Riik: Indoneesia
keel: indoneesia
Allikas: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
MESALAZINE
DARYA-VARIA LABORATORIA TBK - Indonesia
MESALAZINE
500 MG
TABLET SALUT ENTERIK
DUS, 10 BLISTER @ 10 TABLET SALUT ENTERIK
DR. FALK PHARMA GMBH - Germany
2016-10-12
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT SALOFALK ® Mesalazine (5-aminosalicylic acid) Enteric-coated tablet 500 mg 2 COMPOSITION Each tablet contains 500 mg mesalazine. Excipients with known effect: sodium carbonate and croscarmellose sodium For the full list of excipients, see section “Pharmaceutical particulars” further down. 3 DOSAGE FORM Enteric-coated tablet Appearance: oval, light yellow to ochre, enteric-coated tablets, matt with smooth surface; 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 the treatment of acute episodes: 1,5 g to 3,0 g mesalazine in three divided doses (1 or 2 tablets of Salofalk 500 mg three times daily). For the maintenance of remission: 1,5 g mesalazine in three divided doses (1 tablet of 500 mg three times daily). 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:EREG10008712100117 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) Salofalk ® 500 tablets should not be used to treat infants and small children because of insuffici Lugege kogu dokumenti