COAMOX-MEpHaTM Mepha LLC

(amoxicillin + clavulanic acid) Composition CoAmox-Mepha 375, 625 and 1000 Lactab: each film-coated tablet contains: AMX (amoxicillin in the form of the trihydrate) + CLV (clavulanic acid in the form of potassium clavulanate): 250 mg + 125 mg or 500mg + 125mg or 875mg + 125mg and other excipients; CoAmox-Mepha 156.25, 312.5 and 457 Suspension: 5 ml suspension contains: AMX + CLV: 125 mg + 31.25 mg, preservatives: sodium benzoate (E 211), saccharin sodium, aromatics and other excipients or 250 mg + 62.5 mg, preservatives: sodium benzoate (E 211), saccharin sodium, aromatics, vanillin and other excipients or 400mg + 57 mg, saccharin sodium, aromatics, bergamot oil, vanillin and other excipients. Indications and Dosage Gram-positive and negative bacterial infections with pathogens which are sensitive. CoAmox-Mepha 375, 625 and 1000 Lactab, CoAmox-Mepha 156.25 and 312.5 Suspension: ORL infections; lower respiratory tract infections; urinary tract infections; gastrointestinal infections; venereal diseases; infections of the skin and soft tissue; gynaecological infections. CoAmox-Mepha 457 Suspension: tonsillitis, otitis media; lower respiratory tract infections. Adults and children over 40kg: mild, moderately severe and severe infections: 3 x 625 mg/ day, in special cases 2 x 1 g or 3 x 625 mg/day; if necessary possible increase up to max. 3x 1g/day. Children up to 40kg: CoAmox-Mepha 156.25 and 312.5 Suspension (daily dose divided into 3 single doses): <2 years: 2550 mg/kg/day (equivalent to 20mg AMX / 5mg CLV to 40mg AMX / 10mg CLV); >2 years: mild to moderately severe infections: 25-37.5mg/kg/day (equivalent to 20mg AMX / 5mg CLV to 30mg AMX / 7.5mg CLV); severe infections: 50-75 mg/kg/day (equivalent to 40 mg AMX / 10 mg CLV to 60mg AMX / 15mg CLV). CoAmox-Mepha 457 Suspension (daily dose divided into 2 single doses): <2 years: acute otitis media: 29-51 mg/kg/ day (25.4 mg AMX / 3.6 mg CLV to 44.6 mg AMX / 6.4mg CLV); >2 years: tonsillitis and mild to moderate lower respiratory tract infections: 29-51 mg/kg/ day (25.4 mg AMX / 3.6 mg CLV to 44.6 mg AMX / 6.4mg CLV); otitis media: 51-80mg/kg/day (44.6mg AMX / 6.4mg CLV to 70mg AMX / 10mg CLV). Special dosage instructions: adaptation necessary in case of renal failure. Contraindications Hypersensitivity to penicillins, cephalosporins or any of the ingredients of CoAmox-Mepha; patients who developed jaundice or hepatic dysfunction during earlier treatment with CoAmox-Mepha; infectious mononucleosis and lymphatic leukaemia. Precautions Limited kidney function: dosage intervals to be lengthened; do not give CoAmox-Mepha 457 to patients with limited kidney function; possible proliferation of non-sensitive bacteria and fungi with long-term use; emergency measures to be prepared in case of anaphylactic or anaphylactoid reactions; periodic checks on the renal, hepatic and haematopoietic functions recommended during long-term treatment; caution in case of liver function disturbances; prothrombin times monitoring in case of concomitant treatment with anticoagulants; consider parenteral administration in case of severe gastrointestinal disorders with vomiting and diarrhoea; in case of high doses, ensure sufficient fluid intake and appropriate urine excretion (risk of crystalluria); in case of pseudomembranous colitis stop immediately the drug; do not use antiperistaltics; during CoAmox-Mepha treatment take additional anti-conceptive measures; before starting CoAmox-Mepha treatment check allergic reactions to penicillins, clavulanic acid, cephalosporins or any other allergens. Possible increase of jaundice in newborns since

CoAmox-Mepha - p.2/2 CoAmox-Mepha 156.25 and 312.5 Suspension contain sodium benzoate. Pregnancy / Lactation Should be avoided during pregnancy unless prescription considered clearly necessary. Should be avoided during lactation. Undesirable effects Mucocutaneous candidiasis; reversible eosinophilia (allergic reaction); diarrhoea; nausea, vomiting; soft stools and abdominal pain. Increased risk of fluorosis of the definitive maxillary incisors when used at the age of 0-9 months. Interactions Probenecid, oral contraceptives, bacteriostatic antibiotics, glycosides, allopurinol. Presentation CoAmox-Mepha 375, 625 and 1000 Lactab: packs of 12 coated tablets; CoAmox-Mepha 156.25 and 312.5 Suspension: 1 bottle of dry powder for the preparation of 100 ml suspension with pipette with 1 ml graduations up to 5 ml or , , , 1 pipette; CoAmox-Mepha 457 Suspension: 1 bottle of dry powder for the preparation of 70ml suspension with pipette with 0.5 ml graduations up to 5 ml or , , , 1 pipette. Not all pack sizes may be marketed. Since indications, dosage forms and strengths may vary from country to country, please consult your local prescribing information. Full prescribing information, details and literature references are available on request.