Kraj: Australia
Język: angielski
Źródło: Department of Health (Therapeutic Goods Administration)
fenofibrate, Quantity: 145 mg
Viatris Pty Ltd
Fenofibrate
Tablet, film coated
Excipient Ingredients: colloidal anhydrous silica; sodium lauryl sulfate; crospovidone; hypromellose; magnesium stearate; lactose monohydrate; docusate sodium; microcrystalline cellulose; sucrose; titanium dioxide; purified talc; xanthan gum; polyvinyl alcohol; lecithin
Oral
10 tablets, 30 tablets
(S4) Prescription Only Medicine
LIPIDIL is indicated as an adjunct to diet in the treatment of: hypercholesterolaemia; types II, III, IV and V dislipidaemia; dyslipidaemia associated with type 2 diabetes. Lipidil is indicated for the reduction in the progression of diabetic retinopathy in patients with type 2 diabetes and existing diabetic retinopathy. Lipidil does not replace the appropriate control of blood pressure, blood glucose and blood lipids in reducing the progression of diabetic retinopathy.
Visual Identification: White, oval film-coated tablet, engraved with "145" on one side and the Fournier logo on reverse.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2006-06-02
LIPIDIL ® _fenofibrate_ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about LIPIDIL. 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 or pharmacist has weighed the risks of you taking this medicine 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 LIPIDIL IS USED FOR LIPIDIL is used to help regulate cholesterol and triglycerides which are fat-like substances in the blood. Cholesterol is present in many foods and is also made in your body by the liver. If your body does not balance the amount of cholesterol it needs with the amount of cholesterol eaten, then your cholesterol becomes too high. High cholesterol is more likely to occur with certain diseases or if you have a family history of high cholesterol. When you have high levels of cholesterol it may 'stick' to the inside of your blood vessels instead of being carried to the parts of the body where it is needed. Over time, this can form hard areas (called plaque) on the walls of your blood vessels, making it more difficult for the blood to flow. This blocking of your blood vessels can lead to heart disease (such as heart attack and angina), and stroke. Cholesterol is carried through the body by different proteins, LDL and HDL. LDL cholesterol is the 'bad' cholesterol that can block your blood vessels. HDL cholesterol is the 'good' cholesterol that is thought to remove the 'bad' cholesterol from the blood vessels. In most patients, LIPIDIL reduces the bad cholesterol and can actually raise the good cholesterol. Patients with type 2 diabetes may have some level of diabetic retinopathy, a complication of diabetes that may lead to vision loss or impairment. LIPIDIL has been shown to slow the progression of diabetic retinopathy in Przeczytaj cały dokument
AUSTRALIAN PRODUCT INFORMATION LIPIDIL ® _fenofibrate tablet _ 1 NAME OF THE MEDICINE Fenofibrate _ _ 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 48 mg or 145 mg of fenofibrate as the active ingredient. Excipients with known effect: Sugars (as lactose) and soya bean products. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM 48 mg tablets: Yellow, oval, film-coated tablets engraved with “FI” on one side. 145 mg tablets: White, oval, film-coated tablets engraved “145” on one side and “Fournier logo” on the reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS LIPIDIL is indicated as an adjunct to diet in the treatment of: • hypercholesterolaemia; • types II, III, IV and V dyslipidaemia; • dyslipidaemia associated with type 2 diabetes. LIPIDIL is indicated for the reduction in the progression of diabetic retinopathy in patients with type 2 diabetes and existing diabetic retinopathy. LIPIDIL does not replace the appropriate control of blood pressure, blood glucose and blood lipids in reducing the progression of diabetic retinopathy. _ _ 4.2 DOSE AND METHOD OF ADMINISTRATION ADULTS (DYSLIPIDAEMIA AND DIABETIC RETINOPATHY) LIPIDIL is presented as a 145 mg tablet and a 48 mg tablet. The usual dose of fenofibrate is 1 x 145 mg tablet. Although 3 x 48 mg tablets are equivalent to 1 x 145 mg tablet, the 48 mg tablets are only recommended when a decreased dosage is required (see Section 4.2 DOSE AND METHOD OF ADMINISTRATION - Renal Impairment). Patients should never be administered any combination of the 48 mg tablet and the 145 mg tablet of fenofibrate. There is no indication for use of fenofibrate dosages above 145 mg per day. LIPIDIL 145 mg and 48 mg tablets should be swallowed whole with a glass of water. LIPIDIL 145 mg and 48 mg may be given at any time of the day, with or without food, but it is recommended that they be taken at the same time each day. Dietary measures instituted before therapy should be continued. ELDERLY In elderl Przeczytaj cały dokument