FENOFIBRATE TEVA 200 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Fenofibrate Teva 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 pack and other information:

1. What is Fenofibrate Teva and what is it used for
2. What you need to know before you take Fenofibrate Teva
3. How to take Fenofibrate Teva
4. Possible side effects

5 Conservation of Fenofibrate Teva

1. Contents of the pack and further information

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

Fenofibrate Teva belongs to a group of medicines known as fibrates. These medicines are used to lower the level of fats (lipids) in the blood, for example fats known as triglycerides.

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

Fenofibrate Teva 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 you take Fenofibrate Teva

Do not take Fenofibrate Teva

• If you are allergic to fenofibrate or any of the other ingredients of this medicine (listed in section 6).
• If you have photosensitivity (allergic reaction caused by exposure to sunlight or ultraviolet rays) or phototoxic reactions during treatment with fibrates (medicines that modify lipid levels) or ketoprofen (an anti-inflammatory medicine).
• If you have liver, kidney, or gallbladder problems.
• If you have pancreatitis (inflammation of the pancreas, which causes abdominal pain) not caused by high blood fat levels.

Do not take Fenofibrate Teva if any of the above applies to you (or you are unsure), consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Consult your doctor or pharmacist before taking Fenofibrate Teva:

• If you have any liver or kidney problems.
• If you may have an inflamed liver (hepatitis): signs include yellowing of the skin and whites of the eyes (jaundice), increased liver enzymes (shown in blood tests), stomach pain, and itching.
• If you have an underactive thyroid gland (hypothyroidism).

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

Muscle effects

Stop taking Fenofibrate Teva and contact your doctor immediately if you experience:

• unexplained muscle cramps.
• muscle pain, tenderness, or weakness when taking this medicine.

This is because this medicine may cause muscle problems, which can be serious. These problems are rare but include inflammation and breakdown of muscles. 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 breakdown is higher in some patients. In particular, inform your doctor if:

• you have kidney problems.
• you have thyroid problems.
• you have low levels of a certain protein in the blood (hypoalbuminemia).
• you are over 70 years old.
• you or a close relative have a hereditary muscle problem.
• you drink large amounts of alcohol.
• you have ever 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) or other fibrates.

If any of the above applies to you (or you are unsure), talk to your doctor before taking Fenofibrate Teva.

Children and adolescents

Fenofibrate is not recommended in children and adolescents under 18 years of age due to insufficient clinical data.

Other medicines and Fenofibrate Teva

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

• blood-thinning medicines (e.g., warfarin).
• other medicines to control blood fat levels (such as statins or fibrates). This is because taking a statin or another fibrate in addition to Fenofibrate Teva may increase the risk of muscle problems (see 'Warnings and precautions' above).
• a particular class of medicines to treat diabetes (such as rosiglitazone or pioglitazone).
• cyclosporin, an immunosuppressant.

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

Taking Fenofibrate Teva with food and drinks

You should take Fenofibrate Teva with meals, as it will work better than on an empty stomach.

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 Fenofibrate Teva may affect the fetus. You should only use Fenofibrate Teva if your doctor advises you to.

Do not use Fenofibrate Teva if you are breastfeeding or plan to breastfeed your baby. This is because it is not known if fenofibrate passes into breast milk.

Driving and using machines

Fenofibrate Teva has no or negligible influence on the ability to drive and use machines.

Fenofibrate Teva contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; this is essentially 'sodium-free'.

3. How to take Fenofibrate Teva

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will determine the appropriate dose for you, depending on your condition, current treatment, and personal risk factors.

The recommended dose for adults is one capsule per day, including elderly patients.

For the proper use of this medicine, it is essential to undergo regular medical check-ups.

If you have kidney problems

If you have kidney problems, your doctor may recommend a lower dose. Ask your doctor or pharmacist about this. Other doses and pharmaceutical forms of fenofibrate are available for doses not suitable with this medicine.

If you have liver problems

This medicine 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, as there is insufficient data available.

Method of administration

Oral use.

Swallow the capsules whole with water. It is essential to take the capsules with some food, as they do not work in the same way on an empty stomach.

To treat your high cholesterol levels, you should exercise regularly and follow the dietary recommendations given by your doctor while taking this medicine.

If you take more Fenofibrate Teva than you should

If you accidentally take too many capsules or think that someone else has swallowed some, contact your nearest hospital or inform your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor immediately or call the Toxicological Information Service, telephone 915 620 420, indicating the medicine and the amount ingested.

If you forget to take Fenofibrate Teva

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 Fenofibrate Teva

Do not stop taking Fenofibrate Teva unless your doctor tells you to or the capsules make you feel unwell. This is because abnormal blood fat levels need to be treated for a long time.

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Fenofibrate Teva and contact 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, tenderness, or weakness: these can be symptoms of muscle inflammation and muscle breakdown, 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 – signs may include swelling of the face, lips, tongue, or throat, which may cause difficulty in breathing.
• yellowing of the skin and whites of the eyes (jaundice), or increased liver enzymes: these can be symptoms of an inflamed liver (hepatitis).

Not known:frequency cannot be estimated from the available data

• severe skin rash that reddens, scales, and thickens the skin, and resembles severe burns.
• long-term lung problems.

Stop taking Fenofibrate Teva and contact your doctor immediately if you notice any of the above side effects.

Other side effects are:

Tell 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 sex drive.
• skin rash, itching, or redness.
• 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:frequency cannot be estimated from the available data

• muscle wasting.
• complications of gallstones.
• feeling tired (fatigue).

Tell 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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Agency's website for the Pharmacovigilance of Medicines for Human Use: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Fenofibrate Teva

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

Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date is the last day of the month stated.

Store in the original package to protect from light. Store the blister in the outer carton.

Medicines should not be disposed of via wastewater or household waste. Place the empty packaging and any unused medicinal product in the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and unused medicinal products. This will help protect the environment.

6. Contents of the pack and further information

Composition of Fenofibrate Teva

• The active substance is fenofibrate. Each capsule contains 200 mg of fenofibrate.
• The other ingredients are: sodium laurilsulfate, povidone, pregelatinized corn starch, crospovidone, sodium croscarmellose, sodium starch glycolate (from potato), colloidal anhydrous silica, and sodium stearyl fumarate. The capsule contains gelatin, titanium dioxide (E171), allura red AC, and printed ink that contains shellac, iron oxide black, and propylene glycol.

Appearance of Fenofibrate Teva and contents of the pack

Hard gelatin capsule with a red-orange opaque cap and body, filled with a white or almost white powder, with small agglomerates, printed with FM200 on the body and cap.

• Fenofibrate Teva 200 mg is available in packs of 1, 20, 28, 30, 50, 60, 84, 90, 100, or 300 (10x30) capsules.

Not all pack sizes may be marketed.

Marketing authorisation holder

Teva Pharma, S.L.U.

C/Anabel Segura 11, Edificio Albatros B, 1ª Planta

28108 Alcobendas, Madrid

Manufacturers

Pharmachemie B.V.

Swensweg 5, 2031 GA Haarlem

Netherlands

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

Teva Operations Poland Sp. z.o.o.

ul. Mogilska, 80

31-546 Krakow

Poland

Teva Czech Industries s.r.o.

Ostravska 29, c.p. 305, Building No 80 Small OSD and building No 881 NOSD

747 70 Opava-Komarov

Czech Republic

This leaflet was last revised in March 2024

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

You can access detailed and up-to-date information about this medicine by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/72705/P_72705.html.