FENOFIBRATE PENSA 200 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Fenofibrate Pensa 200 mg Hard Capsules EFG

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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

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

Fenofibrate Pensa 200 mg hard capsules 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.

Fenofibrate is used, along with a low-fat diet and other non-drug treatments such as exercise and weight loss, to lower the levels of fats in the blood.

Fenofibrate 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 Fenofibrate Pensa

Do not take Fenofibrate Pensa:

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

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

• If you have kidney or liver problems.
• If you may have inflammation of the liver (hepatitis). The signs include yellowing of the skin and the whites of the eyes (jaundice) and an increase in liver enzymes (which appear in blood tests), stomach pain, and itching.
• If you have hypothyroidism (underactive thyroid gland).

Effects on your muscles

Stop taking Fenofibrate 200 mg and go to your doctor immediately if you experience unexplained muscle pain, cramps, sensitivity, or muscle weakness while 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 do blood tests to check your muscles before and after starting treatment.

The risk of muscle destruction is greater 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).

Fenofibrate 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.

• You are taking medicines called statins to lower cholesterol, such as simvastatin, atorvastatin, pravastatin, rosuvastatin, or fluvastatin.
• You or a close relative have hereditary muscle disorders.

If any of the above situations apply to you (or you are not sure), consult your doctor or pharmacist before taking Fenofibrate 200 mg.

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

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

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

If any of the above cases apply to you (or you are not sure), 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 well if your stomach is empty.

Pregnancy, breastfeeding, and fertility

Tell your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Since there is not enough evidence on the use of Fenofibrate in pregnancy, you should only use Fenofibrate if your doctor considers it absolutely necessary.

It is not known if fenofibrate passes into breast milk. Therefore, you should not use Fenofibrate Pensa if you are breastfeeding or planning to breastfeed your baby.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

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

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

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

3. How to take Fenofibrate Pensa

Follow exactly the administration instructions of this medicine 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 a suitable diet.

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

For good use of this medicine, regular medical monitoring is essential.

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 well if your stomach is empty.

Patients with kidney problems

If you have kidney problems, your doctor may recommend taking a lower dose. Ask your doctor or pharmacist.

Patients with liver problems

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

Use in children and adolescents

Fenofibrate is not recommended for use 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 that a child has swallowed several whole capsules, consult your doctor as soon as possible or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken. It is recommended to take the package and the package leaflet of the medicine 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.

If you have forgotten to take your medicine, do not take a double dose to make up for the forgotten 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 the capsules do not suit you. This is because abnormal blood fat levels need to be treated for a long time.

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

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

4. Possible side effects

Like all medicines, Fenofibrate Pensa can cause side effects, although not everybody gets them.

Stop taking Fenofibrate Pensa 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

• Muscle cramps or pain, sensitivity, or muscle 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 the whites of the eyes (jaundice), or an increase in liver enzymes: these can be symptoms of liver inflammation (hepatitis).

Frequency not known:cannot be estimated from the available data

• Severe skin rash that reddens, scales, and thickens 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 side effects are:

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

• Diarrhea,
• Stomach pain,
• Gas (flatulence),
• Nausea,
• Vomiting,
• High levels of 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 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 patches on the skin
• Increased creatinine (produced by the kidneys); appears in blood tests
• Pancreatitis (inflammation of the pancreas that causes abdominal pain)
• Thromboembolism: pulmonary embolism (blood clot in the lung that causes chest pain and shortness of breath), deep vein thrombosis (blood clot in the leg that causes 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
• Decrease in hemoglobin (which carries oxygen in the blood) and white blood cells; seen in blood tests.

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

• Muscle wasting
• Complications of gallstones
• Feeling of exhaustion (fatigue)

If you experience any side effect, tell your doctor, pharmacist, or nurse, even if it is not listed in this leaflet.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) https://www.notificaram.es. By reporting side 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 which is stated on the carton after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Fenofibrate Pensa

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

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

The ingredients of the capsule are: gelatin, yellow-orange colorant (E-110), and titanium dioxide.

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

Appearance of the product and pack contents

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

The capsules are packaged in thermoformed blister packs (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,

Netherlands

This leaflet was approved in July 2018

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