国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
MEFLOQUINE HYDROCHLORIDE
Roche Products Limited
MEFLOQUINE HYDROCHLORIDE
250 Base Milligrams
Tablets
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
-1- Lariam-PIL-IE-1306-250-Tab PATIENT INFORMATION LEAFLET IRELAND LARIAM ® 250 MG ROCHE TABLETS Mefloquine PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE YOUR MEDICINE. IF YOU HAVE ANY QUESTIONS OR ARE NOT SURE ABOUT ANYTHING, ASK YOUR DOCTOR OR PHARMACIST. In this leaflet you will find: 1. What is Lariam? 2. Things you should know before taking Lariam 3. How to take this medicine 4. Possible side effects 5. Storing your medicine 6. Other information 1. WHAT IS LARIAM? This medicine is used to treat malaria and to help prevent you from catching malaria. Malaria is a life threatening disease and a major health risk for travellers visiting tropical countries. It occurs when small parasites are passed from one person to another by the bites of certain mosquitoes. Lariam is especially useful if you are travelling to countries where there is a type of malaria which is particularly difficult to treat. No single medicine is effective against all malaria parasites. The choice of a particular medicine depends on the sensitivity of the malaria parasites found in the area to be visited. Your doctor will advise you whether Lariam is suitable for the area to which you wish to go. TO HELP MINIMISE YOUR CHANCE OF CATCHING THE DISEASE AND TO PROTECT YOU FROM POSSIBLE SERIOUS SIDE EFFECTS IT IS IMPORTANT THAT YOU READ THIS LEAFLET CAREFULLY. ASK YOUR DOCTOR TO EXPLAIN ANYTHING YOU DO NOT UNDERSTAND. 2. THINGS YOU SHOULD KNOW BEFORE TAKING LARIAM DO NOT TAKE LARIAM IF YOU HAVE, OR HAVE EVER HAD: depression, thoughts about suicide and self-endangering behaviour any other mental problem, including anxiety disorder, schizophrenia or psychosis (losing touch with reality) fits (seizures or convulsions) an allergy to quinin 完全なドキュメントを読む
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lariam 250 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 250 mg mefloquine (as 274.09 mg mefloquine hydrochloride). Each tablet contains 50.61 mg of lactose monohydrate For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Tablets White to off-white cylindrical biplanar tablets, cross-scored and imprinted Roche on one face. The tablet can be divided into equal halves to facilitate dosing. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Therapy and prophylaxis of malaria. _Therapy_: Lariam is especially indicated for therapy of _P. falciparum _malaria in which the pathogen has become resistant to other antimalarial agents. Following treatment of _P. vivax _malaria with Lariam, relapse prophylaxis with an 8-amino-quinoline derivative, for example primaquine, should be considered in order to eliminate parasites in the hepatic phase. _Prophylaxis_: Malaria prophylaxis with Lariam is particularly recommended for travellers to malarious areas in which multiple resistant _P. falciparum _strains occur. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION When chemoprophylaxis with Lariam fails, physicians should carefully evaluate which antimalarial to use for therapy. Regarding the use of halofantrine, see sections 4.3, 4.4 and 4.5. _CHEMOPROPHYLAXIS_ In order to ensure, before arrival in endemic area, that Lariam administration is well tolerated, it is recommended to start chemoprophylaxis with Lariam 10 days before departure (i.e. first intake 10 days before departure and 2 nd intake 3 days before departure). Subsequent doses should be taken once a week (at a fixed day). IRISH MEDICINES BOARD __________________________________________________________________________________________________________________ 完全なドキュメントを読む