FENOFIBRATO 145 mg Tablets

Зміст інструкції

1. FENOFIBRATO DOC Generici 145 mg tablets
   1. What is FENOFIBRATO DOC Generici 145 MG tablets and what is it used for
   2. What you need to know before taking FENOFIBRATO DOC Generici 145 mg tablets
2. FENOFIBRATO DOC Generici 145 mg tablets contains lactose. If your doctor has
   1. How to take FENOFIBRATO DOC Generici 145 mg tablets
   2. Possible side effects
   3. How to store FENOFIBRATO DOC Generici 145 mg tablets
   4. Contents of the pack and other information

FENOFIBRATO DOC Generici 145 mg tablets

Generic medicine

Read this leaflet carefully before 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 their symptoms are the same as yours, as it could 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 DOC Generici 145 mg tablets is and what it is used for
• 2. What you need to know before you take FENOFIBRATO DOC Generici 145 mg tablets
• 3. How to take FENOFIBRATO DOC Generici 145 mg tablets
• 4. Possible side effects
• 5. How to store FENOFIBRATO DOC Generici 145 mg tablets
• 6. Contents of the pack and other information

1. What is FENOFIBRATO DOC Generici 145 MG tablets and what is it 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, for
example fats called triglycerides.
FENOFIBRATO DOC Generici 145 mg tablets is used, together with a low-fat diet and other
non-pharmacological treatments such as exercise and weight loss, to
lower fat levels in the blood.
FENOFIBRATO DOC Generici 145 mg tablets can be used in addition to other drugs
(statins) in some circumstances, when fat levels in the blood are not 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 suffer from severe liver or kidney disease or gallbladder disease,
• if you are allergic to fenofibrate or any of the other ingredients of this medicine (listed in section 6),
• if in the past sunlight or UV radiation has caused you an allergic reaction (photoallergy) or skin damage while you were being treated with fibrates or with an anti-inflammatory medicine called ketoprofen,
• if you suffer from acute or chronic pancreatitis (inflammation of the pancreas that causes 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 (inflammation of the liver) such as mild jaundice (yellowing of the skin and whites of the eyes), stomach pain and itching,
• if you suffer from pancreatitis (inflammation of the pancreas that causes abdominal pain),
• if you suffer from hypothyroidism (underactive thyroid gland),
• if you are pregnant or breastfeeding.

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

• Indeed, this medicine can cause muscle problems that can be serious.
• These problems are rare, but include inflammation and breakdown of muscle. This can cause kidney damage or even death.

The doctor may request a blood test to check your muscles before and after starting
treatment.

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

If any of the information above applies to you (or you are not sure), tell 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, tell your doctor if you are already taking:

• anticoagulants to thin the blood (for example, warfarin),
• other medicines to control the level of lipids (fats) in the blood (for example, medicines called “statins” or “fibrates”). Taking a “statin” (e.g. simvastatin, atorvastatin) together with FENOFIBRATO DOC Generici 145 mg tablets can 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 should be taken with or without
food, at any time of the day.

Pregnancy and breastfeeding
Pregnancy
Tell your doctor if you are pregnant, think you might be pregnant or are planning to become pregnant.
FENOFIBRATO DOC Generici 145 mg tablets should not be taken during pregnancy.

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

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

FENOFIBRATO DOC Generici 145 mg tablets contains lactose. If your doctor has

diagnosed you with intolerance to certain sugars, contact them before taking this medicine.
Patients with lactose intolerance (a rare hereditary condition) should not take this
medicine.

3. How to take FENOFIBRATO DOC Generici 145 mg tablets

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

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

Patients with renal impairment
A dose reduction 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
you should or if someone else has taken your medicine, go to the nearest emergency room or
inform your doctor immediately.

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
this worries you, talk to your doctor.

If you stop taking FENOFIBRATO DOC Generici 145 mg tablets:
Do not stop taking the medicine unless your doctor tells you to do so or the tablets make
you feel unwell. This is because high cholesterol levels require treatment for long
periods of time. Remember that, while taking FENOFIBRATO DOC Generici 145 mg tablets
you must also continue with a low-fat diet.
If your doctor stops the treatment, do not take the remaining tablets unless
your doctor tells you to do so. If you have any doubts about the use of this medicine, ask
your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking FENOFIBRATO DOC Generici 145 mg and contact a doctor immediately if you notice any of the following serious side effects – urgent medical treatment may be needed:

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

Stop taking FENOFIBRATO DOC Generici 145 mg and contact a doctor immediately if you notice any of the above side effects.
Some patients taking fenofibrate have experienced the following side effects:

Common side effects(affects 1 in 10 to 1 in 100 people):

• Stomach discomfort, nausea, vomiting, diarrhoea and flatulence,
• Increased levels of various liver enzymes in the blood.

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

• Inflammation of the pancreas causing abdominal pain (pancreatitis),
• Blood clots in the lungs which can produce chest pain and shortness of breath (pulmonary thrombosis), blood clots in the legs, which can produce redness, pain and swelling of the leg (deep vein thrombosis),
• Reactions such as rashes, itching and red spots on the skin,
• Mild increase in creatinine (a substance eliminated by the kidneys),
• Gallstones,
• Muscle pain, muscle inflammation, muscle cramps and weakness,
• Headache,
• Decreased sexual drive.

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

• Inflammation of the liver (hepatitis), whose symptoms may be mild jaundice (yellowing of the skin and whites of the eyes), stomach pain and itching,
• Allergic reactions (hypersensitivity),
• Hair loss,
• Reduction in haemoglobin (the component of blood that carries oxygen) and reduction in white blood cells,
• Increased sensitivity to sunlight, sunlamps and tanning beds,
• Mild increase in urea (a substance eliminated by the kidneys),
• feeling dizzy (vertigo)
• feeling exhausted (fatigue)

Side effects with unknown frequency of manifestation

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

Reporting of side effects
If you get any side effects, talk to 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 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 indicated on the pack after SCAD. The expiry date refers to the last day of that month.
Store in the original package.
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 FENOFIBRATO DOC Generici 145 mg tablets contain

• The active ingredient is: fenofibrate …………………………………………………………………145 mg in one tablet.
• The other ingredients are: anhydrous lactose, hypromellose, sodium lauryl sulfate, sodium croscarmellose, simethicone, magnesium stearate.

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

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

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 authorised in the Member States of the European Economic Area under the following denominations:Italy: FENOFIBRATO DOC Generici 145 mg tablets