Fenofibrate Aurovitas 145 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Fenofibrate Aurovitas 145 mg film-coated tablets EFG

Read this entire 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, and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Fenofibrato Aurovitas belongs to a group of medicines commonly known as "fibrates". These medicines are used to reduce the level of fats (lipids) in the blood, such as fats called triglycerides.

Fenofibrato Aurovitas is used, together with a low-fat diet and other non-medical treatments such as exercise and weight loss, to reduce the levels of fats in the blood.

Fenofibrato Aurovitas 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 taking Fenofibrate Aurovitas

Do not take Fenofibrate Aurovitas:

• if you are allergic to fenofibrate or to any of the other ingredients of this medicine (listed in section 6: Contents of the pack and further information)
• if you are allergic to peanuts, peanut oil, soy lecithin, or related products
• if you have previously experienced an allergic reaction or skin injury 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 causing abdominal pain) not caused by high levels of fat in the blood.

Do not take Fenofibrate Aurovitas if any of the above apply to you. If you are unsure, 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 liver inflammation (hepatitis) – signs include yellowing of the skin and whites of the eyes (jaundice), increased liver enzymes (seen in blood tests), stomach pain, and itching
• you have an underactive thyroid gland (hypothyroidism).

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

Fenofibrate Aurovitas and muscle effects

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

• unexplained muscle cramps
• muscle pain, tenderness, or weakness.

This is because this medicine may cause muscle problems, which can be serious. These problems are rare but may include inflammation and breakdown of muscle tissue. This can lead to 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 certain patients. Specifically, consult your doctor if:

• you are over 70 years old
• you have kidney problems
• you have thyroid problems
• you or a close family member has an inherited muscle disorder
• 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 previously experienced muscle problems during treatment with statins or fibrates (such as fenofibrate, bezafibrate, or gemfibrozil).

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

Other medicines and Fenofibrate Aurovitas

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

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

• anticoagulants to reduce blood clotting (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 together with Fenofibrate Aurovitas may increase the risk of muscle problems
• certain medicines used to treat diabetes (such as rosiglitazone or pioglitazone)
• cyclosporine (an immunosuppressant).

If any of the above apply to you (or if 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 unknown how Fenofibrate Aurovitas may affect the newborn. Fenofibrate Aurovitas should only be used if prescribed by your doctor.
• You must not use Fenofibrate Aurovitas if you are breastfeeding or planning to breastfeed. This is because it is unknown whether Fenofibrate Aurovitas passes into breast milk.

Driving and using machines

This medicine does not affect your ability to drive or operate tools or machinery.

Fenofibrate Aurovitas contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet; hence, it is essentially “sodium-free”.

Fenofibrate Aurovitas contains sucrose

If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Fenofibrate Aurovitas

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

Taking the medicine

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

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

Please 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 daily, you may switch to one 145 mg Fenofibrate Aurovitas tablet daily. You will continue to receive the same amount of medication.

Patients with renal problems

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

Use in children and adolescents

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

If you take more Fenofibrate Aurovitas than you should

Contact your doctor, pharmacist, or call the Toxicology Information Service immediately at Telephone 91.562.04.20, stating 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 if the tablets make you feel unwell. This is because long-term treatment is required. If your doctor discontinues the medicine, do not keep any remaining tablets unless your doctor instructs you to do so.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Stop taking Fenofibrato Aurovitas and contact your doctor immediately if you experience any of the following serious adverse effects – you may need urgent medical treatment:

Uncommon ( may affect up to 1 in 100 people):

• muscle cramps or pain, tenderness or weakness – these may be signs of muscle inflammation or breakdown, which can cause kidney damage or even death
• stomach pain – this may be a sign that the pancreas is inflamed (pancreatitis)
• chest pain and shortness of breath – these may be signs of a blood clot in the lungs (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 may cause difficulty breathing
• yellowing of the skin and whites of the eyes (jaundice), or increased liver enzymes – these may be signs of liver inflammation (hepatitis).

Not known: frequency cannot be estimated from the available data

• severe skin rash causing redness, peeling and swelling of the skin resembling a severe burn
• long-term lung problems.

Stop taking Fenofibrato Aurovitas and contact your doctor immediately if you notice any of the above adverse effects.

Other adverse effects:

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

Common: may affect up to 1 in 10 people

• diarrhoea
• stomach pain
• gas (flatulence)
• feeling unwell (nausea)
• discomfort (vomiting)
• elevated liver enzymes in the blood – observed in blood tests
• increased homocysteine (elevated levels of this amino acid in blood have 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 sexual desire
• skin rash, itching, hives
• increased creatinine (a substance excreted by the kidneys) – observed in blood tests

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

• hair loss
• increased urea (produced by the kidneys) – observed in blood tests
• skin becoming more sensitive to sunlight, sunlamps and solariums
• decrease in haemoglobin (which carries oxygen in the blood) and decrease in white blood cells – observed in blood tests.

Not known: frequency cannot be estimated from the available data

• muscle wasting
• complications related to gallstones
• feeling of exhaustion (fatigue).

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es/. By reporting adverse 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 stated on the packaging and on the blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of any containers and medicines you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Fenofibrate Aurovitas

• The active substance is leflunomide. Each tablet contains 145 mg of fenofibrate.
• The other components 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).

Nature of the product and contents of the pack

Film-coated white or slightly whitish, oval tablets, marked '145' on one side and smooth on the other. The tablets may appear slightly convex. Size: 18.3 mm x 8.7 mm.

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D, 5th floor

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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Belgium: Fenofibrate AB 145 mg filmomhulde tabletten / comprimés pelliculés / Filmtabletten

France: Fenofibrate Arrow 145 mg, comprimé pelliculé

Italy: Fenofibrato Aurobindo

Portugal: Fenofibrato Aurovitas

Romania: Fenofibrat Aurobindo 145 mg comprimate filmate

Spain: Fenofibrato Aurovitas 145 mg comprimidos recubiertos con película EFG

Date of the most recent review of this leaflet: September 2022

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