Prospecto: Information for the User

Fluvastatina Teva 80 mg prolonged-release tablets EFG

fluvastatin sodium

Read this prospect carefully before starting to take the medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you personally and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is Fluvastatina Teva and for what it is used

2.What you need to know before starting to take Fluvastatina Teva

3.How to take Fluvastatina Teva

4.Possible adverse effects

5.Storage of Fluvastatina Teva

6. Contents of the package and additional information

Fluvastatina Tevacontains the active ingredient fluvastatin sodium, which belongs to a group of medicines called 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 Tevais a medicine that is usedto treat high levels of fats in the blood in adults, particularly total cholesterol and the so-called "bad" 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 fat) in the blood.

Your doctor may also prescribeFluvastatina Tevafor the prevention of other serious heart problems (e.g. a heart attack) in patients after undergoing a heart catheterization through an intervention in the heart vessels.

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

Follow carefully all the instructions given to you by your doctor, which may be different from those listed in this leaflet.

Read the following explanations before taking Fluvastatina Teva.

Do not takeFluvastatina Teva

• if you are allergic (hypersensitive) to fluvastatin or to any of the other ingredients of Fluvastatina Tevalisted in section 6.
• if you have liver problems, or if you have an unexplained and persistent elevation of certain liver enzymes (transaminases)
• if you are pregnant or breastfeeding(see “Pregnancy and lactation”).

If you find yourself in any of these situations, do not takeFluvastatina Tevaandconsult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Fluvastatina Teva.

• if you areor have taken in the last 7 days a medicine containing fusidic acid, (used for the treatment of bacterial infection) by mouth or by injection. The combination of fusidic acid and Fluvastatina Teva may cause severe muscle problems (rhabdomyolysis).
• ifyou have had previouslya liver disease. Normally, you will have blood tests to check the function of your liver before starting treatment with Fluvastatina Teva, when increasing the dose and at different intervals of time during treatment to monitor the appearance of possible adverse effects.
• if you have a kidney disease.
• if you have a thyroid disease(hypothyroidism).
• if you havepersonal or family historyof muscle diseases.
• if you have had muscle problems with another medicine to lower lipid levels
• if you regularly drinklarge quantities ofalcohol.
• if you have a serious infection.
• if you have low blood pressure (these signs may include dizziness, feeling of vertigo)
• if you engage in excessive muscle-controlled or uncontrolled exercise
• if you are about to undergo surgery
• if you have had severe metabolic, endocrine, or electrolyte disorders such as uncontrolled diabetes and low blood potassium levels.
• 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 myasthenia gravis (a disease that causes weakness of the eye muscles), as statins may sometimes worsen the disease or cause myasthenia (see section 4).

While taking this medicine, your doctor will closely monitor you if you have diabetes or are at risk of developing diabetes. You are likely to be at risk of developing diabetes if you have high blood sugar or lipid levels, are overweight, or have high blood pressure.

Check with your doctor or pharmacist before taking Fluvastatina Teva

• if you have severe respiratory failure

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

Also inform your doctor or pharmacist if you experience persistent muscle weakness. You may need additional tests and medications to diagnose and treat this problem.

If during treatment with Fluvastatina Teva, you develop symptoms or signs such as nausea, vomiting, loss of appetite, yellow eyes or skin, confusion, euphoria, depression, mental slowness, difficulty speaking, sleep disturbances, tremors, bruises or bleeding, these may be signs of liver failure. In this case, contact your doctor immediately.

Fluvastatina Teva 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.

Children/adolescents

Fluvastatina Tevahas not been investigated or indicated in children under 9 years old. For information on the dose in children over 9 years old and adolescents, see section 3.

There is no experience with the use ofFluvastatina Tevain combination with nicotinic acid, cholestyramine, or fibrates in children and adolescents.

Other medicines and Fluvastatina Teva

Inform your doctor or pharmacist if you are taking/using or have taken/recently used other medicines or may need to take/use any other medicine, even those purchased without a prescription.

• If you need to take fusidic acid orally to treat a bacterial infection, you will need to stop using this medicine. Your doctor will tell you when you can restart treatment with Fluvastatina ratiopharm. The use of Fluvastatina ratiopharm with fusidic acid may cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Fluvastatina Teva can be taken alone or with other medicines to lower cholesterol that your doctor prescribes.

After taking a resin, for example, cholestyramine (mainly used to treat high cholesterol), wait at least 4 hours before taking Fluvastatina Teva.

