País: Malásia
Língua: inglês
Origem: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
BUDESONIDE
Ferring Sdn. Bhd.
BUDESONIDE
30 Tablets
COSMO S.P.A.,
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ 1 CORTIMENT ® 9MG PROLONGED RELEASE TABLETS Budesonide 9mg WHAT IS IN THIS LEAFLET 1. What Cortiment is used for 2. How Cortiment works 3. Before you take Cortiment 4. How to take Cortiment 5. While you are taking Cortiment 6. Side effects 7. Storage and disposal of Cortiment 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of Revision 1. WHAT CORTIMENT IS USED FOR Cortiment tablets are used FOR ADULTS FOR THE INDUCTION OF REMISSION in patients with mild to moderate active ulcerative colitis (UC) where 5-aminosalicylic acid (5-ASA) treatment is not sufficient or not tolerated. 2. HOW CORTIMENT WORKS Cortiment contains the active substance _budesonide_ . This is an intestinal _antiinflammatory _ _agent,_ corticosteroids acting locally. In general, _budesonide_ inhibits many inflammatory processes. The mode of action of Cortiment is based on a local action in the gut. 3 . BEFORE YOU TAKE CORTIMENT _When you must not use it: _ Do not take Cortiment • IF YOU ARE ALLERGIC to budesonide, soya oil, peanut oil or to any of the other ingredients of Cortiment (listed in ingredients section) • if you have rare hereditary problems such as galactose intolerance, the Lapp lactase deficiency or glucose - galactose malabsorption. → If this applies to you, DO NOT TAKE CORTIMENT AND TELL YOUR DOCTOR IMMEDIATELY. _ Before you start to use it: _ WARNING AND PRECAUTIONS • TELL YOUR DOCTOR OR PHARMACIST IF YOU HAVE OR HAVE HAD ANY OF THE FOLLOWING CONDITIONS: - infections - hypertension - diabetes mellitus - osteoporosis - peptic ulcer - glaucoma or cataracts - family history of diabetes or glaucoma - with any other condition where the use of glucocorticoids may have unwanted effects. - reduced liver function Visual disturbance may be reported with systemic and topical corticosteroid use. If you presents with symptoms such as blurred vision or other visual disturbances, you should consult your doctor or pharmacist for referral to an ophthalmolog Leia o documento completo
PROPOSED PACKAGING MATERIAL Code CORT-I-HK,SG,MY,PH-01.01 Size Submission ☐ NDA ☐ Renewal ☒ Variation change detail no.: common pack_ _ Code of previous version CORT-I-MY-01.01 Changes Common pack – SG PH HK MY ☐ CCDS version: ☐ Core PIL version: ☐ SPC country/version/date: ☐ LAC no.: Name & Date Sok Bee, 08-May-2023 For Internal Use - Internal 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 availabl Leia o documento completo