FENOFIBRATE SUN 200 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

FENOFIBRATE SUN 200 mg HARD CAPSULES EFG

Fenofibrate

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

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

Contents of the Package Leaflet

1. What is Fenofibrate SUN and what is it used for
2. What you need to know before taking Fenofibrate SUN
3. How to take Fenofibrate SUN
4. Possible side effects
5. Storage of Fenofibrate SUN
6. Package Contents and Additional Information

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

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 called 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 medication may be used in combination with other medications (statins) in certain circumstances when a statin alone does not control blood fat levels.

2. What you need to know before taking Fenofibrate SUN

Do not take Fenofibrate SUN

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

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

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

Effects on your muscles

Stop taking Fenofibrate 200 mg and go to your doctor immediately if you experience

• unexplained muscle cramps or
• muscle pain, sensitivity, or weakness when taking this medication

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

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

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

The risk of muscle destruction 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).

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

• 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 medications

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

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

• Anticoagulants to reduce blood thickness (such as acenocoumarol or warfarin).
• Other medications used to control blood fat levels (such as statins or fibrates). Taking a statin at the same time as Fenofibrate 200 mg may increase the risk of muscle problems.
• Cyclosporin (used to suppress your immune system).
• A type of medication for treating diabetes (such as pioglitazone).

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

Taking Fenofibrate SUN with food and drinks

It is essential to take the capsule with food. This medication 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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

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

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

Consult your doctor or pharmacist before taking any medication.

Driving and using machines

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

Fenofibrate SUN contains lactose and orange-yellow colorant (E-110):

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication may cause allergic reactions because it contains orange-yellow colorant (E-110). It can cause asthma, especially in patients allergic to acetylsalicylic acid.

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

3. How to take Fenofibrate SUN

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

The recommended dose for adults is one capsule (200 mg of fenofibrate) per day during one of the main meals, in combination with a suitable diet.

If you are currently taking a 145 mg or 160 mg tablet, you can switch to a 200 mg fenofibrate capsule without needing to adjust the dose.

For proper use of this medication, regular medical monitoring is essential.

Taking the medication

• 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 well if your stomach is empty.

People with kidney problems

If you have kidney problems, your doctor may recommend taking a lower dose. Ask your doctor or pharmacist.

People with liver problems

Fenofibrate SUN is not recommended for patients with liver failure due to the 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. There are no available data. Therefore, the use of fenofibrate is not recommended in children and adolescents under 18 years of age.

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

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 capsules, 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 package and the package leaflet of the medication to the healthcare professional.

If you forget to take Fenofibrate SUN

Do not worry if you have forgotten to take a dose (capsule) of 200 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 taking Fenofibrate SUN 200 mg unless your doctor tells you to or if the capsules make you feel unwell. This is because abnormal blood fat levels need to be treated for a long time.

Remember that taking Fenofibrate SUN is important, as well as having a low-fat diet and exercising regularly.

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

4. Possible side effects

Like all medications, this medication can have side effects, although not everyone gets them.

Stop taking Fenofibrate SUN and go to your doctor immediately if you notice any of the following serious side effects, as you may need urgent medical attention:

Uncommon:may affect up to 1 in 100 people

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

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

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

Frequency not known:cannot be estimated from the available data

• Severe skin rash that reddens, scales, and swells 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 side effects are:

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

• Diarrhea,
• Stomach pain,
• Gas (flatulence)
• Feeling of discomfort (nausea),
• Vomiting,
• High levels of liver enzymes in the blood (appear in laboratory 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
• Skin rash, itching, or red spots on the skin
• Increased creatinine (produced by the kidneys); appears in blood tests.

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

• Hair loss
• Increased urea (produced by the kidneys); appears in blood tests
• Increased sensitivity of the skin to sunlight, sunlamp, and sunbed
• Decrease in hemoglobin (which carries oxygen in the blood) and white blood cells; seen in blood tests.

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

• Muscle wasting
• Complications of gallstones
• Feeling of fatigue

If you experience any side effect, tell your doctor, pharmacist, or nurse, even if it is not listed in this package 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 not listed in this package leaflet. You can also report them directly through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Fenofibrate SUN 200 mg capsules

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 stated on the package.

Medications should not be disposed of via wastewater or household waste. Deposit the packages and medications you no longer need at the SIGRE collection point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of packages and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Fenofibrate SUN

The active ingredient is fenofibrate.

The other ingredients are: lactose monohydrate, sodium lauryl sulfate, pregelatinized cornstarch, crospovidone, talc, anhydrous colloidal silica, magnesium stearate.

The ingredients of the capsule are: gelatin, orange-yellow colorant (E-110), and titanium dioxide (E-171).

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

Appearance of the product and package contents

The capsules are orange in color, size "0", marked with "FB 200", containing white powder inside.

The capsules are packaged in thermoformed blister packs (PVC/PVdC-Alu).

This medication is available in packages of 30 capsules.

Marketing Authorization 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 the last revision of this package leaflet: May 2019

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