FLUVASTATIN VIATRIS 80 mg PROLONGED-RELEASE TABLETS

2. What you need to know before taking Fluvastatina Viatris

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

Read the following explanations before taking fluvastatina.

Do not take Fluvastatina Viatris:

• If you are allergic to fluvastatina 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, breastfeeding, and fertility").

If you are in any of these situations, do not take fluvastatina 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 can sometimes worsen the disease or cause myasthenia to appear (see section 4).
  • If you are taking or have taken in the last 7 days a medication containing fusidic acid (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and fluvastatina can cause serious muscle problems (rhabdomyolysis).
  • If you have previously had liver disease. Normally, your doctor will perform tests to check your liver function before starting treatment with fluvastatina, when increasing the dose, and at different intervals during treatment, to check for possible side effects.
  • If you have kidney disease.
  • If you have thyroid disease (hypothyroidism).
  • If you have a personal or family history of muscle diseases.
  • If you have had muscle problems with other cholesterol-lowering medications.
  • 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 going to undergo surgery.
  • If you have metabolic, endocrine, or electrolyte disorders, such as uncontrolled diabetes and low potassium levels in the blood.

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

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

If, during treatment with fluvastatina, 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, bruising, 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 constant muscle weakness. Additional tests and medications may be necessary 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

Fluvastatina 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 fluvastatina in combination with nicotinic acid, colestyramine, or fibrates in children and adolescents.

Taking Fluvastatina Viatris with other medications

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication, including those obtained without a prescription.

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

Fluvastatina 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 fluvastatina.

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

• Medication used to suppress the immune system (e.g., cyclosporine).
• Fibrates (e.g., 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 fluvastatina 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 or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

You must take adequate precautions (e.g., use a safe contraceptive method) to avoid becoming pregnant while taking fluvastatina.

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 fluvastatina during pregnancy.

Fertility

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

Driving and using machines

No information is available on the effects of fluvastatina on the ability to drive and use machines.

3. How to take Fluvastatina Viatris

Follow your doctor's or pharmacist's instructions for administration of this medication exactly. If in 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 to 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 Fluvastatina Viatris tablets to take. Depending on how you respond to treatment, your doctor may prescribe a higher or lower dose.

Note 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 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 recommended initial 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 Toxicology Information Service at 91 562 04 20, indicating the medication and the amount taken. You may need medical attention.

If you forget to take Fluvastatina Viatris

Take a dose as soon as you remember. However, do not take it if it is less than 4 hours before 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 interrupt 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 it will help control it. It is necessary to check your cholesterol levels regularly to monitor your progress.

If you have any further 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 experiences them.

Some side effects could be serious. If you think you have any of the following side effects, stop taking this medication and inform your doctor immediately or go to the emergency department of the nearest hospital.

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

• If you have unexplained muscle pain, sensitivity, or weakness (rhabdomyolysis), especially if it is constant. These can be early signs of potentially severe muscle degradation. This can be avoided if your doctor interrupts treatment with fluvastatina as soon as possible. These side effects have also been described with other medications in the same family (statins).

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

• If you have unusual fatigue or fever, your skin or eyes are yellow, or your urine is dark (signs of hepatitis).
• If you bleed or bruise more easily than usual (signs of decreased platelet count, which helps blood clot).
• If you have red or purple skin lesions (signs of blood vessel inflammation).
• 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 reaction).
• If you have severe pain in the upper abdomen (signs of pancreatitis).
• If you have swelling of the skin, difficulty breathing, dizziness (signs of a severe allergic reaction).
• If you have signs of an allergic reaction on the skin, such as a rash, hives, red skin, itching, 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 can lead to tendon rupture.
• Respiratory problems, including persistent cough and/or difficulty breathing or fever.

• Diabetes - you may feel hungrier, thirstier, or urinate more often. 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.
• 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 your arms or legs that worsens after periods of activity, double vision, or drooping eyelids, 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 upset (e.g., indigestion, abdominal pain, nausea), abnormal blood test values for muscle and liver.

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

Numbness or tingling in hands or feet, altered or decreased sensitivity.

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

• Impotence.
• Sleep disturbances, including insomnia and nightmares.
• Memory loss.
• Sexual problems.
• Depression.
• Diarrhea.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Fluvastatina Viatris

Keep this medication out of sight and reach of children.

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

Tablet bottles (glass and plastic bottles): keep the container tightly closed to protect it from light and moisture.

Do not store above 30°C.

Do not use this medication after the expiration date stated on the blister pack, packaging, and bottle, after the EXP date. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Place the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medication. This will help protect the environment.

6. Container Contents and Additional Information

Composition of Fluvastatina Viatris

• The active ingredient is: fluvastatina. Each prolonged-release tablet contains 80 mg of fluvastatina (as fluvastatina 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 and Container Contents of the Product

Fluvastatina Viatris 80 mg are prolonged-release, biconvex, round, and yellow tablets and are available in:

Blister pack (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 tamper-evident ring: 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 pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer:

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 under the following names:

Spain Fluvastatina Viatris 80 mg prolonged-release tablets EFG

Finland Fluvastatin Mylan 80 mg depot tablets

France Fluvastatine Mylan LP 80 mg, film-coated prolonged-release tablet

Italy Fluvastatina Mylan Generics

Netherlands Fluvastatine Retard Mylan 80 mg, prolonged-release tablets

Portugal Fluvastatina Mylan 80 mg prolonged-release tablets

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

Date of the last revision of this leaflet:March 2023

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