SECALIP 250 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Secalip 250 mg prolonged-release hard capsules

Fenofibrate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What Secalip 250 mg is and what it is used for
2. What you need to know before you take Secalip 250 mg
3. How to take Secalip 250 mg
4. Possible side effects
5. Storage of Secalip 250 mg
6. Contents of the pack and other information

1. What Secalip 250 mg is and what it is used for

Secalip 250 mg belongs to a group of medicines commonly known as fibrates. These medicines are used to lower the level of fats (lipids) in the blood. For example, fats called triglycerides.

Secalip 250 mg is used, along with a low-fat diet and other non-medical treatments such as exercise and weight loss, to lower the levels of fats in the blood.

Secalip 250 mg may be used along with other medicines (statins) in certain circumstances when a statin alone does not control the levels of fat in the blood.

2. What you need to know before you take Secalip 250 mg

Do not take Secalip 250 mg if:

• you are allergic to fenofibrate or any of the other ingredients of this medicine (listed in section 6: Contents of the pack and other information).
• when taking other medicines (such as other fibrates or an anti-inflammatory medicine called ketoprofen) you have had an allergic reaction (photosensitivity) or skin injury caused by sunlight or UV light.
• you have severe liver, kidney or gallbladder problems.
• you have acute or chronic pancreatitis (inflammation of the pancreas that causes abdominal pain) not caused by high levels of fat in the blood.

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

Warnings and precautions

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

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

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

Effects on your muscles

Stop taking Secalip 250 mg and go to your doctor immediately if you experience:

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

This is because this medicine 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).
• you are taking medicines called 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.

Using Secalip 250 mg with other medicines

Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.

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

• anticoagulants to reduce blood thickness (e.g. warfarin)
• Other medicines 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 can increase the risk of muscle problems.
• a type of medicine for treating diabetes (such as rosiglitazone or pioglitazone).
• cyclosporin (an immunosuppressant)

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

Pregnancy and breastfeeding

Tell your doctor if you are pregnant, think you may be pregnant or are planning to become pregnant. This is because it is not known how Secalip 250 mg may affect the newborn. Secalip 250 mg should only be used if your doctor advises you to do so.

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

This is because it is not known if Secalip 250 mg passes into breast milk.

Driving and using machines

This medicine does not affect the ability to drive or use tools or machines.

Secalip 250 mg contains sucrose and sodium

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

This medicine contains less than 23 mg of sodium (1mmol) per capsule; this is, essentially “sodium-free”.

3. How to take Secalip 250 mg

Follow exactly the administration instructions of this medicine given 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, orally.

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

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

Taking 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 as 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 about this.

People with liver problems

Secalip is not recommended for patients with liver failure 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. 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 action of Secalip 250 mg is too strong or too weak, tell 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, consult the Toxicology Information Service Telephone 915620420, indicating the medicine and the amount ingested, or go to the nearest hospital.

If you forget to take Secalip 250 mg

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

Then continue taking your capsule at the usual time.

Do not take a double dose to make up for forgotten doses.

If you stop taking Secalip 250 mg

Do not stop taking Secalip 250 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 Secalip is important, as well as having a low-fat diet and exercising regularly .

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

4. Possible side effects

Like all medicines, Secalip 250 mg can cause side effects, although not everybody gets them.

Stop taking Secalip 250 mg 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: this can 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 – signs can include swelling of the face, lips, tongue or throat, which can cause difficulty breathing.
• yellowing of the skin and whites of the eyes (jaundice), or an increase in liver enzymes: these can be symptoms of liver inflammation (hepatitis).

Not known:cannot be estimated from the available data

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

Stop taking Secalip and go to your doctor immediately 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 to 1 in 10 patients

• diarrhea,
• stomach pain,
• gas (flatulence)
• feeling sick (nausea),
• being sick (vomiting),
• high 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 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.
• skin more sensitive to sunlight, sun lamp and sunbed.
• decrease in hemoglobin (which carries oxygen in the blood) and decrease in white blood cells - seen in blood tests.

Not known:cannot be estimated from the available data

• Muscle wasting.
• Complications of gallstones.
• feeling tired (fatigue).

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Secalip 250 mg

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

Store below 25°C.

Do not use Secalip 250 mg after the expiry date stated on the pack after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Secalip 250 mg

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

The other ingredients (excipients) are sucrose, corn starch, talc, methacrylic acid-methyl methacrylate copolymer (1:1) and butyl methacrylate-(2-dimethylaminoethyl) methacrylate-methyl methacrylate copolymer (1:2:1). methacrylic acid E, methacrylic acid L, talc. Capsule: gelatin, sodium lauryl sulfate.

Appearance of the product and pack contents

Hard prolonged-release capsules, size 1, with transparent body and cap.

PVC/Aluminum blister packs.

Package sizes with 30 capsules.

Marketing authorization holder and manufacturer

Marketing authorization holder

LACER, S.A. - Boters, 5

08290 Cerdanyola del Vallès

Barcelona – Spain

Manufacturer:

Astrea Fontaine - Fontaine-les-Dijon (France)

This leaflet was last revised in February 2017.

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