Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
MESALAZINE
Tillotts Pharma Limited
MESALAZINE
500 Milligram
Suppositories
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
PACKAGE LEAFLET: INFORMATION FOR THE USER ASACOLON 500 MG SUPPOSITORIES Active substance: mesalazine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. - Keep this leaflet. You may need to read it again. - If you have any further questions, please ask your doctor or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Asacolon is and what it is used for 2. Before you use Asacolon 3. How to use Asacolon 4. Possible side-effects 5. How to store Asacolon 6. Further Information 1. WHAT ASACOLON IS AND WHAT IT IS USED FOR The name of your medicine is Asacolon 500 mg Suppositories. Your suppositories contain the active ingredient mesalazine. This is an anti-inflammatory medicine used to treat proctitis, procto- sigmoiditis and ulcerative colitis. These are diseases of the large bowel (colon) and the back passage (rectum), in which the bowel lining becomes inflamed (red and swollen). ‘Asacolon’ 500 mg Suppositories act locally in the colon and rectum to reduce this inflammation. ‘Asacolon’ 500 mg Suppositories are particularly useful when the symptoms of ulcerative colitis affect the rectum. 2. BEFORE YOU USE ASACOLON DO NOT USE ASACOLON - If you are allergic (hypersensitive) to mesalazine or any of the other ingredients of Asacolon suppositories - If you have a history of allergy to salicylates - If you have kidney problems - If you have severe liver problems - If you have ulcers of the stomach and the part of the gut following the stomach. TAKE SPECIAL CARE WITH ASACOLON Please tell your doctor if you have any medical conditions or i Lesen Sie das vollständige Dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Asacolon 500 mg Suppositories 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each suppository contains: Mesalazine 500 mg. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Suppository. Torpedo-shaped suppositories with a light grey-brown colour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of mild to moderate proctitis and proctosigmoiditis. As an adjunct to oral therapy in severe generalised ulcerative colitis affecting the rectum or rectosigmoid colon. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Rectal administration. Adults: One suppository to be inserted up to three times daily, after defaecation. The dosage is dependent upon the severity of the disease and it may be possible to reduce the dosage as the condition improves. In severe generalised ulcerative colitis affecting the rectum or rectosigmoid, and in cases slow to respond to oral therapy, one suppository may be used morning and evening, as an adjunct to oral therapy. Renal impairment/hepatic impairment: No data from controlled clinical studies are available warranting a specific dose adjustment in patients with mild to moderate renal or hepatic impairment. The maximum daily adult dose of 1.5 g mesalazine for rectal administration appears to carry little additional risk in these patients considering 4.0 g mesalazine being approved as maximum daily dose for oral administration (Asacolon tablets) to treat mild acute ulcerative colitis, see section 4.4. For severe renal or hepatic impairment, see section 4.3. The elderly: As for adults above unless renal function is severely impaired (see section 4.3 and 4.4). No studies have been carried out in the elderly. Paediatric population: There is little experience and only l Lesen Sie das vollständige Dokument