Patient Medication Information: uses, side effects, how to take - Act Solifenacin
ABOUT THIS MEDICATION
What the medication is used for:
ACT 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:
ACT 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 ACT 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 ACT Solifenacin. See ‘What the nonmedicinal ingredients are’.
What the medicinal ingredient is:
The medicinal ingredient in ACT Solifenacin Tablet is ‘solifenacin succinate’.
What the non-medicinal ingredients are:
ACT Solifenacin 5 mg tablet contains the following non-medicinal ingredients: lactose monohydrate, microcrystalline cellulose, magnesium stearate, pregelatinized starch. In addition, the tablet film coating contains: hypromellose, iron oxide yellow, polyethylene glycol, talc, titanium dioxide.
ACT Solifenacin 10 mg tablet contains the following non-medicinal ingredients: lactose monohydrate, microcrystalline cellulose, magnesium stearate, pregelatinized starch. In addition, the tablet film coating contains: Hypromellose, iron oxide black, iron oxide red, polyethylene glycol, talc, titanium dioxide.
What dosage forms it comes in:
ACT Solifenacin is available in 5 and 10 mg tablets
WARNINGS AND PRECAUTIONS
Before you use ACT 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 ACT Solifenacin.
- Are breast feeding or plan to breast feed.
ACT Solifenacin should not be given to children or adolescents.
ACT 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, ACT 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 ACT Solifenacin and see your doctor immediately.
INTERACTIONS WITH THIS MEDICATION
Before and while taking ACT Solifenacin you should tell your doctor about your other medications, even if the medicine you bought without prescription including vitamins and herbal supplements.
Solifenacin succinate 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, ancholinergic drugs, drugs that stimulate the motility of the gut such as metoclopramide, ketoconazole, clarithromycin, erythromycin, diclofenac, nefazodone, verapamil.
Drinking grapefruit juice with ACT 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.
ACT 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 side 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 ACT 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 call your doctor or pharmacist | ||
| 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) | √ | |||
HOW TO STORE IT
Keep ACT Solifenacin 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: ----------------------------------------------------------------------------
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. |
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Actavis Pharma Company, at 1-866-254-6111.
Actavis Pharma Company
6500 Kitimat Road
Mississauga, ON
Canada, L5N 2B8
Date revised: March 7, 2014