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Vesicare 5mg Tablets
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Product ID: **VESICARE5
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Product Summary

PRESCRIPTION REQUIRED


IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

SOLIFENACIN - ORAL

(soul-lee-fen-A-sin)

COMMON BRAND NAME(S): Vesicare

USES: This medication is used to treat an overactive bladder. By relaxing the muscles in the bladder, solifenacin improves your ability to control your urination. It helps to reduce leaking of urine, feelings of needing to urinate right away, and frequent trips to the bathroom. This medication belongs to the class of drugs known as antispasmodics.

HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using solifenacin and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist. Take this medication by mouth, with or without food, usually once a day, or as directed by your doctor. Swallow this medication whole with a full glass of liquid. Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day. Dosage is based on your medical condition (especially kidney and liver disease), response to therapy, and use of certain interacting medicines. Consult your doctor or pharmacist for more details. Do not increase your dose or take this medication more often without your doctor's approval. Your condition will not improve any faster and the risk of serious side effects may be increased. Inform your doctor if your condition does not improve or if it worsens.

SIDE EFFECTS: Dry mouth, constipation, stomach upset, stomach pain, blurred vision, dry eyes, headache, or unusual tiredness/weakness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water or use a saliva substitute. To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated, consult your pharmacist for help in choosing a laxative (e.g., stimulant-type with stool softener). Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor immediately if any of these unlikely but serious side effects occur: severe stomach/abdominal pain, constipation for 3 or more days, hallucinations, confusion, severe drowsiness, difficulty urinating, signs of kidney infection (e.g., burning/painful urination, lower back pain, fever). A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking solifenacin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: problems emptying your bladder (urinary retention), severe blockage of stomach/intestines (gastric retention), a certain eye condition (uncontrolled narrow angle glaucoma), severe liver disease. Before using this medication, tell your doctor or pharmacist your medical history, especially of: other bladder problems (e.g., bladder outflow obstruction), stomach/intestinal disease (e.g., ulcerative colitis), slowed movement of stomach/intestines, severe constipation, controlled narrow angle glaucoma, kidney disease, liver disease, enlarged prostate, a certain muscle disease (myasthenia gravis). This drug may make you drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages. This medication can cause decreased sweating. Avoid becoming overheated in hot weather, saunas, or during exercise or other strenuous activities since heatstroke may occur. Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be more sensitive to this drug. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first. This drug should not be used with the following medication because very serious interactions may occur: pramlintide. If you are currently using the medication listed above, tell your doctor or pharmacist before starting solifenacin. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: potassium tablets/capsules, other drugs that can cause dry mouth and constipation (e.g., anticholinergic medications such as atropine, antihistamines including diphenhydramine and scopolamine, other antispasmodics including dicyclomine, belladonna alkaloids), drugs affecting liver enzymes that remove solifenacin from your body (such as azole antifungals including itraconazole; macrolide antibiotics including erythromycin; cimetidine; rifamycins including rifabutin; St. John's wort; certain anti-seizure medicines including carbamazepine). This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include fast/irregular heartbeat, agitation.

NOTES: Do not share this medication with others.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised June 2012. Copyright(c) 2012 First Databank, Inc.

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