Vesicare - Consumer Medicine Information
|Condition:||Overactive Bladder, Urinary Incontinence|
|Ingredients:||solifenacin succinate, 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)|
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 reduce 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 or operate any machinery, or engage in any activities that requires 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 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 if the medicine you bought without prescription including vitamins and herbal supplements.
VESICARE is known to have drug interactions with the following drugs: Drug 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
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.
|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.|
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 sides 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, angioedema (swelling of face or tongue, difficulty breathing), anaphylactic reactions (hives, difficulty breathing, abdominal cramps, rapid heartbeat and feeling faint), decreased appetite, delirium, dizziness, fast or irregular heartbeat, feeling sleepy, glaucoma, hallucination, headache, high potassium levels, hypersensitivity reactions, intestinal blockage, itchiness, kidney ailment, liver problems, muscle weakness, 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.
|Symptom/effect||Talk with your|
doctor or pharmacist
|Stop taking drug and call your doctor or pharmacist|
|Only if severe||In all cases|
|Constipation for more than 3 days||✓|
|Very rare||Swelling of the face or tongue, difficulty breathing||✓|
|Fast or irregular heartbeat||✓|
|Anaphylactic reactions (severe allergic reactions)||✓|
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:
- 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
Postal Locator 0701D
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site 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.
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.