Label: Information for the Patient

Fluvastatina Viatris 80 mg Extended-Release Tablets EFG

Read this label carefully before taking this medicine, as it contains important information for you.

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

6. Contents of the pack and additional information

Fluvastatina Viatriscontains the active ingredient fluvastatina sodium, which belongs to a group of medicines known as statins, which are medicines for reducing lipids: they decrease the fat (lipids) in the blood. They are used in patients whose condition cannot be controlled solely by diet and exercise.

Fluvastatinais a medicine that is usedin adults to treat high levels of fats in the blood, particularly total cholesterol and the so-called "bad" or LDL-cholesterol, which is associated with a high risk of heart disease and stroke.

Your doctor may also prescribeFluvastatina Viatrisfor 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.

Follow all of your doctor's instructions carefully. They may differ from the general information contained in this leaflet.

Read the following explanations before taking fluvastatin.

Do not take Fluvastatina Viatris:

• If you are allergic to fluvastatin or any of the other components of this medication (including those listed in section 6).
• If you have liver problems or have an unexplained and persistent elevation of certain liver enzymes (transaminases).
• If you are pregnant or breastfeeding (see "Pregnancy, breastfeeding and fertility").

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

Warnings and precautions:

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

-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 are taking or have taken in the last 7 days a medication containing fusidic acid (used for the treatment of bacterial infections) by mouth or injection. The combination of fusidic acid and fluvastatin may cause severe muscle problems (rhabdomyolysis).
• If you have had a previous liver disease. Normally, you will be tested to check your liver function before starting treatment with fluvastatin, when increasing the dose and at different intervals during treatment, to check for any adverse effects.
• If you have any kidney disease.
• If you have any thyroid disease (hypothyroidism).
• If you have a personal or family history of muscle diseases.
• If you have had muscle problems with other medications to lower cholesterol levels.
• If you regularly drink large amounts of alcohol.
• If you have a severe infection.
• If you have very low blood pressure (these signs may include dizziness and fainting).
• If you engage in excessive controlled or uncontrolled muscle exercise.
• If you are about to undergo surgery.
• If you have metabolic, endocrine, or electrolyte disorders such as uncontrolled diabetes and low blood potassium levels.

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

If you are in any of these situations,inform your doctor before takingfluvastatin. Your doctor will perform a blood test before prescribingfluvastatin.

If during treatment with fluvastatin, you develop symptoms or signs such as nausea, vomiting, loss of appetite, yellow eyes or skin, confusion, euphoria, depression, mental slowness, speech disorders, sleep disorders, tremors, bruises or bleeding, these may be signs of liver failure. In these cases, contact your doctor immediately.

If you experience respiratory problems, including persistent cough and/or shortness of breath or fever, consult your doctor.

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.

Fluvastatina Viatris 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 and adolescents:

Fluvastatin 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 fluvastatin in combination with nicotinic acid, cholestyramine, or fibrates in children and adolescents.

Taking Fluvastatina Viatris with other medications:

Inform your doctor or pharmacistif you are taking, have taken recentlyor may need to take any other medication, including those purchased without a prescription.

If you need to take oral fusidic acid to treat a bacterial infection, you will need to stop taking fluvastatina. Your doctor will tell you when you can restart treatment with fluvastatina. The use of fluvastatin with fusidic acid may cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Fluvastatin can be taken alone or with other medications to lower cholesterol levels that your doctor prescribes.

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

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

• Medication used to suppress the immune system (for example, cyclosporine).
• Fibrates (for example, gemfibrozil), nicotinic acid (niacin)or bile acid sequestrants (medications used to lower bad cholesterol levels).
• Fluconazole (a medication used to treat fungal infections).
• Rifampicin or erythromycin (medications used to treat bacterial infections).
• 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).

Pregnancy, breastfeeding and fertility:

Do not take fluvastatin 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 or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

You will need to take the necessary precautions (for example, use a safe contraceptive method) to avoid becoming pregnant while taking fluvastatin.

If you become pregnant while taking this medication, stop taking Fluvastatina Viatris and consult your doctor. Your doctor will discuss the potential risks of taking fluvastatin during pregnancy.

Fertility:

In animal studies, no effects were observed on male and female fertility.

Driving and operating machinery:

No information is available on the effects offluvastatinon the ability to drive and operate machinery.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Do not exceed the recommended dose.

Your doctor will recommend that you follow a low-cholesterol diet. Continue with this diet while taking fluvastatina.

How much Fluvastatina Viatris should you take

• The recommended dose range for adults is 20 mg to 80 mg of fluvastatina per day and depends on the reduction of cholesterol levels needed. Your doctor may adjust your dose at intervals of 4 weeks or more.

Your doctor will inform you exactly how many tablets of Fluvastatina Viatris you should take. Depending on how you respond to treatment, your doctor may prescribe a higher or lower dose.

Be aware that you cannot use Fluvastatina Mylan 80 mg prolonged-release tablets for all the previously described doses. Fluvastatina Viatris is only available as 80 mg prolonged-release tablets. For lower doses (20 mg and 40 mg), your doctor will prescribe other medications containing fluvastatina.

When to take Fluvastatina Viatris

If you are taking fluvastatina, you can take your dose at any time of the day.

Fluvastatina can be taken with or without food. Swallow it whole with a glass of water; do not divide, chew, or crush the tablet.

