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Fesoterodine (Oral) (Tablet, Extended Release)

Fesoterodine (By mouth)
Fesoterodine (fes-oh-TER-oh-deen)Treats symptoms of an overactive bladder such as incontinence (loss of bladder control) or a frequent need to urinate.
Toviaz

When This Medicine Should Not Be Used:
You should not use this medicine if you have had an allergic reaction to fesoterodine or tolterodine tartrate (Detrol®), or if you have problems passing urine, severe liver disease, uncontrolled narrow-angle glaucoma, or problems with food emptying from your stomach (gastric retention).

How to Use This Medicine:
Long Acting Tablet

  • Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
  • You may take this medicine with or without food. Drink a full glass (8 ounces) of water or other liquid when taking your medicine.
  • Swallow the extended-release tablet whole. Do not crush, break, or chew it.
  • Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

  • Make sure your doctor knows if you are using atropine, scopolamine (Transderm-Scop®), or medicine to treat an infection (such as clarithromycin, erythromycin, itraconazole, ketoconazole, Biaxin®, Nizoral®, or Sporanox®).
  • Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine:

  • Make sure your doctor knows if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, bladder blockage, myasthenia gravis (severe muscle weakness), narrow-angle glaucoma, or stomach or bowel problems (such as severe constipation).
  • This medicine can cause a serious reaction called angioedema. Stop using this medicine and tell your doctor right away if you start to have swelling of your face, lips, tongue, throat, arms, or legs, or if you are having trouble swallowing or breathing.
  • This medicine may make you dizzy, drowsy, or cause blurred vision. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert or not able to see well.
  • This medicine may make you sweat less, causing your body temperature to increase. Use extra care not to become overheated during exercise or hot weather while you are taking this medicine, since overheating may result in heat stroke.
  • Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

  • Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
  • Bloody or cloudy urine.
  • Decrease in how much or how often you urinate.
  • Fever, chills, cough, sore throat, and body aches.
  • Rapid weight gain.
  • Swelling in your hands, ankles, or feet.
  • Unusual tiredness or weakness.

If you notice these less serious side effects, talk with your doctor:

  • Back pain.
  • Blurred vision.
  • Constipation, nausea, vomiting, heartburn, or stomach pain or upset.
  • Dry mouth, skin, or eyes.
  • Rash.
  • Trouble sleeping.

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088