FLUVASTATIN Aurovitas Spain 80 mg PROLONGED-RELEASE TABLETS

2. What you need to know before taking Fluvastatin Aurovitas Spain

Follow your doctor's instructions carefully. These may be different from the information included in this package leaflet.

Before taking Fluvastatin Aurovitas Spain, read the following clarifications.

Do not take Fluvastatin 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 have an unexplained and persistent elevation of certain liver enzyme levels (transaminases).
• if you are pregnant or breastfeeding (see "Pregnancy and breastfeeding").

If you are in any of these situations, do not take Fluvastatin Aurovitas Spain and consult your doctor.

Warnings and precautions

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

• if you have previously had liver disease. Normally, you will have liver function tests before starting treatment with Fluvastatin Aurovitas Spain, when the dose is increased, and at different time intervals throughout treatment to monitor the appearance of side effects.
• if you are taking or have taken in the last 7 days a medication called fusidic acid (an antibiotic) orally or by injection. The combination of fusidic acid and Fluvastatin Aurovitas Spain can lead to serious 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 can sometimes worsen the disease or cause myasthenia (see section 4).
• if you regularly drink large amounts of alcohol.
• if you have a severe infection.
• if you have very low blood pressure (signs may include dizziness, vertigo).
• if you engage in excessive controlled or uncontrolled muscle exercise.
• if you are going to undergo surgery soon.
• if you have severe metabolic, endocrine, or electrolyte disorders, such as uncontrolled diabetes and low potassium levels in the blood.

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

• Have severe respiratory failure

If you are in any of these situations, tellyour doctor before takingFluvastatin Aurovitas Spain. Your doctor will perform a blood test before prescribing Fluvastatin Aurovitas Spain.

If during treatment with Fluvastatin 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 failure. In this case, contact your doctor immediately.

While you are taking this medication, your doctor will check if you have diabetes or are at risk of developing diabetes. This risk of diabetes increases if you have high levels of sugars and fats in the blood, are overweight, and have high blood pressure.

Also, inform your doctor or pharmacist if you experience constant muscle weakness. Additional tests and medications may be necessary to diagnose and treat this problem.

Fluvastatin 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.

Fluvastatin Aurovitas Spain and children/adolescents

Fluvastatin Aurovitas Spain has not been investigated and is not 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 Fluvastatin Aurovitas Spain in combination with nicotinic acid, colestyramine, or fibrates in children and adolescents.

Other medications and Fluvastatin Aurovitas Spain

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

Fluvastatin Aurovitas Spain can be taken alone or with other cholesterol-lowering medications prescribed by your doctor.

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

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

• Cyclosporine (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 tell you when it is safe to restart treatment with Fluvastatin Aurovitas Spain. Taking fluvastatin with fusidic acid can, in rare cases, lead to muscle weakness, sensitivity, or pain (rhabdomyolysis). See more information related to rhabdomyolysis in section 4.

Taking Fluvastatin Aurovitas Spain with food and drinks

You can take Fluvastatin Aurovitas Spain with or without food.

Pregnancy and breastfeeding

Do not take Fluvastatin Aurovitas Spain if you are pregnant or breastfeeding, as the active substance may cause harm 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 Fluvastatin Aurovitas Spain. You should take adequate precautions to avoid becoming pregnant while receiving treatment with Fluvastatin Aurovitas Spain.

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

Driving and using machines

There is no information available on the effects of Fluvastatin Aurovitas Spain on the ability to drive and use machines.

Fluvastatin Aurovitas Spain contains sodium

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

3. How to take Fluvastatin Aurovitas Spain

Follow your doctor's instructions for taking this medication exactly. If you are in 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 taking Fluvastatin Aurovitas Spain.

How much Fluvastatin Aurovitas Spain to take

• The dosage range for adults is 20 mg to 80 mg 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 initial dose is usually 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 Fluvastatin Aurovitas Spain tablets to take.

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

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

When to take Fluvastatin Aurovitas Spain

You can take Fluvastatin Aurovitas Spain at any time of day.

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

If you take more Fluvastatin Aurovitas Spain than you should

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

You may need medical attention.

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

If you forget to take Fluvastatin Aurovitas Spain

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

Do not take a double dose to make up for forgotten doses.

If you stop taking Fluvastatin Aurovitas Spain

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Some rare (may affect up to 1 in 1,000 people) or very rare (may affect up to 1 in 10,000 people) side effects could be serious: seek medical attention immediately.

• if you suffer from unexplained muscle pain, sensitivity, or weakness. These can be early signs of potentially serious muscle degradation. This can be avoided if your doctor stops your treatment with fluvastatin as soon as possible. These side effects have also been observed in similar medications of this class (statins).
• if you suffer from unusual fatigue or fever, yellowing of the skin and eyes, dark urine (signs of hepatitis).
• if you have skin reactions such as rash, blisters, redness, itching, swelling of the face, eyelids, and lips.
• if you have swelling of the skin, difficulty breathing, dizziness (signs of a severe allergic reaction).
• if you have bleeding or bruising more easily than normal (signs of a decrease in the number of blood platelets).
• if you have red or purple skin lesions (signs of inflammation of blood vessels).
• if you have a skin rash with red spots mainly on the face that may be accompanied by fatigue, fever, nausea, loss of appetite (signs of a lupus-like reaction).
• if you have severe 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 (may affect up to 1 in 10 people):

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

Very rare (may affect up to 1 in 10,000 people):

• Numbness or tingling of 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.
• Diarrhea.
• • Severe myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing).
  • Ocular myasthenia (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 drooping eyelids, difficulty swallowing or difficulty breathing.

Possible side effects:

• Sleep disorders, including insomnia and nightmares.
• Memory loss.
• Sexual dysfunction.
• Depression.
• Diabetes. This is more likely if you have high levels of sugars and fats in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medication.
• Tendon inflammation, swelling, and irritation.

If you think any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this package leaflet, 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 package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Fluvastatin Aurovitas Spain

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

Do not store above 30°C.

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

Tablet bottle (glass and HDPE bottle): keep the container tightly closed to protect from moisture and light.

Do not use this medication after the expiration date shown on the blister pack and carton after EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Fluvastatina Aurovitas Spain

• The active ingredient is fluvastatina sodium.

Each Fluvastatina Aurovitas Spain tablet contains 84.48 mg of fluvastatina sodium, equivalent to 80 mg of fluvastatina 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).

Product Appearance and Package Contents

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

Package sizes:

Blister pack (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. Package sizes of 250 prolonged-release tablets.

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

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

Generis Farmacêutica, S.A.

Rua João de Deus, 19 2700-487

Amadora, Portugal.

Or

Merckle GmbH

Ludwig Merckle-Strasse 3, 89143

Blaubeuren (Germany)

Date of Last Revision of this Leaflet: May 2023

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