Patient Information Leaflet: Information for the Patient

Fenofibrate Teva 160 mg Film-Coated Tablets

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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms of disease, 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 is Fenofibrate Teva and what it is used for

2. What you need to know before taking Fenofibrate Teva

3. How to take Fenofibrate Teva

4. Possible side effects

5. Storage of Fenofibrate Teva

6. Contents of the pack and additional information

Fenofibrato Teva belongs to a group of medications commonly known as fibrates. These medications are used to decrease the level of fats (lipids) in the blood, for example, fats known as triglycerides.

Fenofibrato Teva is used in conjunction with a low-fat diet and other non-medication treatments such as exercise and weight loss, to decrease blood fat levels.

Fenofibrato Teva may be used in conjunction with other medications (statins) in certain circumstances when a statin alone does not control blood fat levels.

Do not take Fenofibrato Teva

• If you are allergic to fenofibrate or any of the other components of this medication (listed in section 6)
• If you are allergic to peanuts, arachidic oil, soy lecithin, or related products
• While taking other medications (such as other fibrates or a medication 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 levels of blood fat

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

Warnings and precautions

Consult your doctor or pharmacist before taking Fenofibrato Teva:

• Have kidney or liver problems
• If you have liver inflammation (hepatitis) – signs that include yellowing of the skin and white of the eyes (jaundice), increased liver enzymes (present in blood tests), stomach pain, and itching

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

Fenofibrato Teva and muscle effects

Stop taking Fenofibrato Teva and see your doctor immediately if you experience:

• Unexplained muscle cramps
• Muscle pain, sensitivity, or weakness

This is because this medication can cause muscle problems that can be serious. These problems occur in rare cases but include inflammation and muscle 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 problem 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 medications 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 circumstances apply to you (or you are unsure), consult your doctor or pharmacist before taking Fenofibrato Teva.

Your doctor may ask you to have regular blood tests to monitor the function of your liver and kidneys.

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

Taking Fenofibrato Teva and other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or might need to take any other medication.

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

• Anticoagulants to thin the blood (e.g. warfarin): the risk of bleeding may increase
• Other medications 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 Fenofibrato Teva may increase the risk of muscle problems
• A type of medication to treat diabetes (such as rosiglitazone or pioglitazone)
• Ciclosporin (an immunosuppressant)

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

Pregnancy and breastfeeding

Inform your doctor if you are pregnant, think you might be pregnant, or plan to become pregnant. This is because it is unknown how Fenofibrato Teva may affect the newborn. Only use Fenofibrato Teva if your doctor advises you to.

Do not use Fenofibrato Teva if you are breastfeeding or plan to breastfeed. This is because it is unknown if Fenofibrato Teva passes into breast milk.

Driving and using machines

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

Fenofibrato Teva contains soy lecithin

Do not use in case of allergy to peanuts, arachidic oil, or soy (see “do not take Fenofibrato Teva”)

Fenofibrato Teva contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Fenofibrato Teva contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially “sodium-free”

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

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

Medication Taking

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 have 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 capsules of 200 mg of fenofibrate, you can switch to a Fenofibrate Teva 160 mg tablet. You will still receive the same amount of medication.

If You Have Kidney Problems

If you have kidney problems, your doctor may recommend 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 old.

If You Take Too Much Fenofibrate Teva

If you accidentally take too many tablets or think a child has swallowed one, 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, phone 915 620 420, indicating the medication 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 missed doses.

If You Stop Taking Fenofibrate Teva

Do not stop taking Fenofibrate Teva unless your doctor tells you to or if the tablets make you feel unwell. This is because it requires long-term treatment. If your doctor stops the medication, do not keep the remaining tablets unless your doctor tells you to.

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

.

Like all medications, this one may cause side effects, although not everyone will experience them.

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

Rare: may affect up to 1 in 100 people)

• Muscle cramps or pain, sensitivity or weakness – these may be signs of inflammation or muscle rupture, which can cause kidney damage even death
• Abdominal pain: this may mean the pancreas is inflamed (pancreatitis)
• Chest pain and shortness of breath: these may be signs of a blood clot in the lung (pulmonary embolism)
• Pain, redness or swelling in the legs: these may 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 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 signs of an inflamed liver (hepatitis).

Unknown: the frequency 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

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

Other side effects include:

Consult your doctor or pharmacist if you experience any of the following side effects:

Frequent: may affect 1 in 10 patients:

• Diarrhea
• Abdominal pain
• Flatulence
• Unpleasant feeling (nausea)
• Vomiting
• Increased levels of 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 disease, stroke and peripheral vascular disease, although no causal relationship has been established)

Rare: may affect up to 1 in 100 people

• Headache
• Bile stones
• Decreased libido
• 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 tanning beds
• Decreased hemoglobin (which carries oxygen in the blood) and white blood cells – shown in tests

Unknown: the frequency cannot be estimated from available data

• Muscle wasting
• Bile stone complications
• Feeling of exhaustion (fatigue)

Consult your doctor or pharmacist if you experience any side effects mentioned.

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.

• Do not use this medication after the expiration date that appears on the carton and on the blister after CAD. The expiration date is the last day of the month indicated.
• Do not store above 25°C.
• Store in the original packaging. Store the blister in the outer carton.
• Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Fenofibrate Teva Composition

- The active ingredient is fenofibrate. Each film-coated tablet contains 160 mg of fenofibrate.

- The other components are: microcrystalline cellulose, povidone K-30, povidone K-25,

croscarmellose sodium, crospovidone, sodium alginate (type A), sodium lauryl sulfate

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

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

Appearance of Fenofibrate Teva and contents of the packaging

- White or almost white, oval-shaped, film-coated tablets, marked with “93” on one face and “7331” on the other

- Fenofibrate Teva 160 mg is available in packaging of 1, 10, 14, 15, 28, 30, 50, 56, 60, 84, 90, or 100 film-coated tablets.

Not all packaging sizes may be marketed.

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/Anabel Segura 11, Edificio Albatros B, 1st Floor

28108 Alcobendas, Madrid

Manufacturers

Pharmachemie B.V.

Swensweg 5, 2031 GA Haarlem

Holland

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

Republic of Czech

Last review date of this leaflet:January 2022

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

You can access detailed and updated information on this medicine by scanning the QR code included in the carton 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