Patient Information Leaflet

Fluvastatin Alter 80 mg prolonged-release tablets EFG

Fluvastatin sodium

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, and you must not give it to others, even if they have the same symptoms as you, 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.

FluvastatinaAltercontains 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 with diet and exercise.

• FluvastatinaAlteris 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 Alter 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 leaflet.

Before taking Fluvastatina Alter, read the following explanations.

Do not take Fluvastatina Alter

• 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 if you 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 Alter and consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Fluvastatina Alter.

Be especially careful:

• if you have previously suffered from liver disease. Normally, your liver function will be checked before starting treatment with Fluvastatina Alter, when increasing the dose and at different intervals of time during treatment to monitor the appearance of adverse 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 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 is characterized by 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).

Check withyour doctor or pharmacistbefore taking Fluvastatina Alter:

• 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 by injection. The combination of fusidic acid and Fluvastatina Alter may produce severe muscle problems (rhabdomyolysis).
• if you have severe respiratory failure.

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, obesity, and high blood pressure.

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

If during treatment with Fluvastatina Alter you experience symptoms or signs such as nausea, vomiting, loss of appetite, yellow discoloration 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 Alter 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.

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

Taking Fluvastatina Alter with other medications

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

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

Fluvastatina Alter can only be taken with or without other medications for lowering 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 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).
• 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)

Taking Fluvastatina Alter with food and drinks

You can take Fluvastatina Alter with or without food.

Pregnancy and breastfeeding

Do not take Fluvastatina Alter 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 Alter. You should take the necessary precautions to avoid becoming pregnant while receiving treatment with Fluvastatina Alter.

If you become pregnant while taking this medication, stop taking Fluvastatina Alter and consult your doctor.

Your doctor will discuss the potential risk of taking Fluvastatina Alter during pregnancy with you.

Driving and operating machinery

There is no information on the effects of Fluvastatina Alter on the ability to drive and operate machinery.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.ayour doctor or pharmacist.Do not take a higher dose than indicated.

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

How much Fluvastatina Alter should be takenAltershould be taken

• 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 ofFluvastatinaAlteryou should take.

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

When to take Fluvastatina Alter

If you are taking Fluvastatina Alter, you can take your dose at any timeof the day.

Fluvastatina Alter can be taken with or without food. Swallow itwholewith a glass ofwater.

If you take more Fluvastatina Alter than you should

If you have accidentally takentoo muchFluvastatinaAlter, inform your doctorimmediatelyor call the Toxicology Information Service at phone 91 562 04 20, indicating the medication and the amount ingested.You may need medical attention..

If you forget to take Fluvastatina Alter

Takeone doseas soon as you remember. However, do not take it if less than 4 hours remain until 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 with Fluvastatina Alter

To maintain the benefits of your treatment, do not stop takingFluvastatina Alterunless your doctor tells you to.You should continue takingFluvastatina Alteras prescribed to maintain low levels of your "bad" cholesterol. Fluvastatina Alter 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 medicinecan causeside effects, although not everyone will experience them.

Some rare (may affect up to 1 in 1,000 people) or very rare (may affect up to 1 in 10,000 people) 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 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 medications 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 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 pain in the upper abdomen (signs of pancreatitis).

Ifyou experience anyof theseside effects, inform your doctorimmediately.

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

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

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

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

Numbnessortinglingin thehands orfeet, altered or decreased sensitivity.

Unknown frequency (frequency cannot be estimated from available data):

Impotence, constant muscle weakness, diarrhea,severe myasthenia(a disease that causes generalized muscle weakness, which 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 the 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 problemsincludingpersistent cough and/ordifficulty breathing or fever
• 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 taking this medication.
• Tendon inflammation, swelling and irritation.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist or nurse, 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 the Vigilance 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 medication.

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

Do not store above 86°F (30°C).

Store in the original packaging to protect it from humidity.

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. Dispose of the packaging and unused medications at your local SIGRE collection point. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Fluvastatina Alter

• The active ingredient is fluvastatina sodium

Each tablet contains 84.24 mg of fluvastatina sodium equivalent to 80 mg of fluvastatina base.

• The other components are: Tablet core: carrageenan, magnesium stearate. Tablet coating: hydroxypropyl cellulose, hypromellose 6cP, macrogol 8000, iron oxide yellow (E172), iron oxide red (E172), titanium dioxide (E171).

Appearance of the product and contents of the package

Fluvastatina Alter are yellow-brown, round, biconvex tablets in aluminum/aluminum blisters.

Package sizes: Blister containing 28 tablets.

Holder of the marketing authorization andmanufacturer responsible

Holder of the marketing authorization

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid (Spain)

Manufacturer responsible

Pharmathen S.A.,

6 Dervenakion Str,

153 51 Pallini, Attiki (Greece)

Last review date of this leaflet: May 2023

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