SECALIP 200 mg CAPSULES

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Secalip 200 mg 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 thepackage leaflet

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

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

Secalip 200 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 200 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 200 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 200 mg

Do not take Secalip 200 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 200 mg if any of the above circumstances apply to you. If you are not sure, consult your doctor or pharmacist before taking Secalip 200 mg.

Warnings and precautions

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

• you have kidney or liver problems.
• you may have liver inflammation (hepatitis) - signs that 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 200 mg.

Effects on your muscles

Stop taking Secalip 200 mg and go to your doctor immediately if you experience:

• unexplained 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 inflammation and destruction of muscle. 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 200 mg.

Using Secalip 200 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:

• blood thinners to reduce blood thickness (such as warfarin).
• other medicines used to control fat levels in the blood (such as statins or fibrates). This is because taking a statin or another fibrate at the same time as Secalip 200 mg may 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 200 mg.

Pregnancy and breastfeeding

Tell your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. This is because it is not known how Secalip 200 mg may affect the newborn. You should only use Secalip if your doctor tells you to.

Do not use Secalip 200 mg if you are breastfeeding or plan to breastfeed your baby.

This is because it is not known if Secalip 200 mg passes into breast milk.

Driving and using machines

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

Secalip 200 mg contains lactose and sodium.

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult 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 200 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 (200 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 200 mg is too strong or too weak, tell your doctor or pharmacist.

If you take more Secalip 200 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 200 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 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 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 further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Secalip 200 mg can cause side effects, although not everybody gets them.

Stop taking Secalip 200 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

• cramps or muscle 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: these can be symptoms of a blood clot in the leg (deep vein thrombosis)

Rare:may affect up to 1 in 1,000 people

• allergic reaction – the 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, scales, and swells the skin and resembles 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 are:

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

Common:may affect up to 1 in 10 people

• 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 people

• headache
• gallstones
• decreased sexual desire
• skin rash, itching, or red patches on the skin
• increased creatinine (produced by the kidneys); appears in blood tests.

Rare:may affect up to 1 in 1,000 people

• hair loss
• increased urea (produced by the kidneys) - appears in blood tests
• skin more sensitive to sunlight, sunlamps, and sunbeds
• 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 200 mg

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

Store below 30°C.

Do not use Secalip 200 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. Return the containers and any unused medicines to the pharmacy. If you are unsure, ask your pharmacist how to dispose of the containers and any unused medicines. 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 ingredients (excipients) are: lactose monohydrate, sodium lauryl sulfate, pregelatinized corn starch, crospovidone, magnesium stearate.

The ingredients of the capsule are: 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 in the form of 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 revised in February 2017.

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