1007454 vi_en__

IMPORTANT: PLEASE READ
PART III: CONSUMER INFORMATION
Pr Sandoz® Clarithromycin
Clarithromycin 250 and 500 mg film-coated tablets This leaflet is part III of a three-part “Product Monograph” published when ț if you have or develop severe diarrhea as this may be a sign of a more Sandoz Clarithromycin was approved for sale in Canada and is designed specifically for consumers. This leaflet is a summary and will not tell you everything about Sandoz Clarithromycin. Contact your doctor or pharmacist if ț if you are taking astemizole, terfenadine, cisapride, pimozide, ergotamine, dihydro ergotamine, digoxin, or colchicine; ABOUT THIS MEDICATION
ț if you have any unusual or allergic reaction (rash, difficulty of breathing) to What the medication is used for:
clarithromycin or any of the nonmedicinal ingredients in Sandoz Sandoz Clarithromycin is used to treat certain infections caused by bacteria, Clarithromycin (see What the important nonmedicinal ingredients are),
such as pneumonia, bronchitis, infections of the sinuses, skin, and throat.
other medicines, foods, dyes, or preservatives; When used with other medications, it can treat infection caused by a bacte- ț if you are pregnant, trying to get pregnant or are breast-feeding because ria called H. pylori and reduce the risk of duodenal ulcer recurrence. A duo- clarithromycin has been detected in human breast milk.
denal ulcer is a sore on the lining of the duodenum, which is the beginning of WHILE taking Sandoz Clarithromycin, contact your doctor: ț if you develop symptoms of myasthenia gravis or the symptoms of your It can also be prescribed to prevent and combat MAC disease in patients with existing myasthenia gravis worsen. These symptoms could include mus- HIV. MAC is a short word for Mycobacterium avium complex, the germs that cle weakness that gets worse with activity and gets better with rest, drooping eyelid, blurred or double vision, difficulty chewing and swallow- What it does:
Sandoz Clarithromycin is an antibiotic that kills bacteria in your body.
INTERACTIONS WITH THIS MEDICATION
When it should not be used:
Drugs that may interact with Sandoz Clarithromycin include: Alfentanil,
alprazolam, astemizole/terfenadine, atazanavir, atorvastatin, bromocriptine, ț You have ever had an allergic reaction to clarithromycin, or if you are sen- carbamazepine, cilostazol, cisapride/pimozide, colchicine, cyclosporine, sitive to it or to erythromycin, or any other antibacterial agent of the same digoxin, disopyramide/quinidine, efavirenz, ergotamine/dihydroergotamine, family or to any ingredient in the formulation (see What the important
fluconazole, hexobarbital, itraconazole, lansoprazole/ omeprazole, lovastatin/ nonmedicinal ingredients are).
simvastatin, methylprednisolone, midazolam/triazolam, nevirapine, pheny- ț You are taking astemizole*, cisapride*, pimozide, terfenadine*, ergota- mine, or dihydroergotamine. These medicines can interact, possibly lead- toin, rifabutin/rifampin, rifapentine*, ritonavir/indinavir, saquinavir, sildenafil, ing to an irregular heartbeat pattern; deaths have occurred.
tacrolimus, tadalafil, theophylline, tolterodine, valproic acid, vardenafil, vera-pamil, vinblastine, warfarin/acenocoumarol, zidovudine and drugs metabo- What the medicinal ingredient is: Clarithromycin
What the important nonmedicinal ingredients are:
PROPER USE OF THIS MEDICATION
Sandoz Clarithromycin contains microcrystalline cellulose, magnesiumstearate, croscar mellose sodium, powdered cellulose, colloidal silica anhy- Usual Adult Dose:
Sandoz Clarithromycin may be taken with or without meals.
What dosage forms it comes in:
Respiratory Tract or Skin Infections:
Sandoz Clarithromycin: Tablets of 250 & 500 mg The usual dosage of Sandoz Clarithromycin is 250 mg to 500 mg every12 hours for 7 to 14 days.
WARNINGS AND PRECAUTIONS
Infections with H. pylori :
Serious Warnings and Precautions
Triple Therapy: Sandoz Clarithromycin + Omeprazole + Amoxicillin Sandoz Clarithromycin should not be used in pregnancy unless advised by The recommended dose is the following for 10 days: your doctor due to potential hazards to the fetus. Do not take Sandoz – Sandoz Clarithromycin: 500 mg every 12 hours Clarithromycin without first talking to your doctor if you are breast-feeding.
