Package Leaflet: Information for the user

Vaditon Prolib 80 mg prolonged-release tablets

Fluvastatin

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 Vaditon Prolib and what it is used for

2. What you need to know before you start taking Vaditon Prolib

3. How to take Vaditon Prolib

4. Possible side effects

5. Storage of Vaditon Prolib

6. Contents of the pack and additional informationadditional information

Vaditon Prolibcontains the active ingredient fluvastatina sódica, which belongs to a group of medications known as statins, which are medications 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.

• VaditonProlibis a medication that is usedto treat high levels of fats in the blood of adults, particularly total cholesterol and the so-called “bad” cholesterol orLDL-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 VaditonProlibfor 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 Vaditon Prolib works or why you have been prescribed this medication, 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 Vaditon Prolib, read the following clarifications.

Do not takeVaditon Prolib

-if you are allergic (hypersensitive) to fluvastatin or to any of the other components of this medication (includingthose listed 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 takeVaditon Proliband consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to takeVaditon Prolib.

-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 Vaditon Prolib may produce severe muscle problems (rhabdomyolysis).

-if you have previously suffered from liver disease. Normally, liver function controls will be performed before starting treatment withVaditon Prolib, when increasing the dose and at different intervals of time throughout the 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 quantities 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 or uncontrolled muscle exercise.

-if you are about to undergo surgery.

-if you suffer from 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 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 may sometimes worsen the disease or cause myasthenia (see section 4).

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 lipid levels, overweight, and high blood pressure.

Check with your doctor or pharmacistbefore takingVaditon Prolib:

• if you have severe respiratory failure

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

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 Vaditon Prolib 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.

This medication contains less than 23 mg of sodium (1mmol) per prolonged-release tablet; it is essentially “sodium-free”.

Vaditon Prolib and people over 70 years oldyears

If you are over 70years old, your doctor may want to check if you have risk factors for muscle diseases. You may need specific blood tests.

Children and adolescents

Vaditon Prolibhas not been investigated or 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 offluvastatinin combination with nicotinic acid, cholestyramine or fibrates in children and adolescents.

Taking Vaditon Prolib with other medications

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medication, including those purchased without a prescription.

Vaditon Prolibcan be taken alone or with other lipid-lowering medications prescribed by your doctor.

If you need to take fusidic acid orally to treat a bacterial infection, you will need to stop using Vaditon Prolib. Your doctor will tell you when you can restart treatment with Vaditon Prolib. The use of Vaditon Prolib with fusidic acid may produce muscle weakness, sensitivity or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

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

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

• Ciclosporina (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 clotting).
• Glibenclamida (a medication used to treat diabetes).
• Colchicina (used to treat gout).

Pregnancy and breastfeeding

Do not takeVaditon Prolibif you are pregnant or breastfeeding, as the active ingredient may cause damage to the fetus and it is not known if it is excreted in breast milk.

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication. You will need to take the necessary precautions to avoid becoming pregnant while receiving treatment withVaditon Prolib.

If you become pregnant while taking this medication, you should stop takingVaditon Proliband consult your doctor.

Your doctor will discuss the potential risk of taking VaditonProlibduring pregnancy.

Driving and using machines

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

Follow exactly the administration instructions of this medication 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 takingVaditonProlib.

How much VaditonProlibto take

Usual doses in adults

The dosage interval of fluvastatin for adults is 20 mg to 80mg 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 (9years of age and older) the usual initial dose is 20mg 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 how you respond to treatment, your doctor may prescribe a higher or lower dose.

When to take VaditonProlib

If you are takingVaditon Prolib, you can take your dose at any time of the day.

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

If you take more Vaditon Prolibthan you should

If you have accidentally taken too many tablets ofVaditonProlib, inform your doctor immediatelyor call the Toxicological Information Service phone 91 562 04 20, indicating the medication and the amount taken.You may need medical attention.

If you forget to take Vaditon Prolib

Take a dose as soon as you remember. However, do not take it if less than 4hours 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 the treatment with Vaditon Prolib

To maintain the benefits of your treatment, do not stop takingVaditonProlibunless your doctor tells you to.You should continue takingVaditonProlib as prescribed to maintain low levels of your "bad" cholesterol.VaditonProlib 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 can cause side effects, although not everyone will experience them.

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

-If you experience unexplained muscle pain, sensitivity, or muscle 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 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 intense pain in the upper part of the stomach (signs of pancreatitis inflammation).

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 10people):

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

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

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

Unknown frequency (the frequencycannot be estimated from available data):

• Impotence, constant muscle weakness, respiratory problems including persistent cough and/or difficulty breathing or fever.
• Diarrea
• Myasthenia gravis (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing).
• Myasthenia ocular (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 taking this medicine.
• Tendon inflammation, swelling, and irritation.

If you consider any of the side effects you are experiencing to be severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through theSistemaEspañol de Farmacovigilancia de Medicamentos de Uso Humano: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 use this medication after the expiration date that appears on the box and the blister pack after CAD.The expiration date is the last day of the month indicated.
• Do not store at a temperature above 30°C. Store in the original packaging to protect it from moisture.
• Do not use this medication if you observe that the container is damaged or shows signs of manipulation.
• Store Vaditon Prolib tablets in the blister pack until use to protect them from moisture.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at theSIGREcollection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Composition ofVaditon Prolib

• The active ingredient is fluvastatin sodium

Each prolonged-release tablet ofVaditonProlib 80 mg contains 84.24 mg of fluvastatin sodium equivalent to 80 mg of fluvastatin base.

• The other components ofVaditonProlib80 mg prolonged-release tablets are: microcrystalline cellulose, hypromellose, hydroxypropyl cellulose, potassium hydrogen carbonate, povidone, magnesium stearate, yellow iron oxide (E172), titanium dioxide (E171), and macrogol 8000.

Appearanceof VaditonProliband contents of the package

The prolonged-release tablets ofVaditonProlib 80 mg are yellow, round, slightly biconvex, with beveled edges. On one side, they have the letters “LE”.

- Bottles: The prolonged-release tablets are presented in containers containing 28, 30, 50, 98, or 100 (2 x 50 or 1 x 100) tablets and in clinical containers of 300 (15 x 20) or 600 (30 x 20) tablets.

- Blister packs: The prolonged-release tablets are presented in containers containing 7, 14, 28 (4 x 7 or 2 x 14), 28 (in a perforated blister pack for unit dose), 30, 42, 49 (7 x 7), 56 (8 x 7), 70, 84, 90, or 98 (14 x 7 or 7 x 14) tablets and in clinical containers of 28, 56, 98, or 490 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

ETHYX PHARMACEUTICALS

19 rue Duquesne

69006 Lyon - France

Responsible for manufacturing

SIEGFRIED BARBERA S.L.

Ronda Santa Maria 158

Barbera Del Valles, 08210 - Spain

This medicinal product is authorized in theMember States of the European Economic Area withthe following names:

Prolonged-release tablets of 80mg

Last review date of this leaflet:April 2023

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