[modèle de monographie de produit – norme]

PART III: CONSUMER INFORMATION
What dosage forms it comes in:
PrBIAXIN®
clarithromycin for oral suspension, USP
● liquid forms (BIAXIN®, 125 mg/5mL and 250 mg/5mL). ● extended-release tablets (BIAXIN® XL, 500 mg), This leaflet is Part III of a three-part “Product Monograph" published ● regular tablets (BIAXIN BID®, 250 mg and 500 mg). when BIAXIN® was approved for sale in Canada and is designed specifically for consumers. This leaflet is a summary and will not tell WARNINGS AND PRECAUTIONS
you everything about BIAXIN®. Contact your doctor or pharmacist if you have any questions about the drug. Serious Warnings and Precautions
ABOUT THIS MEDICATION
BIAXIN® should not be used in pregnancy unless advised by
your doctor due to potential hazards to the fetus. Do not take
What the medication is used for:
BIAXIN® without first talking to your doctor if you are
breast-feeding a baby.
BIAXIN® is used to treat certain infections caused by bacteria, such as pneumonia, otitis, and infections of the skin and throat Before taking BIAXIN®, tell your doctor if you/your child
have liver or kidney disease. You may not be able to take
clarithromycin, or you/your child may require a lower dose
It can also be prescribed to combat mycobacterial infections. and special monitoring during therapy. Talk to your doctor
Mycobacteria are a group of bacteria that cause several diseases. if BIAXIN® gives you/your child prolonged and severe
diarrhea.
What it does:
The development of antibiotic resistance has been seen in
BIAXIN® is an antibiotic that kills bacteria in your body. patients with HIV receiving clarithromycin. To avoid failure
When it should not be used:
of the treatment with a potential for developing antimicrobial
resistance and a risk of failure with subsequent therapy,
Do not take BIAXIN® if you/your child have ever had an allergic you/your child should follow closely the prescribed regimen.
reaction to it, or if you/your child are sensitive to it or erythromycin, or other antibacterial agents of the same family or to any ingredient in the formulation. See (What the important non-
BEFORE you/your child use BIAXIN® talk to your doctor or
medicinal ingredients are:).
pharmacist:
Do not take BIAXIN® if you/your child are taking astemizole*, ● about all health problems you/your child have now or have cisapride*, colchicine, pimozide, terfenadine*, ergotamine, dihydroergotamine, lovastatin or simvastatin. Astemizole*, ● about all other medicines you/your child are taking, including cisapride*, pimozide, terfenadine*, ergotamine, dihydroergotamine non-prescription medicines, nutritional supplements, or herbal and colchicine can interact with BIAXIN®, possibly leading to an products. See (INTERACTIONS WITH THIS MEDICATION);
irregular heartbeat pattern; deaths have occurred. ● if you/your have or develop severe diarrhea as this may be a ● if you/your child have kidney problems; ● if you/your child have liver problems; Do not take BIAXIN® if you have ever developed liver problems ● if you/your child are taking astemizole, terfenadine, cisapride, pimozide, ergotamine, dihydroergotamine, digoxin, colchicine, atorvastatin, pravastatin, lovastatin or simvastatin. Do not use BIAXIN® if you have a history of heart disturbance or ● if you/your child have any unusual or allergic reaction (rash, irregular heart beat (arrhythmias, QT prolongation, torsade de difficulty breathing) to clarithromycin or any of the non- medicinal ingredients in BIAXIN® (see What the important non-
medicinal ingredients are), other medicines, foods, dyes, or
What the medicinal ingredient is:
● if you are pregnant, trying to get pregnant or are breast-feeding The medicinal ingredient is clarithromycin. because clarithromycin has been detected in human breast milk. What the important non-medicinal ingredients are:
if you are elderly with a history of liver or kidney problems The non-medicinal ingredients are the following: carbopol, povidone, polymer, sucrose or sugar, maltodextrin, xanthan gum, silicon dioxide, potassium sorbate, citric acid, artificial and natural fruit flavour, castor oil, and titanium dioxide. BIAXIN BID®, BIAXIN® XL, BIAXIN® Product Monograph Date of Revision: December 20, 2012 and Control No.159167 WHILE taking BIAXIN®, contact your doctor if:
