Fluvastatin Viatris 20 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Fluvastatin Viatris 20 mg hard capsules EFG

Read the entire leaflet carefully before starting to take 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

2. What you need to know before taking Fluvastatin Viatris

3. How to take Fluvastatin Viatris

4. Possible side effects

5. How to store Fluvastatin Viatris

6. Contents of the pack and other information

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

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

Fluvastatina Viatris is a medicine used to treat high levels of fats in the blood in adults, 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 blood cholesterol levels.
• In adult patients with high levels of both cholesterol and triglycerides (another type of blood lipid).

Your doctor may also prescribe fluvastatin to help prevent other serious heart problems (e.g., a heart attack) in patients who have undergone heart catheterization or a procedure on the blood vessels of the heart.

2. What you need to know before starting to take Fluvastatin Viatris

Carefully follow all instructions given to you by your doctor. These may differ from the information included in this leaflet.

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 persistent, unexplained elevations in certain liver enzymes (transaminases).
• If you are pregnant or breastfeeding (see “Pregnancy and breastfeeding”).

Warnings and precautions

Talk to your doctor or pharmacist before starting fluvastatin:

• If you have or have had myasthenia (a disease characterized by 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 have previously had liver disease. Liver function tests are usually performed before starting fluvastatin treatment, when the dose is increased, and at various intervals during treatment to monitor for adverse effects.
• If you have kidney disease.
• If you have a thyroid gland disorder (hypothyroidism).
• If you or a family member has a history of muscle disorders.
• If you have experienced muscle problems with another lipid-lowering medicine.
• If you regularly consume large amounts of alcohol.
• If you have a serious infection.
• If you have very low blood pressure (symptoms may include dizziness, vertigo).
• If you engage in excessive controlled or uncontrolled physical exercise.
• If you are about to undergo surgery.
• If you have severe metabolic, endocrine, or electrolyte disorders such as uncontrolled diabetes or low potassium levels in the blood.
• If you are taking or have taken within the last 7 days a medicine containing fusidic acid (used to treat bacterial infection) taken orally or by injection. The combination of fusidic acid and fluvastatin may cause serious muscle problems (rhabdomyolysis).

While taking this medicine, your doctor will monitor whether you have diabetes or are at risk of developing diabetes. This risk is higher 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 may perform a blood test before prescribing fluvastatin.

If during treatment with fluvastatin you experience symptoms such as nausea, vomiting, loss of appetite, yellowing of the eyes or skin, confusion, euphoria or depression, mental slowness, difficulty speaking, sleep disturbances, tremors, or easy bruising or bleeding, these may be signs of liver failure. 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 treatments may be needed to diagnose and manage this condition.

Elderly patients

If you are over 70 years of age, your doctor may want to assess whether you have risk factors for muscle disease. 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.

Fluvastatin may be taken alone or together 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:

• Cyclosporine (a medicine used to suppress the immune system).
• 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 (an antibiotic).
• 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).

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

Pregnancy and breastfeeding

Do not take fluvastatin if you are pregnant or breastfeeding, as the active substance may harm the fetus and it is unknown 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 must take appropriate precautions to avoid becoming pregnant while being treated with fluvastatin.

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

Driving and using machines

There is no information available on the effects of fluvastatin on the ability to drive or operate machinery.

3. How to take Fluvastatine Viatris

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

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

The recommended dose range for adults is 20 mg to 80 mg per day, depending on the required reduction in cholesterol levels. Your doctor may adjust your dose every 4 weeks or more.

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

Take your dose in the evening or at bedtime.

If you are taking fluvastatine twice a day, take one capsule in the morning and another in the evening or at bedtime.

Method of administration

Swallow the capsules whole with a glass of water. You may take fluvastatine with or without food.

Use in children and adolescents

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

If you take more Fluvastatine Viatris than you should

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

If you forget to take Fluvastatine 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 the next dose at the usual time.

Do not take a double dose to make up for forgotten doses.

If you stop taking Fluvastatine Viatris

To maintain the benefits of your treatment, you should not stop taking fluvastatine unless your doctor tells you to. You should continue taking fluvastatine as prescribed to maintain low levels of your "bad" cholesterol. Fluvastatine will not cure your condition but 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 medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

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

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

• If you experience unexplained muscle pain, tenderness, or weakness, especially if persistent. These may be early signs of potentially serious muscle breakdown. This can be avoided if your doctor stops your treatment with fluvastatin as soon as possible. These adverse effects have also been observed with similar medicines in this class (statins).
• If you feel unusual tiredness or fatigue, fever, yellowing of the skin or eyes, or dark-colored urine (signs of hepatitis).
• If you bleed or bruise more easily than usual (signs of a decrease in platelets, which help blood to clot).
• If you develop signs of skin reactions such as rash, blisters, redness, itching, or swelling of the face, eyelids, or lips.
• If you have skin swelling, difficulty breathing, or dizziness (signs of a severe allergic reaction).
• If you develop red or purple skin lesions (signs of inflammation of blood vessels).
• If you develop a skin rash with red spots mainly on the face, possibly accompanied by fatigue, fever, nausea, or loss of appetite (signs of a lupus-like reaction).
• If you have severe pain in the upper abdomen (signs of inflammation of the pancreas).

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

• If you experience severe signs of inflammation, swelling, or irritation of a tendon. In some cases, this may lead to tendon rupture.
• Breathing problems such as persistent cough and/or difficulty breathing or fever.
• Diabetes: you may feel very hungry, very thirsty, or pass large amounts of urine. This is more likely if you have high levels of sugar and fats in your blood, are overweight, or have high blood pressure. Your doctor will monitor you while you are taking this medicine.
• Myasthenia gravis (a condition causing generalized muscle weakness, which in some cases affects the muscles used for breathing).
• Ocular myasthenia (a condition causing 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 drooping eyelids, difficulty swallowing, or difficulty breathing.

If you experience any of these adverse effects, inform your doctor immediately.

Other possible adverse 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 related to muscle and liver function.

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

• Tingling or numbness in the hands or feet.
• Altered or decreased sensation.

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

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

Reporting of adverse effects

If you experience any type of 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 through the Spanish Pharmacovigilance System for Human Medicines: 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.

Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and other information

Composition of Fluvastatin Viatris

• The active substance is sodium fluvastatin.

Each capsule contains 21.95 mg of sodium fluvastatin, equivalent to 20 mg of fluvastatin.

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

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

Appearance of the product and contents of the pack

Fluvastatin Viatris 20 mg capsules are pale yellow in colour, marked with 'FL 20' on the body and 'G' on the cap.

Fluvastatin Viatris 20 mg hard capsules are available in blisters of 10, 14, 15, 28, 30, 50, 56, 98, 100, 500 and multi-packs containing 98 capsules, included in 2 packs of 49 capsules.

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

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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

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

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

Denmark: Fluvamyl
Spain: Fluvastatina Viatris 20 mg hard capsules EFG
Finland: Fluvastatin Mylan
Portugal: Fluvastatina Mylan
United Kingdom: Fluvastatin 20 mg Hard Capsules

Date of the latest revision of this leaflet: September 2018

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