Details for: AURO-SOLIFENACIN
Company: AURO PHARMA INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02446375 | AURO-SOLIFENACIN | SOLIFENACIN SUCCINATE | 5 MG | TABLET | ORAL |
| 02446383 | AURO-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
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
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.
| 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:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website ( https://health-products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website www.auropharma.ca, or by calling 1-855-648-6681.
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.