Secalip 250 mg prolonged-release hard capsules

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Secalip 250 mg prolonged-release hard capsules

Fenofibrate

Read the entire 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 must not be given to other people, even if they have the same symptoms, as it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Secalip 250 mg is and what it is used for
2. What you need to know before taking Secalip 250 mg
3. How to take Secalip 250 mg
4. Possible side effects
5. How to store 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 reduce the level of fats (lipids) in the blood. For example, fats called triglycerides.

Secalip 250 mg is used, together 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 together 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 starting to 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 further 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 problems with your liver, kidneys, or gallbladder.
• 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 Secalip 250 mg if any of the above conditions apply to you. If you are unsure, consult your doctor or pharmacist before taking Secalip 250 mg.

Warnings and precautions

Talk to 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), elevated liver enzymes (seen in blood tests), stomach pain, and itching.
• you have an underactive thyroid gland (hypothyroidism).

If any of the above conditions 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 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 could lead to kidney damage or even death.

Your doctor may perform blood tests to check your muscle function before and during treatment.

The risk of muscle breakdown is higher in certain patients. Talk to 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 apply to you (or you are unsure), consult your doctor or pharmacist before taking Secalip 250 mg.

Taking Secalip 250 mg with other medicines

Tell 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 thin the blood (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 together with Secalip 250 mg may increase the risk of muscle problems.
• certain diabetes medicines (such as rosiglitazone or pioglitazone).
• ciclosporin (an immunosuppressant).

If any of the above 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, think you may be pregnant, or plan to become pregnant. This is because it is unknown how Secalip 250 mg may affect the newborn. Secalip 250 mg should only be used if prescribed by your doctor.

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

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

Driving and using machines

This medicine does not affect your ability to drive or operate tools or machinery.

Secalip 250 mg contains sucrose and sodium

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

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

3. How to take Secalip 250 mg

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

The recommended dose is one capsule (250 mg of fenofibrate) daily, taken orally.

If you are currently taking a 145 mg tablet or a 160 mg tablet, you may switch to a 200 mg capsule of micronized fenofibrate 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 as well if your stomach is empty.

Patients with kidney problems

If you have renal impairment, your doctor may recommend a lower dose. Ask your doctor or pharmacist about this.

Patients with liver problems

Secalip 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 Secalip 250 mg is too strong or too weak, inform your doctor or pharmacist.

If you take more Secalip 250 mg than you should

Contact your doctor or pharmacist as soon as possible.

In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone number 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 at your next mealtime.

Then continue taking your capsule at your 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 lipid levels require long-term treatment.

Remember that taking Secalip 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, Secalip 250 mg can cause adverse effects, although not everyone experiences them.

Stop taking Secalip 250 mg and contact your doctor immediately if you experience 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 lead to kidney damage or even death.
• stomach pain: this may be a symptom of inflammation of the 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: this may be a sign 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).

Not known: 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.

Stop taking Secalip and contact your doctor immediately if you notice any of the above adverse effects.

Other adverse effects:

Talk to your doctor or pharmacist if you experience any of the following adverse effects:

Common: may affect up to 1 in 10 patients

• diarrhea,
• stomach pain,
• gas (flatulence),
• feeling unwell (nausea),
• discomfort (vomiting),
• elevated liver enzyme levels in the blood – detected in blood tests,
• increased homocysteine levels (elevated levels of this amino acid in the blood have 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 sexual desire,
• skin rash, itching, or red hives 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,
• skin becoming more sensitive to sunlight, sunlamps, or sunbeds,
• decrease in hemoglobin (which carries oxygen in the blood) and decrease in white blood cells – detected in blood tests.

Not known: frequency 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 adverse effects listed above.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, 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 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 packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and packaging you no longer need. This 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 components (excipients) are sucrose, corn starch, talc, copolymer of (methacrylic acid-methyl methacrylate) (1:1), and copolymer of (butyl methacrylate-(2-dimethylaminoethyl) methacrylate-methyl methacrylate) (1:2:1), methacrylic acid E, methacrylic polymer L, talc. Capsule shell: gelatin, sodium lauryl sulfate.

Appearance of the medicine and contents of the pack

Prolonged-release hard capsules, size 1, with transparent body and cap.

PVC/Aluminum blister strips.

Pack size: 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 reviewed in February 2017.

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