Apo-Darifenacin: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

APO-DARIFENACIN is used for the treatment of the symptoms of overactive bladder in adults which include urge to rush to the toilet, needing to go to the toilet frequently, and/or leaking or wetting accidents. Other causes of these symptoms such as urinary tract infections, pregnancy, and various other conditions in the urinary tract should be excluded by your physician before this treatment is started.

What it does:

APO-DARIFENACIN belongs to a class of medicines called antimuscarinic medicines, which reduces abnormal bladder contractions.

When it should not be used:

Do not take APO-DARIFENACIN:

• if you have or have had previously experienced an allergic reaction when taking darifenacin or any of the other ingredients of APO-DARIFENACIN.

• if you have difficulties in urinating

  (urinary retention).

• if you have delayed or slow emptying of your stomach (gastric retention)
• if you have high pressure in the eyes with gradual loss of eyesight (narrow-angle glaucoma).

What the medicinal ingredient is:

The active substance in APO-DARIFENACIN is darifenacin hydrobromide.

What the important nonmedicinal ingredients are:

Each 7.5 mg tablet also contains anhydrous dibasic calcium phosphate, colloidal silicon dioxide, hypromellose, magnesium stearate, polyvinyl alcohol, polyethylene glycol, talc and titanium dioxide.

Each 15 mg tablet also contains anhydrous dibasic calcium phosphate, colloidal silicon dioxide, euroxide red iron oxide, hypromellose, magnesium stearate, polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide and yellow iron oxide.

What dosage forms it comes in:

APO-DARIFENACIN is available as Extended Release Tablets containing 7.5 or 15 mg of darifenacin (as darifenacin hydrobromide).

WARNINGS AND PRECAUTIONS

Before you use APO-DARIFENACIN talk to your doctor or pharmacists if:

• you have difficulties in passing urine and a poor stream of urine.
• you have severe constipation.
• you have an obstructive gastrointestinal disorder (blockage of the stomach or the intestine).
• If you have or have had high pressure in the eyes with gradual loss of eyesight (narrow-angle glaucoma).
• you have any liver problems.
• You have heart diseases.
• you are pregnant, or trying to become pregnant.
• you are breast-feeding.

• No studies of the effects of darifenacin hydrobromide on the ability to drive and use machines have been performed. However, antimuscarinic such as APO-DARIFENACIN may produce dizziness or blurred vision. Patients experiencing these side effects should not drive or use machines.

INTERACTIONS WITH THIS MEDICATION

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including herbal or non-prescription medicines.

Some medicines may interact with APO-DARIFENACIN. These include: some antibiotics (i.e. clarithromycin), some antifungal medicines (i.e. ketoconazole, itraconazole, miconazole), some antiviral medicines (i.e. ritonavir), some antipsychotic medicines (i.e. thioridazine), some antidepressants (i.e. imipramine, nefazodone), some drugs used to treat heart problems (i.e. flecainide, digoxin), some drugs used to reduce the production of acid in the stomach (i.e. cimetidine) and other antimuscarinic medicines.

PROPER USE OF THIS MEDICATION

Follow your doctor’s instructions carefully. Do not exceed the recommended dosage. You should check with your doctor or pharmacist if you are unsure.

Usual adult dose:

APO-DARIFENACIN is intended for use in adults.

For all patients, the recommended starting dose is 7.5 mg daily, and your doctor may increase to 15 mg if necessary after two weeks. Your doctor may prescribe the lowest dose if you have liver problems.

When and how to take APO-DARIFENACIN

Take APO-DARIFENACIN tablets once a day, at about the same time each day. The tablets should be swallowed whole with water and not chewed, divided or crushed and may be taken with or without food.

Overdose:

If you have taken more tablets than you have been told to take, or if someone else accidentally takes your tablets, go to your doctor or hospital for advice immediately. You may require medical attention. Show them your pack of tablets.

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 you forget to take APO-DARIFENACIN, take it as soon as you remember. If it is nearly time for your next dose, you should leave out the tablet you forgot to take and take the next tablet at the usual time. Do not take a double dose to make up for the one that you missed as this may increase the chance of you getting an unwanted side effect.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medicines, APO-DARIFENACIN can have side effects. The side effects caused by APO-DARIFENACIN are usually mild and temporary.

APO-DARIFENACIN may cause the following:

These side effects are very common (in more than 1 in 10 patients): dry mouth, constipation.

These side effects are common (between 1 and 10 in every 100 patients): headache, abdominal pain, stomach discomfort after meals, nausea, dry eyes, and nasal dryness

These side effects are uncommon (between 1 and 10 in every 1,000 patients): weakness, accidental injury, facial swelling, high blood pressure, diarrhea, flatulence, inflammation of the mucous membrane of the mouth, increased liver enzymes, swollen hands, ankles or feet, generalized swelling, dizziness, insomnia, drowsiness, abnormal thinking, runny or stuffy nose (rhinitis), cough increased, shortness of breath, dry skin, itching, rash, sweating, visual disturbance, disturbed sense of taste, urinary tract disorder or infection, impotence, discharge and itching in the vagina, bladder pain, difficulty or pain when passing urine.

If any of these side effects affects you severely, tell your doctor.

This is not a complete list of side effects. For any unexpected effects while taking APO-DARIFENACIN, contact your doctor or pharmacist.

HOW TO STORE IT

• Keep out of the reach and sight of children.
• Store between 15 to 30°C.
• Do not use after the expiry date stated on the carton.

MORE INFORMATION

For more information, please contact your doctor, pharmacist or other healthcare professional.

This leaflet plus the full product monograph, prepared for health professionals, can be obtained by contacting DISpedia, Apotex's Drug Information Service at:

1-800-667-4708

This leaflet can also be found at: http://www.apotex.ca/products

Last prepared: February 23, 2016

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, Ontario

    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.