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|Oxytrol System

Oxytrol System

Oxytrol System 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 for other conditions as determined by your doctor.

Oxytrol System is an anticholinergic. It works by relaxing muscles in the bladder.

Do NOT use Oxytrol System if:

• you are allergic to any ingredient in Oxytrol System
• 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

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

Before using Oxytrol System:

Some medical conditions may interact with Oxytrol System. 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), 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 Oxytrol System. 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 Oxytrol System"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 Oxytrol System and they may increase the risk of Oxytrol System"s side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Oxytrol System 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 Oxytrol System:

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

• An extra patient leaflet is available with Oxytrol System. Talk to your pharmacist if you have questions about this information.
• Apply the patch to a clean, dry, smooth area of your skin on your stomach, hips, or buttocks. Apply it to an area under clothing to protect it from sunlight. Avoid applying it to your waistline because clothing may rub against the patch.
• Do NOT apply the patch to oily, damaged, or irritated skin. Avoid using oils, lotions, or powders near the application site because the patch may not stick to your skin.
• To use Oxytrol System, open the pouch and remove the patch. Apply it right away. Carefully remove the first protective liner and place the patch firmly onto your skin. Do not touch the adhesive side of the patch. Bend the patch in half and gently roll the remaining part onto your skin. The second protective liner should come off of the patch. Gently apply firm pressure over the patch to be sure it stays in place.
• When it is time to apply a new patch, remove the old patch carefully. Fold the patch in half with the sticky sides together. Discard the patch out of the reach of children and pets because it may still contain medicine.
• Use a different skin site each time you apply a new patch. Do not reuse the same site within 7 days.
• Use Oxytrol System on a regular schedule to get the most benefit from it. Using Oxytrol System at the same time each day will help you remember to use it.
• Continue to use Oxytrol System event if you feel well. Do not miss any doses.
• If the patch comes off, press it back in place and continue to follow your regular application schedule. If it does not stay on, throw it away and put a new patch on in a different area. Continue to follow your regular application schedule.
• If you forget to change the patch on the correct day, remove the old patch and apply a new patch to a different application site as soon as you remember. Continue to follow your regular application schedule. Do not use 2 patches at once.

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

Important safety information:

• Oxytrol System may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Oxytrol System 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 Oxytrol System; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Oxytrol System 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.
• Oxytrol System 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.
• Using Oxytrol System while bathing, swimming, showering, or exercising will not change the way it works. However, avoid rubbing the patch area during these activities.
• Always remove the patch carefully and slowly to avoid damage to your skin. If there is adhesive left on your skin, gently wash the area with warm, soapy water. You may also use baby oil or a medical adhesive removal pad if need. Do not use alcohol or nail polish remover because these may irritate the skin.
• After removing the patch, there may be minor redness of your skin. It should disappear after several hours. Tell your doctor if the irritation or redness becomes worse or if it does not go away.
• Use Oxytrol System with caution in the ELDERLY; they may be more sensitive to its effects.
• Oxytrol System should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: It is not known if Oxytrol System can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Oxytrol System while you are pregnant. It is not known if Oxytrol System is found in breast milk. If you are or will be breast-feeding while you use Oxytrol System, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Oxytrol System:

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; minor redness, itching, or irritation at patch application site; stomach pain.

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; pain, burning, blistering, or oozing at the application site; 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.

Store Oxytrol System 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 in original packaging until just before use. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Oxytrol System out of the reach of children and away from pets

General information:

• If you have any questions about Oxytrol System, please talk with your doctor, pharmacist, or other health care provider.
• Oxytrol System 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 Oxytrol System. 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.