Country: Միացյալ Թագավորություն
language: անգլերեն
source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Budesonide
Tillotts Pharma UK Ltd
A07EA06
Budesonide
20microgram/1ml
Enema
Rectal
No Controlled Drug Status
Valid as a prescribable product
BNF: 01050200; GTIN: 5014162008281
PACKAGE LEAFLET: INFORMATION FOR THE USER ENTOCORT ® ENEMA budesonide 0.02 mg/ml READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Enema is and what it is used for 2. What you need to know before you use Entocort Enema 3. How to use Entocort Enema 4. Possible side effects 5. How to store Entocort Enema 6. Contents of the pack and other information 1. WHAT ENTOCORT ENEMA IS AND WHAT IT IS USED FOR Entocort Enema contains a medicine called budesonide. This belongs to a group of medicines called ‘corticosteroids’. These are used to reduce inflammation. • An enema is a liquid that is inserted into the back passage (rectum). • Entocort Enema is used to treat inflammation and ulcers in the large intestine (colon) and rectum. This is known as ulcerative colitis. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ENTOCORT ENEMA DO NOT USE ENTOCORT ENEMA: If you are allergic to budesonide or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using Entocort Enema: • If you have recently had a bowel infection. • If you have ever had liver problems. • If you or a member of your family has ever had mental health problems. OTHER MEDICINES AND ENTOCORT ENEMA Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Entocort Enema can affect the way some medicines work read_full_document
OBJECT 1 ENTOCORT ENEMA Summary of Product Characteristics Updated 12-Apr-2018 | Tillotts Pharma UK Limited 1. Name of the medicinal product Entocort ® Enema. 2. Qualitative and quantitative composition 0.02 mg/ml budesonide (2 mg budesonide/100 ml). Excipient(s) with known effect: • Lactose anhydrous • Lactose monohydrate • Methyl-parahydroxybenzoate • Propyl-parahydroxybenzoate For the full list of excipients, see section 6.1. 3. Pharmaceutical form Dispersible tablet and solution for rectal suspension_._ Each Entocort enema consists of 2 components • A 2.3 mg faintly yellow, circular biconvex tablet with the engraving B A 1 on one side. On the other side 2.3 is engraved. • A 115 ml clear colourless solution. 4. Clinical particulars 4.1 Therapeutic indications Ulcerative colitis involving rectal and recto-sigmoid disease. 4.2 Posology and method of administration Posology Adults: One Entocort Enema nightly for 4 weeks. Full effect is usually achieved within 2–4 weeks. If the patient is not in remission after 4 weeks, the treatment period may be prolonged to 8 weeks. _Paediatric population_ Children: Not recommended. _Elderly_ Dosage as for adults. No dosage reduction is necessary in patients with reduced liver function. METHOD OF ADMINISTRATION The route of administration is rectal. INSTRUCTIONS FOR CORRECT USE OF ENTOCORT ENEMA. Entocort enema consists of two components: a dispersible tablet and a vehicle. NOTE: IT IS IMPORTANT TO INSTRUCT THE PATIENT • To carefully read the instructions for use in the patient information leaflet which are packed together with each product. • To reconstitute the enema immediately before use, ensuring that the tablet is completely dissolved. • To administer in the evening before going to bed. 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 Side effects typical of systemic corticosteroids may occur. Potential systemic effects include glaucoma. Visua read_full_document