Secalip 200 mg capsules

Patient Information Leaflet

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Secalip 200 mg 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 side effects, talk to your doctor, pharmacist, or nurse, even if the side effects are not listed in this leaflet. See section 4.

Leaflet Contents

1. What Secalip 200 mg hard capsules is and what it is used for
2. What you need to know before taking Secalip 200 mg
3. How to take Secalip 200 mg
4. Possible side effects
5. How to store Secalip 200 mg
6. Contents of the pack and other information

1. What Secalip 200 mg is and what it is used for

Secalip 200 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 200 mg is used, together with a low-fat diet and other non-medical treatments such as exercise and weight loss, to reduce levels of fats in the blood.

Secalip 200 mg may be used together with other medicines (statins) in certain circumstances when a statin alone does not control fat levels in the blood.

2. What you need to know before taking Secalip 200 mg

Do not take Secalip 200 mg if:

• you are allergic to fenofibrate or to any of the other ingredients of this medicine (listed in section 6: Contents of the container and additional 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 damage 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 200 mg if any of the above apply to you. If you are unsure, consult your doctor or pharmacist before taking Secalip 200 mg.

Warnings and precautions

Talk to your doctor or pharmacist before starting 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), increased liver enzymes (seen in blood tests), stomach pain, and itching.
• you have an underactive thyroid gland (hypothyroidism).

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

Effects on your muscles

Stop taking Secalip 200 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 inflammation and breakdown of muscle tissue. This can lead to kidney damage or even death.

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

The risk of muscle breakdown 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 apply to you (or if you are unsure), consult your doctor or pharmacist before taking Secalip 200 mg.

Use of Secalip 200 mg with other medicines

Inform 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 used to reduce blood clotting (such as warfarin).
• other medicines used to control blood lipid levels (such as statins or fibrates). This is because taking a statin or another fibrate together with Secalip 200 mg may increase the risk of muscle problems.
• a type of medicine used to treat diabetes (such as rosiglitazone or pioglitazone).
• cyclosporine (an immunosuppressant).

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

Pregnancy and breastfeeding

Tell your doctor if you are pregnant, suspect you may be pregnant, or plan to become pregnant. This is because it is unknown how Secalip 200 mg may affect the newborn. Secalip should only be used if specifically instructed by your doctor.

Do not use Secalip 200 mg if you are breastfeeding or planning to breastfeed.

This is because it is unknown whether Secalip 200 mg passes into breast milk.

Driving and use of machines

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

Secalip 200 mg contains lactose and sodium.

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

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

3. How to take Secalip 200 mg

Follow exactly the instructions for use 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 (200 mg of fenofibrate) daily, taken orally.

If you are currently taking a 145 mg tablet or a 160 mg tablet, you may switch to one 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 kidney problems, 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 have not been established in children and adolescents under 18 years of age. 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 200 mg is too strong or too weak, tell your doctor or pharmacist.

If you take more Secalip 200 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 medication and the amount ingested, or go to the nearest hospital.

If you forget to take Secalip 200 mg

If you forget 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 make up for a missed dose.

If you stop taking Secalip 200 mg

Do not stop taking Secalip 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 over a long period of time.

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 200 mg can cause adverse effects, although not everyone experiences them.

Stop taking Secalip 200 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 your 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 in 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 – signs may include swelling of the face, lips, tongue or throat, which may cause difficulty breathing.
• yellowing of the skin or whites of the eyes (jaundice), or increased liver enzymes: these may be symptoms of an inflamed liver (hepatitis).

Not known: frequency cannot be estimated from available data

• severe skin rash causing redness, peeling and swelling of the skin resembling 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 include:

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

Common: may affect up to 1 in 10 people

• diarrhea,
• stomach pain,
• gas (flatulence),
• feeling unwell (nausea),
• discomfort (vomiting),
• elevated liver enzymes in the blood – detected in blood tests.
• increased homocysteine (elevated levels of this amino acid in blood have been associated with an increased 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 people

• 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 people

• hair loss,
• increased urea (produced by the kidneys) – detected in blood tests,
• skin more sensitive to sunlight, sunlamps and tanning beds,
• decreased hemoglobin (carries oxygen in blood) and decreased 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 type of 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 through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Secalip 200 mg

Keep this medicine out of sight and reach of children.

Store below 30°C.

Do not use Secalip 200 mg after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Secalip 200 mg

The active substance is fenofibrate. Each Secalip 200 mg capsule contains 200 mg of fenofibrate.

The other components (excipients) are: monohydrate lactose, sodium lauryl sulfate, pregelatinized corn starch, crospovidone, magnesium stearate.

Components of the capsule shell: titanium dioxide (E 171), red iron oxide (E 172), yellow iron oxide (E 172), and gelatin.

Appearance of Secalip 200 mg and contents of the pack

Secalip 200 mg is presented as hard gelatin capsules of ochre color. Each pack contains 30 capsules.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

LACER, S.A. - Boters, 5

08290 Cerdanyola del Vallès

Barcelona – Spain

Manufacturer

Astrea Fontaine. Rue des Prés Potets. 21121 Fontaine-les-Dijon (France)

or

Delpharm L’Aigle. Zone Industrielle No. 1. Route Crulai. 61300 L’Aigle (France)

This leaflet was last reviewed in February 2017.

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