Solifenacin (VESIcare) is used to treat overactive bladder (a condition in which the bladder muscles contract uncontrollably and cause frequent urination, urgent need to urinate, and inability to control urination). Solifenacin (VESIcare LS) is used to treat neurogenic detrusor overactivity (a bladder control condition caused by brain, spinal cord or nerve problem) in children 2 years of age and older. Solifenacin is in a class of medications called antimuscarinics. It works by relaxing the bladder muscles.

Solifenacin comes as a tablet (VESIcare) and a suspension (liquid; VESIcare LS) to take by mouth. Solifenacin tablets are usually taken once a day with or without food. Solifenacin suspension (VESIcare LS) is usually taken once a day. To help you remember to take solifenacin, take it at 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 solifenacin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Shake the suspension well before each use to mix the medication evenly. Use an oral dosing syringe to measure the correct amount of medication. You can swallow the suspension straight from the syringe followed by a small glass of water or milk. To avoid a bitter taste, avoid taking the suspension with another liquid or food.

Swallow the tablets whole; do not split, chew, or crush them. Swallow the tablets with water or another liquid.

Your doctor will probably start you on a low dose of solifenacin and increase your dose later in your treatment.

Solifenacin may help to control your symptoms but will not cure your condition. Continue to take solifenacin even if you feel well. Do not stop taking solifenacin without talking to your doctor.

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

Before taking solifenacin,

• Tell your doctor and pharmacist if you are allergic to solifenacin, any other medications, or any of the ingredients in solifenacin tablets or oral suspension. Ask your pharmacist for a list of the ingredients.
• Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and and herbal products you are taking. Be sure to mention any of the following: amiodarone (Nexterone, Pacerone); clarithromycin; disopyramide (Norpace); dofetilide (Tikosyn); erythromycin (E.E.S., ERYC, Erythrocin); HIV protease inhibitors such as indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra, in Viekira), and saquinavir (Invirase); itraconazole (Sporanox), ketoconazole, nefazodone; pimozide; procainamide; quinidine (in Neudexta); sotalol (Betapace, Sorine, Sotylize); and thioridazine. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with solifenacin, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
• Tell your doctor if you have or have ever had narrow angle glaucoma (a serious eye condition that may cause vision loss), urinary retention (inability to empty your bladder completely or at all), or gastric retention (slow emptying of your stomach). Your doctor may tell you not to take solifenacin.
• Tell your doctor if you have or have ever had a prolonged QT interval (a rare heart problem that may cause irregular heartbeat, fainting, or sudden death), any type of blockage in the bladder or digestive system, 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), benign prostatic hypertrophy (BPH, enlargement of the prostate, a male reproductive organ), constipation; or liver or kidney disease.
• Tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking solifenacin, call your doctor.
• You should know that solifenacin may make you dizzy or drowsy or cause blurred vision. Do not drive a car or operate machinery until you know how this medication affects you.
• You should know that solifenacin 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.

Talk to your doctor about drinking grapefruit juice while taking this medicine.

If you are taking solifenacin tablets (VESIcare), skip the missed dose and take your next dose at the regular time the next day. Do not take two doses of solifenacin tablets in the same day.

If you are taking solifenacin oral suspension (VESIcare LS), take the missed dose as soon as you remember it. However, if it has been more than 12 hours since your last dose, skip the missed dose and continue your regular dosing schedule. Do not take two doses of solifenacin oral suspension in the same day.

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

• Dry mouth
• Constipation
• Stomach pain
• Upset stomach
• Vomiting
• Heartburn
• Dry eyes
• Blurred vision
• Dry skin

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

• Constipation that lasts longer than 3 days
• Painful or frequent urination
• Bloody or cloudy urine
• Back pain
• Swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• Hoarseness
• Difficulty breathing or swallowing
• Rash
• Hives
• Itching
• Hallucinations (seeing things or hearing voices that do not exist)
• Confusion
• Headache
• Extreme tiredness

Solifenacin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

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).

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

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:

• Flushing
• Dry mouth
• Dry eyes
• Dry skin
• Blurred vision
• Enlarged pupils (black circle in the middle of the eye)
• Confusion
• Fever
• Fast heartbeat
• Shaking hands that you cannot control
• Difficulty walking
• Hallucinations (seeing things or hearing voices that do not exist)

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.