国家: 英国
语言: 英文
来源: MHRA (Medicines & Healthcare Products Regulatory Agency)
Fidaxomicin
Astellas Pharma Ltd
Fidaxomicin
200mg
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05010700; GTIN: 5013346051761
PACKAGE LEAFLET: INFORMATION FOR THE USER DIFICLIR 200 MG FILM-COATED TABLETS Fidaxomicin 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 on to others. It may harm them, even if their signs of illness 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 DIFICLIR is and what it is used for 2. What you need to know before you take DIFICLIR 3. How to take DIFICLIR 4. Possible side effects 5. How to store DIFICLIR 6. Contents of the pack and other information 1. WHAT DIFICLIR IS AND WHAT IT IS USED FOR DIFICLIR is an antibiotic which contains the active substance fidaxomicin. DIFICLIR is used in adults to treat infections of the lining of the colon (large intestine) with certain bacteria called _Clostridium difficile_ . This serious illness can result in painful, severe diarrhoea. DIFICLIR works by killing the bacteria that cause the infection and helps to reduce the associated diarrhoea. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIFICLIR DO NOT TAKE DIFICLIR − If you are allergic to fidaxomicin or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking DIFICLIR. If you feel that you might have a severe allergic reaction such as trouble breathing (dyspnea), swelling of the face or throat (angioedema), severe rash or severe itching (pruritus), stop taking DIFICLIR and seek medical advice urgently from your doctor, pharmacist or at your local hospital emergency department (see section 4). If you are allergic to macrolides (a class of antibiotics), ask your doctor for advice before using this medicine. Your doctor will tel 阅读完整的文件
OBJECT 1 DIFICLIR 200 MG FILM-COATED TABLETS Summary of Product Characteristics Updated 23-May-2018 | Astellas Pharma Ltd 1. Name of the medicinal product DIFICLIR 200 mg film-coated tablets 2. Qualitative and quantitative composition Each film-coated tablet contains 200 mg of fidaxomicin. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet. Capsule shaped tablets of 14 mm, white to off-white in colour, debossed with “FDX” on one side and “200” on the other side. 4. Clinical particulars 4.1 Therapeutic indications DIFICLIR is indicated in adults for the treatment of _Clostridium difficile_ infections (CDI) also known as _C. difficile_-associated diarrhoea (CDAD) (see section 5.1). Consideration should be given to official guidelines on the appropriate use of antibacterial agents. 4.2 Posology and method of administration Posology _Adults and elderly (≥65 years of age)_ The recommended dose is 200 mg (one tablet) administered twice daily (once every 12 hours) for 10 days. Special populations _Renal impairment_ No dose adjustment is considered necessary. Due to the limited clinical data in this population, DIFICLIR should be used with caution in patients with severe renal impairment (see sections 4.4 and 5.2). _Hepatic impairment_ No dose adjustment is considered necessary. Due to the limited clinical data in this population, DIFICLIR should be used with caution in patients with moderate to severe hepatic impairment (see sections 4.4 and 5.2). _Paediatric population_ The safety and efficacy of fidaxomicin in children aged below 18 years has not yet been established. No data are available. Method of administration DIFICLIR is intended for oral use. DIFICLIR can be taken with or without food. 4.3 Contraindications Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4 Special warnings and precautions for use Hypersensitivity reactions including severe angioedema have been reported (see section 4.8). If a severe allergic reactio 阅读完整的文件