Fenofibrate Pensa 200 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Fenofibrate Pensa 200 mg hard capsules EFG

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 you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

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

Fenofibrato Pensa 200 mg hard capsules 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.

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

Fenofibrate may be used in combination with other medicines [statins] in certain circumstances when a statin alone does not control blood fat levels.

2. What you need to know before starting to take Fenofibrate Pensa

Do not take Fenofibrate Pensa:

? if you are allergic to fenofibrate or any of the other components of this medicine (listed in section 6).

? if you have ever had an allergic reaction (photosensitivity) or skin injury caused by sunlight or UV light while taking other medications (these medications include other fibrates and an anti-inflammatory drug called ketoprofen).

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

? if 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 Fenofibrate Pensa if any of the above conditions apply to you. If you are unsure, consult your doctor or pharmacist before taking Fenofibrate Pensa.

Warnings and precautions:

Consult your doctor or pharmacist before starting to take this medicine.

• If you have kidney or liver problems.
• If you might 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.
• If you have hypothyroidism (underactive thyroid gland).

Effects on your muscles

Stop taking Fenofibrate 200 mg and contact your doctor immediately if you experience unexplained muscle pain, cramps, tenderness, or muscle 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 perform blood tests to monitor your muscle function before and during 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 previously experienced muscle problems while taking 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.
• You or a close family member has inherited muscle disorders.

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

Use of Fenofibrate Pensa with other medicines

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

In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• Anticoagulants used to reduce blood clotting (such as acenocoumarol or warfarin).
• Other medicines used to control blood fat levels (such as statins or fibrates). Taking a statin together with Fenofibrate 200 mg may increase the risk of muscle problems.
• Cyclosporine (used to suppress your immune system).
• A type of medicine used to treat diabetes (such as pioglitazone).

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

Taking Fenofibrate Pensa with food, drinks and alcohol

It is important to take the capsule with food. This medicine will not work as effectively if your stomach is empty.

Pregnancy, breastfeeding and fertility

Tell your doctor if you are pregnant, suspect you might be pregnant, or plan to become pregnant. As there is insufficient evidence regarding the use of Fenofibrate during pregnancy, Fenofibrate should only be used if your doctor considers it absolutely necessary.

It is unknown whether fenofibrate passes into breast milk. Therefore, you must not use Fenofibrate Pensa if you are breastfeeding or planning to breastfeed.

Consult your doctor or pharmacist before taking any medicine.

Driving and operating machinery

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

Fenofibrate Pensa contains lactose and the colour Orange Yellow S (E-110):

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

This medicine may cause allergic reactions, as it contains the dye Orange Yellow S (E-110). It may provoke asthma, particularly in patients allergic to acetylsalicylic acid.

3. How to take Fenofibrate Pensa

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

The recommended dose for adults is one capsule (200 mg of fenofibrate) daily, taken with one of the main meals, in combination with an appropriate diet.

If you are currently taking a 145 mg tablet or a 160 mg tablet, you may switch to one 200 mg fenofibrate capsule 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 properly 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.

Patients with liver problems

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

Use in children and adolescents

The use of fenofibrate is not recommended in children and adolescents under 18 years of age.

If you take more fenofibrate Pensa than you should

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

If you forget to take Fenofibrate Pensa

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

If you forget to take your medicine, do not take a double dose to make up for the missed doses. If you have any doubts, consult your doctor or pharmacist.

If you stop taking Fenofibrate Pensa

Do not stop taking the medicine unless your doctor tells you to, or if the capsules do not agree with you. This is because abnormal levels of blood fats require long-term treatment.

Remember that taking fenofibrate 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 or pharmacist.

4. Possible adverse effects

Like all medicines, Fenofibrate Pensa can cause adverse effects, although not everyone experiences them.

Stop taking Fenofibrate Pensa and seek immediate medical attention if you experience any of the following serious adverse effects, as you may require urgent medical care:

Uncommon: may affect up to 1 in 100 people

• Muscle cramps, pain, tenderness, or weakness: these may be symptoms of muscle inflammation and muscle breakdown, which can cause kidney damage or even death.
• Stomach pain: this may be a symptom of inflammation of the pancreas (pancreatitis).
• Chest pain and shortness of breath: these may be symptoms 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 elevated liver enzymes: these may be symptoms of liver inflammation (hepatitis).

Frequency not known: 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.

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

Other adverse effects include:

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

• Diarrhea,
• Stomach pain,
• Gas (flatulence),
• Nausea,
• Vomiting,
• Elevated liver enzymes in the blood (detected in laboratory 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,
• Pancreatitis (inflammation of the pancreas causing abdominal pain),
• Thromboembolism: pulmonary embolism (blood clot in the lung causing chest pain and difficulty breathing), deep vein thrombosis (blood clot in the leg causing pain, redness, or swelling).

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

• Hair loss,
• Increased urea (produced by the kidneys); detected in blood tests,
• Increased skin sensitivity to sunlight, sunlamps, or solarium beds,
• Decreased hemoglobin (carries oxygen in the blood) and white blood cells; detected 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 adverse effect, inform your doctor, pharmacist, or nurse, even if it is an effect not listed in this leaflet.

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor or pharmacist, 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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fenofibrate Pensa

Keep out of the sight and reach of children.

This medicine does not require special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fenofibrate Pensa

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

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

Components of the capsule shell: gelatin, orange-yellow colorant S (E-110), and titanium dioxide.

Components of the printing ink: shellac, black iron oxide (E-172), n-butyl alcohol, propylene glycol, dehydrated ethanol, isopropyl alcohol, ammonium hydroxide, and purified water.

Appearance of the product and contents of the pack

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

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

This medicine is available in packs of 30 capsules.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132JH Hoofddorp,

The Netherlands

This patient information leaflet was approved in July 2018

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