful urination; fast or irregular heartbeat; fever; hallucinations; seizures; swelling of the hands, ankles, or feet; vision problems.

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 coma; delirium; fever; flushing; hallucinations; irregular heartbeat; paralysis; seizures; severe or persistent dizziness or headache; tremor; trouble breathing; vomiting.

Proper storage of Ditropan XL Extended-Release Tablets:

Store Ditropan XL Extended-Release 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 Ditropan XL Extended-Release Tablets out of the reach of children and away from pets.

General information:

If you have any questions about Ditropan XL Extended-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
Ditropan XL Extended-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 Ditropan XL 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.

Issue Date: November 1, 2006

Database Edition 06.4.1.002

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