Consumer Information for: ENABLEX

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

ENABLEX* 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

ENABLEX* belongs to a class of medicines called antimuscarinic medicines, which reduces abnormal bladder contractions.

When it should not be used

Do not take ENABLEX*:

  • if you have or have had previously experienced an allergic reaction when taking darifenacin or any of the other ingredients of ENABLEX*.
  • 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 ENABLEX* is darifenacin hydrobromide.

What the non-medicinal ingredients are

Each 7.5 mg tablet also contains colloidal silicon dioxide, dibasic calcium phosphate anhydrous, hypromellose, magnesium stearate, PEG 8000, polyvinyl alcohol, talc and titanium dioxide.

Each 15 mg tablet also contains colloidal silicon dioxide, dibasic calcium phosphate anhydrous, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, PEG 8000, polyvinyl alcohol, talc, and titanium dioxide.

What dosage form it comes in

ENABLEX* is available as Extended Release Tablets containing 7.5 or 15 mg of darifenacin (as darifenacin hydrobromide).

Warnings and precautions

Before you use ENABLEX* 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 ENABLEX* on the ability to drive and use machines have been performed. However, antimuscarinic such as ENABLEX* 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 ENABLEX*.
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

ENABLEX* 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 ENABLEX*
Take ENABLEX* 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 ENABLEX*, 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, ENABLEX* can have side effects. The side effects caused by ENABLEX* are usually mild and temporary.

ENABLEX* 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 ENABLEX*, contact your doctor or pharmacist.

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor or pharmacist Only if severe Talk with your doctor or pharmacist In all cases Stop taking drug and call your doctor or pharmacist
Uncommon
Acute urinary retention (sudden inability to urinate): bladder pain, abdominal pain     ✔
Serious allergic reactions including swelling mainly of the face and throat, rash, itching, hives, difficulty breathing or swallowing, and dizziness     ✔
Swelling of the face, lips, tongue and/or throat (signs of angioedema)     ✔
How to store
  • 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.
Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

NOTE: Should you require information related to the management of the side effect, please contact your health care provider before notifying Canada Vigilance. 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 at:
http://www.searchlightpharma.ca

This leaflet was prepared by Searchlight Pharma Inc.
1600 Notre-Dame West St., Suite 312
Montreal, QC H3J 1M1 Date of Revision: February 4, 2019

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