Fenofibrate Doc Generici

PACKAGE LEAFLET: INFORMATION FOR THE USER

FENOFIBRATE DOC Generici 145 mg tablets

Equivalent medicine
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 their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What FENOFIBRATE DOC Generici 145 mg tablets are and what they are used for
2. What you need to know before taking FENOFIBRATE DOC Generici 145 mg tablets
3. How to take FENOFIBRATE DOC Generici 145 mg tablets
4. Possible side effects
5. How to store FENOFIBRATE DOC Generici 145 mg tablets
6. Contents of the pack and other information

1. What FENOFIBRATO DOC Generici 145 MG tablets is and what it is used for

FENOFIBRATO DOC Generici 145 mg tablets belongs to a group of medicines called fibrates. These medicines are used to lower the level of fats (lipids) in the blood, such as fats known as triglycerides.
FENOFIBRATO DOC Generici 145 mg tablets is used, together with a low-fat diet and other non-pharmacological treatments such as physical exercise and weight loss, to reduce blood fat levels.
FENOFIBRATO DOC Generici 145 mg tablets may be used in addition to other medicines (statins) in certain circumstances, when blood fat levels are not adequately controlled by statins alone.

2. What you need to know before taking FENOFIBRATO DOC Generici 145 mg tablets

Do not take FENOFIBRATO DOC Generici 145 mg tablets:

• if you have severe liver, kidney, or gallbladder disease,
• if you are allergic to fenofibrate or to any of the other ingredients of this medicine (listed in section 6),
• if in the past sunlight or UV light has caused you an allergic reaction (photoallergy) or skin damage while you were being treated with fibrates or with a medicine called ketoprofen (a non-steroidal anti-inflammatory drug),
• if you have acute or chronic pancreatitis (inflammation of the pancreas causing abdominal pain), unless it is caused by high levels of a type of blood fat (hypertriglyceridemia).

Warnings and precautions
Talk to your doctor before taking FENOFIBRATO DOC Generici 145 mg tablets:

• if you have liver or kidney problems,
• if you develop symptoms suggesting hepatitis (liver inflammation), such as mild jaundice (yellowing of the skin and whites of the eyes), stomach ache, or itching,
• if you suffer from pancreatitis (inflammation of the pancreas causing abdominal pain),
• if you have hypothyroidism (underactive thyroid gland),
• if you are pregnant or breastfeeding.

Muscle effects:
Stop taking FENOFIBRATO DOC Generici 145 mg tablets and contact your doctor immediately if you experience unexplained muscle cramps, pain, tenderness, or weakness while taking this medicine.

• This medicine may cause muscle problems, which can be serious.
• These problems are rare but may include inflammation and breakdown of muscle tissue. This can lead to kidney damage or even death.

Your doctor may request a blood test to monitor your muscle function before and during treatment.

• The risk of muscle breakdown is significantly higher in certain patients. Inform your doctor if:
  • you are over 70 years old,
  • you have kidney problems,
  • you have thyroid problems,
  • you or a close family member has inherited muscle disorders,
  • you drink large amounts of alcohol,
  • you are taking cholesterol-lowering medicines called statins such as simvastatin, atorvastatin, pravastatin, rosuvastatin, or fluvastatin,
  • you have ever had muscle problems during treatment with statins or fibrates such as fenofibrate, bezafibrate, or gemfibrozil.

If any of the above applies to you (or if you are unsure), inform your doctor before taking FENOFIBRATO DOC Generici 145 mg tablets.

Other medicines and FENOFIBRATO DOC Generici 145 mg tablets
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking:

• anticoagulants (blood thinners) such as warfarin,
• other medicines to control lipid (fat) levels in the blood (e.g., medicines called “statins” or “fibrates”). Taking a “statin” (e.g., simvastatin, atorvastatin) together with FENOFIBRATO DOC Generici 145 mg tablets may increase the risk of muscle problems,
• cyclosporine (an immunosuppressant).

FENOFIBRATO DOC Generici 145 mg tablets with food and drink
Swallow the tablet with a glass of water. The tablet may be taken with or without food, at any time of day.

Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you are pregnant, think you may be pregnant, or are planning a pregnancy.
FENOFIBRATO DOC Generici 145 mg tablets must not be taken during pregnancy.

Breastfeeding
You must not use FENOFIBRATO DOC Generici 145 mg tablets if you are breastfeeding or planning to breastfeed. Ask your doctor for advice before taking any medicine.

Driving and using machines
This medicine has no effect on your ability to drive or use machinery.

FENOFIBRATO DOC Generici 145 mg tablets contain lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
Patients with lactose intolerance (a rare hereditary disease) must not take this medicine.

3. How to take FENOFIBRATO DOC Generici 145 mg tablets

Take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor.
Your doctor will determine the appropriate dose for you based on your health status, ongoing treatment, and risk factors.
Also, read the label.
Swallow the tablet whole with a glass of water.
The recommended dose for adults is one FENOFIBRATO DOC Generici 145 mg tablet per day. If you are currently being treated with a 200 mg fenofibrate capsule or a 160 mg fenofibrate tablet daily, you may switch to taking one FENOFIBRATO DOC Generici 145 mg tablet per day.

Use in children and adolescents
Due to lack of available data, the use of fenofibrate is not recommended in pediatric patients under 18 years of age.

