Jamp-Solifenacin: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

JAMP-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:

JAMP-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 JAMP-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 JAMP-Solifenacin or any of the

  other ingredients in JAMP-Solifenacin tablets. See ‘What the non-medicinal ingredients are’

What the medicinal ingredient is:

The medicinal ingredient in JAMP-Solifenacin tablet is ‘JAMP-Solifenacin’.

What the non-medicinal ingredients are:

Each JAMP-Solifenacin tablet contains the following inert ingredients: lactose monohydrate, maize starch, hypromellose, magnesium stearate.

Coating: hypromellose, talc, polyethylene glycol and titanium dioxide with yellow ferric oxide (5 mg and 10 mg JAMP-Solifenacin tablets) and red ferric oxide (10 mg JAMP-Solifenacin tablets).

What dosage form it comes in:

JAMP-Solifenacin is available in 5 and 10 mg tablets.

WARNINGS AND PRECAUTIONS

Before you use JAMP-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 JAMP-Solifenacin.

• Are breast feeding or plan to breast feed.

JAMP-Solifenacin should not be given to children or adolescents.

JAMP-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, JAMP-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 JAMP-Solifenacin. If you experience any of these symptoms, stop taking JAMP-Solifenacin and see your doctor immediately.

INTERACTIONS WITH THIS MEDICATION

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

JAMP-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, ancholinergic drugs, drugs that stimulate the motility of the gut such as metoclopramide, ketoconazole, clarithromycin, erythromycin, diclofenac, nefazodone, verapamil.

Drinking grapefruit juice with JAMP-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.

IMPORTANT: PLEASE READ

Solifenacin Succinate Page 26 of 26

JAMP-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 JAMP-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 JAMP-Solifenacin in worldwide post-marketing experience, although the frequency of events or a causal relationship with JAMP-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 JAMP-Solifenacin. This includes any side effects not listed above.

HOW TO STORE IT

Keep JAMP-Solifenacin tablets 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:

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• 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 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 professional can be obtained by contacting the JAMP Pharma Corporation.

JAMP Pharma Corporation.

1380-203 rue Newton

Boucherville, QC

Canada

J4B 5H2

Date of Revision: December 14, 2015