Consumer medicine information

1. Why am I taking FENOFIBRATE LUPIN?

FENOFIBRATE LUPIN contains the active ingredient fenofibrate. FENOFIBRATE LUPIN helps to regulate cholesterol and triglycerides (fat-like substances) in the blood. If untreated, hard areas can form on your blood vessels, which may cause heart attack, and angina or stroke. For more information, see Section 1. Why am I taking FENOFIBRATE LUPIN? in the full CMI.

2. What should I know before I take FENOFIBRATE LUPIN?

Do not use if you have ever had an allergic reaction to fenofibrate, any other any fibrates (such as gemfibrozil), ketoprofen, 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 take FENOFIBRATE LUPIN? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with FENOFIBRATE LUPIN 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 take FENOFIBRATE LUPIN?

• Swallow the tablets whole with a full glass of water.

• The initial recommended dose is 145 mg daily, taken as 1 tablet daily. A lower dose may be required if you have kidney problems.

5. What should I know while taking FENOFIBRATE LUPIN?

6. Are there any side effects?

Common side effects include stomach pain or discomfort, diarrhoea, constipation, nausea, back pain, muscular pain or spasms, skin reactions, photosensitivity reactions, sore throat, discomfort when swallowing, runny or blocked nose, sneezing, facial pressure or pain, sexual dysfunction, headache, unusual tiredness or weakness.
Serious side effects include severe abdominal pain, temporary paralysis of the muscles, yellowing of the skin and eyes, difficulty in breathing, dark coloured urine or chest pain. Symptoms of an allergic reaction include skin rash, itching, shortness of breath or swelling of the face, lips or tongue, which may cause difficulty in swallowing or breathing.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

Notes

Distributed by Generic Health Pty Ltd

1 Name of Medicine

Fenofibrate.

2 Qualitative and Quantitative Composition

Fenofibrate Lupin 48 mg tablets contain 48 mg of fenofibrate (micronised).
Fenofibrate Lupin 145 mg tablets contain 145 mg of fenofibrate (micronised).
List of excipients with known effect. Lactose monohydrate, sucrose.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

48 mg tablets. Yellow coloured oval-shaped, film-coated tablets debossed with "48" on one side and "FB" on the other side.
145 mg tablets. White to off-white coloured oval-shaped, film-coated tablets debossed with "145" on one side and "FB" on the other side.

4 Clinical Particulars

4.9 Overdose

There is no specific treatment for overdose with fenofibrate. General supportive care of the patient is indicated, including monitoring of vital signs and observation of clinical status, should an overdose occur. Because fenofibrate is highly bound to plasma proteins, haemodialysis should not be considered. For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Fenofibrate did not induce gene mutation in bacteria or mouse lymphoma cells in vitro, or chromosome aberration in CHO cells in vitro or rat bone marrow cells in vivo. Nor did it cause DNA damage in rat hepatocytes in vitro.
Carcinogenicity. The carcinogenic potential of fenofibrate was investigated in mice and rats. In two carcinogenicity studies in rats at dietary doses of 10, 45 and 200 mg/kg/day (24-month study) or 10 and 60 mg/kg/day (27-month study), the incidence of liver carcinomas and/or adenomas was increased at ≥ 45 mg/kg/day (≥ 4x the clinical exposure, based on AUC) in the 24-month study. Increased incidence of pancreatic acinar cell tumours (carcinomas and/or adenomas) occurred in males in both studies at ≥ 45 mg/kg/day and increased testicular Leydig cell tumours in both studies at ≥ 60 mg/kg/day (≥ 5x the clinical exposure, based on AUC). In two mouse studies at fenofibrate doses 10, 45 and 200 mg/kg/day (18-month study) or 10, 60 and 200 mg/kg/day (21-month study), the incidence of liver tumours (hepatocellular adenomas and/or carcinomas) was increased in the 18-month study at all doses (0.2x to 4.5x the maximum recommended clinical dose (MRCD) adjusted for body surface area (BSA)), and in the 21-month study at ≥ 60 mg/kg/day (1.4x the MRCD adjusted for BSA). Electron microscopy studies have demonstrated peroxisomal proliferation following fenofibrate administration to the rat. These changes are specific to small rodents and have not been observed in other animal species. This is of no relevance to therapeutic use in humans.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Fenofibrate is a fibric acid derivative. Fenofibrate is a white or almost white crystalline powder, practically insoluble in water, very soluble in methylene chloride and slightly soluble in alcohol. The melting point is 79-82°C.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSFENOFI.gif Chemical name: 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester.
Molecular formula: C₂₀H₂₁O₄Cl.
Molecular weight: 360.83.
CAS number. 49562-28-9.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine - Schedule 4.

Summary Table of Changes

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