Patient Information Leaflet

Fluvastatina Aurovitas Spain 80 mg prolonged-release tablets EFG

Read this leaflet carefully before you start to take 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 as you, 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.

Fluvastatina Aurovitas Spain contains the active ingredient fluvastatin sodium, which belongs to a group of medicines known as statins, which are medicines to reduce lipids: they decrease the fat (lipids) in the blood. They are used in patients whose condition cannot be controlled solely with diet and exercise.

• Fluvastatina Aurovitas Spain is a medicine that is usedto treat high levels of fats in the blood of adults, in particular total cholesterol and the so-called "bad" cholesterol or LDL-cholesterol, which is associated with a high risk of heart disease and stroke

• in adult patients with high levels of cholesterol in the blood.
• in adult patients with high levels of both cholesterol and triglycerides (another type of lipid) in the blood.

• Your doctor may also prescribe Fluvastatina Aurovitas Spain for the prevention of other serious heart problems (e.g. a heart attack) in patients who have undergone a heart catheterization through an intervention in the heart vessels.

If you have any doubts about how fluvastatin works or why you have been prescribed this medicine, consult your doctor.

Follow carefully all the instructions given to you by your doctor. These may be different from the information included in this prospectus.

Before taking Fluvastatina Aurovitas Spain, read the following clarifications.

Do not take Fluvastatina Aurovitas Spain

• if you are allergic to fluvastatin or any of the other components of this medication (listed in section 6).
• if you have liver problems, or present an unknown and persistent elevation of certain liver enzymes (transaminases).
• if you are pregnant or breastfeeding (see “Pregnancy and breastfeeding”).

If you find yourself in any of these situations, do not take Fluvastatina Aurovitas Spain and consult your doctor.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Fluvastatina Aurovitas Spain:

• if you have previously suffered from liver disease. Normally, your liver function will be checked before starting treatment with Fluvastatina Aurovitas Spain, when increasing the dose and at different intervals of time during treatment to monitor the appearance of adverse effects.
• if you are taking or have taken in the last 7 days a medication called fusidic acid (an antibiotic medication) by mouth or injection. The combination of fusidic acid and Fluvastatina Aurovitas Spain may lead to severe muscle problems (rhabdomyolysis).
• if you have kidney disease.
• if you have thyroid gland disease (hypothyroidism).
• if you have a personal or family history of muscle diseases.
• if you have had muscle problems with another lipid-lowering medication.
• if you have or have had myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins may sometimes worsen the disease or cause myasthenia (see section 4).
• if you habitually drink large amounts of alcohol.
• if you have a severe infection.
• if you have very low blood pressure (symptoms may include dizziness, vertigo).
• if you engage in excessive controlled or uncontrolled muscle exercise.
• if you are about to undergo surgery.
• if you have severe metabolic, endocrine, or electrolyte disorders such as uncontrolled diabetes and low blood potassium levels.

Consult your doctor or pharmacist before taking Fluvastatina Aurovitas Spain if you:

• have severe respiratory failure

If you find yourself in any of these situations, inform your doctor before taking Fluvastatina Aurovitas Spain. Your doctor will perform a blood test before prescribing Fluvastatina Aurovitas Spain.

If during treatment with Fluvastatina Aurovitas Spain you experience symptoms or signs such as nausea, vomiting, loss of appetite, yellowing of the eyes or skin, confusion, euphoria or depression, mental slowness, difficulty speaking, sleep disturbances, tremors, or easy bruising or bleeding, these may be signs of liver insufficiency. In this case, contact your doctor immediately.

While you are taking this medication, your doctor will monitor whether you have diabetes or are at risk of developing diabetes. This risk of diabetes increases if you have high blood sugar and fat levels, obesity, and high blood pressure.

Inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and medications may be necessary to diagnose and treat this problem.

Fluvastatina Aurovitas Spain and people over 70 years old

If you are over 70 years old, your doctor may want to check if you have risk factors for muscle diseases. You may need specific blood tests.

