Riik: Austraalia
keel: inglise
Allikas: Department of Health (Therapeutic Goods Administration)
fenofibrate, Quantity: 48 mg
Sun Pharma ANZ Pty Ltd
Fenofibrate
Tablet
Excipient Ingredients: sucrose; pregelatinised maize starch; silicon dioxide; sodium lauryl sulfate; sodium stearylfumarate; hypromellose; crospovidone; microcrystalline cellulose; titanium dioxide; purified talc; xanthan gum; polyvinyl alcohol; lecithin
Oral
60
(S4) Prescription Only Medicine
Fenofibrate 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.
Visual Identification: White to off-white, oval shaped, biconvex film coated tablets debossed with 'RH 37' on one side and other side plain.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2016-02-29
FENOFIBRATE RBX v3.0 1 FENOFIBRATE RBX ® _fenofibrate_ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Fenofibrate RBX. 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 FENOFIBRATE RBX IS USED FOR Fenofibrate RBX is used to help regulate cholesterol and triglycerides which are fat-like substances in the blood. Everyone has cholesterol in their blood. It is a type of blood fat needed by the body for many things, such as making bile acids (which help digest food) and some hormones. 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. Having high levels of ‘bad’ cholesterol and triglycerides can be a problem. 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 pat Lugege kogu dokumenti
FENOFIBRATE RBX PI Version 4 1 AUSTRALIAN PRODUCT INFORMATION FENOFIBRATE RBX (FENOFIBRATE) 48MG AND 145MG TABLETS 1 NAME OF THE MEDICINE Fenofibrate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION FENOFIBRATE RBX tablets contain 48 mg or 145 mg of fenofibrate nanoparticles. Excipients with known effect: Sugars as sucrose. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Tablet. FENOFIBRATE RBX 48mg tablet: white to off-white, oval shaped, biconvex film coated tablets debossed with ‘RH 37’ on one side and plain on the other side. FENOFIBRATE RBX 145mg tablet: White to off-white, oval shaped, biconvex film coated tablets debossed with ‘RH 38’ on one side and plain on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fenofibrate 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. 4.2 DOSE AND METHOD OF ADMINISTRATION ADULTS (DYSLIPIDAEMIA) FENOFIBRATE RBX 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 RENAL IMPAIRMENT). FENOFIBRATE RBX PI Version 4 2 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. FENOFIBRATE RBX 145 mg and 48 mg tablets should be swallowed whole with a glass of water. FENOFIBRATE RBX 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 elderly patients without renal impairment, the normal adult dose is recommended. RENAL IMPAIRMENT In renal dysfunction, the dosage may need to be reduced depending on the rate of creat Lugege kogu dokumenti