Patient Medication Information: uses, side effects, how to take - Dom-Solifenacin
ABOUT THIS MEDICATION
What the medication is used for:
Dom-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:
Dom-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 Dom-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 Dom-SOLIFENACIN. See "What the non-medicinal ingredients are".
What the medicinal ingredient is:
Solifenacin succinate
What the non medicinal ingredients are:
Colloidal Silicon Dioxide, Corn Starch, Hydroxypropyl Methylcellulose, Lactose, Magnesium Stearate, Polyethylene Glycol, Talc and Titanium Dioxide with Yellow Iron Oxide (5 mg Dom-SOLIFENACIN tablet) or Red Iron Oxide (10 mg Dom-SOLIFENACIN tablet)
What dosage form it comes in:
Tablets: 5 mg & 10 mg
WARNINGS AND PRECAUTIONS
BEFORE you use Dom-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 Dom-SOLIFENACIN.
- Are breastfeeding or plan to breastfeed.
Dom-SOLIFENACIN should not be given to children or adolescents.
Dom-SOLIFENACIN 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, Dom-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 Dom-SOLIFENACIN and see your doctor immediately.
INTERACTIONS WITH THIS MEDICATION
Before and while taking Dom-SOLIFENACIN you should tell your doctor about your other medications, even if the medicine you bought without prescription including vitamins and herbal supplements.
Dom-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 Dom-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.
Dom-SOLIFENACIN 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 solifenacin succinate:
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 succinate in worldwide post-marketing experience, although the frequency of events or a causal relationship with solifenacin succinate 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 Dom-SOLIFENACIN. This includes any side effects not listed above.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and seek immediat e medical help | ||
| Only if severe | In all cases | |||
| 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) | √ | |||
This is not a complete list of side effects. For any unexpected effects while taking Dom-SOLIFENACIN, contact your doctor or pharmacist.
HOW TO STORE IT
Keep Dom-SOLIFENACIN and all other medications out of the reach of children.
Store between 15°C and 30°C.
Do not keep medicine that is out of date or that you no longer need.
REPORTING SIDE EFFECTS
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report:
Online at MedEffectTM
(www.healthcanada.gc.ca/medeffect);
- By calling 1-866-234-2345 (toll-free);
By completing a Consumer Side Effect Reporting
Form and sending it by:
- Fax to 1-866-678-6789 (toll-free), or
Mail to: Canada Vigilance Program Health Canada, Postal Locator 1908C Ottawa, ON
K1A 0K9
Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffectTM
(www.healthcanada.gc.ca/medeffect).
| 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 obtained by contacting Dominion Pharmacal at 1-888-550-6060.
Dominion Pharmacal
Montréal Québec
H4P 2T4