Fenofibrate Sandoz

Package leaflet: Information for the patient

Fenofibrate Sandoz 200 mg hard capsules

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 they have the same symptoms as you, because it may 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 Sandoz is and what it is used for
2. What you need to know before taking Fenofibrate Sandoz
3. How to take Fenofibrate Sandoz
4. Possible side effects
5. How to store Fenofibrate Sandoz
6. Contents of the pack and other information

1. What Fenofibrato Sandoz is and what it is used for

This medicinal product contains the active substance fenofibrate, which belongs to a class of medicines called
fibrates, that works by reducing fat levels in the blood.
Fenofibrato Sandoz is indicated as an add-on to a low-fat diet or other non-pharmacological treatments (physical activity, reduction of body weight), for the treatment of:

• high levels of fat in the blood (severe hypertriglyceridemia), with or without low levels of HDL cholesterol;
• high levels of fat in the blood (mixed hyperlipidemia), when treatment with other medicines that lower blood fat levels, called statins, is not possible;
• high levels of fat in the blood (mixed hyperlipidemia) if you are at risk of heart and blood circulation diseases (cardiovascular diseases), together with other medicines that lower blood fat levels (statins), when fat levels (triglycerides) and HDL cholesterol are not adequately controlled.

2. What you should know before taking Fenofibrato Sandoz

Do not take Fenofibrato Sandoz

• 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;
• if you have liver problems (hepatic insufficiency, biliary cirrhosis) or other disorders affecting liver function;
• if you have gallbladder disease;
• if you have previously experienced skin sensitivity to light (known photoallergy, phototoxic reactions) after taking other fibrates or ketoprofen, a medicine used to treat inflammation;
• if you have pancreas problems (chronic or acute pancreatitis), except for acute pancreatitis caused by high levels of triglycerides in the blood (severe hypertriglyceridemia);
• if you are pregnant or breastfeeding (see section "Pregnancy and breastfeeding").

Fenofibrato Sandoz must 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 treatment with this medicine if:

• you have untreated diabetes (uncontrolled type 2 diabetes mellitus);
• you have thyroid gland problems (hypothyroidism);
• you have kidney problems;
• you have abnormal levels of proteins (dysproteinemia);
• you have liver problems (obstructive hepatopathy);
• you are taking other medicines;
• you regularly consume alcohol. In these cases, a non-medicinal therapy (lipid-lowering diet) may need to be tried before using Fenofibrato Sandoz. If, after several months of treatment with this medicine (3–6 months), your lipid levels have not decreased, consult your doctor, who will advise you on alternative or additional treatments.

Exercise particular caution if you have kidney problems (renal dysfunction), as it may be necessary to adjust the dose of Fenofibrato Sandoz according to your kidney function (creatinine clearance level).
If you are elderly and have kidney problems (impaired renal function), your doctor will reduce your dose.
If you experience symptoms such as itching or yellowing of the skin and whites of the eyes (jaundice), consult your doctor, as specific tests may be needed and treatment may need to be discontinued, especially if no improvement occurs or if liver function is impaired.
Your doctor will prescribe periodic monitoring:

• 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 the upper normal limit, treatment with this medicine must be stopped;
• periodically, blood tests (haematological parameters) and lipid levels in the blood;
• periodically during the first 3 months of treatment to monitor kidney function (creatinine levels), as treatment may need to be discontinued.

Use this medicine with caution and consult your doctor if:

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

During treatment with this medicine, pancreas problems (pancreatitis) may occur (see section "Do not take Fenofibrato Sandoz" and "Possible side effects").
Pay special attention when using this medicine if you are predisposed to muscle disorders (myopathies and rhabdomyolysis). In such cases, consult your doctor, as treatment with this medicine must be carefully evaluated, since muscle disorders may occur, especially if you are taking other lipid-lowering medicines (other fibrates or HMG-CoA reductase inhibitors) or have previously experienced muscle problems.
Stop treatment with this medicine and consult your doctor if you experience the following symptoms:

• muscle pain (diffuse myalgia);
• muscle inflammation (myositis);
• involuntary muscle contractions (cramps);
• weakness;
• markedly increased levels of a substance produced by muscles (CPK, levels more than 5 times above normal).

These muscle disorders are more likely to occur if:

• you are over 70 years old;
• you or a family member has had muscle disorders (including hereditary conditions);
• you have or have had kidney problems;
• your thyroid gland is underactive (hypothyroidism);
• you regularly consume large amounts of alcohol;
• your albumin levels (a blood protein) are low.

Fenofibrato Sandoz may be taken together with other lipid-lowering medicines called statins, but only under strict medical supervision and only if you have marked lipid abnormalities (severe combined dyslipidemia) associated with a high risk of heart and circulatory problems, and if you have not previously experienced muscle disorders (myopathy).
Consult your doctor if you are taking medicines used to prevent pregnancy (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
Inform 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 certain circulatory disorders (oral anticoagulants), as this may increase the risk of bleeding; in this case, your doctor will reduce the dose of these medicines;
• other medicines that lower blood lipid levels (HMG-CoA reductase inhibitors) or other fibrates, 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, your doctor will prescribe periodic checks of kidney function; based on the results, your doctor will assess whether treatment should continue or be suspended;
• contraceptive medicines containing estrogens or other estrogen-containing medicines; in this case, inform your doctor, who must determine the type of hyperlipidemia you have (primary or secondary), as an increase in blood lipid levels 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, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are pregnant, take this medicine only after consulting your doctor, who will assess whether treatment is necessary.
Fenofibrato Sandoz must not be used during breastfeeding.
Driving and using machines
This medicine does not affect 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 exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Your doctor will determine the most appropriate dose for you, based on your condition,
your current treatment, and your individual risk status.
Use in adults and elderly patients without kidney problems
The recommended starting dose is one 200 mg capsule daily, taken during a main meal.
Use in patients with kidney problems (renal impairment)
If you have kidney problems, your doctor may reduce the dose depending on the severity of the condition (creatinine clearance level).
If you take more Fenofibrato Sandoz than you should
If you ingest/absorb an excessive dose of this medicine, contact your doctor immediately or go to the Emergency Department of the nearest hospital.
If you forget to take Fenofibrato Sandoz
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:
Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• headache (cephalalgia);
• blood clot formation (thromboembolism, pulmonary embolism, deep vein thrombosis);
• inflammation of the pancreas (pancreatitis);
• formation of gallstones (cholelithiasis);
• skin hypersensitivity (rash, itching, urticaria);
• skin sensitivity to light (photosensitivity reactions);
• muscle problems (myalgia, myositis, cramps, muscle spasms, weakness, increased CPK levels; 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 (leucocytes) 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 the available data)

• changes in heart rhythm (cardiac arrhythmias);
• kidney disorders (dysuria, oliguria, haematuria, proteinuria);
• increased appetite (polyphagia) and weight gain;
• lung disorders (interstitial lung disease);
• impaired liver function causing 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 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.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 Fenofibrate Sandoz

Keep this medicine out of the sight and reach of children.
Store in the original packaging to protect the medicine from light.
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 dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Fenofibrato Sandoz contains

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

Marketing Authorization 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)