Dificid - Consumer Medicine Information
|Manufacture:||Merck and Co., Inc.|
|Ingredients:||fidaxomicin, butylated hydroxytoluene, hydroxypropyl cellulose, lecithin (soy), magnesium stearate , microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinised starch, sodium starch glycolate, talc and titanium dioxide|
About this Medication
What the medication is used for
DIFICID is used in adults to treat infections of the lining of the colon (large intestine) with certain bacteria called Clostridium difficile. This serious illness can result in painful, severe diarrhea.
What it does
DIFICID is used to kill the bacteria which cause Clostridium difficile infections.
When it should not be used
If you are allergic (hypersensitive) to the active substance fidaxomicin, or any of the other ingredients of DIFICID (see What the nonmedicinal ingredients are).
What the medicinal ingredient is
What the nonmedicinal ingredients are
butylated hydroxytoluene, hydroxypropyl cellulose, lecithin (soy), magnesium stearate , microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinised starch, sodium starch glycolate, talc and titanium dioxide.
What dosage forms it comes in
Tablets: 200 mg
Warnings and Precautions
BEFORE you use DIFICID talk to your doctor or pharmacist:
- If you have severe kidney problems or severe liver problems
- If you have inflammatory bowel disease
- If you have any allergies to this drug or its ingredients or components of the container
- If you have a known allergy to other antibiotics
- If you are pregnant or think you may be pregnant, ask your doctor or pharmacist for advice before taking this medicine. You should not take DIFICID if you are pregnant, unless your doctor tells you otherwise.
- If you are breastfeeding ask your doctor or pharmacist for advice before taking this medicine. It is not known whether fidaxomicin passes into breast milk.
- DIFICID should not be used in children or adolescents less than 18 years of age, as there is no information on the use in that population.
Interactions with this Medication
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Proper Use of this Medication
Usual adult dose
The recommended dose is one tablet (200 mg) twice daily (one tablet every 12 hours) for 10 days.
Swallow the tablets whole with a glass of water. You can take DIFICID before, during or after meals.
Full course of medication should be completed as prescribed.
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.
Take the tablet as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.
Side Effects and what to do about them
Like all medicines, this medicine can cause side effects, although not everybody gets them.
DIFICID may cause the following side effects:
- nausea, constipation, vomiting
- decreased appetite
- dizziness, headache
- dry mouth, altered taste (dysgeusia)
- bloated feeling, wind (flatulence)
DIFICID can cause abnormal blood test results (i.e., increased or abnormal liver enzymes). Your doctor will decide when to perform blood tests and will interpret the results.
Serious side effects, how often they happen and what to do about them
|Symptom / effect||Talk with your doctor, nurse, or pharmacist||Stop taking drug and seek immediate medical help|
|Only if severe||In all cases|
|Rare||Severe Allergic Reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing||✓|
This is not a complete list of side effects. For any unexpected effects while taking DIFICID, contact your doctor or pharmacist
How to Store it
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month.
DIFICID should be stored at room temperature (15° to 30°C) in a tightly closed container away from heat and direct light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
Reporting Side Effects
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report:
- Online at MedEffect;
- By calling 1-866-234-2345 (toll-free);
- By completing a Consumer Side Effect Reporting Form and sending it by:
- Fax to 1-866-678-6789 (toll-free), or
- Mail to: Canada Vigilance Program
Health Canada, Postal Locator 0701E
Ottawa, ON K1A 0K9
Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect.
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.
If you want more information about DIFICID:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information (or Consumer Informationdepending of the product ) by visiting the Health Canadawebsite or www.merck.ca or by calling 1-800-567-2594.
To report an adverse event related to DIFICID, please contact 1-800-567-2594.