País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
MESALAZINE
Tillotts Pharma Limited
800 Milligram
Tablets Gastro-Resistant
2005-01-07
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Asacolon 800mg Gastro-resistant Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: mesalazine 800mg Excipients: contains 152.8mg of lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant tablet. The tablets are reddish to brownish and oblong-shaped. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of mild acute ulcerative colitis. For the maintenance of remission of ulcerative colitis. For the maintenance of surgically-induced remission of Crohn’s Disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral administration. The tablets should be swallowed whole with a glass of water one hour before food intake. They must not be chewed, crushed or broken before swallowing. If one or more doses have been missed, the next dose is to be taken as usual. Adults: _Ulcerative colitis:_ Induction of remission: 2.4 g (3 tablets) per day in divided doses. If required the dose may be increased to 4 g (5 tablets) daily. The dosage can be adjusted in accordance with the response to the treatment. Maintenance of remission: 1.2 to 2.4 g per day in divided doses. _Crohn’s disease :_ Maintenance of remission: 2.4 g (3 tablets) per day in divided doses. Paediatric patients There is no dose recommendation for children (see section 4.3 and 4.4). Geriatric patients As for adults above unless renal function is impaired (see section 4.3 and 4.4). No studies have been carried out in the elderly. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 07/11/2011_ _CRN 2103419_ _page number: 1_ 4.3 CONTRAINDICATIONS Asacolon is contraindicated in cases of: - History of Llegiu el document complet