Details for: SOLIFENACIN
Company: PRO DOC LIMITEE
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02458144 | SOLIFENACIN | SOLIFENACIN SUCCINATE | 5 MG | TABLET | ORAL |
| 02458152 | SOLIFENACIN | SOLIFENACIN SUCCINATE | 10 MG | TABLET | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
SOLIFENACIN 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
SOLIFENACIN 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 SOLIFENACIN:
- 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 SOLIFENACIN. See ‘What the non-medicinal ingredients are’
What the medicinal ingredient is
The medicinal ingredient in SOLIFENACIN tablet is ‘solifenacin succinate’.
What the non-medicinal ingredients are
Each SOLIFENACIN tablet contains the following inert ingredients: corn starch, hypromellose, iron oxide yellow (5 mg solifenacin tablet) or iron oxide red (10 mg solifenacin tablet), lactose monohydrate, macrogol, magnesium stearate, talc, titanium dioxide.
What dosage form it comes in
SOLIFENACIN is available in 5 and 10 mg tablets.
Warnings and precautions
Before you use SOLIFENACIN, 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 SOLIFENACIN.
- Are breast feeding or plan to breast feed.
SOLIFENACIN should not be given to children or adolescents.
SOLIFENACIN may cause blurred vision and drowsiness. Do not
drive a car or operate any machinery, or engage in any activities
that require accurate vision and full attention.
In hot weather, SOLIFENACIN 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 solifenacin succinate. If you
experience any of these symptoms, stop taking SOLIFENACIN
and see your doctor immediately.
Interactions with this medication
Before and while taking SOLIFENACIN you should tell your
doctor about your other medications, even if the medicine you
bought without prescription including vitamins and herbal
supplements.
SOLIFENACIN 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 SOLIFENACIN 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.
SOLIFENACIN tablets can be taken with or without food.
Overdose
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
SOLIFENACIN:
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
SOLIFENACIN in worldwide post-marketing experience,
although the frequency of events or a causal relationship with
SOLIFENACIN 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 SOLIFENACIN. This includes any side effects not listed
above.
| Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking drug and seek immediate emergency medical attention |
|---|---|---|---|
| Rare | |||
| Abdominal pain | ✔ | ||
| Constipation for more than 3 days | ✔ | ||
| Urinary retention | ✔ | ||
| Very Rare | |||
| Swelling of the face or tongue, difficulty breathing | ✔ | ||
| Fast or irregular heartbeat | ✔ | ||
| Anaphylactic reactions (severe allergic reactions) | ✔ | ||
How to store
Keep SOLIFENACIN and all other medications out of the reach
of children.
Store SOLIFENACIN between 15° to 30°C.
Do not keep medicine that is out of date or that you no longer
need.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/healthcanada/services/drugs-health-products/medeffectcanada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. 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 by contacting Pro Doc Ltée at
1-800-361-8559, www.prodoc.qc.ca or info@prodoc.qc.ca.
This leaflet was prepared by
Pro Doc Ltée,
Laval, Québec,
H7L 3W9
Last revised: September 3, 2019