Package leaflet: Information for the patient

LIPOFENE 100 mg capsules

Fenofibrate
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What LIPOFENE is and what it is used for
What you need to know before taking LIPOFENE
How to take LIPOFENE
Possible side effects
How to store LIPOFENE
Contents of the pack and other information

1. What LIPOFENE is and what it is used for

This medicinal product contains the active substance fenofibrate, which belongs to a class of medicines called fibrates. It works by reducing levels of cholesterol and fats in the blood.
LIPOFENE is indicated as an additional therapy to a low-fat diet or to other non-pharmacological treatments (physical exercise, reduction of body weight) for the treatment of:

high levels of fats in the blood (severe hypertriglyceridemia), both in the presence and absence of low levels of cholesterol (HDL cholesterol);
high levels of fats in the blood (mixed hyperlipidemia), when treatment with other lipid-lowering medicines called statins is not possible;
high levels of fats in the blood (mixed hyperlipidemia) in patients at risk of heart and blood circulation diseases (cardiovascular diseases), in combination with other lipid-lowering medicines (statins), when levels of fats (triglycerides) and cholesterol (HDL cholesterol) are not adequately controlled.

2. What you need to know before taking LIPOFENE

Do not take LIPOFENE if:

you are allergic to fenofibrate or to any of the other ingredients of this medicine (listed in section 6);
you have severe kidney problems (renal failure);
you have liver problems (hepatic failure);
you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Consult your doctor or pharmacist before taking LIPOFENE if you have kidney problems.
A non-pharmacological therapy (lipid-lowering diet) and lifestyle changes should be tried before resorting to LIPOFENE.
Exercise particular caution if you have kidney problems (renal dysfunction), as it may be necessary to adjust the dose according to your kidney function (creatinine clearance level).
Periodic monitoring is recommended:

to check liver enzyme levels (transaminases) and other liver function tests. If levels rise above the upper limit, discontinue treatment with this medicine;
blood tests (complete blood count);
to monitor kidney function (creatinine levels), as it may be necessary to interrupt treatment with this medicine.

Take this medicine with caution if:

you have previously had liver problems (hepatopathy);
you have had liver disorders (gallstones);
you have had stomach or intestinal problems due to lesions (peptic ulcer).

Pay special attention when using this medicine if you are predisposed to muscle diseases (myopathies and rhabdomyolysis). In such cases, treatment with this medicine must be carefully evaluated, as muscle disorders may occur, especially if you are also taking other medicines that lower blood lipid levels (other fibrates) or medicines called statins (HMG-CoA reductase inhibitors).
Children
There is insufficient information regarding the use of this medicine in children.
Other medicines and LIPOFENE
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Take this medicine with caution and consult your doctor if you are taking:

medicines used to treat certain circulatory disorders (anticoagulants), as this may increase the risk of bleeding; in such cases, the dose of these medicines may need to be reduced;
other medicines that lower blood lipid levels (lipid-lowering agents) or statins (HMG-CoA reductase inhibitors), as muscle problems may occur (see section “Warnings and precautions”);
cyclosporine, a medicine used to treat autoimmune diseases or in transplant patients; in this case, periodic monitoring of kidney function is required, and based on the results, your doctor will assess whether treatment should continue or be suspended;
insulin or other medicines that lower blood sugar levels (oral hypoglycemics); in this case, the dose of these medicines may need to be reduced.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take this medicine if you are pregnant.
Avoid this medicine if you are breastfeeding.
Driving and using machines
The use of LIPOFENE may impair your ability to drive vehicles or operate machinery. Avoid driving or operating machinery if you experience dizziness or drowsiness.
LIPOFENE contains lactose and sodium bisulfite
This medicine contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
This medicine contains sodium bisulfite. Rarely, it may cause severe hypersensitivity reactions and bronchospasm.

3. How to take LIPOFENE

Take this medicine exactly as your doctor has instructed you. If you have any doubts, consult your doctor or pharmacist.
Your doctor will determine the appropriate dose for you, depending on your condition, your current treatment, and your individual risk profile.
Use in adults and elderly
The recommended starting dose is one 100 mg capsule taken three times daily with main meals.
The maximum dose is 500 mg per day.
Use in children
There is insufficient information regarding the use of this medicine in children.
Duration of treatment
Response to treatment is generally rapid and becomes evident within a few weeks. If there is an inadequate response after 3 months of treatment, LIPOFENE therapy should be discontinued.
If you take more LIPOFENE than you should
In case of ingestion/overdose of this medicine, contact your doctor immediately or go to the nearest hospital.
There are no known cases of acute overdose.
If you forget to take LIPOFENE
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur, which are generally mild and transient and do not interfere with treatment:
Common (may affect up to 1 in 10 people)

abdominal pain, nausea, vomiting, diarrhoea and flatulence, digestive difficulties;
increased levels of liver enzymes (transaminases);
inflammation of the liver (hepatitis);
decreased levels of haemoglobin (anaemia) and white blood cells (leucopenia, eosinophilia, agranulocytosis) in the blood;
liver disorders (gallstones);
changes in heart rhythm (cardiac arrhythmias);
headache (cephalalgia);
dizziness;
skin irritation (skin rashes, urticaria), itching;
joint problems (arthralgia); skin sensitivity to light (photosensitivity reactions);
muscle problems (myalgia, myositis, cramps) (see section “Warnings and precautions”), tiredness (asthenia);
somnolence;
kidney problems (dysuria, oliguria, haematuria, proteinuria);
increased levels of creatinine in the blood;
increased levels of the enzyme creatine kinase;
increased levels of urea in the blood;
increased appetite (polyphagia) and weight gain.

Rare (may affect up to 1 in 1,000 people)

sexual disorders (sexual asthenia);
muscle problems (rhabdomyolysis, see section “Warnings and precautions”).

Not known (frequency cannot be estimated from available data)

lung disorders (interstitial lung disease);
inflammation of the pancreas (pancreatitis).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store LIPOFENE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp". The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What LIPOFENE contains

The active substance is fenofibrate. Each capsule contains 100 mg of fenofibrate.
The other components are: lactose, magnesium stearate. Capsule contents: titanium dioxide (E171), sodium bisulphite, gelatin.

Description of the appearance of LIPOFENE and package contents
Box of 50 100 mg capsules in blister packs.
Marketing Authorization Holder
TEOFARMA S.r.l. - Via F.lli Cervi, 8 - 27010 Valle Salimbene (PV)
Manufacturer
TEOFARMA S.r.l. - Viale Certosa 8/A - 27100 Pavia