Država: Velika Britanija
Jezik: engleski
Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)
Rifampicin; Isoniazid
Sanofi
J04AM02
Rifampicin; Isoniazid
150mg ; 100mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010900; GTIN: 5015265300081
TURN OVER _i_ IMPORTANT THINGS YOU KNOW NEED TO ABOUT RIFINAH 150/100MG TABLETS The name of your medicine is Rifinah 150/100mg Coated Tablets (called Rifinah 150/100mg Tablets in this leaflet). • It is very important that you take Rifinah 150/100mg Tablets 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 your tablets every day as you are told • 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 • Rifinah 150/100mg Tablets makes all of your body fluids an orange or red colour. Do not worry - this is normal and not harmful • Take Rifinah 150/100mg Tablets on an empty stomach. This means at least 30 minutes before food or 2 hours after food • While you are taking Rifinah 150/100mg Tablets, you should not eat matured cheeses, cured meat, some fish (like tuna, salmon and mackerel) or drink wine and beer (see ‘Taking Rifinah 150/100mg 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 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 to others. It may harm them, even if their symptoms 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 Rifinah 150/100mg Tablets are and what they are used for 2. What you need to know before you take Rifinah 150/100mg Tablets 3. How to take Rifinah 150/100mg Tablets 4. Possible side effects 5. How Pročitajte cijeli dokument
OBJECT 1 RIFINAH 150MG/100MG TABLETS Summary of Product Characteristics Updated 06-Aug-2019 | SANOFI • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text 1. Name of the medicinal product Rifinah 150/100mg Tablets 2. Qualitative and quantitative composition Active substances (per tablet): Rifampicin 150mg Isoniazid 100mg Excipients with known effect (per tablet): Sucrose 110.06mg For a full list of excipients, see section 6.1. 3. Pharmaceutical form Coated tablet Cyclamen, smooth, shiny, round, curved sugar coated tablet. 4. Clinical particulars 4.1 Therapeutic indications Rifinah is indicated in the treatment of all forms of tuberculosis, including fresh, advanced and chronic cases. 4.2 Posology and method of administration For oral administration. Another antituberculosis drug may be given concurrently with Rifinah until the susceptibility of the infecting organism to rifampicin and isoniazid has been confirmed. _Adults:_ Patients should be given the following single daily dose preferably on an empty stomach at least Pročitajte cijeli dokument