Leaflet: information for the user

Fenofibrate Pensa 200 mg hard capsules EFG

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 have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.See section 4.

1. What Fenofibrate Pensa is and what it is used for

2. What you need to know before you start taking Fenofibrate Pensa

3. How to take Fenofibrate Pensa

4. Possible side effects

5. Storage of Fenofibrate Pensa

6. Contents of the pack and additional information

Fenofibrato Pensa 200 mg hard capsules belong to a group of medications commonly known as fibrates. These medications are used to reduce the level of fats (lipids) in the blood. For example, fats known as triglycerides.

Fenofibrato 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.

Fenofibrato may be used along with other medications [statins] in certain circumstances when a statin alone does not control the levels of fat in the blood.

Do not take Fenofibrato Pensa:

?if you are allergic to fenofibrato or any of the othercomponents of this medication (listed in section 6).

?if you have had an allergic reaction (photosensitivity) or skindamage caused by sunlight or UV light while taking othermedications (including other fibrates and a medication calledketoprofeno).

?if you have severe liver, kidney, or gallbladder problems.

?if you have acute or chronic pancreatitis (inflammation of thepancreas not caused by high blood fat levels).

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

Warnings and precautions:

Consult your doctor or pharmacist before starting this medication.

• If you have kidney or liver problems.
• If you may be prone to liver inflammation (hepatitis). Signs include yellowing of the skin and white of the eyes (jaundice) and an increase in liver enzymes (visible in blood tests), stomach pain, and itching.
• If you have hypothyroidism (thyroid gland with low activity).

Effects on your muscles

Stop taking Fenofibrato 200 mg and see your doctor immediately if you experience unexplained muscle pain, cramps, sensitivity, or weakness while taking this medication.

This is because this medication can cause serious muscle problems.

These problems occur rarely 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 fenofibrato, bezafibrato, or gemfibrozilo).

- You are taking medications called statins to lower cholesterol, such as simvastatina, atorvastatina, pravastatina, rosuvastatina, or fluvastatina.

- You or a close relative have inherited muscle disorders.

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

Use of fenofibrato pensa with other medications

Inform your doctor or pharmacist if you are using or have used recently or may need to use any other medication, including those purchased without a prescription.

Particularly inform your doctor or pharmacist if you are taking any of the following medications:

• Anticoagulants to reduce blood thickness (such as acenocumarol or warfarina).
• Other medications used to control blood fat levels (such as statins or fibrates). Taking a statin at the same time as Fenofibrato 200 mg may increase the risk of muscle problems.
• Ciclosporin (used to suppress your immune system).
• A type of medication to treat diabetes (such as pioglitazona).

If any of the above situations apply to you (or you are unsure), consult your doctor or pharmacist before taking Fenofibrato Pensa.

Taking Fenofibrato Pensa with food, drinks, and alcohol

It is essential to take the capsule with food. This medication will not work as well if your stomach is empty.

Pregnancy, breastfeeding, and fertility

Inform your doctor if you are pregnant, suspect you may be, or plan to become pregnant. As there is not enough evidence on the use of Fenofibrato during pregnancy, you should only use Fenofibrato if your doctor considers it absolutely necessary.

The passage of fenofibrato into breast milk is unknown. Therefore, do not use Fenofibrato Pensa if you are breastfeeding or plan to breastfeed your baby.

Consult your doctor or pharmacist before taking any medication.

Driving and operating machines

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

Fenofibrato Pensa contains lactose and yellow-orange colorant S (E-110):

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

This medication may cause allergic reactions because it contains yellow-orange colorant S (E-110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose for adults is one capsule (200 mg of fenofibrate) per day during one of the main meals, in combination with an adequate diet.

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

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 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.

People with liver problems

Fenofibrate is not recommended for patients with liver insufficiency due to a lack of data.

Use in children and adolescents

Fenofibrate is not recommended for use in children and adolescents under 18 years old.

