Consumer Information for: AURO-SOLIFENACIN

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

AURO-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

AURO-SOLIFENACIN 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 AURO-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 AURO-SOLIFENACIN. See ‘What the non- medicinal ingredients are’
What the medicinal ingredient is

The medicinal ingredient in AURO-SOLIFENACIN Tablet is ‘solifenacin succinate’

What the non-medicinal ingredients are

Each AURO-SOLIFENACIN tablet contains the following inert ingredients:

Core Tablet:
Lactose Monohydrate, Maize starch, Hypromellose, Silica Colloidal Anhydrous & Magnesium stearate.
Film coating:
Aquarius BP14332 yellow (For 5 mg): Hypromellose, Titanium dioxide, Polyethylene Glycol, Talc & Yellow Iron Aquarius BP10212 pink (For 10 mg): Hypromellose, Titanium dioxide, Polyethylene Glycol, Talc, Red Iron Oxide. Oxide

What dosage form it comes in

AURO-SOLIFENACIN is available in 5 mg and 10 mg tablets.

Warnings and precautions

Before you use AURO-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 AURO-SOLIFENACIN.
  • Are breastfeeding or plan to breastfeed.

AURO-SOLIFENACIN should not be given to children or adolescents. AURO-SOLIFENACIN 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, AURO-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 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 lifethreatening, have been reported in some patients taking Solifenacin Succinate. If you experience any of these symptoms, stop taking AURO-SOLIFENACIN and see your doctor immediately.

Interactions with this medication

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

AURO-SOLIFENACIN 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 AURO-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.

AURO-SOLIFENACIN tablets can be taken with or without food.

Overdose

If you think you have taken too much AURO-SOLIFENACIN, contact your healthcare professional, 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 AURO-SOLIFENACIN 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 AURO-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, nurse, or pharmacist only if severe Talk with your doctor, nurse, or pharmacist in all cases Stop taking drug and talk with your doctor or pharmacist
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 AURO-SOLIFENACIN and all other medications out of the reach of children.
Store at room temperature (15°C 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 adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three 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
      Health Canada
      Postal Locator 0701E
      Ottawa ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM 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

If you want more information about AURO-SOLIFENACIN:

This leaflet was prepared by
Auro Pharma Inc.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada.

Date of Revision: March 29, 2019.

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