FENOFIBRATE SUN 160 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

FENOFIBRATE SUN 160 mg FILM-COATED TABLETS EFG

Fenofibrate

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What Fenofibrate SUN is and what it is used for

This medicine belongs to a group of medicines commonly known as fibrates. These medicines are used to lower the level of fats (lipids) in the blood. For example, fats called triglycerides.

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

This medicine may be used along with other medicines (statins) in certain circumstances when a statin alone does not control the levels of fat in the blood.

2. What you need to know before you take Fenofibrate SUN

Do not take Fenofibrate SUN

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

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

Warnings and precautions

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

• If you have liver or kidney problems.
• If you may have inflammation of the liver (hepatitis) – signs that include yellowing of the skin and the whites of the eyes (jaundice), increased liver enzymes (present in blood tests), stomach pain and itching.
• If you have an underactive thyroid gland (hypothyroidism)

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

Fenofibrate SUN and muscle effects

Stop taking Fenofibrate and go to your doctor immediately if you experience:

-unexplained muscle cramps,

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

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

These problems occur rarely but include inflammation and destruction of muscle. This can cause kidney damage or even death.

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

The risk of muscle problems 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 have 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).

if you are taking medicines 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 in doubt), consult your doctor or pharmacist before taking Fenofibrate SUN.

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Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

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

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

Taking Fenofibrate SUN with food and drink

It is important 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 are planning to have a baby, consult your doctor or pharmacist before using this medicine.

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

It is not known whether fenofibrate passes into breast milk. Therefore, you should not use Fenofibrate SUN if you are breastfeeding or planning to breastfeed your baby.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

This medicine has not been observed to affect the ability to drive and use machines.

Fenofibrate SUN 160 mg tablets contain soya lecithin.

Do not use if you are allergic to peanuts or soya.

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

3. How to take Fenofibrate SUN

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

Taking the medicine

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 200 mg Fenofibrate capsule, you can switch to a 160 mg Fenofibrate tablet. You will still receive the same amount of medicine.

Patients with kidney problems

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

Use in children and adolescents

The use of Fenofibrate SUN is not recommended in children and adolescents under 18 years of age.

If you take more Fenofibrate SUN than you should

In case of overdose, accidental ingestion or if you suspect that a child has swallowed several whole tablets, consult your doctor as soon as possible or call the Toxicology Information Service Telephone 91 562 04 20 indicating the medicine and the amount taken. It is recommended to take the package and the package leaflet of the medicine 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 your next meal and then continue with your treatment as usual.

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

If you stop taking Fenofibrate SUN

Do not stop treatment with the medicine unless your doctor tells you to do so or the tablets do not suit you. This is because abnormal levels of fats in the blood need to be treated for a long period of time.

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

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

• Follow a low-fat diet
• Exercise regularly

If you have any other questions about the use of this medicine, ask 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 and go to your doctor immediately, if you notice any of the following serious side effects – you may need urgent medical treatment:

Uncommon: may affect up to 1 in 100 people

• muscle cramps or pain, sensitivity or muscle weakness – these can be signs of muscle inflammation or rupture, which can cause kidney damage or even death
• stomach pain – this can be a sign that the pancreas is inflamed (pancreatitis)
• chest pain and shortness of breath – these can be signs of a blood clot in the lungs (pulmonary embolism)
• pain, redness or swelling in the legs – these can 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 whites of the eyes (jaundice), or an increase in liver enzymes – these can be signs of liver inflammation (hepatitis)
• allergic reaction – the signs can include swelling of the face, lips, tongue or throat, which can cause difficulty in breathing

Frequency not known: (cannot be estimated from the available data)

• severe skin rash that reddens, scales and swells the skin and looks like a severe burn
• long-term lung problems

Stop taking Fenofibrate and go to your doctor immediately, if you notice any of the above side effects.

Other side effects include:

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

• diarrhoea
• stomach pain
• gas (flatulence)
• feeling sick (nausea)
• being sick (vomiting)
• high levels of liver enzymes in the blood - seen in blood tests
• increased homocysteine (excess of this amino acid in the blood has been associated with a higher risk of coronary heart disease, stroke and peripheral vascular disease, although a causal relationship has not been established)

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

• headache
• gallstones
• decreased sex drive
• reactions such as skin rash, itching, hives
• increased creatinine (substance excreted by the kidneys) - seen in blood tests

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

• hair loss
• increased urea (produced by the kidneys) – seen in blood tests
• increased sensitivity of the skin to sunlight, sunlamps and sunbeds
• decrease in haemoglobin (which carries oxygen in the blood) and decrease in white blood cells - seen in blood tests

Frequency not known (cannot be estimated from the available data):

• muscle wasting
• gallstone complications
• feeling tired (fatigue)

If you experience any side effects, tell your doctor, pharmacist or nurse, even if it is not listed in this leaflet.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Fenofibrate SUN

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Fenofibrate SUN

The active substance is fenofibrate.

The other ingredients are: pregelatinized maize starch, povidone, sodium lauryl sulphate, microcrystalline cellulose, crospovidone, anhydrous colloidal silica, sodium stearyl fumarate, partially hydrolyzed polyvinyl alcohol, titanium dioxide, talc, soya lecithin, xanthan gum.

Appearance of the product and contents of the pack

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

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

This medicine is available in packs of 30 tablets.

Marketing authorisation holder

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

Netherlands

Manufacturer

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

Date of last revision of this leaflet: May 2019

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/