البلد: المملكة المتحدة
اللغة: الإنجليزية
المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)
Pyrazinamide; Rifampicin; Isoniazid
Lexon (UK) Ltd
J04AM05
Pyrazinamide; Rifampicin; Isoniazid
300mg ; 120mg ; 50mg
Oral tablet
Oral
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF: 05010900
RIFATER ® TABLETS (isoniazid, rifampicin, pyrazinamide) PATIENT INFORMATION LEAFLET IMPORTANT THINGS YOU NEED TO KNOW ABOUT RIFATER TABLETS - It is very important that you take Rifater Tablets exactly as your doctor has told you - You must keep taking it until your doctor tells you to stop - If you are taking any other medicines, including medicines you have bought from the pharmacy or shop, you must make sure your doctor knows - Rifater Tablets make all your body fluids an orange or red colour. Do not worry - this is normal and not harmful - Take Rifater Tablets on an empty stomach. This means at least 30 minutes before food or 2 hours after food - While you are taking Rifater Tablets, you should not eat matured cheese, cured meat, some fish (like tuna, salmon and mackerel) or drink wine and beer (see ‘Taking Rifater Tablets with food and drink’) - If you get a temperature, are sick, begin to feel more unwell, lose your appetite or have yellowing of the skin, gums or eyes, you must talk to your doctor straight away READ THE REST OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or your pharmacist. This medicine has been prescribed for you. Do not pass it to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. Your medicine is available using the above name but will be referred to as Rifater Tablets throughout this leaflet WHAT IS IN THIS LEAFLET 1. What Rifater Tablets are and what they are used for 2. What you need to know before you take Rifater Tablets 3. How to take Rifater Tablets 4. Possible side effects 5. How to store Rifater Tablets 6. Contents of the pack and other information 1. WHAT RIFATER TABLETS ARE AND WHAT THEY ARE USED FOR Rifater Tablets contain three different medicines called isoniazid, rifampicin and pyrazinamide. اقرأ الوثيقة كاملة
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rifater Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Rifampicin Ph Eur 120mg Isoniazid Ph Eur 50mg Pyrazinamide Ph Eur 300mg 3 PHARMACEUTICAL FORM Tablets 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rifater is indicated in the treatment of pulmonary tuberculosis. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Rifater is recommended in the initial intensive phase of the short-course treatment of pulmonary tuberculosis. During this phase, which lasts for 2 months, Rifater should be administered on a daily continuous basis. The concomitant administration of ethambutol or intramuscular streptomycin over the same period of time is advised. Each Rifater tablet contains isoniazid (INH), pyrazinamide (Z) and rifampicin (RAMP) in such a ratio that the administration of 9-12mg/kg RAMP, 4- 5mg/kg INH and 23-30mg/kg Z can be achieved by giving 3 tablets daily to patients weighing less than 40kg, 4 tablets to patients weighing 40-49kg, 5 tablets to patients weighing 50-64kg and 6 tablets to patients weighing 65kg or more. Rifater should be given as a single dose and preferably on an empty stomach at least 30 minutes before a meal, or 2 hours after a meal to ensure rapid and complete absorption. Once the initial intensive phase of treatment has been completed treatment can be continued with the combination rifampicin-isoniazid (Rifinah) always on a daily basis. This regimen, if correctly applied, is 100% effective with very few, if any, relapses. The clinical evidence indicates that these occur generally in the first 6 months after stopping treatment with bacilli fully sensitive to the drugs employed, so that changes in the drugs to be utilised for further treatment are not required. The regimen has been found to be fully effective also in the presence of a bacillary population resistant to isoniazid, to streptomycin or to both drugs. _CHILDREN:_ The ratio of the three drugs in Rifater may not be appropriate in children (eg higher mg/kg doses of INH ar اقرأ الوثيقة كاملة