Each capsule contains 300 mg fenofibrate.

1- therapeutic indications
Finofib 300 mg capsule reduces elevated serum cholesterol and triglycerides
and is of benefit In the treatment of severe dyslipidaemia in patients in whom
dietary measures alone have failed to produce an adequate response. Finofib
300 mg capsule is therefore indicated in appropriate cases of hyper1ipidaemia
(Frederickson classification types lla, lib, Ill and IV).
 

Finofib 300 mg capsules should only be used in patients whose diseases is
unresponsive to dietary control and in whom a full investigation has been
performed to define their abnormality, and where long -term risks associated
with their condition warrant treatment Other risk factors, such as hypertension
and smoking, may also require management
4.2 Posology and method of administration
Adults
-The recommended initial dose is one capsule taken daily during a main meal.
- In elderly patients without a renal impairment, the normal adult dose is
recommended. Since it is less well absorbed from an empty stomach,finofib
300mg capsules should always be taken with food.Dietaryrestrictions
instituted before therapy should be continued.
- Response to therapy should be monitored by determination of serum lipid
values. Rapid reduction of serum lipid levels usually follows flnofib 300 mg
capsule treatment, but treatment should be discontinued if an adequate
response has not been achieved within three months.
-Capsule should be swallowed whole with water.
4.3 contraindlcatlons
Finofib 300 mg capsules are contraindicated in children , in patients with sever
liver dysfunction , gall>ladder disease , bilary cirrhosis , sever renal disorders and in
patients hypesensltlve to fenofinrate or any component of this medication , known
photoalergy or phototoxic reaction during treatment with fibrates or ketoprofen .
4.4 special warning and precautions
-Secondary case of dyslipidaemia, such as uncontrolled type 2 diabetes mellitus, hypothyroidism, nephritic syndrome, dysproteinemia, obstructive liver disease, pharmacological treatment, alcoholism, should be adequately treated befor fenofibrate therapy is initiated.
- Response to therapy should be monitored by determination of serum lipid values (total cholesterol, LDL, triglycrides). If an adequate response has not been achieved after several months (e.g 3 months) complementary or different therapeutic measures should be considered.
Renal impairment
- In renal dysfunction the dose of fenofibrate may needed to be reduced depending on the rate of creatinine clearance. in this case, fenofibrate 67 mg capsules daily for creatinine clearance levels of< 60 ml/ min and 1 fenofibrate 67 mg capsule daily for creatinine clearance levels< 20 ml/ min.
- It is recommended that creatinine is measured during the first three months after initiation of treatment and thereafter periodically. Treatment should be interrupted in case of an increase in creatinine levels > 50 t of (upper limit of normal)
- Use of fenofibrate 67 mg capsules is also to be preferred In elderly patients with renal impairment where dosage reduction may be required.
Serum transaminase
Moderately elevated levels od serum transaminiases may be found in some patients but rarely interfere with treatment. However, it is recommended that serum transamimiases should be monitored every three months during the first twelve months of treatment. Treatment should be Interrupted in the evebt of ALAT (SGPT) or ASAT (SGOT) elevations to more than 3 times the upper limit of the normal range or more than one hundred international units.
Pancreatitis
- Pancreatitis has been reported in patients taking fenofibrate. The occurrencemay represent a failure of efficacy in patients with severe.
- Hypertriglyceridaemia, a direct drug effect, or a secondary phenomenon mediated through biliary tract stone or sludge formation resliting in the obstruction of the common bile duct.
Myopathy
Muscle toxicity, Including very rare cases of rhabdomylosls, has been reported with administration of fibrates and other lipid-lowering agents. The incidence of this disorder increases in cases of hypoalbuminaemla and previous renal insufficiency. Patients with pre-disposing factors for myopathy and/or rabdomylosis, including age above 70 years, personal or family history of hereditary muscular disorders, renal impairment, hypothyroidism and high alcohol intake, may also be at an increased risk of developing rabdomylosis. For these patients, the putative benefits and risks of fenofibrate therapy should be carefully weighted up.Muscle toxicity should be suspected in patients presenting diffuse myalgia, myositis,and muscular cramps and awakness and/or marked increases in CPK (levels exceeding 5 times the normal range). In such cases treatment with fenofibrate should be stopped.

