Ország: Ausztrália
Nyelv: angol
Forrás: Department of Health (Therapeutic Goods Administration)
budesonide, Quantity: 9 mg
Ferring Pharmaceuticals Pty Ltd
Budesonide
Tablet, modified release
Excipient Ingredients: stearic acid; lecithin; microcrystalline cellulose; hyprolose; lactose monohydrate; silicon dioxide; magnesium stearate; methacrylic acid copolymer; purified talc; titanium dioxide; triethyl citrate
Oral
20 modified release tablets, 80 modified release tablets, 10 modified release tablets, 50 modified release tablets, 30 modified release tablets, 60 modified release tablets
(S4) Prescription Only Medicine
CORTIMENT prolonged-release tablets are indicated in adults for induction of remission in patients with mild to moderate active ulcerative colitis (UC) where 5-ASA treatment is not sufficient or not tolerated.
Visual Identification: Each tablet is a white to off-white, round, biconvex, film-coated tablet, approximately 9.5 mm diameter and 4.7 mm thickness, debossed on one side with "MX9"; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2015-08-31
CORTIMENT ® _PROLONGED-RELEASE TABLETS_ _budesonide_ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about CORTIMENT. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking CORTIMENT against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. Keep this leaflet with the medicine. You may need to read it again. WHAT CORTIMENT IS USED FOR CORTIMENT tablets are indicated in adults for induction of remission in patients with mild to moderate active ulcerative colitis (UC) where 5-ASA treatment is not sufficient or not tolerated. CORTIMENT contains the active ingredient, budesonide. Budesonide belongs to a group of medicines called corticosteroids, which are used to help reduce inflammation. CORTIMENT is used to treat inflammation of the large intestine (colon), which is an area commonly affected in UC. The tablets are designed to release the active ingredient, budesonide in a controlled manner along the colon. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. CORTIMENT is available only with a doctor's prescription. There is not enough information to recommend the use of this medicine for patients under the age of 18 years. BEFORE YOU TAKE CORTIMENT _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE CORTIMENT IF YOU HAVE AN ALLERGY TO: • any medicine containing budesonide • any of the ingredients listed at the end of this leaflet • peanut oil. Some of the symptoms of an allergic reaction may include: • rash, itching or hives on the skin • shortness of breath, wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body. DO NOT TAKE CORTIMENT IF YOU ARE ALLERGIC TO PEANUT OIL OR SOY. CORTIMENT contains l Olvassa el a teljes dokumentumot
Page 1 of 11 #36864-v7A AUSTRALIAN PI - CORTIMENT ® (BUDESONIDE) 9 MG PROLONGED RELEASE TABLETS 1. NAME OF THE MEDICINE Budesonide 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each CORTIMENT prolonged-release tablet contains 9 mg of budesonide. Each tablet is a white to off-white, round, biconvex, film-coated, tablet, approximately 9.5 mm in diameter, approximately 4.7 mm in thickness, debossed on one side with “MX9”. CORTIMENT prolonged-release tablets also contain the following excipients: Tablet core: stearic acid (E570), lecithin (E322), microcrystalline cellulose (E460), hyprolose (E463), lactose monohydrate, silicon dioxide (E551), magnesium stearate (E470b). Tablet film-coating: methacrylic acid copolymer, talc - purified (E553b), titanium dioxide (E171), triethyl citrate. CORTIMENT prolonged-release tablets contain lactose and lecithin (of Soya origin). 3. PHARMACEUTICAL FORM The active ingredient in CORTIMENT is budesonide. Budesonide is a white or almost white, crystalline powder. Practically insoluble in water, freely soluble in methylene chloride, sparingly soluble in ethanol. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS CORTIMENT prolonged-release tablets are indicated in adults for induction of remission in patients with mild to moderate active ulcerative colitis (UC) where 5-ASA treatment is not sufficient or not tolerated. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE Adults The recommended daily dose for induction of remission is one 9 mg tablet in the morning, for up to 8 weeks. Paediatric population The safety and efficacy of CORTIMENT prolonged-release 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 prolonged-release tablets in the elderly is limited. Page 2 of 11 #36864-v7A Hepatic and renal impairment population CORTIMENT was not studied in patients w Olvassa el a teljes dokumentumot