Country: Australia
Language: English
Source: 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
30 tablets
(S4) Prescription Only Medicine
Fenofibrate Viatris 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, 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
2016-04-01
FENOFIBRATE VIATRIS F E N O F I B R A T E V I A T R I S CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING FENOFIBRATE VIATRIS? FENOFIBRATE VIATRIS contains the active ingredient fenofibrate. FENOFIBRATE VIATRIS is used to help regulate cholesterol and triglycerides which are fat-like substances in the blood. For more information, see Section 1. Why am I using FENOFIBRATE VIATRIS? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE FENOFIBRATE VIATRIS? Do not use if you have ever had an allergic reaction to fenofibrate or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use FENOFIBRATE VIATRIS? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with FENOFIBRATE VIATRIS and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE FENOFIBRATE VIATRIS? • The initial recommended dose is 145 mg daily, taken as 1 x 145 mg tablet, your doctor may prescribe a lower dose if you have kidney problems. More instructions can be found in Section 4. How do I use FENOFIBRATE VIATRIS? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING FENOFIBRATE VIATRIS? THINGS YOU SHOULD DO • Remind any doctor, surgery, dentist or pharmacist you visit that you are using this medicine. • Tell you doctor if you have these medical conditions: kidney problems, muscular aching, tenderness or weakness not caused by exercise. • Tell your doctor if you become pregnant. THINGS YOU SHOULD NOT DO • Do not stop using this medicine suddenly. • Do not take this medicine if you have an allergy to any fibrates (such as gemfibrozil) and ketoprofen. • Do not take this medicine if yo Read the complete document
AUSTRALIAN PRODUCT INFORMATION FENOFIBRATE VIATRIS _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: Soya bean products, sulfites and sugars as lactose. 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 FENOFIBRATE VIATRIS 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 VIATRIS 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. FENOFIBRATE VIATRIS 145 mg and 48 mg tablets should be swallowed whole with a glass of water. FENOFIBRATE VIATRIS 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 FENOFIBRATE VIATRIS Dosage reduction is required in patients with renal impairment. In moderate renal dysfunction (eGFR between 30 and 60ml/min/1.73m 2 or creatinine clearance be Read the complete document