Fenofibrate Sun 200 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

FENOFIBRATE SUN 200 mg HARD CAPSULES EFG

Fenofibrate

Read all of this 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, ask 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, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of this leaflet

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 Fenofibrato 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, along 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 fat levels in the blood.

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

Do not take Fenofibrate SUN

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

? if you have previously experienced an allergic reaction (photosensitivity) or skin injury caused by sunlight or UV light while taking other medications (these medications include other fibrates and an anti-inflammatory medicine called ketoprofen).

? if you have severe problems with your liver, kidneys, or gallbladder.

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

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 medicine.

• If you have kidney or liver 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 hypothyroidism (underactive thyroid gland).

Effects on your muscles

Stop taking Fenofibrate 200 mg and contact your doctor immediately if you experience:

• unexplained muscle cramps or
• 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 can lead to kidney damage or even death.

Your doctor may carry out blood tests to monitor your muscle function before and during treatment.

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

• You have kidney problems.
• You have thyroid problems.
• You are over 70 years old.
• 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 medicines called statins to lower cholesterol, such as simvastatin, atorvastatin, pravastatin, rosuvastatin, or fluvastatina.

If any of the above situations apply to you (or if you are unsure), consult your doctor or pharmacist before taking Fenofibrate 200 mg.

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 acenocoumarol or warfarin).
• Other medicines used to control blood lipid levels (such as statins or fibrates). Taking a statin at the same time as Fenofibrate 200 mg may increase the risk of muscle problems.
• Ciclosporin (used to suppress your immune system).
• A type of medicine used to treat diabetes (such as pioglitazone).

If any of the above apply to you (or you are unsure), consult your doctor or pharmacist before taking Fenofibrate 20 mg.

Taking Fenofibrate SUN with food and drink

It is important to take the capsule with food. This medicine will 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.

Consult your doctor or pharmacist before taking any medicine.

Driving and Use of Machines

This medicinal product has not been shown to affect the ability to drive or use machines.

Fenofibrate SUN contains lactose and the colouring agent Orange Yellow S (E-110):

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

This medicine may cause allergic reactions, as it contains Orange Yellow S (E-110). It may provoke asthma, particularly in patients allergic to acetylsalicylic acid.

This medicine contains less than 23 mg of sodium (1 mmol) per capsule; thus, it is essentially "sodium-free".

3. How to take Fenofibrate SUN

Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose for adults is one capsule (200 mg of fenofibrate) daily with one of the main meals, in combination with an appropriate diet.

If you are currently taking a 145 mg tablet or a 160 mg tablet, you may switch to a 200 mg fenofibrate capsule without the need for dose adjustment.

For proper use of this medicine, it is essential to undergo regular medical monitoring.

How to take the medicine

• Swallow the capsule whole with a glass of water.
• Do not open or chew the capsule.
• Take the capsule with food; it will not work properly if your stomach is empty.

Patients with kidney problems

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

Patients with liver problems

Fenofibrate SUN is not recommended for patients with hepatic insufficiency due to lack of data.

Use in children and adolescents

The safety and efficacy of fenofibrate in children and adolescents under 18 years of age have not been established. No data are available. Therefore, the use of fenofibrate is not recommended in children and adolescents under 18 years of age.

If you think that the effect of Fenofibrate SUN is too strong or too weak, inform your doctor or pharmacist.

If you take more Fenofibrato SUN than you should

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

If you forget to take Fenofibrato SUN

Don't worry if you forget a 200 mg dose (capsule). 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 taking Fenofibrato SUN 200 mg unless your doctor tells you to, or if the capsules make you feel unwell. This is because abnormal levels of fats in the blood require long-term treatment.

Remember that taking Fenofibrato SUN is important, as is following a low-fat diet and exercising regularly.

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

4. Possible adverse effects

Like all medicines, this medicine can have adverse effects, although not everyone experiences them.

Stop taking Fenofibrate SUN and contact your doctor immediately if you notice any of the following serious adverse effects, as you may require urgent medical attention:

Uncommon: may affect up to 1 in 100 people

• Muscle cramps or pain, tenderness, or weakness: these may be symptoms of muscle inflammation and muscle breakdown, which can cause kidney damage or even death.
• Stomach pain: this may be a symptom of inflammation of your pancreas (pancreatitis).
• Chest pain and shortness of breath: this may be a sign of a blood clot in the lung (pulmonary embolism).
• Pain, redness, or swelling in the legs: these may be symptoms of a blood clot in the leg (deep vein thrombosis).

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

• Allergic reaction – signs may include swelling of the face, lips, tongue, or throat, which may cause difficulty breathing.
• Yellowing of the skin and whites of the eyes (jaundice), or increased liver enzymes: these may be symptoms of liver inflammation (hepatitis).

Frequency not known: cannot be estimated from available data

• Severe skin rash causing redness, peeling, and swelling of the skin resembling a severe burn.
• Long-term lung problems.

If you experience any of the above effects, consult your doctor immediately and stop taking Fenofibrate 200 mg.

Other adverse effects are:

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

• Diarrhea,
• Stomach pain,
• Gas (flatulence),
• Feeling unwell (nausea),
• Vomiting,
• Elevated liver enzyme levels in the blood (detected in laboratory tests),
• Increased homocysteine (elevated levels of this amino acid in blood have been associated with an increased 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 rash, itching, or red spots on the skin,
• Increased creatinine (produced by the kidneys); detected in blood tests.

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

• Hair loss,
• Increased urea (produced by the kidneys); detected in blood tests,
• Increased sensitivity of the skin to sunlight, sunlamps, or sunbeds,
• Decreased hemoglobin (which carries oxygen in the blood) and white blood cells; detected 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 via 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 200 mg capsules

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

This medicine does not require special storage conditions.

Do not use this medicine after the expiry date stated on the container.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. This way, you 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: monohydrate lactose, sodium lauryl sulfate, pregelatinized corn starch, crospovidone, talc, anhydrous colloidal silica, magnesium stearate.

Components of the capsule shell: gelatin, orange yellow S (E-110), and titanium dioxide (E-171).

Components of the printing ink: shellac, black iron oxide (E-172), n-butyl alcohol, propylene glycol, ammonium hydroxide, dehydrated ethanol, isopropyl alcohol, and purified water.

Appearance of the medicine and contents of the pack

The capsules are orange in colour, size “0”, marked with “FB 200”, containing white powder inside.

The capsules are packed in thermoformed blister strips (PVC/PVdC-Alu).

This medicine is available in packs of 30 capsules.

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 latest revision of this leaflet: May 2019

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