Fluvastatin Viatris 80 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Fluvastatina Viatris 80 mg prolonged-release tablets EFG

Read the entire leaflet carefully before you start taking 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, and you should not give it 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 effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

2. What you need to know before taking Fluvastatina Viatris

3. How to take Fluvastatina Viatris

4. Possible side effects

5. How to store Fluvastatina Viatris

6. Contents of the pack and other information

1. What Fluvastatin Viatris is and what it is used for

Fluvastatin Viatris contains the active substance fluvastatin sodium, which belongs to a group of medicines known as statins, used to lower lipids—these medicines reduce fat (lipids) in the blood. They are used in patients whose condition cannot be controlled by diet and exercise alone.

Fluvastatin is a medicine used in adults to treat elevated levels of fats in the blood, particularly total cholesterol and so-called "bad" cholesterol or LDL-cholesterol, which is associated with an increased 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 blood lipid).

Your doctor may also prescribe Fluvastatin Viatris to help prevent other serious heart problems (e.g., a heart attack) in patients after undergoing heart catheterization or a procedure on the heart's blood vessels.

2. What you need to know before taking Fluvastatin Viatris

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

Read the following information before taking fluvastatin.

Do not take Fluvastatin Viatris:

• If you are allergic to fluvastatin or to any of the other ingredients of this medicine (listed in section 6).
• If you have liver problems or have an unknown and persistent increase in levels 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

Talk to your doctor or pharmacist before starting to take Fluvastatin Viatris.

• If you have or have had myasthenia (a disease causing generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).
  • If you are taking or have taken within the last 7 days fusidic acid (used to treat bacterial infection) by oral or injectable route. The combination of fusidic acid and fluvastatin may cause serious muscle problems (rhabdomyolysis).
  • If you have previously had liver disease. Usually, blood tests will be performed to check your liver function before starting fluvastatin treatment, when increasing the dose, and at various intervals during treatment, to monitor for possible adverse effects.
  • If you have kidney disease.
  • If you have thyroid disease (hypothyroidism).
  • If you have personal or family history of muscle disorders.
  • If you have experienced muscle problems with other cholesterol-lowering medicines.
  • If you regularly drink large amounts of alcohol.
  • If you have a serious infection.
  • If you have very low blood pressure (symptoms may include dizziness and lightheadedness).
  • If you perform excessive controlled or uncontrolled physical exercise.
  • If you are scheduled for surgery.
  • If you have metabolic, endocrine or electrolyte disorders such as uncontrolled diabetes or low potassium levels in the blood.

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

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

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

If you experience breathing 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. Additional tests and treatments may be needed to diagnose and manage this problem.

Fluvastatin Viatris and people over 70 years of age

If you are over 70 years old, your doctor may want to check whether you have risk factors for muscle disorders. Specific blood tests may be required.

Children and adolescents

Fluvastatin has not been studied and is not indicated in children under 9 years of age. For information on dosing in children over 9 years 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 Fluvastatin Viatris with other medicines

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

If you need to take oral fusidic acid to treat a bacterial infection, you must stop using fluvastatin. Your doctor will advise you when you can restart fluvastatin treatment. Using fluvastatin together with fusidic acid may cause muscle weakness, tenderness or pain (rhabdomyolysis). For further information on rhabdomyolysis, see section 4.

Fluvastatin may be taken alone or with other cholesterol-lowering medicines prescribed by your doctor.

After taking a resin, e.g. 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 medicines:

• Medicines used to suppress the immune system (e.g. cyclosporine).
• Fibrates (e.g. gemfibrozil), nicotinic acid (niacin), or bile acid sequestrants (medicines used to lower levels of bad cholesterol).
• Fluconazole (a medicine used to treat fungal infections).
• Rifampicin or erythromycin (medicines used to treat bacterial infections).
• Phenytoin (a medicine used to treat epilepsy).
• Oral anticoagulants such as warfarin (medicines used to reduce blood clots).
• Glibenclamide (a medicine 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 substance may cause harm to the fetus and it is not known whether 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 medicine.

You should take appropriate precautions (e.g. use a reliable contraceptive method) to avoid becoming pregnant while taking fluvastatin.

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

Fertility

Animal studies showed no effects on male or female fertility.

Driving and using machines

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

3. How to take Fluvastatin Viatris

Follow exactly the instructions for the use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Do not exceed the recommended dose.

