GENERIC NAME OF THE MEDICINAL PRODUCT:

Fenofibrate Capsule IP (micronised) 200mg (Fenacor) Taj Pharma

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Fenofibrate 200mg
Excipients q.s.

THERAPEUTIC INDICATIONS:

Fenofibrate Capsule IP 200mg use for the Treatment of severe hypertriglyceridaemia with or without low HDL cholesterol, Mixed hyperlipidaemia when a statin is contraindicated or not tolerated and in Mixed hyperlipidaemia in patients at high cardiovascular risk in addition to a statin when triglycerides and HDL cholesterol are not adequately controlled.

DIRECTION OF USE:

Swallow the capsule whole with a glass of water, do not open or chew the capsule and take the capsule with food - it will not work as well if your stomach is empty.

CAUTION & SCHEDULE:

Keep this and all medication out of reach and sight of children.
SCHEDULE: SCHEDULE ‘H’ DRUG – To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Store at 25°C (77°F); Protect from light and moisture.

Fenofibrate Capsule IP (micronised) 200mg (Fenacor) Taj Pharma

  1. Name of the medicinal product

Fenofibrate Capsule IP (micronised) 200mg (Fenacor) Taj Pharma

  1. Qualitative and quantitative composition

a) Each Capsule Contains:
Fenofibrate           200mg
Excipients                   q.s.

  1. Pharmaceutical form

Capsule, hard.

Orange, hard gelatine capsule.

  1. Clinical particulars

4.1 Therapeutic indications

Fenofibrate 200 mg capsules are indicated as an adjunct to diet and other non pharmacological treatment (e.g. exercise, weight reduction) for the following:

– Treatment of severe hypertriglyceridaemia with or without low HDL cholesterol.

– Mixed hyperlipidaemia when a statin is contraindicated or not tolerated.

– Mixed hyperlipidaemia in patients at high cardiovascular risk in addition to a statin when triglycerides and HDL cholesterol are not adequately controlled.

4.2 Posology and method of administration

Posology

Adults

The recommended initial dose is one capsule taken daily during a main meal. In elderly patients without renal impairment, the normal adult dose is recommended. Since it is less well absorbed from an empty stomach, Fenofibrate 200 mg capsules should always be taken with food. Dietary restrictions 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 Fenofibrate 200 mg capsule treatment, but treatment should be discontinued if an adequate response has not been achieved within three months.

Special populations

Elderly patients (≥ 65 years old)

No dose adjustment is necessary. The usual dose is recommended, except for decreased renal function with estimated glomerular filtration rate < 60 mL/min/1.73 (see Patients with renal impairment).

Patients with renal impairment

A dose reduction is recommended in renal impairment (see section 4.4)

Fenofibrate should not be used if severe renal impairment, defined as eGFR <30 mL/min per 1.73 m2, is present.

If eGFR is between 30 and 59 mL/min per 1.73 m2, the dose of fenofibrate should not exceed 100 mg standard or 67 mg micronized once daily.

If, during follow-up, the eGFR decreases persistently to <30 mL/min per 1.73 m2, fenofibrate should be discontinued.

Paediatric population

The safety and efficacy of fenofibrate in children and adolescents younger than 18 years has not been established. No data are available.

Therefore, the use of fenofibrate is not recommended in paediatric subjects under 18 years

Patients with hepatic disease

Fenofibrate 200mg capsules are not recommended for use in patients with hepatic impairment due to the lack of data.

Method of Administration

Oral use

Fenofibrate 200 mg capsules should be swallowed as a whole with water, and should be taken with food.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Fenofibrate 200 mg capsules are contraindicated in children, gallbladder disease, severe renal disorders and in patients hypersensitive to fenofibrate or any component of this medication, known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen.

Hepatic insufficiency (including biliary cirrhosis and unexplained persistent liver function abnormality).

Chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridemia.

Use during pregnancy and lactation (see section 4.6).

Severe renal insufficiency (estimated glomerular filtration rate < 30 mL/min/1.73 m2).

