البلد: المملكة المتحدة
اللغة: الإنجليزية
المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)
Lumefantrine; Artemether
Novartis Pharmaceuticals UK Ltd
P01BF01
Lumefantrine; Artemether
120mg ; 20mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05040100; GTIN: 5010678918021
PACKAGE LEAFLET: INFORMATION FOR THE USER RIAMET ® 20 MG/120 MG TABLETS artemether and lumefantrine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. – Keep this leaflet. You may need to read it again. – If you have any further questions, ask your doctor or pharmacist. – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. – If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. (See section 4). WHAT IS IN THIS LEAFLET 1. What Riamet is and what it is used for 2. What you need to know before you take Riamet 3. How to take Riamet 4. Possible side effects 5. How to store Riamet 6. Contents of the pack and other information 1. WHAT RIAMET IS AND WHAT IT IS USED FOR Riamet contains two substances called artemether and lumefantrine. They belong to a group of medicines called anti-malarials. Riamet is only used for the treatment of acute uncomplicated malaria infections caused by a parasite called “Plasmodium falciparum”. This parasite is a tiny organism made up of one cell that is found inside red blood cells. Riamet is used to treat adults, children and infants of 5 kg body weight and above. Riamet is not used to prevent malaria or to treat severe malaria (where it has affected the brain, lungs or kidneys). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RIAMET DO NOT TAKE RIAMET – if you are allergic (hypersensitive) to artemether, lumefantrine, or any of the other ingredients of this medicine (listed in section 6). – if you have a severe type of malaria infection where it has affected parts of your body such as the brain, lungs or kidneys. – if you have a heart condition, such as changes in the rhythm or rate of the heart beat, a slow heart beat, or severe heart disease. – if any member of your family (parents, grandparents, brothers or sisters) has died sudd اقرأ الوثيقة كاملة
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Riamet 20mg/120mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 20mg artemether and 120mg lumefantrine For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet Light yellow, round tablet with “NC” debossed on one side and “CG” on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Riamet is indicated for the treatment of acute uncomplicated _Plasmodium falciparum_ malaria in adults, children and infants of 5 kg and above. Consideration should be given to official guidance regarding the appropriate use of antimalarial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults and children weighing 35 kg and above For patients 12 years of age and above and 35 kg body weight and above, a course of treatment comprises six doses of four tablets i.e. total of 24 tablets, given over a period of 60 hours as follows: the first dose of four tablets, given at the time of initial diagnosis, should be followed by five further doses of four tablets given at 8, 24, 36, 48 and 60 hours thereafter. Children and infants weighing 5 kg to less than 35 kg A six-dose regimen is recommended with 1 to 3 tablets per dose, depending on bodyweight: 5 to less than 15 kg bodyweight: the first dose of one tablet, given at the time of initial diagnosis, should be followed by five further doses of one tablet given at 8, 24, 36, 48 and 60 hours thereafter. 15 to less than 25 kg bodyweight: the first dose of two tablets, given at the time of initial diagnosis, should be followed by five further doses of two tablets given at 8, 24, 36, 48 and 60 hours thereafter. 25 to less than 35 kg bodyweight: the first dose of three tablets, given at the time of initial diagnosis, should be followed by five further doses of three tablets given at 8, 24, 36, 48 and 60 hours thereafter. Infants weighing less than 5 kg The safety and efficacy of Riamet tablets have not been established in infants weighing less than 5 kg and no do اقرأ الوثيقة كاملة