Quốc gia: Vương quốc Anh
Ngôn ngữ: Tiếng Anh
Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)
Mesalazine
Allergan Ltd
A07EC02
Mesalazine
500mg
Suppository
Rectal
No Controlled Drug Status
Valid as a prescribable product
BNF: 01050100
PACKAGE LEAFLET: INFORMATION FOR THE USER ASACOL 250MG AND 500MG SUPPOSITORIES (mesalazine) 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. Do not pass it on 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. IN THIS LEAFLET: 1. What Asacol Suppositories are and what they are used for 2. Before you use Asacol Suppositories 3. How to use Asacol Suppositories 4. Possible side effects 5. How to store Asacol Suppositories 6. Further information 1. WHAT ASACOL SUPPOSITORIES ARE AND WHAT THEY ARE USED FOR Asacol Suppositories contain the active substance mesalazine (also known as 5-aminosalicylic acid) which is an anti- inflammatory drug used in the treatment of ULCERATIVE COLITIS – a disease of the large bowel (colon) and back passage (rectum) in which the lining of the bowel becomes inflamed (red and swollen). Symptoms can include rectal bleeding, frequent diarrhoea and abdominal pain. The suppositories act locally in the rectum to reduce inflammation and can also prevent further episodes (flares) of ulcerative colitis. They are particularly useful when symptoms of ulcerative colitis affect the rectum. 2. BEFORE YOU USE ASACOL SUPPOSITORIES DO NOT USE ASACOL SUPPOSITORIES if you: • are allergic (hypersensitive) to any of the ingredients in the product (see Section 6 on “What Asacol Suppositories contain”). • are allergic to aspirin or any other salicylate • had kidney problems or blood abnormalities while taking other medicines such as sulphasalazine • have confirmed severe kidney impairment DO NOT give the suppositories to CHILDREN under 2 years of age. TAKE SPECIAL CARE WITH ASACOL SUPPOSITORIES • Asacol should be used with extreme caution in pati Đọc toàn bộ tài liệu
OBJECT 1 ASACOL 500MG SUPPOSITORIES Summary of Product Characteristics Updated 11-May-2016 | Allergan Ltd • 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 Asacol 500mg Suppositories 2. Qualitative and quantitative composition Asacol Suppositories contain 500mg mesalazine per suppository. 3. Pharmaceutical form Opaque, beige suppositories, containing 500mg mesalazine. 4. Clinical particulars 4.1 Therapeutic indications For the treatment of mild to moderate acute exacerbations of ulcerative colitis. The suppositories are particularly appropriate in patients with distal disease. For the maintenance of remission of ulcerative colitis. 4.2 Posology and method of administration _ADULTS:_ _Suppositories 250 mg:_ Three to six suppositories a day in divided doses, with the last dose at bedtime. _Suppositories 500 mg:_ A maximum of three suppositories a day in divided doses, with the last dose at bedtime. _ELDERLY: _The normal adult dosage may be used unless renal function is impaired (see se Đọc toàn bộ tài liệu