4.4 Special warnings and precautions for use

Secondary causes of hyperlipidaemia:

Secondary causes of hyperlipidaemia, such as uncontrolled type 2 diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemia, obstructive liver disease, pharmacological treatment, alcoholism, should be adequately treated before fenofibrate therapy is initiated. Secondary cause of hypercholesterolemia related to pharmacological treatment can be seen with diuretics, β-blocking agents, estrogens, progestogens, combined oral contraceptives, immunosuppressive agents and protease inhibitors. In these cases it should be ascertained whether the hyperlipidaemia is of primary or secondary nature (possible elevation of lipid values caused by these therapeutic agents).

Renal function:

In renal dysfunction the dose of fenofibrate may need to be reduced, depending on the rate of creatinine clearance. In this case, Fenofibrate 67 mg capsules should be used, e.g. 2 Fenofibrate 67 mg capsules daily for creatinine clearance levels of <60 ml/min and 1 Fenofibrate 67 mg capsule daily for creatinine clearance levels of <20 ml/min.

Fenofibrate 200mg capsules are contraindicated in severe renal impairment (see section 4.3).

Fenofibrate 200mg capsules should be used with caution in patients with mild to moderate renal insufficiency. Dose should be adjusted in patients whose estimated glomerular filtration rate is 30 to 59 mL/min/1.73 m2 (see section 4.2).

Reversible elevations in serum creatinine have been reported in patients receiving fenofibrate monotherapy or co-administered with statins. Elevations in serum creatinine were generally stable over time with no evidence for continued increases in serum creatinine with long term therapy and tended to return to baseline following discontinuation of treatment.

During clinical trials, 10% of patients had a creatinine increase from baseline greater than 30 μmol/L with co-administered fenofibrate and simvastatin versus 4.4% with statin monotherapy. 0.3% of patients receiving co-administration had clinically relevant increases in creatinine to values > 200 μmol/L.

Treatment should be interrupted when creatinine level is 50% above the upper limit of normal. It is recommended that creatinine is measured during the first 3 months after initiation of treatment and periodically thereafter.

Use of Fenofibrate 67 mg capsules are also to be preferred in elderly patients with renal impairment where dosage reduction may be required.

Liver function:

As with other lipid lowering agents, increases have been reported in transaminase levels in some patients. In the majority of cases these elevations were transient, minor and asymptomatic. It is recommended that transaminase levels are monitored every 3 months during the first 12 months of treatment and thereafter periodically. Attention should be paid to patients who develop increase in transaminase levels and therapy should be discontinued if AST (SGOT) and ALT (SGPT) levels increase to more than 3 times the upper limit of the normal range. When symptoms indicative of hepatitis occur (e.g. jaundice, pruritus), and diagnosis is confirmed by laboratory testing, fenofibrate therapy should be discontinued.

Pancreas:

Pancreatitis has been reported in patients taking fenofibrate (see section 4.3 and 4.8). This occurrence may 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, resulting in the obstruction of the common bile duct.

Muscle:

Muscle toxicity, including very rare cases of rhabdomyolysis, with or without renal failure has been reported with administration of fibrates and other lipid-lowering agents. The incidence of this disorder increases in cases of hypoalbuminaemia and previous renal insufficiency. Patients with pre-disposing factors for myopathy and/or rabdomyolysis, including age above 70 years, personal or familial history of hereditary muscular disorders, renal impairment, hypothyroidism and high alcohol intake, may also be at an increased risk of developing rhabdomyolysis. For these patients, the putative benefits and risks of fenofibrate therapy should be carefully weighed up.

Muscle toxicity should be suspected in patients presenting diffuse myalgia, myositis, muscular cramps and weakness 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 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 and a close monitoring of potential muscle toxicity.

This medicine contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction

Oral anti-coagulants

Fenofibrate enhances oral anti-coagulant effect and may increase risk of bleeding. In patients receiving oral anti-coagulant therapy, the dose of anti-coagulant should be reduced by about one-third at the commencement of treatment and then gradually adjusted if necessary according to INR (International Normalised Ratio) monitoring.

