PATIENT INFORMATION LEAFLET

Secalip 250 mg prolonged-release hard capsules

Fenofibrate

Read this leaflet carefully before you start taking this medicine, because 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. Do not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Secalip 250 mg 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.

Secalip 250 mg 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.

Secalip 250 mg 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 Secalip 250 mg if:

• You are allergic to fenofibrate or any of the other components of this medication (listed in section 6: Contents of the pack and additional information).
• You have had an allergic reaction (photosensitivity) or skin lesions caused by sunlight or UV light while taking other medications (such as other fibrates or a nonsteroidal anti-inflammatory drug called ketoprofen).
• You have severe liver, kidney, or gallbladder problems.
• You have acute or chronic pancreatitis (inflammation of the pancreas causing abdominal pain) not caused by high blood fat levels.

Do not take Secalip 250 mg if any of the above circumstances apply to you. If you are unsure, consult your doctor or pharmacist before taking Secalip 250 mg.

Warning and precautions

Consult your doctor, pharmacist, or nurse before starting to take this medication if:

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

If any of the above circumstances apply to you (or you are unsure), consult your doctor or pharmacist before taking Secalip 250 mg.

Muscle effects

Stop taking Secalip 250 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 fenofibrate, bezafibrate, or gemfibrozil).

- You are taking statins to lower cholesterol, such as simvastatin, atorvastatin, pravastatin, rosuvastatin, or fluvastatin.

• If any of the above situations apply to you (or you are unsure), consult your doctor or pharmacist before taking Secalip 250 mg.

Use of Secalip 250 mg with other medications

Inform your doctor or pharmacist if you are using or have used recently or may need to use 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 warfarin).
• Other medications used to control blood fat levels (such as statins or fibrates). This is because taking a statin or another fibrate at the same time as Secalip 250 mg may increase the risk of muscle problems.
• A type of medication to treat diabetes (such as rosiglitazone or pioglitazone).
• Ciclosporin (an immunosuppressant).

If any of the above situations apply to you (or you are unsure), consult your doctor or pharmacist before taking Secalip 250 mg.

Pregnancy and breastfeeding

Inform your doctor if you are pregnant, suspect you may be, or plan to become pregnant.This is because it is unknown how Secalip 250 mg may affect the newborn.Only Secalip 250 mg should be used if your doctor advises it.

Do not use Secalip 250 mg if you are breastfeeding or plan to breastfeed your baby.

This is because it is unknown if Secalip 250 mg passes into breast milk.

Driving and operating machinery

This medication does not affect your ability to drive or use tools or machines.

Secalip 250 mg contains saccharose and sodium

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

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

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

The recommended dose is one capsule (250 mg of fenofibrate) per day and taken orally.

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

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

Medication intake

• Swallow the entire capsule with a glass of water.
• Do not open or chew the capsule
• Take the capsule with food; it will not work as 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 about this.

People with liver problems

Secalip is not recommended for patients with liver insufficiency due to a 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 old. There is no available data. Therefore, the use of fenofibrate is not recommended in children and adolescents under 18 years old.

If you estimate that the action of Secalip 250 mg is too strong or too weak, inform your doctor or pharmacist.

If you take more Secalip 250 mg than you should

Consult your doctor or pharmacist as soon as possible.

In case of overdose or accidental ingestion, contact the Toxicological Information Service Telephone 915620420, indicating the medication and the amount ingested, or go to the nearest hospital.

If you forgot to take Secalip 250 mg

If you forgot to take a dose, take the next dose with your next meal.

Then continue taking your capsule at your usual time.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Secalip 250 mg

Do not stop taking Secalip 250 mg unless your doctor tells you to or unless 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 Secalip is important, as is having a low-fat diet and regular exercise.

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

Like all medicines, Secalip 250 mg may cause side effects, although not everyone experiences them.

Stop taking Secalip 250 mg 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.
• Abdominal pain: this may be a symptom of pancreatitis, where your pancreas is inflamed.
• 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: this may be a symptom 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 liver inflammation (hepatitis).

Unknown:cannot be estimated from available data

• Severe skin eruption that reddens, peels, and swells the skin, resembling a severe burn
• Long-term lung problems

Stop taking Secalip and seek immediate medical attention if you notice any of the above side effects.

Other side effects:

Consult your doctor or pharmacist if you experience any of the following side effects:

Common:may affect up to1 in 10 patients

- Diarrhea,

- Abdominal pain,

- Gas (flatulence)

- Nausea,

- Vomiting,

- Elevated 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 artery disease, stroke, and peripheral vascular disease, although no causal relationship has been established)

Rare:may affect up to1 in 100 patients

- Headache

- Gallstones

- Decreased libido

- Skin rash, itching, or red patches on the skin

- Increased creatinine (produced by the kidneys); appears in blood tests.

Rare:may affect up to1 in 1,000 patients

- Hair loss

- Increased urea (produced by the kidneys); appears in blood tests

- Skin more sensitive to sunlight, sunlamp, and sunbed

- Decreased hemoglobin (which transports oxygen in the blood) and decreased leukocytes - seen in blood tests

Unknown:cannot be estimated from available data

- Muscle wasting

- Complications of gallstones

- Feeling of exhaustion (fatigue)

Consult your doctor or pharmacist if you experience any of the side effects listed above.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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 for 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.

Store below25°C.

Do not use Secalip 250 mg after the expiration date that appears on the packaging after CAD The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Secalip 250 mg

The active ingredient is fenofibrate. Each Secalip 250 mg capsule contains 250 mg of fenofibrate.

The other components (excipients) are sucrose, cornstarch, talc, copolymer of (methacrylic acid-methyl methacrylate) (1:1) and copolymer of (butyl methacrylate-methacrylate of (2-dimethylaminoethyl)-methyl methacrylate) (1:2:1). metacrylic E, metacrylic polymer L, talc. Capsule: gelatin, sodium lauryl sulfate.

Appearance of the product and contents of the packaging

Hard, prolonged-release capsules, No. 1, transparent body and head.

PVC/Aluminum blister strips.

Package sizes containing 30 capsules.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

LACER, S.A. - Boters, 5

08290 Cerdanyola del Vallès

Barcelona – Spain

Responsible for manufacturing:

Astrea Fontaine - Fontaine-les-Dijon (France)

This leaflet was revised in February 2017.

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/