Ülke: Birleşik Krallık
Dil: İngilizce
Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)
Rifampicin
Sandoz Ltd
J04AB02
Rifampicin
150mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010900
Proof no. Colours: Dimensions: Date prepared: Font size: Fonts: 011.0 05/12/2017 7pt Black 138 x 450 mm Helvetica ARTWORK PROOF BOX Ref: V046: Update to SPC + PIL to include PRAC reco Amplodine PACKAGE LEAFLET: INFORMATION FOR THE USER RIMACTANE ® 150 MG CAPSULES RIFAMPICIN IMPORTANT THINGS YOU NEED TO KNOW ABOUT RIMACTANE 150 MG CAPSULES • 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. Rimactane Capsules contain a medicine called rifampicin. It belongs to a group of medicines called anti-bacterials. It works by killing the bacteria that cause infections. Rimactane Capsules are used to treat the following bacterial infections: • In combination with other drugs for the treatment and prevention of tuberculosis (also known as TB), an infectious disease mainly affecting the lungs, and some other infections • Prevention of meningococcal meningitis. DO NOT TAKE RIMACTANE IF YOU: • are allergic to active substance or to any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue. • have jaundice – yellowing of the skin or whites of the eyes caused by liver or blood problems. • are taking saquinavir or ritonavir Belgenin tamamını okuyun
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rimactane® 150 mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The active ingredient is 3-(4-Methyl-1-piperazinyliminomethyl) rifamycin SV. One capsule contains 150 mg rifampicin Ph. Eur. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsules. Opaque, two-piece, hard gelatine capsules, reddish- brown in colour, marked with ‘NG 150’. 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 1 Belgenin tamamını okuyun