Read all of this leaflet carefully before you start taking this

medicine because it contains important information for you.

* Keep this leaflet. You may need to read it again.

* If you have any further questions, ask your doctor or

pharmacist.

* This medicine has been prescribed for you only.

Do not pass it on to others. It may harm them, even if their

signs of illness are the same as yours.

* If you get any side effects talk to your doctor or pharmacist.

This includes any possible side effects not listed in this leaflet.

See section 4.

1- DESCRIPTION:

White to off white oblong shaped tablets packed in PVC - Alu

blister of 10 tablets Box of 30 tablets

2- COMPOSITION:

Each tablet of Lipafib contains 160 mg of fenofibrate micronized

Excipients: Lactose Monohydrate, Diluent Hypromellose (Methocel E3)

Sodium lauryl sulphate, Cellulose Microcrystalline, croscarmellose,

Magnesium Stearate.

3-THERAPEUTIC INDICATIONS

LIPAFIB (fenofibrate) is indicated as an adjunct to diet and other

therapeutic measures for:

•Treatment of patients with hypercholesterolemia, Fredrickson

classification Type IIa and IIb mixed hyperlipidemias, to regulate lipid

levels (reduce serum triglycerides and LDL cholesterol levels and

increase HDL cholesterol).

•Treatment of adult patients with very high serum triglyceride levels,

Fredrickson classification Type IV and Type V hyperlipidemias, who

are at a high risk of sequelae and complications (i.e., pancreatitis)

from their hyperlipidemia.

LIPAFIB alone may not be adequate therapy in some patients with

familial combined hyperlipidemia with Type IIb and Type IV

hyperlipoproteinemia.

Initial therapy for hyperlipidemia should include a specific diet,

weight reduction, and an exercise program; and for patients with

diabetes mellitus, a good diabetic control.

4-MECHANISM OF ACTION AND PHARMACODYNAMIC EFFECTS

LIPAFIB ® (fenofibrate, micronised formulation) lowers elevated

serum lipids by decreasing the low density lipoprotein (LDL) fraction

rich in cholesterol and the very low density lipoprotein (VLDL)

fraction rich in triglycerides. In addition, fenofibrate increases the

high density lipoprotein (HDL) cholesterol fraction. Fenofibrate

appears to have a greater depressant effect on the VLDL than on

the low density lipoproteins (LDL).

Therapeutic doses of fenofibrate produce elevations of HDL

cholesterol, a reduction in the content of the low density lipoproteins

cholesterol, and a substantial reduction in the triglyceride content of

VLDL.

5-PHARMACOKINETICS

Absorption

Fenofibrate’s absorption is low and variable when the product is

administered under fasting conditions. Fenofibrate’s absorption is

increased when the compound is given with food.

Distribution

Fenofibric Acid is extensively bound (> 99 %) to plasma albumin. This

binding is not saturable

Metabolism After oral administration, fenofibrate is rapidly hydrolysed

to fenofibric acid.

Excretion In man it is mainly excreted through the kidney. Half-life is

about 20 hours.

6-CONTRAINDICATIONS

Patients who are hypersensitive to fenofibrate or to any ingredients in

the formulation of components of the container.

• Hepatic insufficiency (including primary biliary cirrhosis and

unexplained persistent liver function abnormality).

• Pre-existing gallbladder disease.

• Severe renal dysfunction (creatinine clearance of < 30ml/min).

• Chronic or acute pancreatitis.

• Hypersensitivity to fenofibrate, any component of this medication or

other drugs of the fibrate class.

• Should not be taken in patients allergic to peanut or arachis oil or

soya lecithin or related products due to the risk of hypersensitivity

reactions.

• The drug should not be used during pregnancy and breast-feeding.

• Known photoallergy or phototoxic reaction during treatment with

fibrates or ketoprofen.

• Should not be co-administered with HMG-CoA reductase inhibitors

(statins) in patients with pre-disposing factors for myopathy.

• Under 18 years of age

7-DOSAGE AND ADMINISTRATION

The usual recommended dose for LIPAFIB ® in adults is one 160 mg

tablet daily taken with the main meal. Tablets should be swallowed

whole with a glass of water. The maximum recommended total daily

dose of LIPAFIB ® is 200 mg .

Missed Dose : If a dose is missed, the next dose should be taken at the

usual time. A double dose should not be taken to make up for a

forgotten dose.

Administration: Tablets can be taken any time with or without food

and should be swallowed whole (not crushed or chewed) with a

glass of water.

8-WARNINGS AND PRECAUTIONS

This medicine contains lactose:

If your doctor has told you that you have an intolerance to lactose,

talk to a doctor or a pharmacist before you take this medicine.

