Solifenacin Succinate Oral tablet

What is this medicine?

SOLIFENACIN (sol i FEN a cin) is used to treat overactive bladder. This medicine reduces the amount of bathroom visits. It may also help to control wetting accidents.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• difficulty passing urine

• glaucoma

• intestinal obstruction

• kidney disease

• liver disease

• an unusual or allergic reaction to solifenacin, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. This medicine can be taken with or without food. Take your doses at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on the advice of your doctor or health care professional.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• certain medicines for fungal infections like fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole

• cisapride

• dofetilide

• dronedarone

• pimozide

• thioridazine

• ziprasidone

This medicine may also interact with the following medications:

• atropine

• other medicines that prolong the QT interval (cause an abnormal heart rhythm)

• oxybutynin

• scopolamine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

It may take 2 or 3 months to notice the full benefit from this medicine.

You may need to limit your intake tea, coffee, caffeinated sodas, and alcohol. These drinks may make your symptoms worse.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your doctor if the problem does not go away or is severe.

This medicine may cause dry eyes and blurred vision. If you wear contact lenses, you may feel some discomfort. Lubricating drops may help. See your eye care professional if the problem does not go away or is severe.

Avoid extreme heat. This medicine can cause you to sweat less than normal. Your body temperature could increase to dangerous levels, which may lead to heat stroke.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• blurred vision or difficulty focusing vision

• breathing problems

• chest pain or palpitations

• confusion

• fast, irregular heartbeat

• feeling faint or lightheaded, falls

• hallucinations

• severe dizziness

• trouble passing urine or change in the amount of urine

• unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• constipation

• drowsiness

• headache

• indigestion or stomach upset

• nausea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.