FENOFIBRATE AUROVITAS 145 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

Fenofibrate Aurovitas 145 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:

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

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

Fenofibrate Aurovitas 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 called triglycerides.

Fenofibrate Aurovitas 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 Aurovitas 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 Aurovitas

Do not take Fenofibrate Aurovitas:

• if you are allergic to fenofibrate or any of the other ingredients of this medicine (listed in section 6: Contents of the pack and other information)
• if you are allergic to peanuts, peanut oil, soy lecithin, or related products
• if you have had an allergic reaction or skin lesion caused by sunlight or UV light when taking other medicines (such as other fibrates or an anti-inflammatory medicine called "ketoprofen")
• 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 fat in the blood.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Fenofibrate Aurovitas if:

• you have liver or kidney problems
• you may have inflammation of the liver (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
• 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 Aurovitas.

Fenofibrate Aurovitas and muscle effects

Stop taking Fenofibrate Aurovitas and consult 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 inflammation and destruction of muscle. This can cause kidney damage or even death.

Your doctor may perform a blood test to check 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 Aurovitas.

Other medicines and Fenofibrate Aurovitas

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 thinners to reduce blood thickness (such as warfarin)
• 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 Aurovitas may increase the risk of muscle problems
• a type of medicine 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 Aurovitas.

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. This is because it is not known how Fenofibrate Aurovitas may affect the newborn. You should only use Fenofibrate Aurovitas if your doctor tells you to.
• Do not use Fenofibrate Aurovitas if you are breastfeeding or plan to breastfeed your baby. This is because it is not known if Fenofibrate Aurovitas passes into breast milk.

Driving and using machines

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

Fenofibrate Aurovitas contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet; this is essentially "sodium-free".

Fenofibrate Aurovitas contains sucrose

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

3. How to take Fenofibrate Aurovitas

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

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

Taking the medicine

The tablet can be taken with or without food at any time of the day.

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

Remember that, in addition to taking Fenofibrate Aurovitas, 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.

If you are currently taking a 200 mg fenofibrate capsule or a 160 mg fenofibrate tablet per day, you may switch to a 145 mg Fenofibrate Aurovitas tablet per day. You will still receive the same amount of medicine.

Patients with kidney problems

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

Use in children and adolescents

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

If you take more Fenofibrate Aurovitas than you should

Consult your doctor, pharmacist, or call the Toxicology Information Service Telephone 91.562.04.20, indicating the medicine and the amount taken.

If you forget to take Fenofibrate Aurovitas

• If you forget to take a dose, 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 Aurovitas

Do not stop taking Fenofibrate Aurovitas unless your doctor tells you to or unless 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 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 Aurovitas and consult your doctor immediately, if you notice 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 can be a sign that the pancreas is inflamed (pancreatitis)
• chest pain and shortness of breath – these can be signs of a blood clot in the lungs (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: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 Aurovitas and consult your doctor immediately, if you notice any of the above side effects.

Other side effects:

Consult 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)
• increased 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, hives
• increased creatinine (substance excreted by the kidneys) - seen in blood tests

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

• hair loss
• increased urea (produced by the kidneys) – seen 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:cannot be estimated from the available data

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

Consult your doctor or pharmacist if you experience any of the above side effects.

Reporting of side effects

If you get 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: https://www.notificaram.es/. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Fenofibrate Aurovitas

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 carton and blister after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fenofibrate Aurovitas

• The active substance is fenofibrate. Each tablet contains 145 mg of fenofibrate.
• The other ingredients are:

Tablet core:Microcrystalline cellulose (Grade 101), poloxamer (Type 407), hypromellose (Type 2910) [E464], sucrose, crospovidone (Type-A) [E1202], sodium lauryl sulfate, silicified microcrystalline cellulose (Grade-90), magnesium stearate.

Tablet coating:Hypromellose (Type 2910) [E464], Macrogol 400, titanium dioxide (E171).

Appearance and packaging

White or almost white, oval, film-coated tablets with '145' marked on one face and smooth on the other. The tablets may appear slightly convex. The size is 18.3 mm x 8.7 mm.

Fenofibrate Aurovitas 145 mg film-coated tablets EFG are available in blister packs of 20, 30, 50, 90, and 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D, 5ª planta

28036 Madrid

Spain

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Venda Nova, Amadora

Portugal

Or

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon,

France

This medicine is authorised in the Member States of the European Economic Area under the following names:

Belgium: Fenofibrate AB 145 mg film-coated tablets / comprimés pelliculés / Filmtabletten

France: Fenofibrate Arrow 145 mg, comprimé pelliculé

Italy: Fenofibrate Aurobindo

Portugal: Fenofibrate Aurovitas

Romania: Fenofibrate Aurobindo 145 mg film-coated tablets

Spain: Fenofibrate Aurovitas 145 mg film-coated tablets EFG

Date of last revision of this leaflet: September 2022

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