Patient Medication Information: uses, side effects, how to take - Campral
ABOUT THIS MEDICATION
What the medication is used for:
CAMPRAL® is used to help alcohol dependent people keep from drinking alcohol. It should be used as part of a complete treatment program that includes counselling. Before beginning this medication, you should no longer be drinking alcohol. CAMPRAL® has not been shown to be effective if you are still drinking when you start taking it.
What it does:
CAMPRAL® is believed to work by restoring the natural balance of chemicals in the brain.
When it should not be used:
If you are sensitive (allergic) to CAMPRAL®, or any
component of this medication (see, "What the important nonmedicinal ingredients are” section).
- If you suffer from severe kidney problems.
If you are breast-feeding.
What the medicinal ingredient is:
Acamprosate calcium
What the important nonmedicinal ingredients are:
anionic copolymer of methacrylic acid and acrylic acid ethyl ester, colloidal anhydrous silica, crospovidone, magnesium silicate, magnesium stearate, microcrystalline cellulose, propylene glycol, sodium starch glycolate and talc.
What dosage forms it comes in:
Each CAMPRAL® delayed-release tablet 333 mg is available as an enteric-coated, white, round-shaped tablet with “333” on one side. Tablets are supplied in blisters of 84 tablets.
WARNINGS AND PRECAUTIONS
If you develop any new or worsening mental health symptoms such as depression or thoughts of suicide while taking CAMPRAL® you should talk to your doctor or pharmacist immediately.
The use of CAMPRAL® does not eliminate or reduce the symptoms of alcohol withdrawal (the symptoms people experience when they stop drinking alcohol abruptly when they are dependent
on alcohol).
CAMPRAL® therapy should be used as a part of a treatment program that includes counselling and support.
CAMPRAL® therapy should be continued as directed, even in the event of relapse (renewed drinking of alcohol) and any renewed drinking should be discussed with your doctor.
BEFORE you use CAMPRAL® talk to your doctor or pharmacist if:
- You are pregnant or likely to become pregnant.
- Campral could be used during pregnancy if you can not abstain from alcohol without being treated with Campral. Campral does not prevent the harmful effect on fetus of alcohol intake.
Although in controlled studies CAMPRAL® has not been shown to impair coordination, certain drugs (e.g. sedatives, antidepressants) may impair judgment, thinking, or motor skills. Take precaution when operating hazardous machinery, including automobiles, until you are reasonably certain that CAMPRAL® therapy does not affect your ability to participate in such activities.
INTERACTIONS WITH THIS MEDICATION
CAMPRAL® has not been shown to interact significantly with other medications. If you are currently taking a medication, whether on prescription or otherwise, inform you doctor or pharmacist.
PROPER USE OF THIS MEDICATION
Usual dose:
The recommended dose of CAMPRAL® is two 333 mg tablets taken three times daily. CAMPRAL® should be swallowed whole, not crushed or chewed or split, and may be taken with or without food.
Treatment in patients with moderate kidney disease requires a dose reduction (one 333 mg tablet taken three times daily).
Never take more than the prescribed dose.
Lower dose may be prescribed temporarily for tolerability reasons.
Overdose:
Seek emergency medical attention. Symptoms of overdose may include diarrhea.
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.
Page 22 of 22 Missed Dose:
If you missed a dose, skipped the missed dose and resume your
usual dosing schedule. Do not double the dose to catch up.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
The side effects most often seen are gastrointestinal in nature, such as diarrhea, abdominal pain, gas and nausea. If you experience any of these effects, continue taking CAMPRAL® and talk to your doctor.
Other less common side effects may include:
- Rash, itching
- Weight gain/loss,
- Change in sexual desire or ability
Check with you doctor or pharmacists if you experience any unexpected effects, or are concerned by the above side effects
| 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 pharmacist | ||
| Only if severe | In all cases | |||
| Common | Rash or itching Thoughts or acts of self harm (suicide) | √ | √ | |
| Uncommon | Allergic reaction (Rash or itching, swelling, severe dizziness, trouble breathing) Joint pain | √ √ | ||
This is not a complete list of side effects. For any unexpected effects while taking CAMPRAL®, contact your doctor or pharmacist.
HOW TO STORE IT
Store at room temperature (15-30°C).
Keep out of reach of children.
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:
- Report online at: www.healthcanada.gc/ca/medeffectt
- 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 0701D
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
This document plus the full product monograph, prepared for health professionals can be found at:
http:// www.mylan.ca
or by contacting the sponsor, Mylan Pharmaceuticals ULC, at: 1-800-575-1379