Toviaz®(fesoterodine)

TOVIAZ is a prescription medicine used to treat:

• Overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency.
• Neurogenic detrusor overactivity (NDO) in children 6 years of age and older weighing more than 55 pounds (25 kg).

TOVIAZ may help increase the amount of urine your bladder can hold and decrease the urge to urinate.

• are allergic to fesoterodine fumarate or any of the ingredients in TOVIAZ, or to tolterodine tartrate products
• have urinary retention (inability to empty your bladder)
• have gastric retention (delayed stomach emptying)
• have uncontrolled narrow-angle glaucoma

• have trouble emptying your bladder or have a weak urine stream
• have constipation or other stomach or intestinal problems
• are being treated for narrow-angle glaucoma
• have myasthenia gravis
• have kidney or liver problems
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

TOVIAZ may affect the way other medicines work, especially:

• antimuscarinic medicines
• certain antibiotics
• antifungal medicines

• Take TOVIAZ exactly as your healthcare provider tells you to take it.
• Swallow TOVIAZ tablets whole with liquid.
• Do not chew, divide, or crush TOVIAZ tablets.
• TOVIAZ may be taken with or without food.
• If you miss a dose of TOVIAZ, begin taking TOVIAZ again the next day. Do not take 2 doses of TOVIAZ on the same day.
• If you take too much TOVIAZ, call your healthcare provider or go to the nearest hospital emergency room right away.

TOVIAZ can cause blurred vision, dizziness, and drowsiness. Do not drive, operate machinery, or do other dangerous activities until you know how TOVIAZ affects you.

• Avoid getting too hot in hot weather, during exercise, or other activities, as TOVIAZ may decrease sweating, causing you to overheat.
• Limit your alcohol use while taking TOVIAZ.

TOVIAZ may cause serious side effects, including:

• Allergic reactions. TOVIAZ may cause allergic reactions that may be serious. Stop taking TOVIAZ and call your healthcare provider or get emergency help right away if you have swelling of the face, lips, throat, or tongue.
• Urinary retention. TOVIAZ may cause you to not be able to empty your bladder completely (urinary retention). Tell your healthcare provider right away if you are unable to empty your bladder.
• Dizziness and drowsiness. TOVIAZ may cause drowsiness and dizziness. Do not drive or operate heavy machinery until you know how TOVIAZ affects you.
• Central nervous system effects. TOVIAZ may cause confusion, hallucinations, and somnolence.

The most common side effects of TOVIAZ in adults include:

• dry mouth
• constipation

The most common side effects of TOVIAZ in children include:

• diarrhea
• urinary tract infections
• dry mouth
• constipation
• stomach pain
• nausea
• weight gain
• headache

These are not all the possible side effects of TOVIAZ. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• Store TOVIAZ at room temperature between 68°F to 77°F (20°C to 25°C).
• Protect from moisture by keeping the bottle closed tightly.
• Keep TOVIAZ and all medicines out of the reach of children.

Active ingredient: fesoterodine fumarate Inactive ingredients: glyceryl behenate, hypromellose, indigo carmine aluminum lake, lactose monohydrate, soya lecithin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and xylitol