FLUVASTATIN VIATRIS 40 mg HARD CAPSULES

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

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

Do not take Viatris Fluvastatin:

• If you are allergic to fluvastatin or any of the other ingredients of this medicine (listed in section 6).
• If you have liver problems or have elevated liver enzymes (transaminases) of unknown cause and persistent.
• If you are pregnant or breastfeeding (see "Pregnancy and breastfeeding").

Warnings and precautions

Consult your doctor or pharmacist before starting to take fluvastatin:

• If you have or have had myasthenia (a disease characterized by 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 exacerbate the disease or cause myasthenia (see section 4).
• If you have previously had liver disease. Normally, your doctor will perform liver function tests before starting treatment with fluvastatin, when the dose is increased, and at different time intervals during treatment to monitor the occurrence of side effects.
• If you have kidney disease.
• If you have 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 medicine.
• If you regularly drink large amounts of alcohol.
• If you have a severe infection.
• If you have very low blood pressure (signs may include dizziness, vertigo).
• If you engage in excessive controlled or uncontrolled muscle exercise.
• If you are going to undergo surgery soon.
• If you have severe metabolic, endocrine, or electrolyte disorders, such as uncompensated diabetes and low blood potassium levels.
• If you are taking or have taken in the last 7 days a medicine that contains fusidic acid (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and fluvastatin can cause serious muscle problems (rhabdomyolysis).

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

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

If during treatment with fluvastatin 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 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 constant muscle weakness. Additional tests and medications may be necessary to diagnose and treat this problem.

Elderly patients

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 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, colestyramine, or fibrates in children and adolescents.

Taking Viatris Fluvastatin with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

After taking a resin, e.g., colestyramine (mainly used to treat high cholesterol), wait at least 4 hours before taking fluvastatin.

Tell 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 "bad" cholesterol levels).
• 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 will need to stop using this medicine. Your doctor will tell you when you can restart treatment with fluvastatin. The use of fluvastatin 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 fluvastatin if you are pregnant or breastfeeding, as the active substance may harm 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 medicine.

You should take adequate precautions to avoid becoming pregnant while receiving treatment with fluvastatin.

If you become pregnant while taking this medicine, 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

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

3. How to take Viatris Fluvastatin

Follow exactly the administration instructions of this medicine given to you by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

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

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

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

Take your dose at night or before bedtime.

If you are taking fluvastatin twice a day, take one capsule in the morning and one at night or before bedtime.

Method of administration

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

Use in children and adolescents

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

If you take more Viatris Fluvastatin than you should

If you have taken too much fluvastatin by mistake, inform your doctor immediately or call the Toxicology Information Service telephone 91 562 04 20, indicating the medicine and the amount taken. You may need medical attention.

If you forget to take Viatris Fluvastatin

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 stop taking Viatris Fluvastatin

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 keep your "bad" cholesterol levels low. Fluvastatin 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 on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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

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

• If you experience severe signs of tendon inflammation, swelling, or irritation. In some cases, this may be due to 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 levels of sugar and fat in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.
• Severe myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing).
• Severe ocular myasthenia (a disease that causes 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 breathing.

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

Other possible side effects:

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

• Difficulty sleeping.
• Headache.
• Stomach upset, e.g., indigestion.
• Abdominal pain.
• Nausea (discomfort).
• Altered blood parameters for muscle and liver.

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

• Numbness or tingling of the hands or feet.
• Altered or decreased sensitivity.

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

• Impotence.

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency through the website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Viatris Fluvastatin

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

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

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

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to the pharmacy. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Viatris Fluvastatin

• The active substance is fluvastatin sodium.

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

• The other ingredients are: cornstarch, 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 pack contents

Viatris Fluvastatin 40 mg capsules are red, marked with 'FL 40' on the body and 'G' on the cap.

Viatris Fluvastatin 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.

Not all 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

You can request more information about this medicine from 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:

Denmark:Fluvamyl

Spain:Fluvastatina Viatris 40 mg hard capsules EFG

Finland:Fluvastatin Mylan

Portugal:Fluvastatina Mylan

United Kingdom:Fluvastatin 40 mg Hard Capsules

Date of the last revision of this leaflet:September 2018

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