Artemether 20mg/lumefantrine 120mg WHOPAR part 5 12/2011 Dispersible tablets (Novartis Pharma AG), MA069 LABELLING. Page 1 of 6

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1 LABELLING Page 1 of 6

2 PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARTON OF UNIT PACK 1. NAME OF THE MEDICINAL PRODUCT Coartem Dispersible Artemether/Lumefantrine 2. STATEMENT OF ACTIVE SUBSTANCE(S) Artemether 20 mg Lumafantrine 120 mg 3. LIST OF EXCIPIENTS Each tablet contains 8 mg saccharin sodium. 4. PHARMACEUTICAL FORM AND CONTENTS Dispersible Tablets 6 dispersible tablets/30 blister strips 12 dispersible tablets/30 blister strips 18 dispersible tablets/30 blister strips 5. METHOD AND ROUTE(S) OF ADMINISTRATION FOR CHILDREN Weight: 5 kg to less than 15 kg Weight: 15 kg to less than 25 kg Weight: 25 kg to less than 35 kg For oral use. 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN Keep out of the reach and sight of children. 7. OTHER SPECIAL WARNING(S), IF NECESSARY Antimalarial agent. Presentation for hospitals or care centers contains one information leaflet placed inside the dispenser. Information on the leaflet has to be explained to the patient by the caregiver. Page 2 of 6

3 8. EXPIRY DATE Mfd: Exp: 9. SPECIAL STORAGE CONDITIONS Do not store above 30 0 C. 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Manufactured by: Novartis Pharmaceuticals Corporation, Suffern, New York, USA for Novartis Pharma AG, Basle, Switzerland under licence from the PRC. 12. MARKETING AUTHORISATION NUMBER(s) (Swissmedic) 13. BATCH NUMBER Batch: 14. GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription. 15. INSTRUCTIONS ON USE Put the tablet in a little water. Mix water and tablet well. Give now. Make sure the child drinks all the medicine. Any adverse events should be notified to the prescriber or reported to NOVARTIS at Fax number: Page 3 of 6

4 PARTICULARS TO APPEAR ON OUTER PACKAGING CARTON WALLET CONTAING BLISTERS 1. NAME OF THE MEDICINAL PRODUCT Coartem Dispersible 2. STATEMENT OF ACTIVE SUBSTANCE(S) Artemether/Lumefantrine 3. LIST OF EXCIPIENTS 4. PHARMACEUTICAL FORM AND CONTENTS 20 mg/120 mg Dispersible Tablets 6 dispersible tablets 12 dispersible tablets 18 dispersible tablets 5. METHOD AND ROUTE(S) OF ADMINISTRATION FOR CHILDREN Weight: 5 kg to less than 15 kg Weight: 15 kg to less than 25 kg Weight: 25 kg to less than 35 kg 0 hrs Day 1 Morning Day 2 Night Morning Day 3 Night For oral use. 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN Keep out of the reach and sight of children. 7. OTHER SPECIAL WARNING(S), IF NECESSARY Antimalarial agent. 8. EXPIRY DATE MFD: Page 4 of 6

5 Exp: 9. SPECIAL STORAGE CONDITIONS Do not store above 30 0 C. 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Manufactured by: Novartis Pharmaceuticals Corporation, Suffern, New York, USA for Novartis Pharma AG, Basle, Switzerland under licence from the PRC. 12. MARKETING AUTHORISATION NUMBER(s) (Swissmedic) 13. BATCH NUMBER Batch: 14. GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription. 15. INSTRUCTIONS ON USE Put the tablet in a little water. Mix water and tablet well. Give now. Make sure the child drinks all the medicine. Any adverse events should be notified to the prescriber or reported to NOVARTIS at Fax number: Page 5 of 6

6 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS 1. NAME OF THE MEDICINAL PRODUCT Coartem Dispersible (artemether/lumefantrine) 20 mg/120 mg Dispersible Tablets 2. NAME OF THE PREQUALIFICATION HOLDER 3. EXPIRY DATE MFD: Exp: 4. BATCH NUMBER Batch: 5. OTHER Page 6 of 6

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