If you take more fenofibrate than you should

In case of overdose, accidental ingestion, or if you suspect a child has swallowed several capsules whole, consult your doctor as soon as possible or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forget to take Fenofibrate Pensa

Do not worry if you have forgotten to take a dose (capsule) of 200 mg. Take a dose with the next meal and then continue with your treatment as usual.

Do not take a double dose to compensate for the missed doses. If you have any doubts, consult your doctor or pharmacist.

If you interrupt treatment with Fenofibrate Pensa

Do not stop taking the medication unless your doctor tells you to or the capsules do not agree with you. This is because abnormal levels of fats in the blood need to be treated for a long period of time.

Remember that taking fenofibrate is important, as is having a low-fat diet and exercising regularly.

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

Like all medications, Fenofibrate Pensa may cause side effects, although not everyone will experience them.

Stop taking Fenofibrate Pensa and seek immediate medical attention if you notice any of the following severe side effects:

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.

- Stomach pain: this may be a symptom of an inflamed 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 of the legs: these may be symptoms of a blood clot in the leg (deep vein thrombosis)

Uncommon: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 an inflamed liver (hepatitis).

Frequency not known:cannot be estimated from available data

- Severe skin eruption that reddens, peels and swells the skin and resembles a severe burn.

- Long-term respiratory problems.

If you experience any of the above effects, consult your doctor immediately and stop taking Fenofibrate 200 mg.

Other side effects are:

Common(may affect up to 1 in 10 patients):

- Diarrhea,

- Stomach pain,

- Gas (flatulence),

- Nausea,

- Vomiting,

- Elevated liver enzymes in the blood (appear in laboratory tests).

• Increased homocysteine (excess of this amino acid in the blood has been associated with a higher risk of coronary disease, stroke and peripheral vascular disease, although no causal relationship has been established).

Uncommon(may affect up to 1 in 100 patients):

- Headache

- Gallstones

- Decreased libido

- Skin rash, itching or red, itchy patches on the skin

- Increased creatinine (produced by the kidneys); appears in blood tests

- Pancreatitis (inflammation of the pancreas that produces abdominal pain)

- Thromboembolism: pulmonary embolism (blood clot in the lung that produces chest pain and shortness of breath), deep vein thrombosis (blood clot in the leg that produces pain, redness or swelling)

Rare(may affect up to 1 in 1,000 patients):

- Hair loss

- Increased urea (produced by the kidneys); appears in blood tests

- Increased sensitivity of the skin to sunlight, sunlamp and sunbed

- Decreased hemoglobin (the one that carries oxygen from the blood) and white blood cells; seen in blood tests.

Frequency not known(cannot be estimated from available data):

- Muscle wasting

- Complications of gallstones

• Feeling of exhaustion (fatigue)

If you experience any side effect, report it to your doctor, pharmacist or nurse, even if it is a side effect not included in this prospectus.

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance 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 medication.

Keep out of sight and reach of children.

This medication does not require special conditions for conservation.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. This way, you will help protect the environment.

Composition of Fenofibrate Pensa

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

The other components are: lactose monohydrate, sodium lauryl sulfate, pregelatinized cornstarch, crospovidone, talc, anhydrous colloidal silica, magnesium stearate.

The capsule components are: gelatin, yellow-orange colorant S (E-110) and titanium dioxide.

The printing ink components are: shellac, iron oxide black (E-172), n-butyl alcohol, propylene glycol, anhydrous ethanol, isopropyl alcohol, ammonium hydroxide, and purified water.

Appearance of the product and contents of the packaging

The capsules are orange in color, size “0” marked with “FB 200” containing white powder inside.

The capsules are packaged in thermoformed blister strips (PVC/PVdC-Alu).

This medication is presented in packs of 30 capsules.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for Manufacturing

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132JH Hoofddorp,

Netherlands

This leaflet was approved in July 2018

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