FLUVASTATIN ALTER 80 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the Patient

Fluvastatin Alter 80 mg prolonged-release tablets EFG

Fluvastatin Sodium

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Fluvastatin Alter and what is it used for
2. What you need to know before taking Fluvastatin Alter
3. How to take Fluvastatin Alter
4. Possible side effects
5. Storage of Fluvastatin Alter
6. Additional information

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

Fluvastatin Alter contains the active ingredient fluvastatin sodium, which belongs to a group of medications known as statins, used to reduce lipid levels: they decrease blood fat (lipids). They are used in patients whose condition cannot be controlled solely with diet and exercise.

• Fluvastatin Alter is a medication used to treat high levels of fat 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 blood cholesterol levels.
• in adult patients with high levels of both cholesterol and triglycerides (another type of lipid) in the blood.

• Your doctor may also prescribe Fluvastatin Alter to prevent other serious heart problems (e.g., a heart attack) in patients after undergoing heart catheterization through an intervention in the heart vessels.

2. What you need to know before taking Fluvastatin Alter

Follow your doctor's instructions for administering this medication carefully. They may be different from the information included in this package leaflet.

Before taking Fluvastatin Alter, read the following clarifications.

Do not take Fluvastatin Alter

• if you are allergic to fluvastatin or any of the other components of this medication (listed in section 6).
• if you have liver problems or present an unexplained and persistent elevation of certain liver enzyme levels (transaminases).
• if you are pregnant or breastfeeding (see "Pregnancy and Breastfeeding").

If you are in any of these situations, do not take Fluvastatin Alter and consult your doctor.

Warnings and precautions

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

Be particularly careful:

• if you have previously suffered from liver disease. Normally, you will undergo liver function tests before starting treatment with Fluvastatin Alter, when the dose is increased, and at different time intervals throughout treatment to monitor the appearance of side 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 regularly drink large amounts of alcohol.
• if you have a severe infection.
• if you have very low blood pressure (symptoms 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 have or have had myasthenia (a disease that causes 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 worsen the disease or cause myasthenia to appear (see section 4).

Check with your doctor or pharmacist before taking Fluvastatin Alter:

• If you are taking or have taken in the last 7 days a medication containing fusidic acid (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and Fluvastatina Alter can cause serious muscle problems (rhabdomyolysis).
• if you have severe respiratory failure.

While you are taking this medication, your doctor will monitor whether you have diabetes or are at risk of developing diabetes. This risk of diabetes increases if you have high levels of sugars and fats in the blood, are overweight, and have high blood pressure.

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.

If you are 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, 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.

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

Fluvastatin has not been investigated and is not indicated in children under 9 years old. For information on dosing 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 recently taken, or may need to take any other medication.

• If you need to take oral fusidic acid to treat a bacterial infection, you will have 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 can cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Fluvastatina Alter can be taken alone or with other cholesterol-lowering medications prescribed by your doctor.

After taking a resin, e.g., cholestyramine (mainly used 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:

• Cyclosporine (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 can cause harm to the fetus and it is not known if it is excreted in breast milk. If you are pregnant, consult your doctor or pharmacist before taking Fluvastatina Alter. You should take adequate precautions to avoid becoming pregnant while receiving treatment with Fluvastatina Alter.

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

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

Driving and using machines

There is no information available on the effects of Fluvastatina Alter on the ability to drive and use machines.

3. How to take Fluvastatina Alter

Follow your doctor's instructions for administering this medication exactly. If you are unsure, 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 Fluvastatina Alter.

How much Fluvastatina Alter to take

• The dosage 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 at intervals of 4 weeks or more.
• In children (9 years old and older), the initial dose is normally 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 Fluvastatina Alter tablets to take.

Depending on how you respond 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 time of day.

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

If you take more Fluvastatina Alter than you should

If you have accidentally taken too much Fluvastatina Alter, inform your doctor immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medication and the amount ingested. You may need medical attention.

If you forget to take Fluvastatina Alter

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 interrupt treatment with Fluvastatina Alter

To maintain the benefits of your treatment, do not stop taking Fluvastatina Alter unless your doctor tells you to. You should continue taking Fluvastatina Alter as prescribed to maintain low levels of "bad" cholesterol. Fluvastatina Alter will not cure your disease, but it will help control it. It is necessary to check your cholesterol levels regularly to monitor your progress.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences 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 attention immediately.

• if you suffer from unexplained muscle pain, sensitivity, or weakness. These can be early signs of potentially severe muscle degradation. 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 medications of this class (statins).
• if you suffer from unusual fatigue or fever, yellowing of the skin and eyes, dark urine (signs of hepatitis).
• 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 bleeding or bruising more easily than usual (signs of a decrease in blood platelet count).
• if you have red or purple skin lesions (signs of blood vessel inflammation).
• if you have a skin rash with red spots mainly on the face, which can 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).

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 people):

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

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 (frequency cannot be estimated from available data):

Impotence, constant muscle weakness, diarrhea, severe myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing), 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 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
• Diabetes. This is more likely if you have high levels of sugars and fats in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medication.
• Tendon inflammation, swelling, and irritation.

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Fluvastatina Alter

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

Do not store above 30°C.

Keep in the original packaging to protect it from moisture.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE Point in your usual pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Additional information

Composition of Fluvastatina Alter

• The active ingredient is fluvastatin sodium

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

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

Appearance of the product and packaging content

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

Packaging sizes: Blister containing 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid (Spain)

Manufacturer

Pharmathen S.A.,

6 Dervenakion Str,

153 51 Pallini, Attiki (Greece)

Date of the last revision of this package leaflet: May 2023

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