FENOFIBRATO 200 mg Hard Capsule

Зміст інструкції

1. Fenofibrato Sandoz 200 mg hard capsules
   1. What is Fenofibrato Sandoz and what is it used for
   2. What you need to know before taking Fenofibrato Sandoz
   3. How to take Fenofibrato Sandoz
   4. Possible side effects
   5. How to store Fenofibrato Sandoz
   6. Contents of the pack and other information

Fenofibrato Sandoz 200 mg hard capsules

Generic medicine

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

1. What is Fenofibrato Sandoz 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 fat levels in the blood.
Fenofibrato Sandoz 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 HDL cholesterol;
• high levels of fats in the blood (mixed hyperlipidemia), when treatments with other medicines that lower fat levels in the blood, 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 medicines that lower fat levels in the blood (statins), when the levels of fats (triglycerides) and HDL cholesterol are not adequately controlled.

2. What you need to know before taking Fenofibrato Sandoz

Do not take Fenofibrato Sandoz

• if you are allergic to fenofibrate or any of the other ingredients of this medicine (listed in section 6);
• if you have severe kidney problems;
• if you have liver problems (hepatic insufficiency, biliary cirrhosis) or other disorders of liver function;
• if you have diseases of the gallbladder;
• if you have previously experienced skin sensitivity to light (known photoallergy, phototoxicity reactions) following the intake of other fibrates or ketoprofen, a medicine used for the treatment of inflammation;
• if you have problems with the pancreas (chronic and acute pancreatitis), except for acute pancreatitis caused by high levels of triglycerides in the blood (severe hypertriglyceridemia);
• if you are pregnant or if you are breastfeeding (See section Pregnancy and breastfeeding).

Fenofibrato Sandoz should not be used in children and adolescents under 18 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking Fenofibrato Sandoz.
Talk to your doctor before starting therapy with this medicine if:

• you have diabetes (type 2 diabetes mellitus) not treated with appropriate therapy (uncontrolled);
• you have problems with the thyroid gland (hypothyroidism);
• you have problems with the kidneys;
• alteration of protein levels (dysproteinemia);
• you have problems with the liver (obstructive hepatopathy);
• you are taking other medicines;
• you regularly drink alcohol. In these cases, it may be necessary to try a therapy without medicines (hypolipidemic dietary treatment) before resorting to Fenofibrato Sandoz. If, after several months of treatment with this medicine (3-6 months), the levels of fats are not reduced, consult your doctor, who will indicate complementary or different therapies.

Pay particular attention if you have kidney problems (renal dysfunction), as it may be
necessary to adjust the dose of Fenofibrato Sandoz based on the function of your kidneys (level of creatinine
clearance).
If you are an elderly person and have kidney problems (impaired renal function), your doctor will reduce
the dose.
If you experience symptoms such as itching and yellowing of the skin and whites of the eyes (jaundice),
consult your doctor as specific checks are necessary and it may be necessary to stop the
treatment, especially if no improvements are noticed or if liver function is altered.
Your doctor will prescribe periodic checks:

• every 3 months for the first 12 months of treatment to check the levels of liver enzymes (ASAT and ALAT transaminases). If the levels increase more than 3 times the maximum limit, treatment with this medicine must be stopped;
• periodically, of the blood (hematological examinations) and the levels of fats in the blood;
• periodically, during the first 3 months of treatment to check kidney function (creatinine levels) as it may be necessary to stop treatment with this medicine.

Use this medicine with caution and consult your doctor if:

• you have had liver problems (hepatopathy) in the past;
• you have problems with the stomach and intestines due to the presence of lesions (peptic ulcer).

During treatment with this medicine, problems with the pancreas (pancreatitis) may occur (See
section “Do not take Fenofibrato Sandoz” and “Possible side effects”).
Pay particular attention to the use of this medicine if you have a predisposition to muscle
diseases (myopathies and rhabdomyolysis). In these cases, consult your doctor, as treatment with this medicine
must be carefully evaluated as muscle disorders may occur, especially if you are
taking other medicines that reduce fat levels in the blood (other fibrates or HMG-CoA
reductase inhibitors) and if you have already suffered from muscle problems in the past.
Stop treatment with this medicine and consult your doctor if you experience the following symptoms:

• muscle pain (widespread myalgia);
• muscle inflammation (myositis);
• involuntary muscle contractions (cramps);
• weakness;
• marked increase in the levels of a substance produced by the muscles (CPK, levels more than 5 times normal).

These muscle disorders are more likely to occur if:

• you are over 70 years of age;
• you or someone in your family has suffered from muscle disorders (including hereditary disorders);
• if you suffer from or have suffered from kidney problems;
• if your thyroid gland is not functioning properly (hypothyroidism);
• if you regularly drink large amounts of alcohol;
• if the levels of albumin (a blood protein) are low.

