PART III: CONSUMER INFORMATION Sandoz …

1 If you have or develop severe diarrhea as this may be a sign of a moreserious condition; if you have kidney problems; if you have liver problems; if you are taking astemizole, terfenadine, cisapride, pimozide, ergotamine,dihydro ergotamine, digoxin, or colchicine; if you have any unusual or allergic reaction (rash, difficulty of breathing) toclarithromycinor any of the nonmedicinal ingredients in Sandoz Clarithromycin (see What the importantnonmedicinal ingredients are),other medicines, foods, dyes, or preservatives.

2 If you are pregnant, trying to get pregnant or are breast-feeding becauseclarithromycin has been detected in human breast taking Sandoz Clarithromycin, contact your doctor: if you develop symptoms of myasthenia gravis or the symptoms of yourexisting myasthenia gravis worsen. These symptoms could include mus-cle weakness that gets worse with activity and gets better with rest,drooping eyelid, blurred or double vision, difficulty chewing and swallow-ing, or trouble WITH THIS MEDICATIOND rugs that may interact with Sandoz Clarithromycin include.

3 Alfentanil,alprazolam, astemizole/terfenadine, atazanavir, atorvastatin, bromocriptine,carbamazepine, cilostazol, cisapride/pimozide, colchicine, cyclosporine,digoxin, disopyramide/quinidine, efavirenz, ergotamine/dihydroergotamine,fluconazole , hexobarbital, itraconazole, lansoprazole/ omeprazole, lovastatin/simvastatin, methylprednisolone, midazolam/triazolam, nevirapine, pheny-toin, rifabutin/rifampin, rifapentine*, ritonavir/indinavir, saquinavir, sildenafil,tacrolimus, tadalafil, theophylline, tolterodine, valproic acid, vardenafil, vera-pamil, vinblastine,warfarin/acenocoumarol, zidovudine and drugs metabo-lized by cytochrome P450 system.

4 * not marketed in USE OF THIS MEDICATIONU sual Adult Dose: Sandoz Clarithromycin may be taken with or without Tract or Skin Infections:The usual dosage of Sandoz Clarithromycin is 250 mg to 500 mg every12 hours for 7 to 14 with H. pylori:Triple Therapy: Sandoz Clarithromycin + Omeprazole + AmoxicillinThe recommended dose is the following for 10 days: Sandoz Clarithromycin: 500 mg every 12 hours Omeprazole: 20 mg once daily Amoxicillin: 1 g every 12 hoursDouble Therapy: Sandoz Clarithromycin + OmeprazoleThe recommended dose is the following for 14 days: Sandoz Clarithromycin: 500 mg every 8 hours Omeprazole: 40 mg once daily followed by 20 mg omeprazole once dailyfor 14 Disease.

5 The recommended dose of Sandoz Clarithromycin for prevention and treat-ment of MAC disease is 500 mg every 12 of disseminated MAC infection (MAC infection spread through yourwhole body) in patients with HIV should continue for life if improvement ofsymptoms is : PLEASE READPART III: CONSUMER INFORMATIONS andoz ClarithromycinClarithromycin 250 and 500 mg film-coated tabletsPrThis leaflet is part III of a three-part product Monograph published whenSandoz Clarithromycin was approved for sale in Canada and is designedspecifically for leaflet is a summary and will not tell youeverything about Sandoz Clarithromycin.

6 Contact your doctor or pharmacist ifyou have any questions about the drug. ABOUT THIS MEDICATIONWhat the medication is used for: Sandoz Clarithromycin is used to treat certain infections caused by bacteria,such as pneumonia, bronchitis, infections of the sinuses, skin, and used with other medications, it can treat infection caused by a bacte-ria called H. pyloriand reduce the risk of duodenal ulcer recurrence. A duo-denal ulcer is a sore on the lining of the duodenum, which is the beginning ofthe small can also be prescribed to prevent and combat MAC disease in patients withHIV.

7 MAC is a short word for Mycobacterium aviumcomplex, the germs thatcause MAC it does: Sandoz Clarithromycin is an antibiotic that kills bacteria in your it should not be used:Do not take Sandoz Clarithromycin if: You have ever had an allergic reaction to clarithromycin, or if you are sen-sitive to it or to erythromycin, or any other antibacterial agent of the samefamily or to any ingredient in the formulation (see What the importantnonmedicinal ingredients are). You are taking astemizole*, cisapride*, pimozide, terfenadine*, ergota-mine, or dihydroergotamine.

8 These medicines can interact, possibly lead-ing to an irregular heartbeat pattern; deaths have occurred.* no longer marketed in the medicinal ingredient is: ClarithromycinWhat the important nonmedicinal ingredients are: Sandoz Clarithromycin contains microcrystalline cellulose, magnesiumstearate, croscar mellose sodium, powdered cellulose, colloidal silica anhy-drous and Opadry dosage forms it comes in: Sandoz Clarithromycin: Tablets of 250 & 500 mgWARNINGS AND PRECAUTIONSS erious Warnings and PrecautionsSandoz Clarithromycin should not be used in pregnancy unless advised byyour doctor due to potential hazards to the fetus.

9 Do not take Sandoz Clarithromycin without first talking to your doctor if you are taking Sandoz Clarithromycin, tell your doctor if you have liver orkidney disease. You may not be able to take clarithromycin, or you mayrequire a lower dose and special monitoring during therapy. Talk to yourdoctor if Sandoz Clarithromycin gives you prolonged and severe development of antibiotic resistance has been seen in patients with HIVreceiving clarithromycin. To avoid failure of the treatment with a potentialfor developing antimicrobial resistance and a risk of failure with subsequenttherapy, you/your child should follow closely the prescribed you use Sandoz Clarithromycin talk to your doctor or pharmacist: about all health problems you have now or have had in the past; about all other medicines you are taking, including non-prescription medi-cines, nutritionalsupplements, or herbal products (see INTERACTIONSWITH THIS MEDICATION).

10 MORE INFORMATIONThis document, plus the full product monograph prepared for health profes-sionals, can be found at: by contacting the sponsor, Sandoz Canada 1-800-361-3062or by written request at: 145, Jules-L ger, Boucherville (QC) Canada J4B 7K8or by e-mail at: leaflet was prepared by Sandoz Canada :Contact your doctor, pharmacist or local poison control centre if you havetaken more than the recommended dose. Symptoms of Sandoz Clarithromycin overdose are abdominal pain, vomiting, nausea, and Dose:If you miss a dose, take it as soon as you remember unless it is almost timefor the next dose.