General

Fenofibrate and HMG-CoA Reductase Inhibitors (Statins) The

concomitant administration of LIPAFIB ® (fenofibrate, micronized

formulation) and statins should be avoided unless the benefit for

further alteration in lipid levels is likely to outweigh the increased risk

of this combination.

This combination therapy must not be used in patients with

predisposing factors for myopathy (pre-existing myopathy, age >70

years, renal impairment, hepatic impairment, severe infection,

surgery and trauma, frailty, hypothyroidism or electrolyte

imbalance, personal or family history of hereditary muscular

disorders, previous history of muscle toxicity with another HMG-CoA

reductase inhibitor, concomitant use of a fibrate, niacin or

ezetimibe, alcohol abuse, excessive physical exercise, diabetes with

hepatic fatty change situations where an increase in plasma levels

of active ingredient may occur)

The use of fibrates alone, may occasionally be associated with

myositis, myopathy or rhabdomyolysis. Patients receiving LIPAFIB®

and complaining of muscle pain, tenderness, or weakness should

have prompt medical evaluation for myopathy, including serum

creatine kinase level determination. If myopathy and or myositis is

suspected or diagnosed, LIPAFIB ® therapy should be stopped.

Initial Therapy

Before instituting LIPAFIB® (fenofibrate, micronized formulation)

therapy, laboratory tests should be conducted to ensure that lipid

levels are consistently abnormal.

Attempts should be made to control serum lipids with appropriate

diet, exercise and weight loss in obese patients. Secondary causes

of hypercholesterolemia, such as uncontrolled type 2 diabetes

mellitus, hypothyroidism, nephrotic syndrome, dysproteinemia,

obstructive liver disease, pharmacological treatment and excessive

alcohol intake should be adequately treated before fenofibrate

therapy is initiated. In patients at high risk, consideration should be

given to the control of other risk factors such as smoking, use of

preparations containing estrogen and inadequately controlled

hypertension.

Long-term therapy

Because long-term administration of fenofibrate is recommended,

the potential risks and benefits should be carefully weighed.

Adequate pretreatment laboratory studies should be performed to

ensure that patients have elevated serum cholesterol and/or

triglycerides or low HDL-cholesterol levels. Response to therapy

should be monitored by determination of serum lipid values (e.g.

total cholesterol, LDL-C, triglycerides). If a significant serum lipid

response is not obtained in 3 months, LIPAFIB® should be

discontinued.

Carcinogenicity

In long-term animal toxicity and carcinogenicity studies fenofibrate

has been shown to be tumorigenic for the liver in male rats at 12

times the human dose. At this dose level in male rats there was also

an increase in benign Leydig cell tumors. Pancreatic acinar cell

tumors were increased in male rats at 9 and 40 times the human

dose. Such changes have not been found in the human liver after

up to 3.5 years of fenofibrate administration.

Haematologic changes

Mild hemoglobin, haematocrit and white blood cell decreases have

been observed occasionally in patients following initiation of

fenofibrate therapy. However, these levels stabilize during long-term

administration. Periodic blood counts are recommended during the

first 12 months of fenofibrate administration.

Hepatobiliary disease

LIPAFIB ® is not recommended for use in patients with hepatic

impairment due to the lack of data. Fenofibrate may increase

cholesterol excretion into the bile, and may lead to cholelithiasis.

Pancreatitis

In common with some other fibrates, pancreatitis has been

reported in patients taking fenofibrate. This occurrence may

represent a failure of efficacy in patients

with severe hypertriglyceridemia, a direct

drug effect, or a secondary phenomenon

mediated through biliary tract stone or

sludge formation with obstruction of the

common bile duct. In patients with severe

hypertriglyceridemia, cases of acute

pancreatitis have been reported.

Cholelithiasis

Fenofibrate may increase cholesterol

excretion into the bile, and may lead to

cholelithiasis. If cholelithiasis is suspected,

gallbladder studies are indicated. LIPAFIB®

therapy should be discontinued if

gallstones are found.

Liver Function

Abnormal liver function tests have been

observed occasionally during fenofibrate

administration, including elevations of

transaminases, and decreases or, rarely,

increases in alkaline phosphatase.

Follow-up measurements, performed either

at the end of treatment or during continued

treatment, showed that transaminase

values generally returned to normal limits.

Therefore, regular periodic liver function

tests (AST, ALT and GGT) in addition to other

baseline tests are recommended every 3

months for the first 12 months and at least

yearly thereafter. LIPIDIL SUPRA® should be

terminated if abnormalities persist and/ or

AST and ALT levels increase to more than 3

times the upper limit of normal.

