Trospium

WHY is this medicine 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 antimuscarinics. It works by relaxing the bladder muscles to prevent urgent, frequent, or uncontrolled urination.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

Trospium comes as a tablet and an extended-release capsule to take by mouth. The tablet is usually taken twice a day on an empty stomach or 1 hour before meals,or is sometimes taken once a day at bedtime. Trospium extended-release capsule is usually taken once daily in the morning with water on an empty stomach, at least 1 hour before a meal. 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.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before taking trospium,

• tell your doctor and pharmacist if you are allergic to trospium, any other medications, or any of the ingredients in trospium tablets or extended-release capsules. Ask your pharmacist for a list of the ingredients.

• 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: antacids; antihistamines; cold medications; ipratropium (Atrovent); medications for depression or mental illness; medications for inflammatory bowel disease or diarrhea, motion sickness, Parkinson's disease, ulcers, or urinary problems; metformin (Glucophage); morphine (MSIR, Oramorph, others); muscle relaxants; 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) or any type of blockage in the bladder or digestive system which causes delays or causes difficulty in emptying your bladder or stomach. Your doctor may tell you not to take trospium.

• tell your doctor if you have or have ever had myasthenia gravis (a disorder of the nervous system that causes muscle weakness); ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum); any disease of the stomach or intestines; frequently occurring constipation; problems emptying your bladder;or 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.

• 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 not drink alcohol within 2 hours of taking trospium.

• 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 heartbeat 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 to take 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 medicine cause?

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

• dry mouth, eyes, or nose
• constipation
• headache
• confusion
• gas

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

• difficulty urinating
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• rash
• hives
• itching
• difficulty breathing or swallowing
• hallucinations (seeing things or hearing voices that do not exist)

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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

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).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• 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.