País: Regne Unit
Idioma: anglès
Font: MHRA (Medicines & Healthcare Products Regulatory Agency)
Rifampicin
Sandoz Ltd
J04AB02
Rifampicin
300mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010900; GTIN: 05010678061208
Page 1 of 2 CP00057 PACKAGE LEAFLET: INFORMATION FOR THE USER RIMACTANE ® 300MG CAPSULES (rifampicin) Your medicine is available using the name Rimactane 300mg Capsules but will be referred to as Rimactane throughout this leaflet. Other strengths of this medicine are also available. IMPORTANT THINGS YOU NEED TO KNOW ABOUT RIMACTANE It is very important that you take Rimactane exactly as your doctor has told you. There is a chance of you having a severe and dangerous allergic reaction if you do not take Rimactane each day as you are told. You must keep taking Rimactane 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. Rimactane makes all your body fluids an orange or red colour. Do not worry – this is normal and not harmful. Take Rimactane on an empty stomach. This means at least 30 minutes before food or 2 hours after food. 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 ALL 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 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 of the 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 Rimactane is and what it is used for 2. What you need to know before you take Rimactane 3. How to take Rimactane 4. Possible side effects 5. How to store Rimactane 6. Contents of the pack and other information 1. WHAT RIMACTANE IS AND WHAT IT IS USED FOR Rimactane contains a medicine called rifampicin. It belongs to a group of medicines called Llegiu el document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rimactane® 300 mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The active ingredient is 3-(4-Methyl-1-piperazinyliminomethyl) rifamycin SV. One capsule contains 300 mg rifampicin Ph. Eur. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsules. Opaque, two-piece, hard gelatine capsule, reddish-brown in colour, marked with ‘NG 300’. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rifampicin is a major drug in the management of tuberculosis (all forms) and certain opportunistic mycobacterial infections. It is effective in cases resistant to other anti-tuberculosis agents and shows no cross-resistance outside the rifampycin group of drugs. In the treatment of tuberculosis Rifampicin must always be combined with other anti-tuberculosis agents. It is effective in combination with isoniazid, streptomycin, pyrazinamide, ethambutol and the majority of second line drugs. Prophylaxis of meningococcal meningitis in close contact adult and paediatric patients 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _For the management of tuberculosis and certain opportunistic mycobacterial _ _infections_: Rifampicin must always be given in association with other anti-tuberculosis drugs, to prevent emergence of resistant strains. _ Use in Adults_: 450-600mg daily as a single dose (based on approximately 10mg per kg body weight). (Those patients 50kg (8 stone) and over should take 600mg rifampicin daily, whilst patients under 50kg should take 450mg). The following chemotherapeutic agents are employed today as combined therapy for tuberculosis: rifampicin (Rimactane) (RMP), isoniazid (INH), pyrazinamide (PZA), ethambutol (EMB), streptomycin (STM). The dosages recommended by the Centres for Disease Control and Prevention are as follows: DAILY TWICE A WEEK 3 TIMES A WEEK DRUG MG/KG MAX. MG MG/KG MAX. MG MG/KG MAX. MG CHILDR EN ADUL TS CHILD REN ADULT S CHILD REN ADULT S RMP 10-20 10 600 10-20 10 600 10-20 10 600 INH 10-15 5 300 20-40 15 90 Llegiu el document complet