Prospecto: information for the user

FENOFIBRATO SUN 160 mg FILM-COATED TABLETS

Fenofibrate

Read this prospectus carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

1. What isFenofibrate SUNand for what it is used

2. What you need to know before starting to takeFenofibrate SUN

3. How to takeFenofibrate SUN

4. Possible adverse effects

5. Storage ofFenofibrate SUN

6. Contents of the package and additional information

This medication belongs to a group of medications commonly known as fibrates. These medications are used to reduce the level of fats (lipids) in the blood. For example, fats known as triglycerides.

Fenofibrate is used, along with a low-fat diet and other non-medical treatments such as exercise and weight loss, to reduce the levels of fats in the blood.

This medication may be used along with other medications [statins] in certain circumstances when a statin alone does not control the levels of fat in the blood.

Do not take Fenofibrato SUN

?If you are allergic to fenofibrato or any of the other components of this medication (listed in section 6).

?If you are allergic to peanuts or peanut oil or soy oil or related products.

?If you have had an allergic reaction or skin lesion caused by sunlight or UV light while taking other medications (such as other fibrates or a medication called ketoprofen).

?If you have severe liver, kidney, or gallbladder disease.

• If you have pancreatitis (inflammation of the pancreas that causes abdominal pain) not caused by high levels of blood fat.

Do not take Fenofibrato SUN if any of the above circumstances apply to you. If you are unsure, consult your doctor or pharmacist before taking Fenofibrato SUN.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

• If you have liver or kidney problems.
• If you may be prone to liver inflammation (hepatitis) – signs that include yellowing of the skin and the white of the eyes (jaundice), increased liver enzymes (present in blood tests), stomach pain, and itching.
• If you have a thyroid gland with low activity (hypothyroidism)

If any of the above circumstances apply to you (or you are unsure), consult your doctor or pharmacist before taking Fenofibrato SUN.

Fenofibrato SUN and muscle effects

Stop taking Fenofibrato and see your doctor immediately if you experience:

-unexplained muscle cramps,

-pain, sensitivity, or muscle weakness while taking this medication.

This is because this medication can cause muscle problems that can be serious.

These problems occur in rare cases but include inflammation and muscle destruction. This can cause kidney damage or even death.

Your doctor may do blood tests to check the condition of your muscles before and after starting treatment.

The risk of muscle problem is higher in certain patients. Consult your doctor if:

-You have kidney problems.

-You have thyroid problems.

-You are over 70 years old.

-You or a close relative has a hereditary muscle problem.

-You drink large amounts of alcohol.

-You have had muscle problems during treatment with statins or fibrates (such as fenofibrate, bezafibrate, or gemfibrozil).

-You are taking medications called statins to lower cholesterol, such as simvastatin, atorvastatin, pravastatin, rosuvastatin, or fluvastatin.

If any of the above circumstances apply to you (or you are unsure), consult your doctor or pharmacist before taking Fenofibrato SUN.

Use of Fenofibrato SUN with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Particularly inform your doctor or pharmacist if you are taking any of the following medications:

• Anticoagulants to reduce blood thickness (such as warfarin).
• Other medications used to control blood fat levels (such as statins or fibrates). Taking a statin at the same time as Fenofibrato may increase the risk of muscle problems.
• Ciclosporin (used to suppress your immune system).
• A type of medication to treat diabetes (such as rosiglitazone or pioglitazone).

If any of the above circumstances apply to you (or you are unsure), consult your doctor or pharmacist before taking Fenofibrato SUN.

Taking Fenofibrato SUN with food and drinks

It is essential to take the tablet with food, as it does not work as well if your stomach is empty.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

As there is not enough evidence on the use of fenofibrate during pregnancy, you should only use Fenofibrato SUN if your doctor considers it absolutely necessary.

It is unknown whether fenofibrate passes into breast milk. Therefore, do not use Fenofibrato SUN if you are breastfeeding or plan to breastfeed your baby.

Consult your doctor or pharmacist before taking any medication.

Driving and operating machinery

This medication has not been observed to affect your ability to drive and use machines.

Fenofibrato SUN 160 mg tablets contain soy lecithin.

Do not use in case of allergy to peanuts or soy.

Fenofibrato SUN 160 mg tablets contain less than 23 mg of sodium(1 mmol) per coated tablet; This is, essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Medication Intake

Swallow the tablet with a glass of water.

Do not crush or chew the tablet.

Take the tablet with food, as it does not work as well if your stomach is empty.

How Much to Take

The recommended dose is one tablet per day.