Ciclosporin

Some severe cases of reversible renal function impairment have been reported during concomitant administration of fenofibrate and ciclosporin. 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 parameters.

HMG-CoA reductase inhibitors or Other Fibrates

The risk of serious muscle toxicity is increased if fenofibrate is used concomitantly with HMG-CoA reductase inhibitors or other fibrates. Such combination therapy should be used with caution and patients monitored closely for signs of muscle toxicity (see Section 4.4).

There is currently no evidence to suggest that fenofibrate affects the pharmacokinetics of simvastatin.

Glitazones

Some cases of reversible paradoxical reduction of HDL-cholesterol have been reported during concomitant administration of fenofibrate and glitazones. Therefore it is recommended to monitor HDL-cholesterol if one of these components is added to the other and stopping of either therapy if HDL-cholesterol is too low.

Cytochrome P450 enzymes

In vitro studies using human liver microsomes indicate that fenofibrate and fenofibric acid are not inhibitors of cytochrome (CYP) P450 isoforms CYP3A4, CYP2D6, CYP2E1, or CYP1A2. They are weak inhibitors of CYP2C19 and CYP2A6, and mild-to-moderate of CYP2C9 at therapeutic concentrations.

Patients co-administered fenofibrate and CYP2C19, CYP2A6, and especially CYP2C9 metabolised drugs with a narrow therapeutic index should be carefully monitored and, if necessary, dose adjustment of these drugs is recommended.

Other

No proven clinical 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 oxidases involved in fatty acid metabolism in rodents and may interact with drugs metabolised by these enzymes.

4.6 Fertility, pregnancy and lactation

Pregnancy

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 (see section 5.3). The potential risk for humans is unknown.

Breast-feeding

There are no data on the excretion of fenofibrate and/or its metabolites into breast milk.

It is therefore recommended that Fenofibrate 200 mg capsules should not be administered to women who are pregnant or are breast feeding.

4.7 Effects on ability to drive and use machines

Fenofibrate 200mg capsules has no or negligible influence on the ability to drive and use machines.

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 (>1/1,000; <1/100); rare (>1/10,000; <1/1,000); very rare (<1/10,000) including isolated reports.

Blood and lymphatic system disordersRare:

Decrease in haemoglobin and leukocytes

Nervous system disordersCommon:

Headache

Rare:

Peripheral neuropathy

Ear and labyrinth disordersCommon:

Vertigo

Vascular disordersUncommon:

Thromboembolism (pulmonary embolism, deep vein thrombosis)*

Respiratory, thoracic and mediastinal disordersVery rare:

Interstitial pneumopathies

Gastrointestinal disordersCommon:

Digestive, gastric or intestinal disorders (abdominal pain, nausea, vomiting, diarrhoea, and flatulence)

Uncommon:

Pancreatitis*

Hepato-biliary disordersUncommon:

Elevated levels of serum transaminases (see section 4.4)

Very rare:

hepatitis (see section 4.4), gallstones

Skin and subcutaneous tissue disordersCommon:

Reactions such as rashes, pruritus, urticaria or photosensitivity reactions; cutaneous photosensitivity may occur with erythema, vesiculation or nodulation on parts of the skin exposed to sunlight or artificial UV light (e.g. sun lamp)

Rare:

Alopecia

Musculoskeletal, connective tissue and bone disordersUncommon:

muscle toxicity (diffuse myalgia, myositis, muscular cramps and weakness) (see section 4.4)

Very rare:

Rhabdomyolysis. (see section 4.4)

Renal and urinal disordersRare:

Increases in serum creatinine and urea

General disorders and administration site conditionsCommon:

Fatigue

Rare:

Sexual asthenia

* In the FIELD-study, a randomized placebo-controlled trial performed in 9795 patients with type 2 diabetes mellitus, a statistically significant increase in pancreatitis cases was observed in patients receiving fenofibrate versus patients receiving placebo (0.8% versus 0.5%; p = 0.031). In the same study, a statistically significant increase was reported in the incidence of pulmonary embolism (0.7% in the placebo group versus 1.1% in the fenofibrate group; p = 0.022) and a statistically non-significant increase in deep vein thromboses (placebo: 1.0 % [48/4900 patients] versus fenofibrate 1.4% [67/4895 patients]; p = 0.074).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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.