Before taking Sandoz Clarithromycin, tell your doctor if you have liver or kidney disease. You may not be able to take clarithromycin, or you may Double Therapy: Sandoz Clarithromycin + Omeprazole require a lower dose and special monitoring during therapy. Talk to your The recommended dose is the following for 14 days: doctor if Sandoz Clarithromycin gives you prolonged and severe diarrhea.
– Sandoz Clarithromycin: 500 mg every 8 hours The development of antibiotic resistance has been seen in patients with HIV – Omeprazole: 40 mg once daily followed by 20 mg omeprazole once daily receiving clarithromycin. To avoid failure of the treatment with a potential for developing antimicrobial resistance and a risk of failure with subsequenttherapy, you/your child should follow closely the prescribed regimen.
MAC Disease:
The recommended dose of Sandoz Clarithromycin for prevention and treat-
BEFORE you use Sandoz Clarithromycin talk to your doctor or pharmacist: ment of MAC disease is 500 mg every 12 hours.
ț about all health problems you have now or have had in the past; Treatment of disseminated MAC infection (MAC infection spread through your ț about all other medicines you are taking, including non-prescription medi- cines, nutritional supplements, or herbal products (see INTERACTIONS
whole body) in patients with HIV should continue for life if improvement of WITH THIS MEDICATION);
Overdose:
MORE INFORMATION
Contact your doctor, pharmacist or local poison control centre if you have This document, plus the full product monograph prepared for health profes- taken more than the recommended dose. Symptoms of Sandoz sionals, can be found at: www.sandoz.ca or by contacting the sponsor,
Clarithromycin overdose are abdominal pain, vomiting, nausea, and diarrhea.
Sandoz Canada Inc. at 1-800-361-3062
Missed Dose:
If you miss a dose, take it as soon as you remember unless it is almost time 145, Jules-Léger, Boucherville (QC) Canada J4B 7K8 for the next dose. In that case, skip the missed dose and take the next one as directed. Do not take double or extra doses.
This leaflet was prepared by Sandoz Canada Inc.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medicines, Sandoz Clarithromycin can cause side effects. The majorityof side effects observed in clinical trials with Sandoz Clarithromycin were ofa mild and transient nature.
The following adverse reactions were reported during the clinical studies withclarithromycin, the medicinal ingredient (occurring between 1% and 10% inclinical trials) or during postmarketing surveillance: abdominal pain, abnor-mal taste, diarrhea, ear disorder, flatulence, indigestion, headache, nausea,rash, vomiting. Talk to your doctor or pharmacist if any of these side effectspersist or become bothersome.
Serious side effects from Sandoz Clarithromycin are not common.
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN
AND WHAT TO DO ABOUT THEM
Symptom/effect
Talk with your
Stop taking
doctor or
drug and call
pharmacist
your doctor or
pharmacist
severe cases
Uncommon Allergic reactions*
*Allergic reactions, with symptoms such as itching, skin eruptions, rash, sore throat, fever, swelling, skin rash, itchiness, difficulty breathing, lightheadedness/dizziness.
This is not a complete list of side effects. For any unexpected effects whiletaking Sandoz Clarithromycin, contact your doctor or pharmacist.
HOW TO STORE IT
Sandoz Clarithromycin should be stored at controlled room temperaturebetween 15 and 30°C in a tightly closed container. Keep out of reach fromchildren.
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:
1. Report online at www.healthcanada.gc.ca/medeffect2. Call toll-free at 1-866-234-23453. Complete a Canada Vigilance Reporting Form and: – Fax toll-free to 1-866-678-6789, or– Mail to: Canada Vigilance Program Health CanadaPostal Locator 0701COttawa ON K1A 0K9 ® Registered trademark used under license by Sandoz Canada Inc.
Postage paid labels, Canada Vigilance Reporting Form and the adversereaction reporting guide lines are available on the MedEffectTM Canada Website at www.healthcanada.gc.ca/medeffect Sandoz Canada Inc.
QC, Canada J4B 7K8 NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does ? 1-800-361-3062

Source: http://hexal-elements.de/sandoz_ca/2/docs/package_inserts/13580-13590-13600-13605_Clarithromycin_EN_1007454.pdf