- The risk of muscle toxicity may be increased if the drug Is administered with another fibrate or an HMG-CoA reductase inhibitor, especially in cases of pre-existing muscular disease. Consequently, the co-prescription of fenofibrate with a statin should be reserved to patients with severe combined dyslipidaemia and high cardiovascular risk without any history of muscular disease. This combination therapy should be used with caution and patients should be monitored closely for signs of muscle toxicity.
- For hyperlipidaemic patients taking estrogens or contraceptives containing estrogen it should be ascertained whether the hyperllpldaemia Is of primary or secondary nature (possible elevation of lipid values caused by oral estrogen).
4.5 Interaction with medicinal other products and other fonns of Interaction
Oral anti-coagulants
Fenoflbrate enhance oral antk:oagulant effect and mayincrease risk of bleeding in patients receiving oral anti-coagulant therapy, the dose of anti-coagulant should be reduced by about one-third at the commencementof reatment and then gradually adjusted if necessary according to INR (international normal ratio) monitoring.
HMG-CoA reductase inhibitors or other fibrates
-The risk of serious muscle toxicity is increased if fenofibrate is used coa1comitantly with HMG-CoA reductase inhibitors or other flbrates. Such combination therapy should be used with caution and patients monitored dosely for signs of muscle toxicity.
-There Is currently no evidence to suggest that fenofibrate affects the pharmacokinetics of simvastatin.
Ciclosporin
Some severe cases of reversible renal function impairment have been reported during concomitant administration of fenofibrate and ciclosporib. The renal function of these patients must therefore be closely monitored and the treatment with fenofibrate stopped in the case of severe alteration of laboratory paramenters.
Other
No proven dinical interactions of fenofibrate with other drugs have been reported, although in vitro interaction studies suggest displacement of phenylbutazone from plasma protein binding sites. In common with other fibrates, fenofibrate induces microsomal mixed function oxidase involved in fatty acid metabolism in rodents and may Interact with drugs metabolized by these enzymes.
4.6 Pregnancy and lactation
-There are no adequate data from the use of fenofibrate in pregnant women. Animal studies have not demonstrated any teratogenic effects. Embryotoxic effects have been shown at doses in the range of maternal toxicity. The potential risk for humans is unknown.
- There are no data on excretion of fenoflbrate and/or its metabolites Into breast milk.
- It is therefore recommended that finofib 300 mg capsules not be administered to women who are pregnant or are breast feeding.
4.7 Effects on ability to drive and use machines
No effect noted to date.
4.8 Undesirable effects
The adverse drug reactions are stated in the table below using the following
convention:
Very common (>1/10); common (>1/100 & <1/10); uncommon (>1/1000 & <1 /100); rare {>1 /10000 & <1 /1000); very rare (<1 /10000) Including isolated reports.

4.9 Overdose
No case of overdosage has been reported. No specific antidote is known. If overdose is suspected, treat symptomatically and institute appropriate supportive measures as required. Fenofibrate cannot be eliminated by haemodialysis.

5.1 Pharmacodynamic properties
- Serum lipid reducing agents/cholesterol and triglyceride
- Reducers/Fibrates.
- The lipid-lowering properties of fenolibrate seen in clinical practice been explained in vivo in transgenic mice and in human hepatocyte cultures by activation of peroxisome proliferator activated receptor a (PPARa ). Through this mechanism, fenolibrate increases lipolysis and elimination of triglyceride-rich particles from plasma by acrivating lipoprotein lipase and reducing production of apoprotein C-111. Activation of PPARa also induces an increase in the synthesis of Apoprotein A-l,A-11 and of HDL cholesterol.

- Studies with fenofdubrate on lipoprotein fractions show decrease in levels of LDL and VLDL cholesterol.HDL cholesterol levels are frequently increased.There are no data on excretion of fenofibrate and/or its metabolites into breast milk. 
L DL and VLDL triglycerides levels are also reduced. The overall effect is a decrease in the ratio of low density lipoproteinsto high density lipoproteins, which epidemiological studies have correlated with a decrease in atherogenic risk. Apolipoprotein-A and apolipoprotein-B levels are altered in parallel with HDL and LDL and VLDL levels respectively.

- Plasma uric acid levels are increased in approximately 20% of hyperlipidaemic patients, particularly in those with type IV phenotype. Finofib 300mg capsules have a uricosuric effect and are therefore of additional benefit in such patients.

5.2 Pharmacokinetic properties
Absorption
- The unchanged compound is not recovered in the plasma. Fenofibric acid is the major plasma metabolite. Peak plasma concentration occurs after a mean period of 5 hours following dosing.

- Steady state levels are observed throughout continuous treatments.

- Fenofibric acid is highly bound to plasma albumin; it can displace antivitamin K compounds from the protein binding sites and potentiate their anti-roagulant effect.

Plasma half-life
The plasma half-life of elimination of fenofibric acid is approximately 20 hours

Metabolism and excretion.
- The product is mainly excreted in the urine 70% in 24 hours and 88 % in 6 days at which time total excretion in urine and feaces reaches 93% . fenofibrate is mainly excreted as fenofibric acid and its derived glucuroconjugate
- Kinetic studies after administration of repeated doses show the absence of accumulation of the product ..
- Fenofibric acid is not eliminated during haemodialysis.

6.1 List of excipients
- Excipients: pregelatinised starch, sodium lauryl sulphate, magnesium stearate, talc purified.
- Composition of the capsule shell: gelatin, titanium dioxide (E171), quinolein yellow (E 104) and erythrosine (E 127)
6.2 Special precaution for storage
- Do not store above 300 C.
- Store in the original package.
- Away from light, in a dry place.
6.3 Nature and content of the container
Carton box contains strip (Al/PVC) of 10 hard gelatin capsules + leaflet