  1. Pharmacological properties

5.1 Pharmacodynamic properties

Serum Lipid Reducing Agents/Cholesterol and Triglyceride Reducers/Fibrates.

Fenofibrate 200 mg capsule is a formulation containing 200 mg of micronised fenofibrate: the administration of this product results in effective plasma concentrations identical to those obtained with 3 capsules of Fenofibrate 67 mg capsules containing 67 mg of micronised fenofibrate.

The lipid-lowering properties of fenofibrate seen in clinical practice have been explained in vivo in transgenic mice and in human hepatocyte cultures by activation of Peroxisome Proliferator Activated Receptor α (PPARα). Through this mechanism, fenofibrate increases lipolysis and elimination of triglyceride-rich particles from plasma by activating lipoprotein lipase and reducing production of Apoprotein C-III. Activation of PPARα also induces an increase in the synthesis of Apoprotein A-I, A-II and of HDL cholesterol.

Epidemiological studies have demonstrated a positive correlation between abnormally increased serum lipid levels and an increased risk of coronary heart disease. The control of such dyslipidaemias forms the rationale for treatment with fenofibrate. However, the possible beneficial and adverse long-term consequences of drugs used in the mangement of dyslipidaemia are still the subject of scientific discussion. Therefore the presumptive beneficial effect of Fenofibrate 200 mg capsules on cardiovascular morbidity and mortality is as yet unproven.

There is evidence that treatment with fibrates may reduce coronary heart disease events but they have not been shown to decrease all cause mortality in the primary or secondary prevention of cardiovascular disease.

The Action to Control Cardiovascular Risk in Diabetes (ACCORD) lipid trial was a randomized placebo-controlled study of 5518 patients with type 2 diabetes mellitus treated with fenofibrate in addition to simvastatin. Fenofibrate plus simvastatin therapy did not show any significant differences compared to simvastatin monotherapy in the composite primary outcome of non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death (hazard ratio [HR] 0.92, 95% CI 0.79-1.08, p = 0.32 ; absolute risk reduction: 0.74%). In the pre-specified subgroup of dyslipidaemic patients, defined as those in the lowest tertile of HDL-C (≤34 mg/dl or 0.88 mmol/L) and highest tertile of TG (≥204 mg/dl or 2.3 mmol/L) at baseline, fenofibrate plus simvastatin therapy demonstrated a 31% relative reduction compared to simvastatin monotherapy for the composite primary outcome (hazard ratio [HR] 0.69, 95% CI 0.49-0.97, p = 0.03 ; absolute risk reduction: 4.95%). Another prespecified subgroup analysis identified a statistically significant treatment-by-gender interaction (p = 0.01) indicating a possible treatment benefit of combination therapy in men (p=0.037) but a potentially higher risk for the primary outcome in women treated with combination therapy compared to simvastatin monotherapy (p=0.069). This was not observed in the aforementioned subgroup of patients with dyslipidaemia but there was also no clear evidence of benefit in dyslipidaemic women treated with fenofibrate plus simvastatin, and a possible harmful effect in this subgroup could not be excluded.

Studies with fenofibrate on lipoprotein fractions show decreases in levels of LDL and VLDL cholesterol. HDLcholesterol levels are frequently increased. LDL and VLDL triglycerides levels are also reduced. The overall effect is a decrease in the ratio of low and very low density lipoproteins to 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.

Regression of xanthomata has been observed during fenofibrate therapy.

Plasma uric acid levels are increased in approximately 20 % of hyperlipidaemic patients, particularly in those with type IV phenotype. Fenofibrate 200 mg capsules have a uricosuric effect and is therefore of additional benefit in such patients.

Patients with raised levels of fibrinogen and Lp(a) have shown significant reductions in these measurements during clinical trials with fenofibrate.