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

• Ciclosporin (a medicine used to suppress the immune system)
• Fibrates (for example, gemfibrozil), nicotinic acidor bile acid sequestrants (medicines used to lower bad cholesterol)
• Fluconazol (a medicine used to treat fungal infections)
• Rifampicina (an antibiotic)
• Fenitoína (a medicine used to treat epilepsy).
• Oral anticoagulants such as warfarin (medicines used to reduce blood clots)
• Glibenclamida (a medicine for diabetes)
• Colchicina (used to treat gout)

Taking Fluvastatina Teva with food and drinks

You can takeFluvastatina Tevawith or without food.

Pregnancy and Lactation

Do not takeFluvastatina Tevaif 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 or breastfeeding, consult your doctor or pharmacist before using this medicine.

Take the necessary precautions to avoid becoming pregnant while receiving treatment with Flluvastatina Teva.

If you become pregnant while taking this medicine, stop takingFluvastatina Tevaandconsult your doctor.

Your doctor will discuss with you the potential risks of taking Fluvastatina Teva during pregnancy.

Driving and operating machines

There is no information on the effects ofFluvastatina Tevaonthe ability to drive and operate machines.

Fluvastatina Teva contains Sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. 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 Teva.

How much Fluvastatina Teva should you take

Usual doses in adults

The fluvastatina dosage interval 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.

Use in children and adolescents

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 muchfluvastatinayou should take.

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

Fluvastatina Teva is only available in 80 mg prolonged-release tablets. For lower doses (20 mg and 40 mg), your doctor will prescribe other medications with fluvastatina.

When to take Fluvastatina TevaFluvastatina Teva

If you are taking Fluvastatina Teva 80 mg prolonged-release tablets EFG, you can take your dose at any time of the day.

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

If you takemoreFluvastatina Tevathan you should

If you have accidentally taken too muchFluvastatina Teva, inform your doctor 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 forgot to takeFluvastatina Teva

Take a dose as soon as you remember. However, do not take it if less than 4 hours remain until 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 the treatment withFluvastatina Teva

To maintain the benefits of your treatment, do not stop takingFluvastatina Teva unless your doctor tells you to.You should continue takingFluvastatina Tevaas prescribed to maintain low levels of your "bad" cholesterol.Fluvastatina Tevawill 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 doubts about the use of this medication, ask your doctor or pharmacist.

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

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

•if you experience unexplained muscle pain, sensitivity, or muscle weakness. These may be the first signsof a potentially severe muscle degradation. This may be prevented if your doctor interrupts your treatment with fluvastatin as soon as possible.This side effect has also been described with other medicines in the same family (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 – anaphylaxis).

•if you experience bleeding or bruising more easily than normal (signs of decreased platelet count)

•if you experience red or purple skin lesions (signs of blood vessel inflammation - vasculitis). This side effect is very rare

•if you experience a skin rash with red spots mainly on the face that may be accompanied by fatigue, fever,nausea, loss of appetite(signs of systemic lupus erythematosus-like reaction).

•if you experience severe upper stomach pain (signs of pancreatitis inflammation).

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 1 in 10 people)

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

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

Tickling or numbness of hands or feet, alteration or decrease in sensitivity.

Unknown frequency (frequency 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.

Other possible side effects:

• Alterations in sleep, including insomnia and nightmares
• Memory loss
• Sexual difficulties
• Depression
• Diabetes. This is more likely if you have had high blood sugar and fat levels, are overweight, and have high blood pressure. Your doctor will monitor you while taking this medicine.
• Tendon inflammation, swelling, and irritation.

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 appearing in this prospectus. You can also report them directly through the Spanish System for the 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 medicine.

Keep 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 it from light.

Bottle (glass and HDPE bottle):

Store the container hermetically sealed to protect it from moisture and light.

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

Medicines should not be disposed of through the drains. Dispose of the containers and medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Fluvastatina Teva

The active ingredient is fluvastatin sodium, equivalent to 80 mg of fluvastatin.

The other components are:

Tablet core:

Povidone, microcrystalline cellulose, hydroxyethylcellulose, mannitol (E421) magnesium stearate, magnesium stearate,

Tablet coating:

Hydroxypropyl methylcellulose 50, macrogol 6000, yellow iron oxide (E172), titanium dioxide (E171).

Appearance of the product and content of the packaging

Fluvastatina Teva 80 mg are prolonged-release biconvex, round, yellow tablets.

Packaging sizes:

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

Only some packaging sizes may be commercially marketed.

Marketing authorization holder and responsible manufacturer:

Marketing authorization holder:

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1st floor.

28108 Alcobendas. Madrid

Responsible manufacturer:

Actavis Ltd.

BLB015-016, Belebel Industrial Estate,

Zejtun ZTN 3000

Malta

Last review date of this leaflet: March 2023

The 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/