Država: Izrael
Jezik: engleski
Izvor: Ministry of Health
BUDESONIDE
FERRING PHARMACEUTICALS LTD
A07EA06
TABLETS PROLONGED RELEASE
BUDESONIDE 9 MG
PER OS
Required
COSMO SPA, ITALY
BUDESONIDE
For induction of remission in patients with mild to moderate active ulcerative colitis (UC).
2020-12-31
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS)-1986 The medicine is dispensed with a doctor’s prescription only _ _ CORTIMENT ® MMX Prolonged release tablets ACTIVE INGREDIENT: Each prolonged release tablet of Cortiment ®MMX contains 9 mg budesonide. INACTIVE INGREDIENTS AND ALLERGENS: see section 2 under “Important information about some of this medicine’s ingredients” and section 6 “Additional information”. Read the entire leaflet carefully before you start using this medicine. This leaflet contains concise information about the medicine. If you have further questions, consult your doctor or pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them even if it seems to you that their illness is similar to yours. This medicine is intended for adults above 18 years of age. 1. WHAT IS THIS MEDICINE INTENDED FOR? The medicine is used to induce remission in patients with mild to moderate active ulcerative colitis (UC). THERAPEUTIC GROUP: glucocorticoids. 2. BEFORE USING THIS MEDICINE: DO NOT USE THIS MEDICINE IF: • you are sensitive (allergic) to the active ingredient or to any of the other ingredients in this medicine (see section 6) • you are allergic to peanuts or soya, since Cortiment ®MMX tablets contain lecithin which is produced from soya oil. SPECIAL WARNING ABOUT USING THIS MEDICINE Contact your doctor if you experience blurred vision or other visual disturbances. Before starting treatment with the medicine, tell your doctor if: • you have an infection, such as a viral, bacterial, or fungal infection • you have ever had high blood pressure • you have diabetes • you have ever had brittle bones • you have ever had a stomach ulcer • you have ever had elevated eye pressure (glaucoma) or cataract • a family member has ever had diabetes or elevated eye pressure (glaucoma) • you have ever had liver problems • you took other steroid therapy before starting treatment with Cortiment ®MMX as th Pročitajte cijeli dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Cortiment MMX 2. 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. For a full list of excipients, see section 6.1. 3. 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”. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Cortiment is indicated for induction of remission in patients with mild to moderate active ulcerative colitis (UC). 4.2. 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 4.4). _ _ _ _ _ _ _ _ _ _ _ _ _Paediatric population _ The safety and efficacy of Cortiment tablets in children aged 0- 18 years has 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 Cortiment in the elderly is limited. _Hepatic and renal impairment population _ Cortiment 9mg was not studied in patients with hepatic and renal impairment, therefore caution should be exercised in the administration and monitoring of the product in these patients. Method of administration One tablet of Cortiment 9mg is taken orally in the morning, with or without food. The tablet should be swallowed with a glass of water and must not be broken, crushed or chewed as the film coating is intended to ensure a prolonged release. 4.3. CONTRAINDICATIONS Hypersensitivity to the active substance or to soya oil, peanut oil or to any of the excipients list Pročitajte cijeli dokument