Fluvastatina Aurovitas Spain and children/adolescents

Fluvastatina Aurovitas Spain has not been investigated or indicated in children under 9 years old. For information on dosing in children over 9 years old and adolescents, see section 3.

There is no experience with the use of Fluvastatina Aurovitas Spain in combination with nicotinic acid, cholestyramine, or fibrates in children and adolescents.

Other medications and Fluvastatina Aurovitas Spain

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

Fluvastatina Aurovitas Spain can be taken alone or with other medications to lower cholesterol prescribed by your doctor.

After taking a resin, e.g. cholestyramine (mainly used to treat high cholesterol), wait at least 4 hours before taking Fluvastatina Aurovitas Spain.

Inform your doctor and pharmacist if you are taking any of the following medications:

• Ciclosporin (a medication used to suppress the immune system).
• Fibrates (e.g. gemfibrozil), nicotinic acid, or bile acid sequestrants (medications used to lower bad cholesterol levels).
• Fluconazole (a medication used to treat fungal infections).
• Rifampicin (an antibiotic).
• Phenytoin (a medication used to treat epilepsy).
• Oral anticoagulants such as warfarin (medications used to reduce blood clots).
• Glibenclamide (a medication used to treat diabetes).
• Colchicine (used to treat gout).
• If you need to take fusidic acid orally to treat a bacterial infection, you will need to temporarily interrupt the use of this medication. Your doctor will indicate when it is safe to restart treatment with Fluvastatina Aurovitas Spain. The combination of fluvastatin with fusidic acid may lead, in rare cases, to muscle weakness, sensitivity, or pain (rhabdomyolysis). See more information about rhabdomyolysis in section 4.

Taking Fluvastatina Aurovitas Spain with food and drinks

You can take Fluvastatina Aurovitas Spain with or without food.

Pregnancy and breastfeeding

Do not take Fluvastatina Aurovitas Spain if you are pregnant or breastfeeding, as the active ingredient may cause damage to the fetus and it is not known if it is excreted in breast milk. If you are pregnant, consult your doctor or pharmacist before taking Fluvastatina Aurovitas Spain. You should take the necessary precautions to avoid becoming pregnant while receiving treatment with Fluvastatina Aurovitas Spain.

If you become pregnant while taking this medication, stop taking Fluvastatina Aurovitas Spain and consult your doctor.

Driving and operating machines

There is no information on the effects of Fluvastatina Aurovitas Spain on the ability to drive and operate machines.

Fluvastatina Aurovitas Spain contains sodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Do not take a higher dose than indicated.

Your doctor will recommend that you follow a low-cholesterol diet. Continue with this diet while takingFluvastatina Aurovitas Spain.

How muchFluvastatina Aurovitas Spain should be taken

• The dosage interval for adults is 20 mg to 80mg per day and depends on the reduction of cholesterol levels needed. Your doctor may adjust your dose at intervals of 4 weeks or more.
• In children (9 years of age and older), the usual initial dose is 20 mg per day. The maximum daily dose is 80 mg. Your doctor may adjust your dose at intervals of 6 weeks.

Your doctor will inform you exactly how many tablets of Fluvastatina Aurovitas Spain you should take.

Depending on how you respond to treatment, your doctor may prescribe a higher or lower dose.

Fluvastatina Aurovitas Spain is only available in prolonged-release tablets.For lower doses (20mg and 40mg), your doctor will prescribe other medications.

When to take Fluvastatina Aurovitas Spain

You can take Fluvastatina Aurovitas Spain at any time of the day.

Fluvastatina Aurovitas Spain can be taken with or without food. Swallow it whole with a glass of water.

If you take more Fluvastatina Aurovitas Spain than you should

If you have accidentally taken too muchFluvastatina Aurovitas Spain, inform your doctor immediately.

You may need medical attention.

In case of overdose or accidental ingestion,consult your doctor or pharmacist immediatelyor call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. You may need medical attention.