next dose at the regular time. Do not take/give to your child double or extra doses. ● You develop symptoms of myasthenia gravis or the symptoms of your existing myasthenia gravis worsen. These symptoms SIDE EFFECTS AND WHAT TO DO ABOUT THEM
could include muscle weakness that gets worse with activity and gets better with rest, drooping eyelid, blurred or double vision, difficulty chewing and swallowing, or trouble breathing. Like all medicines, BIAXIN® can cause side effects. The majority ● You develop symptoms of hepatitis (liver inflammation) such of side effects observed in clinical trials with BIAXIN® were of a as abdominal pain, nausea, vomiting, yellowing of skin and eyes, dark urine etc. Stop taking the drug immediately. The following adverse reactions were reported during the clinical studies with clarithromycin, the medicinal ingredient (occurring INTERACTIONS WITH THIS MEDICATION
between 1% and 10% in clinical trials) or during post-marketing surveillance: abdominal pain, abnormal taste, diarrhea, ear disorder, Drugs that may interact with BIAXIN® includes:
flatulence, indigestion, headache, nausea, rash, vomiting. Talk to your doctor or pharmacist if any of these side effects persist or become Alfentanil, alprazolam, amlodipine, astemizole*/terfenadine*, atazanavir, atorvastatin, bromocriptine, carbamazepine, cilostazol, cisapride*/pimozide, colchicine, cyclosporine, digoxin, diltiazem, Serious side effects from BIAXIN® are not common. disopyramide/quinidine, efavirenz, ergotamine/ dihydroergotamine, etravirine, fluconazole, hexobarbital, insulin, If dizziness, confusion or disoritentation occur while taking BIAXIN®, do not drive or operate machinery. lovastatin/pravastatin/simvastatin, methylprednisolone, midazolam/triazolam, nateglinide, nevirapine, SERIOUS SIDE EFFECTS, HOW OFTEN THEY
phenobarbital, phenytoin, pioglitazone, repaglinide, HAPPEN AND WHAT TO DO ABOUT THEM
rifabutin/rifampin, rifapentine*, ritonavir/indinavir, Talk with your
Stop taking
rosiglitazone, rosuvastatin, saquinavir, sildenafil, St. John’s Wort doctor or
(Hypericum perforatum), tacrolimus, tadalafil, theophylline, Symptom/effect
pharmacist
tolterodine, valproic acid, vardenafil, verapamil, vinblastine, call your
warfarin/acenocoumarol, zidovudine and drugs metabolized by doctor or
pharmacist
PROPER USE OF THIS MEDICATION
Usual Dose:
BIAXIN® may be taken with or without meals. The recommended daily dosage of BIAXIN® is 15 mg/kg/day, in divided doses every 12 hours, not to exceed 1000 mg/day. The usual duration of treatment is for 5 to 10 days. Ask your pharmacist to Overdose:
*Allergic reactions, with symptoms such as itching, skin In case of overdose, contact your healthcare professional, hospital eruptions, rash, sore throat, fever, swelling, skin rash, itchiness, emergency department or regional poison control centre, even if difficulty breathing, lightheadedness/dizziness. there are no symptoms. Symptoms of BIAXIN® overdose are abdominal pain, vomiting, nausea, and diarrhea. This is not a complete list of side effects. For any unexpected effects
while taking BIAXIN®, contact your doctor or pharmacist.

Missed Dose:
HOW TO STORE IT
If you/your child miss a dose of BIAXIN®, take/give to your child the missed dose as soon as you remember. If it is almost time for Keep BIAXIN® and all other medicines out of reach of children. your/your child’s next dose, wait and take/give to your child the BIAXIN BID®, BIAXIN® XL, BIAXIN® Product Monograph Date of Revision: December 20, 2012 and Control No.159167 Store at room temperature (15 to 25°C) in a tightly closed container. Protect from light. Do not use beyond the expiration date. 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 on line at:

● Call toll-free at 1-866-234-2345
● Complete a Canada Vigilance Reporting Form and:
Fax toll-free to 1-866-678-6789
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

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: or by contacting the sponsor, Abbott Laboratories, Limited, Saint-Laurent, Qc H4S 1Z1 at: 1-800-699-9948 This leaflet was prepared by Abbott Laboratories, Limited. BIAXIN BID®, BIAXIN® XL, BIAXIN® Product Monograph Date of Revision: December 20, 2012 and Control No.159167

Source: http://alphatrackmeter.com/static/cms_workspace/en_CA/content/document/BIAXIN-PM-20DEC12-PI.pdf