Package Insert: Information for the User

Fluvastatina Kern Pharma80 mg prolonged-release tablets EFG

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given 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 not listed in this package insert. See section 4.

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

• Fluvastatina Kern Pharmais a medicine that is usedto treat high levels of fats in the blood of adults, particularly total cholesterol and the so-called “bad” cholesterol 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 of both cholesterol and triglycerides (another type of lipid) in the blood.

Your doctor may also prescribe Fluvastatina Kern Pharma for the prevention of other serious heart problems (e.g. a heart attack) in patients after undergoing 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.

Before taking Fluvastatina Kern Pharma, read the following clarifications.

Do not takeFluvastatina Kern Pharma

• If you are allergic to fluvastatina or to any of the other components of this medication (including those 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").

If you find yourself in any of these situations, do not take Fluvastatina Kern Pharma and consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Fluvastatina Kern Pharma.

• 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 a liver disease. Normally, liver function tests will be performed before starting treatment with fluvastatina, when increasing the dose, and at different intervals during treatment to monitor the appearance of adverse effects.
• If you have a 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 medication to lower blood lipid levels.
• If you present constant muscle weakness. Further tests and additional medications may be necessary to diagnose and treat this problem.
• If you habitually drink large amounts of alcohol.
• If you are taking or have taken in the last 7 days a medication that contains fusidic acid, (used for the treatment of bacterial infection) by oral or injection route. The combination of fusidic acid and Fluvastatina Kern Pharma may produce severe muscle problems (rhabdomyolysis).

Check with your doctor or pharmacist before taking Fluvastatina Kern Pharma:

• If you have severe respiratory failure.

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

Fluvastatina Kern Pharma 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.

Fluvastatina Kern Pharma and children/adolescents

Fluvastatina has not been investigated or indicated in children under 9 years old.For information on the dose 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, cholestyramine, or fibrates, in children and adolescents.

Use of other medications

Inform your doctor or pharmacist if you are using or have used recently other medications, even those acquired without a prescription.

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

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

Inform your doctor and pharmacist if you are takingany of the following medications:

• Ciclosporin (a medication used to suppress the immune system).
• Fibrates (e.g. gemfibrozil), nicotinic acid, 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 (a medication used to treat gout).

If you have to take fusidic acid orally to treat a bacterial infection, you will have to stop using this medication. Your doctor will indicate when you can restart the treatment with Fluvastatina Kern Pharma. The use of Fluvastatina Kern Pharma with fusidic acid may produce muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Taking Fluvastatina Kern Pharma with food and drinks

You can take Fluvastatina with or without food.

Pregnancy and breastfeeding

Do not take Fluvastatina if you are pregnant or breastfeeding, as the active ingredient may cause damage to the fetus and it is not known if it is eliminated through breast milk. If you are pregnant, consult your doctor or pharmacist before taking Fluvastatina. You should take the necessary precautions to avoid becoming pregnant while receiving treatment with Fluvastatina.

If you become pregnant while taking this medication, you should stop taking fluvastatina and consult your doctor.

Driving and using machines

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

Follow exactly the administration instructions for Fluvastatina indicated by your doctor. Consult your doctor or pharmacist if you have any doubts. Do not take a higher dose than indicated.

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

How much Fluvastatina Kern Pharma you should take

• The dosage interval 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 at intervals of 4 weeks or more.
• In children (9 years of age and older), the usual 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.

Your doctor will inform you exactly how many tablets of Fluvastatina Kern Pharma you should take.

Depending on how you respond to treatment, your doctor may prescribe a higher or lower dose.

When to take Fluvastatina Kern Pharma

If you are taking Fluvastatina Kern Pharma, you can take your dose at any time of the day.

Fluvastatina Kern Pharma can be taken with or without food. Swallow it whole with a glass of water.

If you take moreFluvastatinaKern Pharmathan you should

If you have accidentally taken too muchFluvastatina, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. You may need medical attention.

If you forgot to takeFluvastatinaKern Pharma

If you forgot to take a dose, take a dose as soon as you remember. However, do not take it if less than 4 hours are left for 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 the treatment withFluvastatinaKern Pharma

To maintain the benefits of your treatment, do not stop taking Fluvastatina unless your doctor tells you to. You should continue taking Fluvastatina Kern Pharma as prescribed to maintain low levels of your "bad" cholesterol. Fluvastatina will not cure your disease but will help you control it. It is necessary to regularly check your cholesterol levels 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 may cause side effects, although not everyone will experience them.

• Very common: may affect more than 1 in 10 people,
• Common: may affect up to 1 in 10 people,
• Uncommon: may affect up to 1 in 100 people,
• Rare: may affect up to 1 in 1,000 people,
• Very rare: may affect up to 1 in 10,000 people,
• Frequency not known: the frequency cannot be estimated from the available data.

Some rare or very rare side effects could be serious: seek medical help immediately.

-If you experience unexplained muscle pain, sensitivity or weakness. These may be early signs of a potentially serious muscle degradation. This can be prevented if your doctor stops your fluvastatin treatment as soon as possible. These side effects have also been observed in similar medicines of this class (statins).

-If you experience unusual fatigue or fever, yellow skin and eyes, dark urine (signs of hepatitis).

-If you have skin reaction signs such as skin rash, blisters, redness, itching, swelling of the face, eyelids and lips.

-If you have skin swelling, difficulty breathing, dizziness (signs of a severe allergic reaction).

-If you experience bleeding or bruising more easily than normal (signs of a decrease in blood platelet count).

-If you experience skin lesions that are red or purple (signs of blood vessel inflammation).

-If you experience 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).

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

Other side effects: inform your doctor if you are concerned.

Common:

• Difficulty sleeping, headache, stomach discomfort, abdominal pain, nausea.

Very rare:

• Tickling or numbness of the hands or feet, altered or decreased sensitivity.

Frequency not known:

• Constant muscle weakness
• Diarrhea
• Myasthenia gravis (a disease that causes generalized muscle weakness that, in some cases,

affects the muscles used for breathing).

• Myasthenia gravis (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 eyelid drooping, difficulty swallowing or difficulty breathing.

Other possible side effects:

• Sleep disturbances, including insomnia and nightmares
• Memory loss
• Sexual problems
• Depression
• Respiratory problems, including persistent cough and/or difficulty breathing or fever

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of sight and reach of children.

Do not store above 30°C.

Do not usethis medicationafter the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

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

Composition ofFluvastatinaKern Pharma

• The active ingredient is fluvastatina sodium. Each tablet contains 84.48 mg of fluvastatina sodium, equivalent to 80 mg of fluvastatina base.
• The other components are: povidone, microcrystalline cellulose, hydroxyethylcellulose, mannitol (E-421), magnesium stearate, hypromellose 50, macrogol 6000, yellow iron oxide (E172) and titanium dioxide (E171).

Appearance of the product and contents of the packaging

This medicationis presented in the form of prolonged-release tablets,yellow, circular, and biconvex.

This medicationis available in a packaging (blister) of 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Responsible for manufacturing

Actavis Limited

BLB015-016 Bulebel Industrial Estate (Zejtun)

ZTN3000 Malta

Date of the last review of this leaflet: May 2023

The detailed and updated information of this medication is available on the webpage of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/