LIPOFENE 100 mg Capsule

Зміст інструкції

1. LIPOFENE 100 mg capsule
   1. What is LIPOFENE and what is it used for
   2. What you need to know before taking LIPOFENE
   3. How to take LIPOFENE
   4. Possible side effects
   5. How to store LIPOFENE
   6. Contents of the pack and other information

LIPOFENE 100 mg capsule

Fenofibrate

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is LIPOFENE and what is it used for

This medicine contains the active ingredient fenofibrate, belonging to the class of medicines called
fibrates, which works by reducing cholesterol and fat levels in the blood.
LIPOFENE is indicated as an adjunct to a low-fat diet or other non-pharmacological treatments (physical activity, weight reduction), for the treatment of:

• high levels of fats in the blood (severe hypertriglyceridemia), both in the absence or presence of low levels of cholesterol (HDL cholesterol);
• high levels of fats in the blood (mixed hyperlipidemia), when treatments with other lipid-lowering medicines, called statins, are not possible;
• high levels of fats in the blood (mixed hyperlipidemia) if you are at risk of heart and blood vessel diseases (cardiovascular pathologies), together with other lipid-lowering medicines (statins), when the 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 any of the other ingredients of this medicine (listed in section 6);
• you have severe kidney problems (renal insufficiency);
• you have liver problems (hepatic insufficiency);
• you are pregnant or breastfeeding (See section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking LIPOFENE if you have kidney problems.
It is necessary to try a non-medicinal therapy (hypolipidemic diet) and lifestyle changes before resorting to LIPOFENE.
Pay particular attention if you have kidney problems (renal dysfunction), as it may be necessary to adjust the dose based on your kidney function (creatinine clearance level).
Periodic checks are recommended:

• to check the levels of liver enzymes (transaminases) and other liver function tests. If levels increase above the maximum limit, stop treatment with this medicine;
• of the blood (hematological tests);
• to check kidney function (creatinine levels) as it may be necessary to stop treatment with this medicine.

Take this medicine with caution if:

• you have suffered from liver problems (hepatopathy) in the past;
• you have had liver disorders (gallstones);
• you have suffered from stomach and intestinal problems due to the presence of lesions (peptic ulcer).

Pay particular attention to the use of this medicine if you have a predisposition to muscle diseases (myopathies and rhabdomyolysis). In these cases, treatment with this medicine should be carefully evaluated as muscle disorders may occur, especially if you are taking other medicines that reduce blood fat levels (other fibrates) or medicines called statins (HMG-CoA reductase inhibitors).

Children
There is not enough information regarding the use of this medicine in children.

Other medicines and LIPOFENE
Tell 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 it may increase the risk of bleeding; in this case it is necessary to reduce the dose of these medicines;
• other medicines that reduce blood fat levels (hypolipidemic agents) or statins (HMG-CoA reductase inhibitors) because muscle problems may occur (See section “Warnings and precautions”);
• cyclosporine, a medicine used to treat autoimmune diseases or in case of transplantation; in this case, periodic checks of kidney function should be performed, based on the results the doctor will evaluate the need to continue or discontinue treatment;
• insulin or other medicines that reduce blood sugar levels (oral hypoglycemic agents); in this case it is necessary to reduce the dose of these medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice 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 the ability to drive vehicles and use machines. Avoid driving or using machines if you experience dizziness and drowsiness.

LIPOFENE contains lactose and sodium bisulfite
This medicine contains lactose, a type of sugar. If your doctor has diagnosed you with intolerance to certain sugars, contact them before taking this medicine.
This medicine contains sodium bisulfite. Rarely, it can cause severe hypersensitivity reactions and bronchospasm.

3. How to take LIPOFENE

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist.
The doctor will establish the appropriate dosage for you, depending on your condition, your current treatment
and your personal risk status.

Use in adults and the elderly
The recommended initial dose is one 100 mg capsule per day to be taken three times a day with meals
main.
The maximum dose is 500 mg per day.

Use in children
There is not enough information regarding the use of this medicine in children.

Duration of treatment
The response to treatment is generally rapid and manifests within a few weeks. In case of inadequate
response after 3 months of treatment, treatment with LIPOFENE should be discontinued.

If you take more LIPOFENE than you should
In case of ingestion/taking an excessive dose of this medicine, immediately inform your
doctor or go to the nearest hospital.
No cases of acute overdose are known.

If you forget to take LIPOFENE
Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of 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 enzymes produced by the liver (transaminases);
• inflammation of the liver (hepatitis);
• decrease in the levels of haemoglobin (anaemia) and white blood cells (leucopenia, eosinophilia, agranulocytosis) in the blood;
• liver disorders (biliary calculi);
• irregular heartbeat (cardiac arrhythmias);
• headache;
• 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”), fatigue (asthenia);
• drowsiness;
• kidney problems (dysuria, oliguria, haematuria, proteinuria);
• increased levels of creatinine in the blood;
• increased levels of the creatinine kinase enzyme;
• 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 get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through 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 which is stated on the packaging after “Exp”. The expiry date
refers to the last day of that month.
Do not store at a temperature above 25° C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What LIPOFENE contains

• The active ingredient is fenofibrate. Each capsule contains 100 mg of fenofibrate.
• The other ingredients are: lactose, magnesium stearate. Capsule content: titanium dioxide (E171), sodium bisulfite, gelatin.

Description of the appearance of LIPOFENE and contents of the pack
Pack of 50 capsules of 100 mg in blisters.

Marketing Authorisation 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