Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
Mesalazine
Dr. Falk Pharma GmbH
A07EC; A07EC02
Mesalazine
250 milligram(s)
Suppository
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 ® 250MG SUPPOSITORIES 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. - 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 250mg Suppositories are and what they are used for 2. What you need to know before you use Salofalk 250mg Suppositories 3. How to use Salofalk 250mg Suppositories 4. Possible side effects 5. How to store Salofalk 250mg Suppositories 6. Contents of the pack and other information 1. WHAT SALOFALK 250MG SUPPOSITORIES ARE AND WHAT THEY ARE USED FOR Salofalk 250mg Suppositories contain the active substance mesalazine, an anti-inflammatory agent used to treat inflammatory bowel disease. Salofalk 250mg Suppositories 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 250MG SUPPOSITORIES DO NOT USE SALOFALK 250MG SUPPOSITORIES: – 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 250mg Suppositories (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 250MG SUPPOSITORIES − 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 rel Pročitajte cijeli dokument
Health Products Regulatory Authority 14 February 2024 CRN00DLPP Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Salofalk 250 mg Suppositories 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each suppository contains 250 mg of mesalazine. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Suppository White to creamy coloured suppository. 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, for acute inflammatory symptoms, 2 Salofalk 250 Suppositories are to be introduced rectally morning, noon and evening. In severe cases of the disease, the dosage may be doubled. For long-term treatment and prevention of recurrences, one suppository to be introduced rectally morning, noon and evening. Treatment with Salofalk 250 Suppositories, whether during an acute inflammatory stage or in long-term treatment of patients, must be faithfully and strictly adhered to, as this is essential if the desired therapeutic success is to be obtained. _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 suppositories are for rectal administration. 4.3 CONTRAINDICATIONS Salofalk is contraindicated in cases of: Hypersensitivity to the active substance to salicylates or 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 t Pročitajte cijeli dokument