Country: অস্ট্রেলিয়া
ভাষা: ইংরেজি
সূত্র: Department of Health (Therapeutic Goods Administration)
fenofibrate, Quantity: 145 mg
Southern Cross Pharma Pty Ltd
Tablet
Excipient Ingredients: lactose; sodium lauryl sulfate; hypromellose; croscarmellose sodium; magnesium stearate; purified water; xanthan gum; PEG-40 stearate; benzoic acid; glyceryl monostearate; methylcellulose; polysorbate 65; simethicone; sorbic acid; sulfuric acid
Oral
30
(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: Fenofibrate 145 mg tablets are white to off-white biconvex oblong tablets, ca 15.5 x 8.5 mm debossed with "F" on one side and "145" on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2019-05-17
BLOOMS THE CHEMIST FENOFIBRATE 1 BLOOMS THE CHEMIST FENOFIBRATE _fenofibrate _ CONSUMER MEDICINE INFORMATION FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 WHAT IS IN THIS LEAFLET This leaflet answers some common questions about this medicine. 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 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 THIS MEDICINE IS USED FOR Blooms The Chemist Fenofibrate contains the active ingredient fenofibrate. Fenofibrate is used to help regulate cholesterol and triglycerides which are fat-like substances in the blood. Fenofibrate belongs to a group of medicines known as fibric acid derivatives. It works through the activation of a cell nuclear receptor called PPARα, which reduces the amount of triglycerides and bad cholesterol made in the body and increases the good cholesterol. 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 bl সম্পূর্ণ নথি পড়ুন
1 AUSTRALIAN PRODUCT INFORMATION BLOOMS THE CHEMIST FENOFIBRATE (FENOFIBRATE) TABLETS 1 NAME OF THE MEDICINE Fenofibrate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Fenofibrate is a fibric acid derivative. Chemical name: 2-[4-(4-chlorobenzoyl) phenoxy]-2- methyl- propanoic acid, 1-methylethyl ester. The empirical formula is C 20 H 21 O 4 Cl. MW: 360.8. Fenofibrate is a white or almost white crystalline powder, stable under ordinary conditions and practically insoluble in water. The melting point is 79-82°C. Fenofibrate 48 mg tablets contain 48 mg of fenofibrate nanoparticles Fenofibrate 145 mg tablets contain 145 mg of fenofibrate nanoparticles For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Fenofibrate 48 mg tablets are white to off-white biconvex oblong tablets, ca 10.5 x 5.8 mm, debossed with “F” on one side and “48” on the other side, in blister (PVC/PVDC/Al) packs of 60. Fenofibrate 145 mg tablets are white to off-white biconvex oblong tablets, ca 15.5 x 8.5 mm, debossed with “F” on one side and “145” on the other side, in blister (PVC/PVDC/Al) packs of 30. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC 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 2 4.2 D OSE AND METHOD OF ADMINISTRATION Adults (Dyslipidaemia) Fenofibrate 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). 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 145 mg and 48 mg tablets should be swallowed whole with a glass of water. Fenofibrate 145 mg and 48 mg may be given at any time সম্পূর্ণ নথি পড়ুন