Fenofibrate Zentiva

Package leaflet: Information for the patient

Fenofibrate Zentiva 200 mg hard capsules

Equivalent medicine
Please read all of 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 their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Fenofibrate Zentiva 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. Fenofibrate Zentiva is indicated as an additional therapy to a low-fat diet or other non-pharmacological treatments (physical activity, reduction of body weight) for the treatment of:

• high levels of fats in the blood (severe hypertriglyceridemia), with or without 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), if you are at high risk of heart and blood circulation diseases (cardiovascular diseases), in combination with another lipid-lowering medicine (a statin), when levels of fats (triglycerides) and cholesterol (HDL cholesterol) are not adequately controlled.

2. What you need to know before taking Fenofibrate Zentiva

Do not take Fenofibrate Zentiva

• if you are allergic to fenofibrate or to any of the other ingredients of this medicine (listed in section 6);
• if you have severe kidney problems (severe renal disease);
• if you have various liver problems (including hepatic failure and biliary cirrhosis);
• if you have gallbladder disease;
• if you have previously experienced skin sensitivity to light (known photosensitivity, phototoxic reactions) after taking other fibrates or ketoprofen, a medicine used to treat inflammation;
• if you have pancreas problems (chronic and acute pancreatitis), except for acute pancreatitis caused by high levels of triglycerides in the blood (severe hypertriglyceridemia);
• if you are breastfeeding (see section “Pregnancy and breastfeeding”);
• if the person who is to take this medicine is a child or adolescent.

Warnings and precautions
Talk to your doctor or pharmacist before taking Fenofibrate Zentiva.
If any of the following conditions apply to you, consult your doctor before starting treatment with this medicine:

• you have uncontrolled diabetes (type 2 diabetes mellitus) not managed by therapy;
• you have an underactive thyroid gland (hypothyroidism);
• you have kidney problems (nephrotic syndrome);
• you have an abnormality in protein levels (dysproteinemia);
• you have liver problems (obstructive hepatopathy);
• you are taking other medicines;
• you regularly consume alcohol. In these cases, a non-pharmacological treatment (hypolipidemic diet) may need to be tried before using Fenofibrate Zentiva. If after several months of treatment with this medicine (3–6 months), your fat levels have not decreased, consult your doctor.

Pay special attention if you have kidney problems (renal dysfunction), as your doctor will prescribe appropriate monitoring. It may be necessary to discontinue treatment if kidney function becomes too impaired (excessively high creatinine clearance levels).
If you are elderly and have kidney problems (impaired renal function), your doctor will need to reduce the dose.
Regular monitoring is recommended:

• every 3 months during the first 12 months of treatment to check liver enzyme levels (ASAT and ALAT transaminases). If levels increase more than 3 times above the upper normal limit, treatment with this medicine must be stopped and you should consult your doctor;
• of blood cells (haematological tests) and blood fat levels;
• during the first 3 months of treatment to monitor kidney function (creatinine monitoring), as it may be necessary to discontinue treatment with this medicine.

If you experience symptoms such as itching or yellowing of the skin and whites of the eyes (jaundice), consult your doctor, as specific tests are needed and treatment may need to be discontinued. Even if no improvement is observed or if liver function test results remain persistently abnormal, treatment may need to be stopped.
Use this medicine with caution if:

• you have previously had liver problems (hepatopathy);
• you have stomach and intestinal problems due to lesions (peptic ulcer, which could reactivate);
• you have low levels of albumin in the blood, due to the possible occurrence of muscle disorders with pain and cramps (such as myalgia, muscle cramps, rhabdomyolysis, and increased creatine phosphokinase, a substance present in the blood).

During treatment with this medicine, pancreas problems (pancreatitis) may occur (see section “Do not take Fenofibrate Zentiva” and “Possible side effects”).
Pay particular 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.
The risk of muscle damage is higher in certain patients. Remember to inform your doctor if:

• you are over 70 years old;
• you have low levels of albumin in the blood;
• you have or have had muscle problems, or if any member of your family has had muscle problems;
• you have kidney problems;
• you have reduced thyroid function (hypothyroidism);
• you drink large amounts of alcohol;
• you are taking other medicines belonging to the “fibrate” class;
• you are taking medicines called statins, used to lower blood fat levels, such as simvastatin, atorvastatin.

Stop treatment with this medicine and consult your doctor if you experience any of the following symptoms:

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

Consult your doctor if you are taking estrogens or medicines used to prevent pregnancy containing estrogens (see section “Other medicines and Fenofibrate Zentiva”).

Other medicines and Fenofibrate Zentiva
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 thin the blood (oral anticoagulants), as this may increase the risk of bleeding. In such cases, your doctor may reduce the dose of anticoagulants;
• other medicines that reduce blood fat levels (HMG-CoA reductase inhibitors or other fibrates), as muscle problems may occur (see section “Warnings and precautions”);
• glitazones, medicines used in diabetes;
• cyclosporine, a medicine used to treat autoimmune diseases or in transplant patients, as the combination may damage the kidneys. In this case, you will need regular monitoring of kidney function; based on the results, your doctor will assess whether treatment with fenofibrate should continue or be suspended;
• medicines used to prevent pregnancy containing estrogens or other medicines containing estrogens; in this case, inform your doctor, who will need to determine the type of hyperlipidemia (fat disorder) you have (primary or secondary hyperlipidemia), as blood fat levels may increase (possible increase in lipid values caused by orally administered estrogens).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not take this medicine if you are pregnant. The medicine may be taken during pregnancy only after consulting your doctor, who must carefully evaluate the actual need for treatment.
Do not take this medicine if you are breastfeeding.

