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Trospium Safety Reports

Drug Information: Trospium

Why is this medication prescribed?

Trospium is used to treat an overactive bladder (a condition in which the bladder muscles contract uncontrollably and cause frequent urination, urgent need to urinate, and inability to control urination). Trospium is in a class of medications called anticholinergics. It works by relaxing the bladder muscles to prevent urgent, frequent, or uncontrolled urination.

How should this medicine be used?

Trospium comes as a tablet to take by mouth. It is usually taken twice a day on an empty stomach or one hour before meals. Trospium is sometimes taken once a day at bedtime. To help you remember to take trospium, take it around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take trospium exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before taking trospium,

• tell your doctor and pharmacist if you are allergic to trospium, any other medications, or wheat.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: antihistamines; digoxin (Lanoxin); ipratropium (Atrovent); medications for irritable bowel disease, motion sickness, Parkinson's disease, ulcers, or urinary problems; metformin (Glucophage); morphine (MSIR, Oramorph, others); procainamide; tenofovir (Viread); and vancomycin (Vancocin). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had glaucoma (an eye disease that can cause vision loss); any type of blockage in the bladder or digestive system; myasthenia gravis (a disorder of the nervous system that causes muscle weakness); ulcerative colitis (sores in the intestine that cause stomach pain and diarrhea); benign prostatic hypertrophy (BPH, enlargement of the prostate, a male reproductive organ); or liver or kidney disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking trospium, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking trospium.
• you should know that trospium may make you drowsy or dizzy and may cause blurred vision. Do not drive a car or operate machinery until you know how this medication affects you.
• remember that alcohol can add to the drowsiness caused by this medication.
• you should know that trospium may make it harder for your body to cool down when it gets very hot. Avoid exposure to extreme heat, and call your doctor or get emergency medical treatment if you have fever or other signs of heat stroke such as dizziness, upset stomach, headache, confusion, and fast pulse after you are exposed to heat.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose?

Take the missed dose 1 hour before your next meal. However, if you are due to take your next dose at that time, skip the missed dose and continue your normal dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medication cause?

Trospium may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• dry mouth
• constipation
• headache

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:

• difficulty urinating
• rash
• hives
• itching
• difficulty breathing or swallowing

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/index.html] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

• fast heartbeat
• widened pupils (black circle in the middle of the eye)
• sensitivity to light

What other information should I know?

Keep all appointments with your doctor .

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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