País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
Mesalazine
Dr. Falk Pharma GmbH
A07EC; A07EC02
Mesalazine
4g/60 millilitre(s)
Rectal suspension
Product subject to prescription which may be renewed (B)
Aminosalicylic acid and similar agents; mesalazine
Marketed
1989-02-08
PACKAGE LEAFLET: INFORMATION FOR THE USER SALOFALK ® 4G/60ML ENEMA Mesalazine (5-aminosalicylic acid) 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 Salofalk 4g/60ml Enema is and what it is used for 2. What you need to know before you use Salofalk 4g/60ml Enema 3. How to use Salofalk 4g/60ml Enema 4. Possible side effects 5. How to store Salofalk 4g/60ml Enema 6. Contents of the pack and other information 1. WHAT SALOFALK 4G/60ML ENEMAS ARE AND WHAT THEY ARE USED FOR Salofalk 4g/60ml Enemas contain the active substance mesalazine, an anti-inflammatory agent used to treat inflammatory bowel disease. Salofalk 4g/60ml Enemas are used for the treatment of: Inflammation of the large intestine (colon) and rectum (back passage) known by doctors as ulcerative colitis. It may be used alone or, particularly in the acute phase, with corticosteriods. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE SALOFALK 4G/60ML ENEMAS DO NOT USE SALOFALK 4G/60ML ENEMA: – If you are allergic to salicylic acid, to salicylates such as acetylsalicylic acid (e.g., aspirin) or to any of the other ingredients of Salofalk 4g/60ml Enemas (listed in section 6). – If you have a serious liver or kidney disease. WARNINGS AND PRECAUTIONS TALK TO YOUR DOCTOR OR PHARMACIST BEFORE USING SALOFALK 4G/60ML ENEMAS – If you have a history of problems with your lungs, particularly if you suffer from BRONCHIAL ASTHMA . – If you have a HISTORY OF ALLERGY to SULPHASALAZINE , a substance related to mesalazine. – If you suffer with problems of yo Leer el documento completo
Health Products Regulatory Authority 14 February 2024 CRN00DLPP Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Salofalk 4g/60ml Enema 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Salofalk enema contains 4.0 g of mesalazine (5-aminosalicylic acid) in 60.0 g of suspension (60 g = 60 ml). Excipients with known effect: One Salofalk 4g/60ml Enema contains 280.8 mg potassium metabisulphite (E 224) and 60 mg sodium benzoate (E 211). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Rectal suspension (enema). Creamy coloured rectal suspension with lubricated applicator. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As an anti-inflammatory in the management of ulcerative colitis, alone or, particularly in the acute phase, with corticosteroids. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults and elderly_ Unless prescribed otherwise, the contents of one enema vial (60ml suspension) are given once per day rectally before retiring. The best results are obtained if gut lavage is carried out prior to the Salofalk enema. _Paediatric population_ There is little experience and only limited documentation for an effect in children. _Duration of treatment_ The duration of use is determined by the physician. Method of administration Salofalk enemas are for rectal administration. Shake well before use to homogenise the suspension. 4.3 CONTRAINDICATIONS Salofalk is contraindicated in cases of: Hypersensitivity to the active substance, salicylates or to any of the excipients listed in section 6.1. Severe impairment of hepatic or renal function. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Blood tests (differential blood count; liver function parameters such as ALT or AST; serum creatinine) and urinary status (dip sticks) should be determined prior to and during treatment, at the discretion of the treating physician. As a guideline, follow-up tests are recommended 14 days after commencement of treatment, then a further two to three tests at intervals of 4 weeks. If t Leer el documento completo