FENOFIBRATE TEVA 160 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Fenofibrate Teva 160 mg film-coated tablets 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. Storing Fenofibrate Teva
6. Contents of the pack and other 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 are allergic to peanuts, arachis oil, soy lecithin or related products
• If you are taking other medicines (such as other fibrates or an anti-inflammatory medicine called ketoprofen), you have had an allergic reaction or skin lesion caused by sunlight or UV light.
• If you have severe liver, kidney or gallbladder disease
• If you have pancreatitis (inflammation of the pancreas that causes abdominal pain) not caused by high blood fat levels

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

Warnings and precautions

Consult your doctor or pharmacist before taking Fenofibrate Teva:

• If you have kidney or liver problems
• If you have liver inflammation (hepatitis) - signs include yellowing of the skin and the whites of the eyes (jaundice), increased liver enzymes (present 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.

Fenofibrate Teva and muscle effects

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

• unexplained muscle cramps
• Muscle pain, tenderness or weakness

This is because this medicine can cause muscle problems that can be serious. These problems occur rarely but include muscle inflammation and destruction. This can cause kidney damage or even death.

Your doctor may do a blood test to check the condition of your muscles before and after starting treatment. The risk of muscle problems is higher in some patients. In particular, consult your doctor if:

• you are over 70 years old
• you have kidney problems
• you have thyroid problems
• you or a close relative have a hereditary muscle problem
• you drink large amounts of alcohol
• you are taking medicines called "statins" to lower cholesterol (such as simvastatin, atorvastatin, pravastatin, rosuvastatin or fluvastatin)
• you have had muscle problems during treatment with statins or fibrates (such as fenofibrate, bezafibrate or gemfibrozil).

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

Your doctor may ask for regular blood tests to monitor your liver and kidney function.

Sometimes pancreatitis occurs in some patients taking fenofibrate (inflammation of the pancreas that causes abdominal pain): see the section above "Do not take Fenofibrate Teva" and section 4 below.

Taking Fenofibrate Teva with other medicines

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 taking any of the following medicines:

• Blood-thinning medicines (e.g. warfarin): the risk of bleeding may increase
• Other medicines 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 Fenofibrate Teva may increase the risk of muscle problems
• A type of medicine used to treat diabetes (such as rosiglitazone or pioglitazone)
• Ciclosporin (an immunosuppressant)

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

Pregnancy and breastfeeding

Tell your doctor if you are pregnant, think you may be pregnant or are planning to become pregnant. This is because it is not known how Fenofibrate Teva may affect the newborn. You should only use Fenofibrate Teva if your doctor recommends it.

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

Driving and using machines

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

Fenofibrate Teva contains soy lecithin

Do not use if you are allergic to peanuts, arachis oil or soy (see "Do not take Fenofibrate Teva").

Fenofibrate Teva contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Fenofibrate Teva contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; 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.

Taking the medicine

Take the tablet with food, as it does not work as well if your stomach is empty.

• Swallow the tablet with a glass of water
• Do not crush or chew the tablet

Remember that, in addition to taking Fenofibrate Teva, it is also important that:

• You follow a low-fat diet
• You exercise regularly

How much to take

The recommended dose is one tablet per day, including elderly patients.

If you are currently taking 200 mg fenofibrate capsules, you can switch to a Fenofibrate Teva 160 mg tablet. You will still receive the same amount of medicine.

If you have kidney problems

If you have kidney problems, your doctor may recommend that you take a lower dose. Consult your doctor or pharmacist about this.

Use in children and adolescents

Fenofibrate Teva is not recommended for use in children and adolescents under 18 years of age.

If you take more Fenofibrate Teva than you should

If you accidentally take too many tablets or think a child 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 Toxicology 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 take the next dose 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 tablets make you feel unwell. This is because it requires long-term treatment. If your doctor stops the medicine, do not keep the remaining tablets unless your doctor tells you to.

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

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4. Possible side effects

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

Stop taking Fenofibrate Teva and consult your doctor immediately if you experience any of the following serious side effects - you may need urgent medical treatment:

Uncommon: may affect up to 1 in 100 people

• Muscle cramps or pain, tenderness or weakness - these can be signs of muscle inflammation or rupture, which can cause kidney damage or even death
• Stomach pain: this may mean that the pancreas is inflamed (pancreatitis)
• Chest pain and shortness of breath: these can be signs of a blood clot in the lung (pulmonary embolism)
• Pain, redness or swelling in the legs: these can be signs of a blood clot in the leg (deep vein thrombosis)

Rare: may affect up to 1 in 1,000 people

• Allergic reaction: 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 increased liver enzymes: these can be signs of liver inflammation (hepatitis)

Not known: frequency cannot be estimated from the available data

• Severe skin rash that reddens, scales and swells the skin and resembles a severe burn

Long-term lung problems

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

Other side effects include:

Tell your doctor or pharmacist if you suffer from any of the following side effects:

Common: may affect up to 1 in 10 people:

• Diarrhea
• Stomach pain
• Flatulence
• Feeling unwell (nausea)
• Vomiting
• Increased liver enzymes in the blood - shown in 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
• Rash, itching or red spots on the skin
• Increased creatinine (produced by the kidneys) - shown in tests

Rare: may affect up to 1 in 1,000 people

• Hair loss
• Increased urea (produced by the kidneys) - shown in tests
• Skin more sensitive to sunlight, sunlamps or sunbeds
• Decrease in hemoglobin (which carries oxygen in the blood) and white blood cells - shown in tests

Not known: frequency cannot be estimated from the available data

• Muscle wasting
• Gallstone complications
• Feeling tired (fatigue)

Tell your doctor or pharmacist if you suffer from any side effect.

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 through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Fenofibrate Teva

• Keep out of the sight and reach of children.

• Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date is the last day of the month shown.
• Do not store above 25°C.
• Store in the original package. Keep the blister in the outer carton.
• Medicines should not be disposed of via wastewater or household waste. Return any medicine you no longer need to your pharmacist. This will help to protect the environment.

6. Contents of the pack and other information

Composition of Fenofibrate Teva

• The active substance is fenofibrate. Each film-coated tablet contains 160 mg of fenofibrate.
• The other ingredients are: microcrystalline cellulose, povidone K-30, povidone K-25,

croscarmellose sodium, crospovidone, sodium starch glycolate (type A), laurilsulfate

sodium, lactose monohydrate, colloidal anhydrous silica, sodium stearyl fumarate, partially

hydrolyzed polyvinyl alcohol, titanium dioxide (E171), talc, soy lecithin and xanthan gum.

Appearance of Fenofibrate Teva and contents of the pack

• White or almost white, oval-shaped, film-coated tablet, marked with "93" on one side and "7331" on the other

Fenofibrate Teva 160 mg is available in packs of 1, 10, 14, 15, 28, 30, 50, 56, 60, 84, 90

• or 100 film-coated tablets.

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 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

Date of last revision of this leaflet:January 2022

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/72706/P_72706.html