Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Mesalazine
Dr. Falk Pharma GmbH
A07EC; A07EC02
Mesalazine
1 gram(s)
Rectal foam
Product subject to prescription which may be renewed (B)
Aminosalicylic acid and similar agents; mesalazine
Marketed
2009-01-09
1 PACKAGE LEAFLET: INFORMATION FOR THE USER SALOFALK ® 1G/ACTUATION RECTAL FOAM mesalazine 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 rectal foam is and what it is used for 2. What you need to know before you use Salofalk rectal foam 3. How to use Salofalk rectal foam 4. Possible side effects 5. How to store Salofalk rectal foam 6. Contents of the pack and other information 1. WHAT SALOFALK RECTAL FOAM IS AND WHAT IT IS USED FOR Salofalk rectal foam contains the active substance mesalazine, an anti-inflammatory agent used to treat inflammatory bowel disease. Salofalk rectal foam is used for the treatment of: - Inflammation of the large intestine (colon) and rectum (back passage) known by doctors as ulcerative colitis. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE SALOFALK RECTAL FOAM DO NOT USE SALOFALK RECTAL FOAM - If you are allergic to mesalazine, to salicylic acid, to salicylates such as acetylsalicylic acid (e.g., Aspirin ® ) or to any of the other ingredients of this medicine (listed in section 6). - If you have a serious liver or kidney disease. WARNINGS AND PRECAUTIONS BEFORE YOU START USING THIS MEDICINE YOU SHOULD TELL YOUR DOCTOR - 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 your LIVER. - If you suffer with problems of your KIDNEY. - If you have ever developed a severe skin rash or skin peeling, blis Les hele dokumentet
Health Products Regulatory Authority 14 February 2024 CRN00DLPP Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Salofalk 1g/Actuation Rectal Foam 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 actuation contains: Mesalazine 1.0g Excipients with known effect: Each actuation of Salofalk rectal foam contains 3.44 g propylene glycol, 50 mg sodium metabisulphite and 9.1 mg cetostearyl alcohol. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Rectal foam. White-greyish to slightly reddish-violet, creamy firm foam. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of active, mild ulcerative colitis of the sigmoid colon and rectum. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults and elderly:_ Two administrations once a day at bedtime. Salofalk rectal foam should be used at room temperature (between 20°C and not more than 30°C; see also section 6.4. The canister is first fitted with an applicator and then shaken for about 20 seconds before the applicator is inserted into the rectum as far as comfortable. To administer a dose of Salofalk, the pump dome is fully pushed down and released. Note that the spray will only work properly when held with the pump dome pointing down. Following the first or second activation depending upon need (see below) the applicator should be held in position for 10-15 seconds before being withdrawn from the rectum. If the patient has difficulty in holding this amount of foam, the foam can also be administered in divided doses: one at bedtime and the other during the night (after evacuation of the first single dose) or in the early morning. The best results are obtained when the intestine is evacuated prior to administration of Salofalk rectal foam. In general, an acute episode of a mild ulcerative colitis subsides after 4-6 weeks. It is recommended to continue the maintenance therapy with an oral mesalazine preparation e.g., Salofalk prolonged release granules at a dosage recommended for this preparation. _Paediatric pop Les hele dokumentet