Land: Australië
Taal: Engels
Bron: Department of Health (Therapeutic Goods Administration)
fenofibrate, Quantity: 145 mg
Cipla Australia Pty Ltd
Tablet, film coated
Excipient Ingredients: docusate sodium; hypromellose; sodium lauryl sulfate; sucrose; silicified microcrystalline cellulose; crospovidone; magnesium stearate; lactose monohydrate; titanium dioxide; purified talc; xanthan gum; polyvinyl alcohol; lecithin
Oral
10 tablets, 30 tablets
(S4) Prescription Only Medicine
FENOFIBRATE CIPLA is indicated as an adjunct to diet in the treatment of:,- hypercholesterolaemia;,- types II, III, IV and V dyslipidaemia;,- dyslipidaemia assocated with type 2 diabetes.
Visual Identification: White to off white coloured, oval biconvex film coated tablet debossed with Cipla on one side and code 458 on other side; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2018-04-30
FENOFIBRATE CIPLA _48 MG AND 145 MG TABLETS _ _fenofibrate _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Fenofibrate Cipla. 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 CIPLA IS USED FOR Fenofibrate Cipla 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, Fenofibrate Cipla reduces the bad cholesterol and can actually raise the good cholesterol. Fenofibrate Cipla does not reduce the cholesterol that comes from fat in food. Therefore, when you are taking Fenofibrate Cipla, you also need t Lees het volledige document
AUSTRALIAN PRODUCT INFORMATION FENOFIBRATE CIPLA (FENOFIBRATE) TABLETS 1. NAME OF THE MEDICINE Fenofibrate 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Fenofibrate Cipla 48 mg film-coated tablet Each tablet of Fenofibrate Cipla for oral administration contains 48 mg of fenofibrate. _Excipients with known effect: _ Contains sugar (as lactose monohydrate). Fenofibrate Cipla 145 mg film-coated tablet Each tablet of Fenofibrate Cipla for oral administration contains 145 mg of fenofibrate _Excipients with known effect: _ Contains sugars (as lactose and sucrose). For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Fenofibrate Cipla 48 mg film-coated tablet Fenofibrate Cipla 48 mg film-coated tablets are yellow coloured, oval shaped, biconvex film-coated tablet, debossed with ‘cipla’ on one side and code '459' on other side. Fenofibrate Cipla 145 mg film-coated tablet Fenofibrate Cipla 145 mg film-coated tablets are white to off white coloured, oval shaped, biconvex film coated tablet, debossed with 'cipla' on one side and code '458' on other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fenofibrate Cipla 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 Cipla is presented as a 145 mg and 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. Fenofibrate Cipla 145 mg and 48 mg tablets should be swallowed whole with a glass of water. Fenofibrate Cipla 145 mg and 48 mg ta Lees het volledige document