Renal Function

LIPAFIB® should not be used in patients with

severe renal dysfunction (creatinine

clearance < 30ml/min) including patients

on dialysis. In patients with hypoalbumin-

emia, e.g., nephrotic syndrome, and in

patients with renal insufficiency, the dosage

of fibrates must be reduced and renal

function should be monitored regularly .

Treatment should be interrupted in case of

an increase in creatinine levels > 50% upper

limit of normal. It is recommended that

creatinine measurement may be

considered during the first three months

after initiation of treatment.

Skeletal muscle

Treatment with drugs of the fibrate class

has been associated on rare occasions

with myositis or rhabdomyolysis, usually in

patients with impaired renal function and in

cases of hypoalbuminaemia.

Myopathy should be considered in any

patient with diffuse myalgias, myositis,

muscle cramps, tenderness or weakness,

and/or marked elevation of creatine

phosphokinase levels. Patients should be

advised to promptly report unexplained

muscle pain, tenderness or weakness,

particularly if accompanied by malaise or

fever. CK levels should be assessed in

patients reporting these symptoms, and

fenofibrate therapy should be discontinued if markedly elevated CK

levels (5 times the upper limit of normal) occur or myopathy is

diagnosed.

Patients with pre-disposing factors for myopathy may be at an

increased risk of developing rhabdomyolysis. For these patients, the

putative benefits and risks of fenofibrate therapy should be carefully

weighed. The risk of muscle toxicity may be increased if the drug is

administered with another fibrate or an HMG-CoA reductase inhibitor,

especially in case of pre-existing muscular disease.

Consequently, the co-administration of fenofibrate with a HMG-CoA

reductase inhibitor or another fibrate should be reserved to patients

with severe combined dyslipidaemia and high cardiovascular risk

without any history of muscular disease.

9- SPECIFIC PATIENT POPULATIONS

Pediatrics: Limited experience is available in children and

adolescents, at the dose of 5 mg/kg/day fenofibrate non-micronized

formulation. However, safety and effectiveness have not been

established in this sub-population.

Renal Insufficiency: In patients with severe renal failure, significant

accumulation was observed with a large increase in half-life.

Therefore, fenofibrate is contraindicated.

Pregnancy Strict birth control procedures must be exercised by

women of childbearing potential. If pregnancy occurs despite birth

control procedures, LIPAFIB should be discontinued. Women who are

planning pregnancy should discontinue fenofibrate products several

months prior to conception.

Nursing mothers In the absence of information concerning the

presence of fenofibrate in human breast milk, LIPAFIB should not be

used by nursing mothers.

10-DRUG INTERRACTIONS

Concomitant Oral Anticoagulants: Caution should be exercised

when oral anticoagulants are given in conjunction with LIPAFIB. The

dosage of oral anticoagulant should be reduced to maintain the

prothrombin time at the desired level to prevent bleeding

complications. Careful monitoring of prothrombin time is therefore

recommended until it has been definitely determined that the

prothrombin level has been stabilized.

Statins and Cyclosporine: Severe myositis and rhabdomyolysis have

occurred when a statin or cyclosporine was administered in

combined therapy with a fibrate. Therefore, the benefits and risks of

using fenofibrate concomitantly with these drugs should be carefully

considered.

Bile Acid Sequestrants: The absorption of fibrates is impaired by

cholestyramine.

When a fibrate is used concurrently with cholestyramine or any other

resin, an interval of at least 2 hours should be maintained between

the administrations of the two drugs.

Estrogens: Estrogens may lead to a rise in lipid levels. Prescribing

LIPAFIB® in patients taking estrogens or estrogen-containing

contraceptives must be considered clinically on an individual basis.

MAO-Inhibitors: MAO-inhibitors with hepatotoxic potential must not

be administered together with fibrates such as fenofibrate as they

may increase the risk of hepatotoxicity.



Fenofibrate 160mg Tablet

Sulphonylureas and Insulin: It has been previously reported that the

fibrates may potentiate the effects of these classes of drug. This

effect has not yet been documented in the case of fenofibrate. No

case of hypoglycemia or hypoglycemic reaction has been reported

to date.

11-ADVERSE REACTIONS

The most frequently reported adverse events include: gastrointestinal

(epigastric distress, flatulence, abdominal pain, nausea, diarrhea,

constipation), dermatologic (erythema, pruritus, urticaria),

musculoskeletal (muscle pain and weakness, arthralgia), central

nervous system (headache, dizziness, insomnia), miscellaneous

(decreased libido, hair loss, weight loss).

12- STORAGE CONDITION

storebelow30degree, protect from light

Manufacturedby

Athena Drug Delivery Solutions Pvt Ltd. Plot No-Al To A5 , MIDC,

Chemical Zone, Ambernath (W), Thane 421501 Maharashtra State,

India

Marketing Authorisation Holder