Driving and using machines
This medicine does not affect the ability to drive vehicles or operate machinery.

3. How to take Fenofibrato Zentiva

Take this medicine exactly as directed by your doctor or pharmacist. 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 factors.
Dosage
The usual dose is 1 capsule (200 mg) daily.
Please remember that in addition to taking Fenofibrato Zentiva, it is important to:

• follow a low-fat diet;
• exercise regularly.

If after 3–6 months of treatment the levels of fats in the blood have not decreased, your doctor will assess whether to modify your therapy.
Method of administration
The capsules must be taken whole during a meal. Swallow the capsule whole with a glass of water.
Patients with liver or kidney problems
If you have liver or kidney problems, your doctor may advise you to take a lower dose than those indicated above.
Children and adolescents
The use of Fenofibrato Zentiva is not recommended in children and adolescents under 18 years of age.
If you take more Fenofibrato Zentiva than you should
If you take too much of this medicine, contact your doctor immediately or go to the nearest hospital.
If you forget to take Fenofibrato Zentiva
If you forget to take a dose of this medicine, take the next dose at the next meal.
Do not take a double dose to make up for the forgotten dose.
If you stop taking Fenofibrato Zentiva
Do not stop taking Fenofibrato Zentiva and follow the treatment duration prescribed by your doctor. This is important because abnormal levels of fats in the blood need to be treated for a long period of time.
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.
Stop taking Fenofibrate Zentiva immediately and contact your doctor if you experience any of the following serious conditions:

• allergic reactions showing symptoms such as swelling of the face, eyes, lips, tongue or throat, possibly causing breathing difficulties, increased heart rate and possibly a sudden drop in blood pressure;
• widespread muscle pain, weakness or cramps. These problems are signs of muscle inflammation (myositis) and muscle breakdown (rhabdomyolysis); rarely, these may also cause kidney damage;
• yellowing of the skin and eyes (jaundice) or increased liver enzymes in the blood, possible signs of liver inflammation (hepatitis);
• severe skin rashes with redness, blistering and peeling, and mouth, lip and skin ulcers (e.g. erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).

Inform your doctor if, during treatment with Fenofibrate Zentiva, you notice:
Common side effects (may affect up to 1 in 10 people)

• stomach or intestinal problems such as abdominal pain, nausea, vomiting, diarrhoea, gas in the intestine (flatulence);
• increased transaminases in the blood;
• increased homocysteine (elevated levels of this amino acid in the blood have been associated with a higher risk of coronary heart disease, stroke and peripheral vascular disease, although a causal relationship has not been established).

Uncommon side effects (may affect up to 1 in 100 people)

• headache;
• chest pain and shortness of breath, possible signs of blood clot in the lung (pulmonary embolism);
• pain, redness or swelling in the legs, possible signs of blood clot in the leg (deep vein thrombosis);
• abdominal pain and indigestion, possible signs of inflammation of the pancreas (pancreatitis);
• gallstones;
• skin rashes, itching or hives (due to allergy);
• sexual problems;
• increased creatinine (a substance used to assess kidney function) in the blood.

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

• blood abnormalities such as: decreased haemoglobin (the substance that carries oxygen in the blood) and white blood cells, increased urea (a substance used to assess kidney function);
• hair loss (alopecia);
• increased sensitivity of the skin to sunlight or sunbeds (photosensitivity).

Other side effects (frequency cannot be estimated)

• changes in heart rhythm;
• changes in kidney function such as: difficulty urinating (dysuria), reduced urine output (oliguria), presence of blood (haematuria) or protein (proteinuria) in the urine;
• increased appetite (polyphagia) and weight gain;
• lung problems (interstitial lung disease);
• complications of gallstones, for example inflammation of the gallbladder (cholecystitis, cholangitis) or abdominal pain (biliary colic);
• feeling exhausted (fatigue).

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website
https://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 Fenofibrate Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Exp". The expiry date refers to the last day of that month.
Do not store this medicine above 25°C and keep it in the original packaging to protect the medicine from moisture.
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. Contents of the pack and other information

What Fenofibrato Zentiva contains

• The active substance is fenofibrate. Each capsule contains 200 mg of fenofibrate.
• The other components are: polyglycylated saturated glycerides, polyethylene glycol, hydroxypropylcellulose, gelatin, red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172), titanium dioxide (E171), indigo carmine (E132).

Description of the appearance of Fenofibrato Zentiva and contents of the pack
Pack containing 20 hard capsules of 200 mg.
Marketing Authorization Holder
Zentiva Italia S.r.l., Via P. Paleocapa 7, 20121 Milano
Manufacturer
S.M.B. TECHNOLOGY
rue du Parc Industriel n.39, Marche - en - Famenne - Belgium