Use in children and adolescents

In children (9 years of age and older), the initial recommended dose is 20 mg of fluvastatina per day. The maximum daily dose is 80 mg. Your doctor may adjust your dose at intervals of 6 weeks.

If you take more Fluvastatina Viatris than you should

If you have accidentally taken too much fluvastatina, inform your doctor immediately or call the Toxicological Information Service at phone 91 562 04 20, indicating the medication and the amount taken. You may need medical attention.

If you forgot to take Fluvastatina Viatris

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 with Fluvastatina Viatris

To maintain the benefits of your treatment, do not stop taking fluvastatina unless your doctor tells you to. You should continue taking fluvastatina as prescribed to maintain low levels of your "bad" cholesterol. Fluvastatina will not cure your disease but will help 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 side effects could be serious. If you think you have any of the following side effects, stop taking this medicine and tell your doctor immediately or go to the emergency department of the nearest hospital right away.

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

• If you have muscle pain without an apparent cause, sensitivity, or muscle weakness(rhabdomyolysis),especially if it is persistent.These may be early signs of a potentially severe muscle degradation.This can be prevented if your doctor interrupts your treatment with fluvastatin as soon as possible. These side effects have also been described with other medicines in the same family (statins).

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

• If you have unusual fatigue or fever, the skin or eyes have a yellowish color, or the urine is dark (signs of hepatitis).
• If you bleed or have bruises on the skin more easily than normal (signs of decreased platelet count, which helps blood to clot).
• If you have skin lesions with red or purple color (signs of inflammation of blood vessels).
• If you have a rash with red spots, mainly on the face, accompanied by fatigue, fever, nausea, loss of appetite (signs of systemic lupus erythematosus-like reaction).
• If you have severe upper stomach pain (signs of pancreatitis inflammation).
• If you have swelling in the skin, difficulty breathing, dizziness (signs of severe allergic reaction).
• If you have skin allergy signs such as rash, itching, redness, swelling of the face, eyelids, and lips.

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

• If you have signs of inflammation, swelling, and irritation of a tendon. In some cases, this may lead to tendon rupture.
• Respiratory problems, including persistent cough and/or difficulty breathing or fever.

• Diabetes - you may have increased hunger, excessive thirst, and urinate too much. This is more likely if you have high blood sugar and fat levels, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.
• Myasthenia gravis (a disease that causes generalized muscle weakness, which 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 your arms or legs that worsens after periods of activity, double vision, eyelid drooping, difficulty swallowing, or difficulty breathing.

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

Other possible side effects:

Frequent(may affect up to 1 in 10 people):

Difficulty sleeping, headache, stomach discomfort, e.g. indigestion, abdominal pain, nausea (feeling sick), abnormal blood test results for muscle and liver.

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

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

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

• Impotence.
• Alterations in sleep, including insomnia and nightmares.
• Memory loss.
• Sexual problems.
• Depression.
• Diarhea.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. 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 this medication out of the sight and reach of children.

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

Bottles of tablets (glass and plastic bottles): keep the container perfectly closed to protect it from light and moisture.

Do not store at a temperature above30°C.

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

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

Composition of FluvastatinViatris

• The active ingredient is: fluvastatin. Each prolonged-release tablet contains 80 mg of fluvastatin (as fluvastatin sodium).
• The other components are:

Tablet core:povidone (E1201), microcrystalline cellulose, hydroxyethylcellulose, mannitol (E421), magnesium stearate (E470b).

Tablet coating:hypromellose 50 (E464),macrogol 6000, yellow iron oxide (E172), titanium dioxide (E171).

Appearance of the product and contents of the package

FluvastatinViatris80 mg are prolonged-release biconvex, round, and yellow tablets and are available in:

Blister (OPA/Aluminum/PVC-Aluminum): 10,14, 20, 28, 30, 50, 56, 60, 90, 98, 100 or 490 prolonged-release tablets.

HDPE bottle with desiccant (Do not ingest the desiccant) and snap-on cap (LDPE) with a visible ring seal: 250 prolonged-release tablets.

Glass bottle with desiccant (Do not ingest the desiccant) and HDPE cap: 28, 98, 100, 250 or 500 prolonged-release tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible manufacturer:

McDermott Laboratories Ltd t/a Gerard Laboratories

35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13

Ireland

or

Actavis Ltd.

BLB015-016 Bulebel Industrial Estate, Zejtun ZTN3000

Malta

or

Mylan Hungary Kft.

H-2900, Komárom

Mylan utca 1

Hungary

or

Mylan S.A.S. (Meyzieu)

ZAC des Gaulnes

360 Avenue Henri Schneider

69330 Meyzieu

France

or

Mylan S.A.S. (Saint Priest)

117 Allée des Parcs

69800 Saint Priest

France

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medication is authorized in the member states of the European Economic Area with the following names:

SpainFluvastatin Viatris 80 mg prolonged-release tablets EFG

FinlandFluvastatin Mylan 80 mg depottablet

FranceFluvastatine Mylan LP 80 mg, prolonged-release tablet

ItalyFluvastatina Mylan Generics

NetherlandsFluvastatine Retard Mylan 80 mg, prolonged-release tablets

PortugalFluvastatina Mylan 80 mg prolonged-release tablets

United Kingdom(Northern Ireland)Pinmactil 80 mg prolonged-release tablets

Last review date of this leaflet:March 2023

More detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)https://www.aemps.gob.es/