Package Leaflet: Information for the User

Fluvastatin cinfa 80 mg prolonged-release tablets 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 pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start taking Fluvastatin cinfaFluvastatin cinfa

3. How to take Fluvastatin cinfa

4. Possible side effects

5. Storage of Fluvastatin cinfa

6. Contents of the pack and additional information

Fluvastatinacinfa contains the active ingredient fluvastatina sódica 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 cinfa is a medicine that is usedto treat high levels of fats in the blood of 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 of both cholesterol and triglycerides (another type of lipid) in the blood.

• Your doctor may also prescribe fluvastatina for the prevention of other serious heart problems (e.g. a heart attack) in patients who have already undergone a heart catheterization through an intervention in the heart vessels.

If you have any doubts about how fluvastatina works or why your doctor has prescribed this medicine for you, consult your doctor.

Follow carefully all the instructions given to you by your doctor, even if they differ from the general information included in this prospectus.

Before taking Fluvastatina cinfa, read the following clarifications.

Do not takeFluvastatina cinfa

• if you are allergic to fluvastatina or to any of the other components of this medication (included in section 6).
• if you have liver problems, or present an unknown and persistent elevation 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 and consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Fluvastatina cinfa:

• if you are taking or have taken in the last 7 days a medication containing fusidic acid, (used for the treatment of bacterial infection) by oral or injection route. The combination of fusidic acid and fluvastatina may produce severe muscle problems (rhabdomyolysis).
• if you have had a previous liver disease. Normally, your doctor will perform liver function controls before starting treatment with fluvastatina cinfa, when increasing the dose and at different intervals of time during treatment to control 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 signs 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 have or have had myasthenia (a disease that presents with generalized muscle weakness that, in some cases, affects the muscles used for breathing) or myasthenia gravis (a disease that causes weakness of the eye muscles), as statins may sometimes worsen the disease or cause myasthenia (see section 4).

While you are taking this medication, your doctor will check 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.

Check with your doctor or pharmacist before takingFluvastatina cinfa:

• 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.

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.

If during treatment with fluvastatina you experience symptoms or signs 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 insufficiency. In this case, contact your doctor immediately.

Fluvastatina cinfaand 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.

Children and 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 of the use of fluvastatina in combination with nicotinic acid, cholestyramine, or fibrates in children and adolescents.

Taking fluvastatina cinfa 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.

If you need 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. The use of fluvastatina with fusidic acid may produce muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Inform your doctor and 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, or bile acid sequestrants (medications used to lower bad cholesterol levels).
• Fluconazol (a medication used to treat fungal infections).
• Rifampicina (an antibiotic).
• Fenitoína (a medication used to treat epilepsy).
• Oral anticoagulants such as warfarin (medications used to reduce blood clots).
• Glibenclamida (a medication used to treat diabetes).
• Colchicina (used to treat gout)

Takingfluvastatina cinfawith food and drinks

You can take Fluvastatina cinfa with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

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. You should 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 machines

There is no information on the effects of fluvastatina on the ability to drive and operate machines.

Fluvastatina cinfa contains sodium.This medication contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially“sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. 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 fluvastatin.

How much Fluvastatin cinfa should be taken

Recommended doses in adults

• The dosage interval of fluvastatin 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.

Use in children and adolescents

• In children (9 years of age and older), the usual initial 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.

Your doctor will inform you exactly how much fluvastatin you should take.

Depending on your response to treatment, your doctor may prescribe a higher or lower dose.

When to take Fluvastatin cinfa

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

Fluvastatin can be taken with or without food. Swallow it whole with a glass of water.

If you take moreFluvastatin cinfathan you should

In case of overdose or accidental ingestion, 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 takeFluvastatin cinfa

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 the treatment withFluvastatina cinfa

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 disease but will help 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.

Rare or very rare side effects(may affect up to 1 in 1,000 patients)could be serious: seek medical help immediately.

• If you experience unexplained muscle pain, sensitivity, or weakness. These may be early signs of a potentially severe 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 usual (signs of a decrease in blood platelet count).
• If you experience red or purple skin lesions (signs of blood vessel inflammation).
• If you experience a skin rash with red patches mainly on the face that may be accompanied by fatigue, fever, nausea, loss of appetite (signs of lupus erythematosus-like reaction).
• If you experience intense 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.

Frequent (may affect up to 1 in 10 patients):

Difficulty sleeping, headache, stomach discomfort, abdominal pain, nausea, altered muscle and liver parameters in blood tests.

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

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

Unknown frequency (cannot be estimated from available data):

Impotence, constant muscle weakness, respiratory problems including persistent cough and/or difficulty breathing or fever, diarrhea.

Severe myasthenia (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, eyelid drooping, difficulty swallowing, or difficulty breathing.

Other possible side effects:

• Sleep disturbances, including insomnia and nightmares
• Memory loss
• Sexual problems
• Depression
• Diabetes. It 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.
• Tendon inflammation, swelling, and irritation.

Reporting 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 store at a temperature above 30°C.

Do not use this medication after 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.Deposit the packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubtask your pharmacist how to dispose of the packaging and medicines you no longer need.By doing so, you will help protect the environment.

Composition ofFluvastatina cinfa

• The active ingredient is fluvastatin sodium.

Each prolonged-release tablet of Fluvastatina cinfa of80 mgcontains 84.48 mg of fluvastatin sodium equivalent to 80 mg of fluvastatin base.

The other componentsare: povidone, microcrystalline cellulose, hydroxyethyl cellulose, mannitol (E-421), magnesium stearate, hypromellose 50, macrogol 6000, yellow iron oxide (E-172) and titanium dioxide (E-171).

Appearance of the product and contents of the packaging

Fluvastatina cinfais presented in the form of prolonged-release tablets,yellow in color, round and biconvex.

Fluvastatina cinfa80 mg tabletsare available in a blister pack of 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Cinfa Laboratories, S.A.

Olaz-Chipi Road, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Responsible for manufacturing

Cinfa Laboratories, S.A.

Olaz-Chipi Road, 10. Areta Industrial Estate.

31620 Huarte (Navarra) - Spain

Actavis Ltd.

BLB015-016 Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

Date of the last review of this leaflet:May 2023

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/71845/P_71845.html

QR code link to:https://cima.aemps.es/cima/dochtml/p/71845/P_71845.html