Your doctor will advise you to follow a low-cholesterol diet. Continue this diet while taking fluvastatin.

How much Fluvastatin Viatris should you take

• The recommended dose range for adults is 20 mg to 80 mg of fluvastatin per day, depending on the required reduction in cholesterol levels. Your doctor may adjust your dose at intervals of 4 weeks or longer.

Your doctor will inform you precisely how many Fluvastatin Viatris tablets you should take. Depending on your response to treatment, your doctor may prescribe a higher or lower dose.

Please note that you cannot use Fluvastatin Mylan 80 mg prolonged-release tablets for all the above-mentioned doses. Fluvastatin Viatris is only available as 80 mg prolonged-release tablets. For lower doses (20 mg and 40 mg), your doctor will prescribe other fluvastatin-containing medicines.

When to take Fluvastatin Viatris

If you are taking fluvastatin, you may take your dose at any time of day.

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

Use in children and adolescents

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

If you take more Fluvastatin Viatris than you should

If you have accidentally taken too much fluvastatin, inform your doctor immediately or call the Toxicology Information Service at 91 562 04 20, stating the medicine and the amount taken. You may require medical attention.

If you forget to take Fluvastatin Viatris

Take a dose as soon as you remember. However, do not take it if less than 4 hours remain before your next dose. In this case, take your next dose at the usual time. Do not take a double dose to make up for a missed dose.

If you stop taking Fluvastatin Viatris

To maintain the benefits of your treatment, do not stop taking fluvastatin unless your doctor tells you to. You should continue taking fluvastatin as prescribed to maintain low levels of your "bad" cholesterol. Fluvastatin will not cure your condition but will help you control it. Regular monitoring of your cholesterol levels is necessary to track your progress.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

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

• If you have muscle pain without apparent cause, tenderness, or muscle weakness (rhabdomyolysis), especially if persistent. These may be early signs of potentially severe muscle breakdown. This can be prevented if your doctor stops your treatment with fluvastatin as soon as possible. These adverse effects have also been reported with other medicines in the same class (statins).

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

• If you have unusual tiredness or fever, yellowing of the skin or eyes, or dark urine (signs of hepatitis).
• If you bleed or bruise more easily than normal (signs of reduced platelet count, which help blood to clot).
• If you develop red or purple skin lesions (signs of inflammation of blood vessels).
• If you develop a rash with red spots, mainly on the face, accompanied by fatigue, fever, nausea, or loss of appetite (signs of a systemic lupus erythematosus-type reaction).
• If you have severe pain in the upper abdomen (signs of pancreatitis).
• If you have swelling of the skin, difficulty breathing, or dizziness (signs of a severe allergic reaction).
• If you have signs of skin allergy such as rash, hives, red skin, itching, or swelling of the face, eyelids, or 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.

• Breathing problems including persistent cough and/or difficulty breathing or fever.

• Diabetes – you may feel hungrier, very thirsty, and urinate frequently. This is more likely if you have high levels of sugar and fats in your blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

• Myasthenia gravis (a disease causing generalized muscle weakness which, in some cases, affects the muscles used for breathing).

• Ocular myasthenia (a disease causing weakness of the eye muscles).

Consult your doctor if you experience worsening weakness in arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

If you experience any of the adverse effects listed above, contact your doctor immediately.

Other possible adverse effects:

Common (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):

Tingling or numbness in hands or feet, altered or reduced sensation.

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

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fluvastatin Viatris

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

Blister packs: store blisters 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 medicine after the expiry date stated on the blister, packaging, and bottle, after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Unused medicines and their containers should be taken to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fluvastatin Viatris

• The active substance 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 pack

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

Blister (OPA/Aluminium/PVC-Aluminium): 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 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 certain 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

For more information about this medicine, contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.U.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Spain: Fluvastatin Viatris 80 mg prolonged-release tablets EFG
Finland: Fluvastatin Mylan 80 mg depottabletit
France: Fluvastatine Mylan LP 80 mg, comprimé pelliculé à libération prolongée
Italy: Fluvastatina Mylan Generics
Netherlands: Fluvastatine Retard Mylan 80 mg, tabletten met verlengde afgifte
Portugal: Fluvastatina Mylan 80 mg comprimidos de libertação prolongada
United Kingdom (Northern Ireland): Pinmactil 80 mg prolonged-release tablets

Date of the most recent review of this leaflet: March 2023

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