Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
Budesonide
Tillotts Pharma GmbH
A07EA; A07EA06
Budesonide
3 milligram(s)
Gastro-resistant capsule, hard
Product subject to prescription which may be renewed (B)
Corticosteroids acting locally; budesonide
Marketed
1996-09-24
Page 1 of 5 PACKAGE LEAFLET: INFORMATION FOR THE USER ENTOCORT ® CR 3 MG GASTRO-RESISTANT CAPSULE, HARD 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): Entocort Capsules can be used to treat both active illness as well as in severe cases to prevent recurring problems (maintenance treatment). 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, including viral, bacterial or fungal infections. 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 Capsu Belgenin tamamını okuyun
Health Products Regulatory Authority 21 August 2023 CRN00DFNX Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Entocort® CR 3 mg Gastro-resistant Capsule, Hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains budesonide 3 mg. Excipient(s) with known effect: not more than 295 mg sucrose For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Gastro-resistant, prolonged release capsules, hard. Hard gelatin capsules with an opaque, light grey body and opaque, pink cap marked CIR 3MG in black radial print 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Crohn's disease: Entocort CR Capsules are indicated for the induction of remission in patients with mild to moderate Crohn's disease affecting the ileum and/or the ascending colon. Active microscopic colitis: Entocort CR Capsules are indicated for the induction of remission in patients with active microscopic colitis. Entocort CR Capsules are indicated for the maintenance treatment of severe, recurrent 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 to 4 weeks of therapy. When treatment is to be discontinued, the dose should normally be reduced for the last 2 to 4 weeks of therapy. Entocort CR can be used for up to 3 months at the dose of 6 mg administered once daily in the morning. Long-term use is not recommended. To replace prednisolone in steroid dependent patients, the recommended dose is 6 mg, administered once daily in the morning. When treatment with Entocort CR Capsules is initiated the prednisolone dose should be tapered. To prevent recurrence after surgery in patients with high disease activity, the recommended dose is 6 mg, administered once daily in the morning. No benefit of Entocort has been shown in post surgical patients with obstructive fibrostenotic Crohn's disease. _Active Mi Belgenin tamamını okuyun