If you forget to take Fluvastatina Aurovitas Spain

Take a dose as soon as you remember. However, do not take it if less than 4 hours are left before the next dose. In this case, take the next dose at the usual time.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Fluvastatina Aurovitas Spain

To maintain the benefits of your treatment, do not stop takingFluvastatina Aurovitas Spainunless your doctor tells you to. You should continue takingFluvastatina Aurovitas Spainas prescribed to maintain low levels of your "bad" cholesterol.Fluvastatina Aurovitas Spainwill not cure your disease but will help you control it. It is necessary to regularly check your cholesterol levels to monitor your progress.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Rare or very rare side effects (affecting up to 1 in 1,000 people) may be severe: seek immediate medical assistance.

• If you experience unexplained muscle pain, sensitivity, or weakness. These may be early signs of a potentially severe muscle degradation. This can be prevented if your doctor stops your fluvastatin treatment as soon as possible. These side effects have also been observed in similar medications of this class (statins).
• If you experience unusual fatigue or fever, yellow skin and eyes, dark urine (signs of hepatitis).
• If you have skin reaction signs such as skin rash, blisters, redness, itching, swelling of the face, eyelids, and lips.
• If you experience skin swelling, difficulty breathing, dizziness (signs of a severe allergic reaction).
• If you experience bleeding or bruising more easily than usual (signs of a decrease in blood platelet count).
• If you experience red or purple skin lesions (signs of blood vessel inflammation).
• If you experience a skin rash with red patches mainly on the face that may be accompanied by fatigue, fever, nausea, loss of appetite (signs of lupus erythematosus-like reaction).
• If you experience intense pain in the upper abdomen (signs of pancreatitis).

If you experience any of these side effects, inform your doctor immediately.

Other side effects: inform your doctor if you are concerned.

Frequent (affecting up to 1 in 10 people):

Difficulty sleeping, headache, stomach discomfort, abdominal pain, nausea, altered muscle and liver parameters in blood tests.

Rare (affecting up to 1 in 10,000 people):

• Tickling or numbness in the hands or feet, altered or decreased sensitivity.

Frequency not known (cannot be estimated from available data):

• Impotence, constant muscle weakness,respiratory problems including persistent cough and/or difficulty breathing or fever..
• Dyspepsia.
• • Myasthenia gravis (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing).
  • Myasthenia ocular (a disease that causes weakness of the eye muscles).

Consult your doctor if you experience weakness in the arms or legs that worsens after periods of activity, double vision or eyelid drooping, difficulty swallowing or difficulty breathing.

Possible side effects:

If you consider any of the side effects you experience to be severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not store at a temperature above 30°C.

Blister packs: store in the original packaging to protect from light.

Bottle for tablets (glass bottle and HDPE): store the sealed container to protect from moisture and light.

Do not usethis medicationafter the expiration date that appears on the blister pack and on the carton after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointat the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Fluvastatina Aurovitas Spain

• The active ingredient is fluvastatin sodium.

Each Fluvastatina Aurovitas Spain tablet contains 84.48 mg of fluvastatin sodium equivalent to 80 mg of fluvastatin base.

• The other components are:

Tablet core:povidone, microcrystalline cellulose, hydroxyethylcellulose, mannitol (E-421), magnesium stearate.

Tablet coating:hypromellose 50, macrogol 6000, yellow iron oxide (E172), titanium dioxide (E171).

Appearance of the product and content of the container

Fluvastatina Aurovitas Spain are prolonged-release biconvex, round, yellow tablets.

Container sizes:

Blister (OPA/Aluminum/PVC-Aluminum): 10, 20, 28, 30, 50, 60, 98, and 100 prolonged-release tablets.

HDPE bottle with desiccant and easy-open cap (LDPE) and integrated safety ring. Container sizes of 250 prolonged-release tablets.

Glass bottle with desiccant and HDPE cap: 250 prolonged-release tablets.

Only some container sizes may be commercially marketed.

Marketing authorization holder and responsible manufacturer:

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer

Generis Farmacêutica, S.A.

Rua João de Deus, 19 2700-487

Amadora, Portugal.

Or

Merckle GmbH

Ludwig Merckle-Strasse 3, 89143

Blaubeuren (Germany)

Last review date of this leaflet: May 2023

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