Fenofibrate Sun 160 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

FENOFIBRATE SUN 160 mg FILM-COATED TABLETS, EFG

Fenofibrate

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

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

Leaflet contents

1. What Fenofibrate SUN is and what it is used for
2. What you need to know before taking Fenofibrate SUN
3. How to take Fenofibrate SUN
4. Possible adverse effects
5. How to store 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 reduce the level of fats (lipids) in the blood. For example, fats known as triglycerides.

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

This medicine may be used together with other medicines [statins] in certain circumstances when a statin alone does not control blood fat levels.

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

Do not take Fenofibrate SUN

? if you are allergic to fenofibrate or to any of the other ingredients of this medicine (listed in section 6).

? if you are allergic to peanuts or peanut oil or soybean oil or related products.

? if you have had an allergic reaction or skin injury caused by sunlight or UV light while taking other medications (such as other fibrates or an anti-inflammatory drug called ketoprofen).

? if you have severe liver, kidney disease, or gallbladder problems.

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

Do not take Fenofibrate SUN if any of the above conditions apply to you. If you are unsure, 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 liver inflammation (hepatitis) – signs include yellowing of the skin and whites of the eyes (jaundice), increased liver enzymes (detected in blood tests), stomach pain, and itching.
• If you have an underactive thyroid gland (hypothyroidism).

If any of the above conditions apply to you (or if you have any doubts), consult your doctor or pharmacist before taking Fenofibrate SUN.

Fenofibrate SUN and muscle effects

Stop taking Fenofibrate and contact your doctor immediately if you experience:

• Unexplained muscle cramps,
• Muscle pain, tenderness, or weakness while taking this medicine.

This is because this medicine may cause muscle problems, which can be serious.

These problems are rare but may include muscle inflammation and muscle breakdown. This could lead to kidney damage or even death.

Your doctor may perform blood tests to monitor the condition of your muscles before and during 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 of age.
• You or a close family member has an inherited muscle disorder.
• You drink large amounts of alcohol.
• You have previously experienced muscle problems during treatment with statins or fibrates (such as
  fenofibrate, bezafibrate, or gemfibrozil).
• You are taking medicines called statins to lower cholesterol, such as simvastatin, atorvastatin, pravastatin, rosuvastatin, or fluvastatina.

If any of the above conditions apply to you (or if you have any doubts), consult your doctor or pharmacist before taking Fenofibrate SUN.

Use of Fenofibrate SUN with other medicines

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

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

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

If any of the above situations apply to you (or if you have any doubts), 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 become pregnant, consult your doctor or pharmacist before using this medicine.

As there is insufficient evidence regarding the use of fenofibrate during pregnancy, Fenofibrate SUN should only be used if your doctor considers it absolutely necessary.

It is unknown whether fenofibrate passes into breast milk. Therefore, Fenofibrate SUN must not be used if you are breastfeeding or planning to breastfeed your baby.

Consult your doctor or pharmacist before taking any medicine.

Driving and use of machines

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

Fenofibrate SUN 160 mg tablets contain soya lecithin.

It must not be used in case of allergy to peanut 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 for using this medicine given by your doctor. If in doubt, check with 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 daily.

If you are currently taking a 200 mg fenofibrate capsule, you may switch to a 160 mg fenofibrate tablet. You will continue to receive the same amount of medicine.

Patients with kidney problems

If you have kidney problems, your doctor may advise you to 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 Fenofibrato 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 at Telephone 91 562 04 20, indicating the medication and the amount taken. You will be advised to bring the medication container and package leaflet to the healthcare professional.

If you forget to take Fenofibrato SUN

Do not worry if you forget to take a 160 mg dose (tablet). Take the missed dose with your next meal and then continue 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 Fenofibrato SUN

Do not stop treatment with this medicine unless your doctor tells you to do so, or if the tablets do not agree with you. This is because abnormal blood fat levels require long-term treatment.

If your doctor discontinues the medication, do not keep any remaining tablets unless your doctor instructs you otherwise.

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

• Follow a low-fat diet
• Exercise regularly

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them:

Stop taking Fenofibrate and contact your doctor immediately if you experience any of the following serious adverse effects – you may need urgent medical treatment:

Uncommon: may affect up to 1 in 100 people

• 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 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 whites of the eyes (jaundice), or increased liver enzymes – these may be signs of liver inflammation (hepatitis)
• allergic reaction – signs may include swelling of the face, lips, tongue or throat, which may cause difficulty breathing

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

• severe skin rash that reddens, peels and swells the skin and resembles a severe burn
• long-term lung problems

Stop taking Fenofibrate and contact your doctor immediately if you notice any of the above adverse effects.

Other adverse effects include:

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

• diarrhoea
• stomach pain
• gas (flatulence)
• feeling unwell (nausea)
• discomfort (vomiting)
• elevated 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 sexual desire
• skin reactions such as rash, itching, hives
• increased creatinine (a 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 leucocytes – seen in blood tests

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

• muscle wasting
• complications of gallstones
• feeling of exhaustion (fatigue)

If you experience any adverse effect, inform your doctor, pharmacist or nurse, even if it is an adverse effect not listed in this leaflet.

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 stated on the container.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point in your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fenofibrate SUN

The active substance is fenofibrate.

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

Appearance of the medicine and contents of the pack

The tablets are white or almost white, oval, biconvex, film-coated tablets, marked “RX901” on one side.

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

This medicine is available in packs of 30 tablets.

Marketing Authorization Holder

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

The Netherlands

Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

The 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 the most recent revision of this leaflet: May 2019

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/