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.

Mean plasma concentration is 15μg/ml for a daily dosage of 200 mg of micronised fenofibrate, equivalent to 3 capsules of 67 mg micronised fenofibrate.

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-coagulant 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 faeces 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.

5.3 Preclinical safety data

Chronic toxicity studies have yielded no relevant information about specific toxicity of fenofibrate. Studies on mutagenicity of fenofibrate have been negative.

In rats and mice, liver tumours have been found at high dosages, which are attributable to peroxisome proliferation. 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 man.

Studies in mice, rats and rabbits did not reveal any teratogenic effect. Embryotoxic effects were observed at doses in the range of maternal toxicity. Prolongation of the gestation period and difficulties during delivery were observed at high doses. No sign of any effect on fertility has been detected.

  1. Pharmaceutical particulars

6.1 List of excipients

Excipients: lactose monohydrate, pregelatinised starch, sodium lauryl sulfate, povidone, magnesium stearate.

Composition of the capsule shell: gelatin, titanium dioxide, yellow iron oxide and ponceau 4R, cochineal red.

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

30 months.

6.4 Special precautions for storage

Do not store above 25°C.

Store in the original package

6.5 Nature and contents of container

Blister, PVC (250 μm)-PVDC (40 g/m2)/Alu (20 µm) and

Blister, PVC (250 μm)-PVDC (60 g/m2)/Alu (20 µm)

Pack sizes: 20, 28, 30.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special requirements.

7. Manufactured in India By:
TAJ PHARMACEUTICALS LTD.
PlotNo.220, Mahagujarat Industrial Estate,
At & Post: Moraiya, TAL- Sanand,
Dist. Ahmedabad, Gujarat(India)

Fenofibrate Capsules IP 200mg (FENACOR) Taj Pharma

PACKAGE LEAFLET: INFORMATION FOR THE USER

Fenofibrate

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 or nurse.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, or pharmacist or nurse.

What is in this leaflet:

1. What Fenofibrate is and what it is used for
2. What you need to know before you take Fenofibrate
3. How to take Fenofibrate
4. Possible side effects
5. How to store Fenofibrate
6. Contents of the pack and other information

  1. What Fenofibrate is and what it is used for

Fenofibrate belongs to a group of medicines, commonly known as ‘fibrates’. These medicines are used to lower the level of fats (lipids) in the blood. For example the fats known as ‘triglycerides’.

Fenofibrate is used, alongside a low fat diet and other non-medical treatments such as exercise and weight loss, to lower levels of fats in the blood.

Fenofibrate can be used in addition to other medicines (called ‘statins’) in some circumstances when levels of fats in the blood are not controlled with a statin alone.

Fenofibrate can often also increase the amount of a ‘good’ type of cholesterol, called HDL or high density lipoprotein cholesterol.

It is always essential to continue a low-fat diet during treatment with Fenofibrate.

  1. What you need to know before you take Fenofibrate

Do not take Fenofibrate if:

  • You are allergic to fenofibrate or any of the other ingredients of this medicine (listed in Section 6: Contents of the pack and other information)
  • While taking other medicines, you have had an allergic reaction or skin damage from sunlight or UV light (these medicines include other fibrates and an anti-inflammatory medicine called ‘ketoprofen’)
  • You have severe liver, kidney or gallbladder problems
  • You have pancreatitis (an inflamed pancreas which causes abdominal pain), which is not caused by high levels of fat in the blood

Do not take Fenofibrate if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Fenofibrate.

Warnings and Precautions

Talk to your doctor or pharmacist or nurse before taking Fenofibrate if:

  • You have any liver or kidney problems
  • You may have an inflamed liver (hepatitis) – signs include yellowing of the skin and the whites of the eyes (jaundice) and an increase in liver enzymes (shown in blood tests)
  • You have an under-active thyroid gland (hypo-thyroidism)
  • You have diabetes, especially Type 2 diabetes, that is not well controlled
  • You have problems with certain proteins in your blood
  • You have an alcohol problem
  • You are taking other medicines
  • You or your family have had muscle problems
  • You are over 70 years of age

(Some of the above conditions can lead to high levels of lipids in your blood and need to be corrected before you start therapy with fenofibrate).

