Vesicare: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

VESICARE is used in the treatment of overactive bladder in adults with symptoms of frequent and urgent need to urinate (urinary frequency, urinary urgency) with urine leakage (urge urinary incontinence).

What it does:

VESICARE is a urinary antispasmodic medication that helps to relax the smooth muscle of the bladder which leads to reduction of the symptoms caused by overactive bladder.

When it should not be used:

You should not take VESICARE:

• If you are not able to empty your bladder (also called

  urinary retention).

• If you have End-Stage Kidney Disease and require

  dialysis.

• If you are not able to empty your stomach (also called

  gastroparesis).

• If you have narrow-angle glaucoma (high pressure and

  pain in the eyes).

• If you are allergic to solifenacin succinate or any of the

  other ingredients in VESICARE. See ‘What the non-medicinal ingredients are’

What the medicinal ingredient is:

The medicinal ingredient in VESICARE Tablet is ‘solifenacin succinate’.

What the non-medicinal ingredients are:

Each VESICARE tablet contains the following inert ingredients: lactose monohydrate, corn starch, hypromellose, magnesium stearate, talc, polyethylene glycol and titanium dioxide with yellow ferric oxide (5 mg VESICARE tablet) or red ferric oxide (10 mg VESICARE tablet).

What dosage form it comes in:

VESICARE is available in 5 and 10 mg tablets

WARNINGS AND PRECAUTIONS

Before you use VESICARE, talk to your doctor or pharmacist if you:

• Have stomach problems affecting passage and digestion of food, or severe constipation.
• Have glaucoma.
• Have difficulty urinating, or weak urine stream.
• Have heart disease
• Have a rare heart problem called QT/QTc prolongation or family history of QT/QTc prolongation.
• Have kidney or liver problems.
• Have reduced ability to sweat.

• Are pregnant or planning to become pregnant. Women who might get pregnant should use an effective birth control method while taking VESICARE.

• Are breastfeeding or plan to breastfeed.

VESICARE should not be given to children or adolescents.

VESICARE may cause blurred vision and drowsiness. Do not drive a car, operate any machinery, or engage in any activities that require accurate vision and full attention.

In hot weather, VESICARE can cause heat prostration (fever and heat stroke due to decreased sweating). Do not stay long in a hot environment while taking the drug. If you have any symptoms of heat prostration, keep yourself cool and drink a lot of water.

Angioedema (the symptoms include swelling of the face or tongue, difficulty breathing) and anaphylactic reactions (the symptoms include hives, difficulty breathing, abdominal cramps, rapid heartbeat and feeling faint), which could be life-threatening, have been reported in some patients taking VESICARE. If you experience any of these symptoms, stop taking VESICARE and see your doctor immediately.

INTERACTIONS WITH THIS MEDICATION

Before and while taking VESICARE you should tell your doctor about your other medications, even the medicine you bought without prescription, including vitamins and herbal supplements.

VESICARE is known to have drug interactions with the following drugs: Drugs known to prolong the QT/QTc interval and/or cause torsade de pointes, drugs that decrease electrolyte levels, anticholinergic drugs, drugs that stimulate the motility of the gut such as metoclopramide, ketoconazole, clarithromycin, erythromycin, diclofenac, nefazodone, verapamil.

Drinking grapefruit juice with VESICARE may increase your blood level of solifenacin.

PROPER USE OF THIS MEDICATION

Usual Dose:

5 mg daily. The daily dose may be increased to 10 mg following consultation with your doctor. Swallow the tablet whole with water.

VESICARE tablets can be taken with or without food.

Overdose:

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose:

If a dose is missed, the next tablet should be taken as planned. Doses should not be doubled to make up for a missed dose.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

The following side effects have been reported in clinical trials with VESICARE:

Most common side effects: dry mouth and constipation Common side effects: dry eyes, urinary retention, blurred vision, nausea, abdominal pain, indigestion, urinary tract infection.

The following side effects have been reported with the use of VESICARE in worldwide post-marketing experience, although the frequency of events or a causal relationship with VESICARE could not always be confirmed:

acid reflux, change in sense of taste, decreased appetite, delirium, dizziness, dry skin, fast or irregular heartbeat, feeling sleepy, glaucoma, hallucination, headache, high potassium levels, hypersensitivity reactions, intestinal blockage, itchiness, kidney ailment, liver problems, muscle weakness, nasal dryness, voice disorder, severe skin scaling and redness, itching (exfoliative dermatitis), severe skin rash, itchiness and fever (erythema multiforme), swelling in the lower limbs and vomiting.

Tell your doctor or pharmacist if you have any side effects while taking VESICARE. This includes any side effects not listed above.

HOW TO STORE IT

Keep VESICARE and all other medications out of the reach of children.

Store between 15°C - 30°C.

Do not keep medicine that is out of date or that you no longer need.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

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• Report online at www.healthcanada.gc.ca/medeffect
• Call toll-free at 1-866-234-2345

• Complete a Canada Vigilance Reporting Form and:

  • Fax toll-free to 1-866-678-6789, or

  • Mail to: Canada Vigilance Program Health Canada

    Postal Locator 0701D

    Ottawa, ON

    K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^™ Canada Website at:

www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document, plus the full product monograph prepared for health professionals, can be found at:

http://www.astellas.ca

Or by contacting Astellas Pharma Canada, Inc., at 1-888-338-1824.

Last Revised: December 31, 2018

VESICARE^® is a registered trademark of Astellas Pharma Inc.

218634-VES-CAN