Pays: Royaume-Uni
Langue: anglais
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Budesonide
Tillotts Pharma UK Ltd
A07EA06
Budesonide
3mg
Modified-release capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01050200; GTIN: 5014162008298 7640129621880
Package leaflet: Information for the user Entocort ® CR 3 mg Capsules budesonide 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 Entocort Capsules are and what they are used for 2. What you need to know before you take Entocort Capsules 3. How to take Entocort Capsules 4. Possible side effects 5. How to store Entocort Capsules 6. Contents of the pack and other information 1. What Entocort Capsules are and what they are used for Entocort Capsules contain the active substance budesonide. This belongs to a group of medicines called ‘corticosteroids’. These are used to reduce inflammation. Crohn’s disease: Entocort Capsules are used to treat an inflammation of the small bowel and the first part of the large bowel. Microscopic colitis: Entocort Capsules are used to treat microscopic colitis (a disease with chronic inflammation of the large bowel which is typically with chronic watery diarrhoea). 2. What you need to know before you take Entocort Capsules Do not take Entocort Capsules: • If you are allergic to budesonide or any of the other ingredients of this medicine (listed in section 6). • If you have an infection. Do not take Entocort Capsules if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Entocort Capsules. Warnings and precautions Talk to your doctor or pharmacist before taking Entocort Capsules if: • You have ever had tuberculosis (TB). • You have ever had high blood pressure. • You have diabetes. • You have ever Lire le document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Entocort CR 3 mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains budesonide 3 mg Excipient(s) with known effect: Sucrose For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Hard gelatin capsules for oral administration with an opaque, light grey body and opaque, pink cap marked CIR 3MG in black radial print. Each capsule contains budesonide 3 mg as gastro-resistant, prolonged-release granules. 4.1 THERAPEUTIC INDICATIONS Crohn’s disease - Induction of remission in patients with mild to moderate active Crohn’s disease affecting the ileum and/or the ascending colon. Microscopic colitis - Induction of remission in patients with active microscopic colitis Maintenance of remission in patients with microscopic colitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY ADULTS _Active Crohn’s disease_: The recommended daily dose for induction of remission is 9 mg once daily in the morning, for up to eight weeks. The full effect is usually achieved within 2–4 weeks. When treatment is to be discontinued, the dose should normally be reduced for the last 2 to 4 weeks of therapy. _Active Microscopic colitis_: The recommended dose is 9 mg once daily in the morning (corresponding to 3 capsules). _Maintenance of Microscopic colitis: _The recommended dose is 6 mg once daily in the morning (corresponding to 2 capsules), or the lowest effective dose. _ _ _Paediatric population _ There are limited data on the use of Entocort CR Capsules in children (see Sections 5.1 and 5.2). The available data are insufficient to support safety and efficacy in the paediatric population, therefore such use cannot be recommended until further data become available. _Older people _ No special dose adjustment is recommended. However, experience with Entocort CR Capsules in older people is limited. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS Lire le document complet