Patient Information Leaflet: Package Insert

Fluvastatina Viatris 40 mg Hard Capsules EFG

Read this 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. Do not give it to others even if they have similar 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 leaflet. 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 with diet and exercise.

Fluvastatina Viatrisis a medicine that is usedto treat high levels of fats in the blood in adults, in particular, 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, both of cholesterol and triglycerides (another type of lipid in the blood).

Yourdoctor,may also prescribefluvastatinafor the prevention of other serious heart problems (e.g. a heart attack) in patients who have undergone a heart catheterization through an intervention in the heart vessels.

Follow carefully all the instructions given to you by your doctor. These may be different from the information included in this prospectus.

Do not take Fluvastatina Viatris:

• If you are allergic to fluvastatina or to any of the other components of this medication (listed in section 6).
• If you have liver problems, or present an elevation of unknown and persistent levels of certain liver enzymes (transaminases).
• If you are pregnant or breastfeeding (see “Pregnancy and breastfeeding”).

Warnings and precautions

Consult your doctor or pharmacist before starting to take fluvastatina:

• If you have or have had myasthenia (a disease that runs with generalized muscle weakness that, in some cases, affects the muscles used to breathe) or myasthenia ocular (a disease that causes weakness of the eye muscles), as statins sometimes can worsen the disease or cause myasthenia (see section 4).
• If you have previously had liver disease. Normally, blood tests will be performed to check liver function before starting treatment with fluvastatina, when the dose is increased, and at different intervals during treatment to monitor the appearance of adverse effects.
• If you have kidney disease.
• If you have a 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 habitually drink large amounts of alcohol.
• If you have a severe infection.
• If you have very low blood pressure (the symptoms may include dizziness, vertigo).
• If you engage in excessive controlled or uncontrolled muscle exercise.
• If you are about to undergo surgery.
• If you have severe metabolic, endocrine, or electrolyte disorders such as uncontrolled diabetes and low blood potassium levels.
• 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 fluvastatina can cause severe muscle problems (rhabdomyolysis).

While you are taking this medication, your doctor will monitor if you have diabetes or are at risk of developing diabetes. This risk of diabetes 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 taking fluvastatina. Your doctor will perform a blood test before prescribing fluvastatina.

If during treatment with fluvastatina you experience symptoms or signs such as nausea, vomiting, loss of appetite, yellowing of the eyes and skin, confusion, euphoria or depression, mental slowness, difficulty speaking, sleep disturbances, tremors, or easy bruising or bleeding, these may be signs of liver insufficiency. In this case, contact your doctor immediately.

If you develop respiratory problems such as persistent cough, difficulty breathing, or fever, contact your doctor.

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

Patients 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 or indicated in children under 9 years old. For information on dosing in children over 9 years old and adolescents, see section 3.

No experience has been reported on the use of fluvastatina in combination with nicotinic acid, cholestyramine, or fibrates, in children and adolescents.

Fluvastatina Viatris with other medications

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

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

After taking a resin, for example, cholestyramine (used mainly 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:

• Ciclosporin (a medication used to suppress the immune system).
• 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 (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 stop taking this medication. Your doctor will indicate 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.

Pregnancy and breastfeeding

Do not take fluvastatina if you are pregnant or breastfeeding, as the active ingredient can cause damage to the fetus and it is not known if it is eliminated through breast milk.

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

You will need to take the necessary precautions to avoid becoming pregnant while receiving treatment with fluvastatina.

If you become pregnant while taking this medication, stop taking fluvastatina and consult your doctor. Your doctor will discuss the potential risk of taking fluvastatina during pregnancy.

Driving and operating machinery

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

The recommended dosage interval for adults ranges from 20 mg to 80 mg per day and depends on the reduction of cholesterol levels needed. Your doctor may adjust your dosage every 4 weeks or more.

Your doctor will inform you exactly how many Fluvastatina Viatris capsules you should take. Depending on your response to treatment, your doctor may prescribe a higher or lower dosage.

Take your dose at night or before going to bed.

If you are taking fluvastatina twice a day, take one capsule in the morning and another at night or before going to bed.

Administration Form

Swallow the capsules whole with a glass of water. You can take fluvastatina with or without food.

Use in Children and Adolescents

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

If You Take MoreFluvastatina ViatrisThan You Should

If you have taken too much fluvastatina accidentally, 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 Forget to TakeFluvastatina Viatris

Take a dose as soon as you remember. However, do not take it if less than 4 hours remain before 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 Treatment withFluvastatina 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 check your cholesterol levels regularly 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 can cause side effects, although not everyone will experience them.

Some side effects can 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 nearest emergency service.

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

• If you experience unexplained muscle pain, sensitivity, or weakness, especially if it is persistent. These may be early signs of a potentially severe muscle degradation. This can be prevented 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 experience unusual fatigue or fever, yellow skin and eyes, dark urine (signs of hepatitis).
• If you bleed or bruise more easily (signs of a decrease in platelet count, which helps blood clotting).
• If you have skin reactions 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).
• If you have red or purple skin lesions (signs of blood vessel inflammation).
• 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 lupus erythematosus-like reaction).
• If you experience severe upper stomach pain (signs of pancreatitis).

Frequency unknown (cannot be estimated from available data):

• If you experience severe inflammation, swelling, or irritation of a tendon. In some cases, this may be due to a tendon rupture.
• Respiratory problems such as persistent cough and/or difficulty breathing or fever.
• Diabetes: you may feel hungry, very thirsty, or urinate in large amounts. This is more likely if you have high blood sugar and fat levels, obesity, and 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 these 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 (discomfort).

-Blood parameters altered for muscle and liver.

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

-Numbness or tingling in the hands or feet.

-Altered or decreased sensitivity.

Frequency unknown (cannot be estimated from available data):

• Impotence.

• Changes in sleep, including insomnia and nightmares.
• Memory loss.
• Sexual problems.
• Depression.
• Diarrhea.

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 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.

Do not use this medication after the expiration date that appears on the box and the blister pack after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C. Store in the original packaging to protect it from moisture.

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

Composition ofFluvastatina Viatris

• The active ingredient is fluvastatin sodium.

Each capsule contains 43.90 mg of fluvastatin sodium equivalent to 40 mg of fluvastatin.

• The other components are: maize starch, crospovidone, talc, magnesium stearate.

Hard gelatin capsule: iron oxide, titanium dioxide, water, and gelatin, and the printed ink contains iron oxide and varnish.

Appearance of the product and contents of the pack

Fluvastatina Viatris 40 mg capsules are red in color, marked with ‘FL 40’ on the body and ‘G’ on the cap.

Fluvastatina Viatris 40 mg capsules are available in blisters of 10, 14, 15, 28, 30, 50, 56, 98, 100, 500, and multi-packs containing 98 capsules, including 2 packs of 49 capsules.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible Manufacturers

McDermott Laboratories Ltd. t/a Gerard Laboratories

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

Ireland

or

Mylan Hungary Kft.

H-2900, Komárom

Mylan utca 1

Hungary

You can request more information about this medicine by contacting 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 with the following names:

Denmark:Fluvamyl

Spain:Fluvastatina Viatris 40 mg hard capsules EFG

Finland:Fluvastatin Mylan

Portugal:Fluvastatina Mylan

United Kingdom:Fluvastatin 40 mg Hard Capsules

Last review date of this leaflet:September 2018

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