Страна: Индонезия
Език: индонезийски
Източник: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
MESALAZINE
DARYA-VARIA LABORATORIA TBK - Indonesia
MESALAZINE
250 MG
TABLET SALUT ENTERIK
DUS, 10 BLISTER @ 10 TABLET SALUT ENTERIK
DR. FALK PHARMA GMBH - Germany
2016-10-12
1 / 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT SALOFALK ® Mesalazine (5-aminosalicylic acid) Enteric-coated tablet 250 mg 2 COMPOSITION Each tablet contains 250 mg mesalazine. Excipients with known effect: sodium carbonate For the full list of excipients, see section “Pharmaceutical particulars” further down. 3 DOSAGE FORM Enteric-coated tablet Appearance: round, butter-yellow to ochre, enteric-coated tablets, matt with smooth surface; they are not scored. 4 CLINICAL PARTICULARS 4.1 INDICATIONS Ulcerative colitis, for treatment of mild to moderate acute phases and prevention of recurrences. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and elderly Depending upon the clinical requirements in individual cases, the following daily doses are recommended. For treatment of acute episodes: 1,5g to 3,0g mesalazine daily in three divided doses (six to 12 tablets daily in three divided doses). For the maintenance of remission: 1,5g mesalazine in three divided doses (six tablets daily in three divided doses – two 250 mg tablets three times a day). Method of Administration: Oral General instructions for use Salofalk tablets should be taken in the morning, at midday and in the evening, 1 hour before meals. They should be swallowed whole, not chewed and taken with plenty of fluid. DISETUJUI OLEH BPOM: 01/06/2023 ID REG: EREG10008712100115 2 / 9 Treatment with Salofalk tablets should be administered regularly and consistently, both in the acute inflammatory stage and during maintenance therapy in order to achieve the desired therapeutic effect. The duration of use is determined by the physician. 4.3 CONTRAINDICATIONS Salofalk tablets are contraindicated in cases of - Hypersensitivity to the active substance, salicylates or to any of the excipients listed in section “Pharmaceutical particulars”. - Severe impairment of hepatic or renal function. - Gastric and duodenal ulcers - Haemorrhagic diathesis (presdisposition to bleeding) - Infants and young children 4.4 WARNINGS AND PRECAUTIONS Bloo Прочетете целия документ