Nchi: Singapoo
Lugha: Kiingereza
Chanzo: HSA (Health Sciences Authority)
(Tablet Core) Budesonide micronized
FERRING PHARMACEUTICALS PRIVATE LIMITED
A07EA06
TABLET, FILM COATED, EXTENDED RELEASE
(Tablet Core) Budesonide micronized 9.0 mg
ORAL
Prescription Only
Cosmo SpA
ACTIVE
2017-08-04
Cortiment Shared Pack Master PI CORTIMENT ® PROLONGED RELEASE TABLETS 9 MG CORTICOSTEROID QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 9 mg of budesonide. Excipients with known effect: Lactose monohydrate 50 mg Contains lecithin, derived from soya oil. List of excipients: Tablet Core: Stearic Acid (E570), Lecithin (soya) (E322), Microcrystalline cellulose (E460), Hydroxypropylcellulose (E463), Lactose Monohydrate, Silica, Colloidal Hydrated (E551), Magnesium Stearate (E470b). Tablet Film-coating: Methacrylic acid – methyl methacrylate copolymer (1:1), Methacrylic acid – methyl methacrylate copolymer (1:2), Talc (E553b), Titanium Dioxide (E171), Triethyl citrate. PHARMACEUTICAL FORM Prolonged release tablet. White to off-white, round, biconvex, film-coated, gastro-resistant tablet, approximately 9.5 mm diameter, approximately 4.7 mm thickness, debossed on one side with “MX9”. THERAPEUTIC INDICATIONS Budesonide (CORTIMENT) is indicated in adults for induction of remission in patients with mild to moderate active ulcerative colitis (UC) where 5-ASA treatment is not sufficient. POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Adults The recommended daily dose for induction of remission is one 9 mg tablet in the morning, for up to 8 weeks. When treatment is discontinued, it may be useful to gradually reduce the dose (for more details on treatment discontinuation, see section SPECIAL WARNINGS AND PRECAUTIONS FOR USE). Paediatric population The safety and efficacy of Budesonide (CORTIMENT) tablets in children aged 0-18 years have not yet been established. No data are available, therefore the use in paediatric population is not recommended until further data become available. Elderly No special dose adjustment is recommended. However, experience of the use of Budesonide (CORTIMENT) in the elderly is limited. Hepatic and renal impairment population Budesonide (CORTIMENT) 9 mg was not studied in patients with hepatic and renal impairment, therefore caution should be exercised in the administration an Soma hati kamili