Package Leaflet: Information for the User

Digaril 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, consult 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.

1. What Digaril Prolib is and what it is used for

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

3. How to take Digaril Prolib

4. Possible side effects

5. Storage of Digaril Prolib

6. Contents of the pack and additional information

Digaril Prolibcontains the active ingredient fluvastatin sodium, 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.

• Digaril Prolibis 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 prescribeDigaril Prolibfor 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 Digaril 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 Digaril Prolib, read the following clarifications.

Do not take Digaril Prolib

-if you are allergic (hypersensitive) to fluvastatin or to any of the other components of this medication (including those listed in section 6).

-if you have liver problems, or if you present a persistent and unknown 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 Digaril Prolib and consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Digaril Prolib.

-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 Digaril 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 with Digaril Prolib, 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 experienced muscle problems with another lipid-lowering medication.

-if you habitually consume 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 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, obesity, and high blood pressure.

Check with your doctor or pharmacist before taking Digaril Prolib:

• if you have severe respiratory failure

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

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

Digaril Prolib 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

Digaril Prolib 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 fluvastatin in combination with nicotinic acid, cholestyramine, or fibrates in children and adolescents.

Taking Digaril 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.

Digaril Prolib can be taken alone or with other medications to lower cholesterol that your doctor prescribes.

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

After taking a resin, for example, cholestyramine (used mainly to treat high cholesterol), wait at least 4 hours before taking Digaril Prolib.

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).

-Fenitoin (a medication used to treat epilepsy).

-Oral anticoagulants such as warfarin (medications used to reduce blood clotting).

-Glibenclamide (a medication used to treat diabetes).

-Colchicine (used to treat gout)

Pregnancy and breastfeeding

Do not take Digaril Prolib if 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 with Digaril Prolib.

If you become pregnant while taking this medication, stop taking Digaril Prolib and consult your doctor.

Your doctor will discuss the potential risk of taking Digaril Prolib during pregnancy.

Driving and operating machinery

There is no information on the effects of Digaril Prolib on the ability to drive and operate machinery.

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 takingDigarilProlib.

How much DigarilProlibto take

Usual doses in adults

The fluvastatina dosage interval 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 fluvastatina 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 fluvastatina you should take.

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

When to take DigarilProlib

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

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

If you takemore Digaril Prolibthan you should

If you have taken an accidental overdose ofDigarilProlibtablets, 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 forgot to takeDigaril Prolib

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

To maintain the benefits of your treatment, do not stop takingDigarilProlibunless your doctor tells you to.You should continue takingDigarilProlibas prescribed to maintain low levels of your "bad" cholesterol.DigarilProlib 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.

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

-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 experience skin reactions such as skin rash, blisters, redness, itching, swelling of the face, eyelids, and lips.

-If you experience 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 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 10 people):

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

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

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

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

• Impotence, persistent muscle weakness, respiratory problems including persistent cough and/or difficulty breathing or fever.
• Diarrea
• Myasthenia gravis (a disease that causes generalized muscle weakness, which 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 the 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 medication.
• Tendon inflammation, swelling, and irritation.

If you consider any of the side effects you experience to be severe or if you notice any side effect not mentioned in this prospectus, 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 prospectus. 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 medication.

• 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 Digaril 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.Deposit the containers and medications you no longer need at the SIGRE collection pointat the pharmacy. In case of doubtask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Composition ofDigaril Prolib

• The active ingredient is fluvastatin sodium

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

• The other components of Digaril Prolib 80 mg prolonged-release tablets are: microcrystalline cellulose, hypromellose, hydroxypropylcellulose, potassium hydrogen carbonate, povidone, magnesium stearate, iron oxide yellow (E172), titanium dioxide (E171), and macrogol 8000.

Appearance of DigarilProliband packaging contents

The prolonged-release tablets of Digaril Prolib 80 mg are yellow, round, slightly biconvex, with bisected 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 packaging sizes may be commercially available.

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 80 mg

Last review date of this leaflet:April 2023

For detailed and updated information on this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/