Patients with renal impairment
A reduced dosage is recommended (67 mg of micronized fenofibrate capsules or 100 mg of standard fenofibrate capsules).
A lower dose of fenofibrate will be used.

If you take more FENOFIBRATO DOC Generici 145 mg tablets than you should:
If you have accidentally taken more FENOFIBRATO DOC Generici 145 mg tablets than prescribed, or if someone else has taken your medicine, go immediately to the nearest emergency room or contact your doctor without delay.

If you forget to take FENOFIBRATO DOC Generici 145 mg tablets:
Do not take a double dose to make up for the missed tablet. Take the next dose with the next meal and then continue taking the tablets as usual. If you are concerned, speak to your doctor.

If you stop taking FENOFIBRATO DOC Generici 145 mg tablets:
Do not stop taking this medicine unless your doctor tells you to, or if the tablets make you feel unwell. This is because high cholesterol levels require long-term treatment. Remember that while taking FENOFIBRATO DOC Generici 145 mg tablets, you should also continue a low-fat diet.
If your doctor discontinues your treatment, do not take any leftover tablets unless your doctor instructs you to do so. If you have any questions about using this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop taking FENOFIBRATO DOC Generici 145 mg and consult a doctor immediately
if you notice any of the following serious side effects – urgent medical treatment
may be required:

• allergic reaction – signs may include swelling of the face, lips, tongue or throat, which may cause difficulty breathing
• muscle cramps or pain, tenderness or weakness – these may be signs of muscle inflammation or muscle breakdown, which can lead to kidney damage or even death
• stomach pain – this may be a sign that your pancreas is inflamed (pancreatitis)
• chest pain and shortness of breath – these may be signs of a blood clot in the lung (pulmonary embolism)
• pain, redness or swelling in the legs – these may be signs of a blood clot in the leg (deep vein thrombosis)
• yellowing of the skin and whites of the eyes (jaundice), or increased liver enzymes – these may be signs of liver inflammation (hepatitis).

Stop taking FENOFIBRATO DOC Generici 145 mg and consult a doctor immediately if you notice any of the side effects listed above.
Some patients taking fenofibrate have experienced the following side effects:
Common side effects (affects from 1 in 10 to 1 in 100 patients):

• stomach ache, nausea, vomiting, diarrhoea and flatulence,
• increased blood levels of various liver enzymes.

Uncommon side effects (affects from 1 in 100 to 1 in 1,000 patients):

• inflammation of the pancreas causing abdominal pain (pancreatitis),
• blood clots in the lungs which may cause chest pain and breathlessness (pulmonary embolism), blood clots in the legs which may cause redness, pain and swelling of the leg (deep vein thrombosis),
• skin reactions such as rashes, itching and red spots on the skin,
• slight increase in creatinine (a substance eliminated by the kidneys),
• gallstones,
• muscle pain, muscle inflammation, muscle cramps and weakness,
• headache,
• reduced sexual desire.

Rare side effects (affects less than 0.1% of treated patients):

• inflammation of the liver (hepatitis), whose symptoms may include mild jaundice (yellowing of the skin and whites of the eyes), stomach ache and itching,
• allergic reactions (hypersensitivity),
• hair loss,
• reduction in haemoglobin (the component in blood that carries oxygen) and reduction in white blood cells,
• increased sensitivity to sunlight, sunlamps and solariums,
• slight increase in urea (a substance eliminated by the kidneys),
• feeling dizzy (vertigo),
• feeling exhausted (fatigue).

Side effects for which the frequency is unknown

• severe form of skin rash with redness, peeling and swelling of the skin resembling severe burns
• long-term lung disorders
• muscle deterioration
• complications of gallstones
• if you experience any unusual breathing problems, inform your doctor immediately

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 the website
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 DOC Generici 145 mg tablets

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of that month.
Store in the original packaging.
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 FENOFIBRATO DOC Generici 145 mg tablets contain

• The active substance is: fenofibrate ………………………………………………………………… 145 mg per tablet.
• The other components are: anhydrous lactose, hypromellose, sodium lauryl sulfate, sodium croscarmellose, simethicone, magnesium stearate.

Description of the appearance of FENOFIBRATO DOC Generici 145 mg tablets and pack contents
FENOFIBRATO DOC Generici is a tablet.
It is available in blisters, in pack sizes of 10, 20, 28, 30, 50, 84, 90, 98, 100, 280 or 300 tablets.

Marketing Authorization Holder
DOC Generici S.r.l., Via Turati 40, 20121 Milano, Italy

Manufacturer
ETHYPHARM, Chemin de la Poudrière, 76120 Grand-Quevilly, France
ETHYPHARM, Zone Industrielle de Saint-Arnoult, 28170 Châteauneuf-en-Thymerais, France
FAMAR L'AIGLE, Zone industrielle N°1, Route de Crulai, 61300 L'AIGLE, France
LAPHAL INDUSTRIES, 248 avenue de la Victoire, 13106 Rousset, France
ROTTENDORF PHARMA, Zone industrielle N°2, Batterie 1000, 59309 Valenciennes Cedex, France

This medicinal product is authorized in the Member States of the European Economic Area under the following name:
Italy: FENOFIBRATO DOC Generici 145 mg tablets