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Fenofibrate.

Your doctor might want to test your blood or urine to check if Fenofibrate is working properly and also if your kidneys, muscles and liver are working properly.

Effects on muscles

Stop taking Fenofibrate and see a doctor straight away if you get unexplained cramps or painful, tender or weak muscles while taking this medicine.

  • This is because this medicine may cause muscle problems, which may be serious
  • These problems are rare but include muscle inflammation and breakdown. This can cause kidney damage or even death

Your doctor may do a blood test to check your muscles before and after starting treatment.

The risk of muscle breakdown is higher in some patients. Tell your doctor if:

  • You are over 70 years old
  • You have kidney problems
  • You have thyroid problems
  • You or a close family member has a muscle problem which runs in the family
  • You drink large amounts of alcohol
  • You are taking medicines called statins to lower cholesterol – such as simvastatin, atorvastatin, pravastatin, rosuvastatin or fluvastatin
  • You have ever had muscle problems during treatment with statins or fibrates – such as fenofibrate, bezafibrate or gemfibrozil

If any of the above apply to you (or you are not sure), talk to your doctor before taking Fenofibrate.

Other medicines and Fenofibrate

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

In particular tell your doctor or pharmacist if you are taking any of the following medicines:

  • Anti-coagulants to thin your blood (such as warfarin)
  • Other medicines to control fat levels in the blood (such as statins or fibrates). Taking a statin at the same time as Fenofibrate may increase the risk of muscle problems
  • A particular class of medicines to treat diabetes (such as rosiglitazone or pioglitazone)
  • Cyclosporin – used to suppress your immune system

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Fenofibrate.

Fenofibrate with food, drink and alcohol

It is important to take the capsule with food – it will not work as well if your stomach is empty.

Pregnancy, breast-feeding and fertility

  • Do not take Fenofibrate and tell your doctor if you are pregnant, think you might be pregnant or are planning to have a baby
  • Do not take Fenofibrate if you are breast-feeding or planning to breast-feed your baby.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

This medicine will not affect you being able to drive or use tools or machines.

Important information about some of the ingredients of Fenofibrate

Fenofibrate contains lactose (a type of sugar). If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine.

  1. How to take Fenofibrate

Always take this medicine exactly as your doctor or pharmacist has told you. Also, please read the label on the packet. You should check with your doctor or pharmacist if you are not sure.

Your doctor will determine the appropriate strength for you, depending on your condition, your current treatment and your personal risk status.

Taking this medicine

  • Swallow the capsule whole with a glass of water
  • Do not open or chew the capsule
  • Take the capsule with food – it will not work as well if your stomach is empty

How much to take

The recommended dose for adults is one capsule of Fenofibrate 200mg a day, taken at mealtimes.

Use in children and adolescents

The use of Fenofibrate 200mg is not recommended in children under the age of 18.

People with kidney problems

If you have kidney problems, your doctor may tell you to take a lower dose. Ask your doctor or pharmacist about this.

If you take more Fenofibrate than you should

If you take more Fenofibrate than you should or if someone else has taken your medicine, contact your nearest hospital casualty department or tell your doctor immediately.

If you forget to take Fenofibrate

  • If you forget a dose, take the next dose with your next meal
  • Then take your next capsule at the normal time
  • Do not take a double dose to make up for a forgotten dose

If you are worried about this talk to your doctor.

If you stop taking Fenofibrate

Do not stop taking Fenofibrate unless your doctor tells you to, or the capsules make you feel unwell. This is because abnormal levels of fats in the blood need treating for a long period of time.

Remember that as well as taking Fenofibrate it is also important that you:

  • Have a low fat diet
  • Take regular exercise

If you have any further questions on the use of this product, ask your doctor or pharmacist or nurse.

