LIPANTHYL Capsule

For the treatment of hypercholesterolaemia (abnormally elevated levels of cholesterol in the blood) and/or hypertriglyceridaemia (abnormally elevated levels of triglycerides -fats- in the blood) in adults, when the response to an appropriate and correctly observed diet is inadequate.

Dosage

The dosage is set at 1 capsule daily.

For adults and elderly patients:

The recommended dosage in elderly patients without kidney problems is 1 tablet daily.

See the package insert about the details below:

- People with kidney problems

- Use in children and adolescents

- Patient with liver problems

Administration method and route

Oral Route

Frequency and time at which you should take this medication

The treatment is to be taken as 1 capsule daily, during a meal, as noted in your doctor’s prescription.

Treatment duration

In combination with dieting this medication constitutes long-term symptomatic treatment that is regularly monitored.

To use this medication correctly it is very important that you undergo regular medical check-ups.

- hepatic impairment,

- renal impairment,

- severe gall bladder problems

- pancreatitis (an inflamed pancreas which causes abdominal pain) which is not caused by high levels of fat in the blood

- in children,

- known allergy to fenofibrate or to one of the excipients,

- known phototoxic or photoallergic reactions (skin reactions following exposure to the sun or to artificial UV light) in the course of a treatment with fenofibrate or with a structurally- related substance, in particular ketoprofen.

Stop taking this capsule 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 (see the package insert about the details below.)

- cramps or painful, tender or weak muscles

- stomach pain

- chest pain and feeling breathless

- pain, redness or swelling in the legs

- yellowing of the skin and whites of the eyes (jaundice), or an increase in liver enzymes

Common: diarrhoea, stomach pain, wind (flatulence), feeling sick (nausea), being sick (vomiting), raised levels of liver enzymes in the blood - shown in tests.

Uncommon: headache, gallstones, reduced sex drive, rash, itching or red patches on the skin, increase in creatinine - shown in tests, pancreatitis, 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: hair loss, feeling dizzy (vertigo), feeling exhausted (fatigue), increase in urea - shown in tests, increased sensitivity of your skin to sunlight, sun lamps and sunbeds, drop in haemoglobin and white blood cells - shown in tests, hepatitis, symptoms of which may be mild jaundice (yellowing of the skin and whites of the eyes) stomach pain and itching, hypersensitivity

Side effect where the chance of it happening are not known: long-term lung problems, muscle breakdown, complications of gallbladder stones.

- other medicines to control fat levels in the blood (such as, statins or fibrates). Taking a statin at the same time as this capsule may increase the risk of muscle problems,

- anti-coagulants to thin your blood (such as warfarin)

- a particular class of medicines to treat diabetes (such as rosiglitazone or pioglitazone)

- cyclosporin (an immunosuppressant)

- Tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby. As there is not enough experience with use of this capsule during pregnancy, you should use this capsule only if your doctor considers it absolutely necessary.

- It is not known, whether the active substance in this capsule passes into breast-milk. Therefore, you should not use this capsule if you are breast-feeding or planning to breast-feed your baby.

- Inform your doctor immediately if you experience muscle pains.

- Liver tests will be performed before the treatment starts. These will be repeated regularly during the first year of treatment.

- The rate of creatinine must be monitored during the first 3 months of treatment.

Talk to your doctor or pharmacist or nurse before taking this capsule if:

- you have any liver or kidney problems

- you may have an inflamed liver - signs include yellowing of the skin and the whites of the eyes (jaundice), an increase in liver enzymes (shown in blood tests), stomach pain and itching

- you have an under-active thyroid gland (hypothyroidism)

- This capsule contains lactose. If you have been told by your doctor that you cannot tolerate or digest some sugars (have intolerance to some sugars), talk to your doctor before taking this medicine.

Effects on muscles

- Stop taking this capsule 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.

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 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 of fluvastatin

- you have ever had muscle problems during treatment with statins or fibrates such as fenofibrate, bezafibrate or gemfibrozil.