PATIENT INFORMATION LEAFLET

Secalip 200 mg 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 are unsure about anything, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have similar 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.

Table of Contents

1. What Secalip 200 mg is and what it is used for
2. What you need to know before you start taking 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 additional information

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 known as triglycerides.

Secalip 200 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 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.

Do not take Secalip 200 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 that causes abdominal pain) not caused by high blood fat levels.

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

Warning and precautions

Consult your doctor or pharmacist 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 200 mg.

Effects on your muscles

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

• Unexplained muscle cramps or
• Sensitivity, pain, or muscle 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 circumstances apply to you (or you are unsure), consult your doctor or pharmacist before taking Secalip 200 mg.

Use of Secalip 200 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 200 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 circumstances apply to you (or you are unsure), consult your doctor or pharmacist before taking Secalip 200 mg.

Pregnancy and breastfeeding

Inform your doctor if you are pregnant, suspect you may be pregnant, or intend to become pregnant.This is because it is unknown how Secalip 200 mg may affect the newborn.Only use Secalip if your doctor advises you to.

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

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

Driving and operating machinery

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

Secalip 200 mg contains lactose and sodium.

This medication contains lactose. If your doctor has told 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 (200 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 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 200 mg is too strong or too weak, inform 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, 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 200 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 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 period of time.

Remember that taking Secalip is important, as well as following a low-fat diet and exercising regularly..

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

Like all medicines, Secalip 200 mg may cause side effects, although not everyone will experience them.

Stop taking Secalip 200 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: 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 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 rash 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 are:

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

Common:may affect up to1 in 10 people

• Diarrhea,
• Abdominal pain,
• Gas (flatulence)
• Unpleasant feeling (nausea),
• Unpleasant feeling (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 heart disease, stroke, and peripheral vascular disease, although no causal relationship has been established).

Rare:may affect up to1 in 100 people

• Headache
• Bile stones
• Decreased libido
• 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 people

• Hair loss
• Increased urea (produced by the kidneys) – appears in blood tests
• Skin more sensitive to sunlight, sunlamps, and sunbeds
• 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 bile stones
• 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 the Vigilance 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 below 30°C.

Do not use Secalip 200 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 the packaging and unused medicines at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Secalip 200 mg

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

The other components (excipients) are:monohydrate lactose, sodium laurilsulfate, pregelatinized cornstarch, crospovidone, magnesium stearate.

The capsule components are: titanium dioxide (E 171), iron oxide red (E 172), iron oxide yellow (E172), and gelatin.

Appearance of Secalip 200 mg and content of the packaging

Secalip 200 mg is presented in the form of hard gelatin capsules of ocre color. Each package contains 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. 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 has been reviewed in February 2017.

The detailed and updated information of this medicine is available on the webpage of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/