  1. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Fenofibrate and see a doctor straight away, if you notice any of the following serious side effects — you may need urgent medical treatment:

  • Allergic reaction – the signs may include swelling of the face, lips, tongue or throat, which may cause difficulty in breathing
  • Cramps or painful, tender or weak muscles – these may be signs of muscle inflammation or breakdown, which can cause kidney damage or even death
  • Stomach pain – this may be a sign that your pancreas is inflamed (pancreatitis)
  • Chest pain and feeling breathless – these may be signs of a blood clot in the lung (pulmonary embolism)
  • Pain, redness or swelling in the legs – these may be signs of a blood clot in the leg (deep vein thrombosis)
  • Yellowing of the skin and whites of the eyes (jaundice), or an increase in liver enzymes – these may be signs of an inflamed liver (hepatitis)

Stop taking Fenofibrate and see a doctor straight away, if you notice any of the side effects above.

Other side effects include:

Common (affects less than 1 in 10 people):

  • Diarrhoea
  • Stomach pain
  • Wind (flatulence)
  • Feeling sick (nausea)
  • Being sick (vomiting)
  • Raised levels of liver enzymes in the blood – shown in tests
  • Increase in homocysteine (too much of this amino acid in the blood has been associated to a higher risk of coronary heart disease, stroke and peripheral vascular disease, although a causal link has not been established)

Uncommon (affects less than 1 in 100 people):

  • Headache
  • Gallstones
  • Reduced sex drive
  • Rash, itching or red patches on the skin
  • Increase in ‘creatinine’ produced by the kidneys – shown in tests
  • Pancreatitis (inflammation of the pancreas leading to abdominal pain)
  • Thromboembolism: pulmonary embolism (blood clot in the lung causing chest pain and breathlessness), deep vein thrombosis (blood clot in the leg causing pain, redness or swelling)
  • Muscle pain, muscle inflammation, muscle cramps and weakness

Rare (affects less than 1 in 1,000 people):

  • Hair loss
  • Increase in ‘urea’ produced by the kidneys – shown in tests
  • Increased sensitivity of your skin to sunlight, sun lamps and sunbeds
  • Drop in haemoglobin (that carries oxygen in the blood) and white blood cells – shown in tests.
  • Hepatitis (inflammation of the liver), symptoms of which may be mild jaundice (yellowing of the skin and whites of the eyes), stomach pain and itching
  • Hypersensitivity (allergic reaction)

Side effect where the chance of it happening are not known

  • Severe form of skin rash with reddening, peeling and swelling of the skin that resembles severe burns
  • Long-term lung problems
  • Muscle breakdown
  • Complications of gallbladder stones
  • Jaundice
  • Feeling dizzy (vertigo)
  • Feeling exhausted (fatigue)

If you get any unusual breathing discomfort, tell your doctor straight away

If you get any side effects, talk to your doctor, or pharmacist or nurse. This includes any side effects not listed in this leaflet.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

By reporting side effects you can help provide more information on the safety of this medicine.

  1. How to store Fenofibrate

Keep this medicine out of the sight and reach of children.

Keep this medicine in the original package in order to protect from moisture. Do not store above 30°C.

Do not use Fenofibrate after the expiry date which is stated on the carton and the blister after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

  1. Content of the pack and other information

What Fenofibrate  contains

The active substance is fenofibrate. Each Fenofibrate 200 capsule contains 200 milligrams (mg) of fenofibrate.

The other ingredients are: lactose monohydrate, sodium laurilsulfate, pregelatinised maize starch, crospovidone and magnesium stearate. The capsule is made of gelatin, titanium dioxide (E171), yellow iron oxide (E172) and red iron oxide (E172).

What Fenofibrate looks like and contents of the pack

Fenofibrate 200mg is supplied to you as ochre, hard gelatin capsules.

Fenofibrate 200mg is provided in blister packs of 10, 28 or 30 capsules.

Not all pack sizes may be marketed.

7. Manufactured in India By:
TAJ PHARMACEUTICALS LTD.
PlotNo.220, Mahagujarat Industrial Estate,
At & Post: Moraiya, TAL- Sanand,
Dist. Ahmedabad, Gujarat(India)