País: Indonésia
Língua: indonésio
Origem: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
Dus, 10 Blister @ 10 Tablet Pelepasan Lambat
2022-06-10
PROPOSED PACKAGING MATERIAL Code PENTAB05-I-ID-01.02 Size NA Submission ☒ NDA ☐ Renewal ☐ Variation change detail no.: Code of previous version NA Changes NA Reference ☒ CCDS version: CCDS Ver.17 (Jan 2021) ☐ Core PIL version: ☐ SPC country/version/date: ☐ LAC no.: Name & Date IRM, 24-Jan-2022 1 PENTASA ® MESALAZINE Prolonged release tablets 500 mg COMPOSITION Each tablet contains 500 mg mesalazine. Excipients: Magnesium stearate, talc, ethylcellulose, povidone, microcrystalline cellulose. PHARMACEUTICAL DOSAGE FORM Prolonged release tablets. White grey to pale brown, speckled round tablets. Breakmark and embossing: 500 mg on one side, PENTASA on the other side. INDICATIONS Treatment of mild to moderate ulcerative colitis. POSOLOGY AND METHOD OF ADMINISTRATION _ _ _Posology: _ ULCERATIVE COLITIS Treatment of active disease: Adults: Individual dosage, up to 4 g given once daily or in divided doses. Maintenance treatment: Adults: Individual dosage. Recommended dosage, 2 g mesalazine once daily. Can also be taken in divided doses. _Method of administration: _ PENTASA tablets must not be chewed. To facilitate swallowing, the tablets may be dispersed in 50 ml of cold water. Stir and drink immediately. CONTRAINDICATIONS Hypersensitivity to mesalazine, any of the excipients, or salicylates. Severe liver or renal impairment. SPECIAL WARNINGS AND PRECAUTIONS FOR USE Most patients who are intolerant or hypersensitive to sulphasalazine are able to take PENTASA without risk of similar reactions. However, caution is recommended when treating patients allergic to sulphasalazine (risk of allergy to salicylates). Severe cutaneous adverse reactions, including Stevens- Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in association with mesalazine treatment. In case of acute intolerance reactions such as abdominal cramps, acute abdominal pain, fever and severe headache and/or the first appearance of signs and symptoms of severe skin reactions, such as skin rash, mucosal lesions, or any Leia o documento completo