Label: information for the user

FENOFIBRATE SUN 200 mg HARD GELATIN CAPSULES

Fenofibrate

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

• Keep this label, 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 should 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 label. See section 4.

1. What isFenofibrate SUNand what it is used for

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 pack 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 have had an allergic reaction (photosensitivity) or skin damage caused by sunlight or UV light while taking other medications (including other fibrates and a medication called ketoprofeno).

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

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

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

Effects on your muscles

Stop taking Fenofibrato 200 mg and see your doctor immediately if you experience

- unexplained muscle cramps or

- muscle pain, sensitivity, or 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 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 fenofibrato, bezafibrato, or gemfibrozilo).

- You are taking medications called statins to lower cholesterol, such as simvastatina, atorvastatina, pravastatina, rosuvastatina, or fluvastatina.

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

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 acenocumarol or warfarina).
• Other medications used to control blood fat levels (such as statins or fibrates). Taking a statin at the same time as Fenofibrato 200 mg may increase the risk of muscle problems.
• Ciclosporina (used to suppress your immune system).
• A type of medication to treat diabetes (such as pioglitazona).

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

Taking Fenofibrato 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.

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

It is unknown whether fenofibrato 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 contains lactose and yellow-orange colorant S (E-110):

This medication contains Lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

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

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, 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 an adequate diet.

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

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

Medication intake

• 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 a lower dose. Ask your doctor or pharmacist.

People with liver problems

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

Use in children and adolescents

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

If you estimate that the action of Fenofibrate SUN is too strong or too weak, inform 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 capsules whole, consult your doctor as soon as possible or call the Toxicology Information Service Telephone 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 forgot to take Fenofibrate SUN

Do not worry if you have forgotten to take a dose (capsule) of 200 mg. Take a dose with the next meal and then continue with your treatment as usual.

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

If you interrupt the treatment with 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 levels of fats in the blood need to be treated for a long period of time.

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

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

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

Stop taking Fenofibrate SUN and seek immediate medical attention if you notice any of the following severe side effects, as you may need urgent medical care:

Rare:may affect up to 1 in 100 people

- Muscle cramps or pain, sensitivity or weakness: these may be symptoms of muscle inflammation and muscle destruction, which can cause kidney damage or even death.

- Stomach pain: this may be a symptom of an inflamed pancreas (pancreatitis).

- Chest pain and shortness of breath: this may be a symptom of a blood clot in the lung (pulmonary embolism).

- Pain, redness or swelling of 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 – symptoms may include swelling of the face, lips, tongue or throat, which can cause difficulty breathing.

- Yellowing of the skin and white of the eyes (jaundice), or an increase in liver enzymes: these may be symptoms of an inflamed liver (hepatitis).

Unknown frequency: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.

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 unwell (nausea),

- Vomiting,

- Elevated 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 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

- Skin rash, itching or red, itchy patches 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

- Decreased hemoglobin (the one that carries oxygen from the blood) and white blood cells; 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: lactose monohydrate, sodium lauryl sulfate, pregelatinized cornstarch, crospovidone, talc, anhydrous colloidal silica, magnesium stearate.

The capsule components are: gelatin, yellow-orange S (E-110), and titanium dioxide (E-171).

The printing ink components are: shellac, iron oxide black (E-172), n-butyl alcohol, propylene glycol, ammonium hydroxide, anhydrous ethanol, isopropyl alcohol, and purified water.

Product appearance and packaging contents

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

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

This medication is presented in packs of 30 capsules.

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 for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/