If you are currently taking a capsule of Fenofibrate 200 mg, you can switch to a tablet of Fenofibrate 160 mg. You will still receive the same amount of medication.

Patients with Kidney Problems

If you have kidney problems, your doctor may recommend a lower dose. Consult your doctor or pharmacist about this.

Use in Children and Adolescents

Fenofibrate SUN is not recommended for use in children and adolescents under 18 years old.

If You Take More Fenofibrate SUN Than You Should

In case of overdose, accidental ingestion, or if you suspect a child has swallowed several tablets, consult your doctor as soon as possible or call the Toxicology Information Service at 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If You Forget to Take Fenofibrate SUN

Do not worry if you have forgotten to take a dose (tablet) of 160 mg. Take a dose with the next meal and then continue with your treatment as usual.

Do not take a double dose to make up for the missed doses. If you have any doubts, consult your doctor or pharmacist.

If You Interrupt Treatment with Fenofibrate SUN

Do not stop taking the medication unless your doctor tells you to or the tablets do not agree with you. This is because abnormal levels of fat in the blood need to be treated for a long period of time.

If your doctor stops the medication, do not keep the remaining tablets unless your doctor tells you to.

Remember that in addition to taking Fenofibrate SUN, it is also important for you to:

• Follow a low-fat diet
• Exercise regularly

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them:

Stop taking Fenofibrate and see your doctor immediately if you notice any of the following serious side effects – you may need urgent medical treatment:

Rare: may affect up to 1 in 100 people

• Muscle cramps or pain, sensitivity or weakness – these may be signs of inflammation or muscle rupture, which can cause kidney damage or even death

• Abdominal pain – this may be a sign that the pancreas is inflamed (pancreatitis)

• Chest pain and shortness of breath – these may be signs of a blood clot in the lungs (pulmonary embolism)

• Pain, redness or swelling in the legs – these may be signs of a blood clot in the leg (deep vein thrombosis)

Rare:may affect up to 1 in 1,000 people

-Yellowing of the skin and the white of the eyes (jaundice), or an increase in liver enzymes – these may be signs of liver inflammation (hepatitis)

-Allergic reaction – symptoms may include swelling of the face, lips, tongue or throat, which can cause difficulty breathing

Unknown frequency: (cannot be estimated from available data)

-Severe skin eruption that reddens, peels and swells the skin and resembles a severe burn

-Long-term lung problems

Stop taking Fenofibrate and see your doctor immediately if you notice any of the side effects mentioned above.

Other side effects include:

Common(may affect up to 1 in 10 patients):

• Diarrhea

• Abdominal pain

• Gas (flatulence)

• Feeling unwell (nausea)

• Nausea (vomiting)

• Elevated liver enzymes in the blood – seen in blood tests

• Elevated homocysteine (excess of this amino acid in the blood has been associated with an increased risk of coronary heart disease, stroke and peripheral vascular disease, although no causal relationship has been established)

Rare(may affect up to 1 in 100 patients):

• Headache

• Gallstones

• Decreased libido

• Reactions such as skin rash, itching, hives on the skin

• Elevated creatinine (substance excreted by the kidneys) – seen in blood tests

Rare(may affect up to 1 in 1,000 patients):

• Hair loss

• Elevated urea (produced by the kidneys) – seen in blood tests

• Increased sensitivity of the skin to sunlight, sunlamps and sunbeds

• Decreased hemoglobin (which transports oxygen in the blood) and decreased leukocytes – seen in blood tests

Unknown frequency (cannot be estimated from available data):

• Muscle wasting

• Complications of gallstones

• Feeling of exhaustion (fatigue)

If you experience any side effect, report it to your doctor, pharmacist or nurse, even if it is a side effect not included in this leaflet.

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Fenofibrate SUN Composition

The active ingredient is fenofibrate.

The other components are: corn pregelatinized starch, povidone, sodium lauryl sulfate, microcrystalline cellulose, crospovidone, anhydrous colloidal silica, sodium stearate fumarate, partially hydrolyzed polyvinyl alcohol, titanium dioxide, talc, soy lecithin, xanthan gum.

Product appearance and container content

The tablets are white or almost white, oval, and biconvex, and coated with a film, with the mark “RX901” on one of its faces.

The tablets are contained in a thermoformed PVC/Aclar-Alu blister.

This medication is presented in containers of 30 tablets.

Marketing Authorization Holder

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

Netherlands

Responsible for Manufacturing

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

Netherlands

Alkaloida Chemical Company Zrt.

Kabay Janós u. 29.,

Tiszavasvári - 4440

Hungary

Local Representative

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 Barcelona

Spain

Last review date of this leaflet: May 2019

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/