Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Budesonide
IMED Healthcare Ltd.
A07EA06
Budesonide
3 milligram(s)
Gastro-resistant capsule, hard
budesonide
2021-07-23
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 Capsules. WARNING Citiți documentul complet
Health Products Regulatory Authority 26 July 2021 CRN00CDQ7 Page 1 of 2 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 with known effect: sucrose For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant, prolonged release capsules, hard. Product imported from _Belgium_ Hard gelatin capsules with an opaque, light grey body and opaque, pink cap marked CIR 3MG in black radial print. 4 CLINICAL PARTICULARS As per PA2018/003/001 5 PHARMACOLOGICAL PROPERTIES As per PA2018/003/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Ethylcellulose Tributyl acetylcitrate Methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30 per cent Triethyl citrate Simeticone (Antifoam M) Polysorbate 80 Talc Sucrose spheres Capsule shell: Black iron oxide (E172) Titanium dioxide (E171) Gelatin Sodium laurilsulfate Colloidal anhydrous silica Red iron oxide (E172) Yellow iron oxide (E172) Ink (der. 41/370-42/1015) 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf-life expiry date of this product shall be the date shown on the container and outer package of the product on the market in the country of origin. Health Products Regulatory Authority 26 July 2021 CRN00CDQ7 Page 2 of 2 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 30 °C. Store in the original package. Keep the container tightly closed. 6.5 NATURE AND CONTENTS OF CONTAINER White, polyethylene bottles of 100 capsules, having a tamper-evident, childproof polypropylene screw cap, with an integral desiccant. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL White, polyethylene bottles of 100 capsules, having a tamper-evident, childproof polypropylene screw cap, with an integral desiccant. 7 PARALLEL PRODUCT AUTHORISATION HOLDER IMED Healthcare Ltd. Unit 625 Kilshane Avenue Northwest Business Park Ballycoolin Dublin 15 Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA1463/178/00 Citiți documentul complet