VESIcare is a prescription medicine used to treat symptoms of overactive bladder, such as frequent or urgent urination, and incontinence (urine leakage).

VESIcare LS oral suspension (liquid) is used to treat overactive bladder caused by a neurologic disorder (such as multiple sclerosis or spinal cord injury) in children at least 2 years old when other medicines cannot be used or have not worked.

VESIcare 5 mg and 10 mg tablets are not approved for use in children.

You should not use this medicine if you have untreated or uncontrolled narrow-angle glaucoma, a blockage in your digestive tract (stomach or intestines), or if you are unable to urinate.

Before taking this medicine

You should not use VESIcare if you are allergic to solifenacin, or if you have:

• untreated or uncontrolled narrow-angle glaucoma;

• a stomach disorder causing delayed emptying; or

• if you are unable to urinate.

To make sure VESIcare is safe for you, tell your doctor if you have ever had:

• glaucoma;

• liver disease;

• kidney disease;

• trouble emptying your bladder (or you have a weak stream of urine);

• slow digestion;

• a blockage in your stomach or intestines; or

• long QT syndrome.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

You should not breastfeed while using VESIcare.

Take VESIcare exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

VESIcare is usually taken once per day with or without food. Follow your doctor's instructions.

Do not crush, chew, or break the tablet. Swallow it whole.

Shake the oral suspension (liquid) before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Take the tablet with water.

After taking VESIcare LS liquid drink a glass of water or milk. Avoid taking the liquid with food or other drinks or you may have a bitter aftertaste.

Store this medicine in the original container at room temperature, away from moisture and heat. Keep the bottle tightly closed when not in use. Throw away any unused liquid 28 days after you first opened the bottle.

Usual Adult Dose for Urinary Incontinence:

Initial dose: 5 mg orally once daily
Maintenance dose: 5 to 10 mg orally once daily

Use: For the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency

Usual Adult Dose for Urinary Frequency:

Initial dose: 5 mg orally once daily
Maintenance dose: 5 to 10 mg orally once daily

Use: For the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency

You should not use VESIcare if you are allergic to solifenacin, or if you have:

• untreated or uncontrolled narrow-angle glaucoma;

• a stomach disorder causing delayed emptying; or

• if you are unable to urinate.

To make sure VESIcare is safe for you, tell your doctor if you have ever had:

• glaucoma;

• liver disease;

• kidney disease;

• trouble emptying your bladder (or you have a weak stream of urine);

• slow digestion;

• a blockage in your stomach or intestines; or

• long QT syndrome.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

You should not breastfeed while using VESIcare.

Tablets: Skip the missed dose and use your next dose at the regular time. Do not take 2 doses on the same day.

Oral suspension: Take the medicine as soon as you can, but skip the missed dose if you are more than 12 hours late for the dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Avoid becoming overheated or dehydrated during exercise and in hot weather. VESIcare can decrease perspiration and you may be more prone to heat stroke.

Get emergency medical help if you have signs of an allergic reaction to VESIcare (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Stop using VESIcare and call your doctor at once if you have:

• severe stomach pain, or constipation for 3 days or longer;

• pain or burning when you urinate;

• headache, confusion, drowsiness, hallucinations;

• vision changes, eye pain, or seeing halos around lights;

• little or no urination, pain or burning when you urinate;

• dehydration symptoms - dizziness, tiredness, feeling very thirsty or hot, decreased sweating, or hot and dry skin; or

• high potassium level - nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement.

Common VESIcare side effects may include:

• blurred vision;

• dry mouth, dry eyes;

• painful urination;

• constipation; or

• heat stroke - decreased sweating, dry skin, dizziness, tiredness, nausea, feeling hot.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can interact with solifenacin. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.