Patient Medication Information: uses, side effects, how to take - Enablex
ABOUT THIS MEDICATION
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 important nonmedicinal 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 forms 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 | Stop taking drug and call your doctor or pharma-cist | |||
| Only if severe | In all cases | ||||
| 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 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.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. 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
1600 Notre-Dame West St., Suite 312
Montreal, QC H3J 1M1
Date of Revision: February 4, 2019