Fenofibrato Sandoz can be taken together with other medicines that reduce fats in the blood, called
statins, under strict medical control and only if you have a marked alteration of fat levels
(severe combined dyslipidemia) associated with a high risk of heart and circulatory problems and if you have not
suffered from muscle disorders (myopathy) in the past.
Consult your doctor if you are taking medicines used to prevent pregnancy (estrogen-containing or estrogen-containing contraceptives, see section “Other medicines and Fenofibrato Sandoz”).

Children and adolescents
The use of this medicine is contraindicated in children and adolescents under 18 years of age
(see section “Do not take Fenofibrato Sandoz”).

Other medicines and Fenofibrato Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
In particular, consult your doctor if you are taking:

• medicines used to treat some circulatory disorders (oral anticoagulants) as it may increase the risk of bleeding; in this case, the doctor will reduce the dose of these medicines;
• other medicines that reduce fat levels in the blood (HMG-CoA reductase inhibitors) or other fibrates 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, the doctor will prescribe periodic checks of kidney function; based on the results, the doctor will assess the need to continue or discontinue treatment;
• medicines used to prevent pregnancy containing estrogens or other medicines containing estrogens; in this case, inform your doctor, who will need to ascertain the type of hyperlipidemia you suffer from (primary or secondary hyperlipidemia), because an increase in fat levels in the blood may occur (possible increase in lipid values caused by orally administered estrogens).

Fenofibrato Sandoz and food
It is important that you take the capsule during a meal

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant, take this medicine only after consulting your doctor, who will assess
the need for treatment.
Fenofibrato Sandoz should not be used during breastfeeding.

Driving and operating machinery
This medicine does not impair the ability to drive or operate machinery.

Fenofibrato Sandoz contains sucrose (a type of sugar)
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this
medicine.

3. How to take Fenofibrato Sandoz

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The doctor will determine the most suitable dose for you, taking into consideration your condition, your current
treatment and your personal risk status.

Use in adults and the elderly without kidney problems
The recommended initial dose is one 200 mg capsule per day to be taken during a main meal.

Use in patients with kidney problems (renal impairment)
If you suffer from kidney problems, your doctor may reduce the dose based on the severity of the problem (level of
creatinine clearance).

If you take more Fenofibrato Sandoz than you should
In case of ingestion/taking an excessive dose of this medicine, immediately inform your
doctor or go to the Emergency Room of the nearest hospital.

If you forget to take Fenofibrato Sandoz
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:

Common(may affect up to 1 in 10 people)

• stomach or intestinal disorders with abdominal pain, nausea, vomiting, diarrhoea and flatulence;
• increased levels of enzymes produced by the liver (transaminases).

Uncommon(may affect up to 1 in 100 people)

• headache;
• formation of blood clots (thromboembolism, pulmonary embolism, deep vein thrombosis);
• inflammation of the pancreas (pancreatitis);
• formation of gallstones (cholelithiasis);
• skin hypersensitivity (skin rashes, itching, urticaria);
• skin sensitivity to light (photosensitivity reactions);
• muscle problems (myalgia, myositis, cramps, muscle spasms, weakness, increased levels of CPK, see section “Warnings and precautions”);
• sexual disorders;
• increased levels of creatinine in the blood.

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

• decreased levels of haemoglobin and white blood cells (leukocytes) in the blood;
• allergic reactions (hypersensitivity);
• fatigue and dizziness;
• inflammation of the liver (hepatitis);
• hair loss (alopecia);
• increased levels of urea in the blood.
• skin sensitivity to light (photosensitivity reactions);

Not known(frequency cannot be estimated from available data)

• altered heartbeat (cardiac arrhythmias);
• kidney disorders (dysuria, oliguria, haematuria, proteinuria);
• increased appetite (polyphagia) and weight gain;
• lung disorders (interstitial lung disease);
• impaired liver function which manifests with yellowing of the skin and whites of the eyes (jaundice);
• complications associated with gallstones (cholecystitis, cholangitis, biliary colic);
• severe skin disorders (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side
effects you can help provide more information on the safety of this medicine.

5. How to store Fenofibrato Sandoz

Keep this medicine out of the sight and reach of children.
Store in the original package to protect the medicine from light.
Do not use this medicine after the expiry date which is reported on the packaging after “Exp”. The expiry
date refers to the last day of that month.
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 contains Fenofibrato Sandoz

• The active ingredient is fenofibrate. Each capsule contains 200 mg of fenofibrate.
• The other ingredients are: Capsule content: sodium lauryl sulfate, sucrose, dimethicone 35%, simethicone 30%, talc, corn starch, hypromellose; Capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172). Description of the appearance of Fenofibrato Sandoz and contents of the packPacks of 20, 30, 50 or 100 hard capsules containing 200 mg.

Marketing Authorisation Holder
Sandoz Spa – Largo U. Boccioni, 1 – 21040 Origgio (VA), Italy

Manufacturer
Ethypharm – ZI de Saint Arnoult – 28170 Chateauneuf en Thymerais (France)
Ethypharm – Chemin de La Poudriere – 76120 Grand-Quevilly (France)
Salutas Pharma GmbH – Otto von Guericke Allee 1 – 39179 Barleben (Germany)