Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Mesalazine
Tillotts Pharma GmbH
A07EC02
Mesalazine
1000 milligram(s)
Suppository
mesalazine
Marketed
2021-01-29
1 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ASACOLON 1000 MG SUPPOSITORIES 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 Asacolon 1000 mg Suppositories are and what they are used for 2. What you need to know before you use Asacolon 1000 mg Suppositories 3. How to use Asacolon 1000 mg Suppositories 4. Possible side effects 5. How to store Asacolon 1000 mg Suppositories 6. Contents of the pack and other information 1. WHAT ASACOLON 1000 MG SUPPOSITORIES ARE AND WHAT THEY ARE USED FOR Asacolon 1000 mg Suppositories contain the active substance mesalazine, an anti-inflammatory agent used to treat inflammatory bowel disease. Asacolon 1000 mg Suppositories are used for the treatment of acute mild to moderate ulcerative colitis limited to the rectum (ulcerative proctitis). 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ASACOLON 1000 MG SUPPOSITORIES DO NOT USE ASACOLON 1000 MG SUPPOSITORIES - if you are allergic to salicylic acid, to salicylates such as acetylsalicylic acid (aspirin) or the other ingredients of this medicine (listed in section 6). - If you have a serious liver or kidney disease. WARNINGS AND PRECAUTIONS TALK TO YOUR DOCTOR BEFORE USING ASACOLON 1000 MG 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 related to mesalazine. - If you suffer with problems of your LIVER. - If you suffer with problems of your KIDNEY. - If you have ev Citiți documentul complet
Health Products Regulatory Authority 20 December 2023 CRN00DVZ4 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Asacolon 1000 mg Suppository 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each suppository contains 1000 mg mesalazine. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Suppository Light beige coloured, torpedo-shaped suppositories dimension of 33 x 11 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of acute mild to moderate ulcerative colitis limited to the rectum (ulcerative proctitis). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults and older people_ One Mesalazine 1000 mg Suppository once daily (equivalent to 1000 mg mesalazine daily) inserted into the rectum. _ _ _Paediatric population_ There is little experience and only limited documentation for an effect in children. _ _ Method of administration For rectal administration only. Asacolon 1000 mg Suppositories should be administered preferably at bedtime. Treatment with Asacolon 1000 mg Suppositories must be administered regularly and consistently, because only in this way can healing be successfully achieved. _Duration of treatment_ The duration of use is determined by the physician. 4.3 CONTRAINDICATIONS Asacolon 1000 mg Suppositories are contraindicated in patients with: - known hypersensitivity to salicylates or to the excipient 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 the findings are normal, follow-up tests should be carried out every 3 months. If additional symptoms occur, these tests should be performed immediate Citiți documentul complet