DIGARIL PROLIB 80 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Digaril Prolib 80 mg prolonged-release tablets

Fluvastatin

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Digaril Prolib and what is it used for
2. What you need to know before you take Digaril Prolib
3. How to take Digaril Prolib
4. Possible side effects
5. Storage of Digaril Prolib
6. Contents of the pack and other information

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

Digaril Prolib contains the active substance fluvastatin sodium, which belongs to a group of medicines known as statins, which are lipid-lowering medicines: they reduce the fat (lipids) in the blood. They are used in patients whose condition cannot be controlled by diet and exercise alone.

• Digaril Prolib is a medicine used to treat high levels of fat in the blood in adults, in particular 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 Digaril Prolib to prevent other serious heart problems (e.g. a heart attack) in patients who have already undergone a heart catheterization procedure.

If you have any doubts about how Digaril Prolib works or why it has been prescribed for you, ask your doctor.

2. What you need to know before you take Digaril Prolib

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

Before taking Digaril Prolib, read the following clarifications.

Do not take Digaril Prolib

• if you are allergic (hypersensitive) to fluvastatin or any of the other ingredients of this medicine (listed in section 6).
• if you have liver problems or have elevated liver enzymes (transaminases) of unknown cause and persist over time.
• if you are pregnant or breastfeeding (see "Pregnancy and breastfeeding").

If you are 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 medicine containing fusidic acid (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and Digaril Prolib can cause serious muscle problems (rhabdomyolysis).
• if you have had liver disease in the past. Normally, your doctor will perform liver function tests before starting treatment with Digaril Prolib, when the dose is increased, and at different time intervals during treatment to monitor the appearance of side 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 medicine.
• 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, fainting).
• 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 (see section 4).

While you are taking this medicine, your doctor will check if you have diabetes or are at risk of developing diabetes. This risk of diabetes increases if you have high levels of sugar and fat in the blood, are overweight, and have high blood pressure.

Check with your doctor or pharmacist before taking Digaril Prolib

• if you have severe respiratory failure

If you are in any of these situations, tell your doctor before takingDigaril Prolib. Your doctor will perform a blood test before prescribing Digaril Prolib.

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 during treatment with Digaril 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 failure. In this case, contact your doctor immediately.

This medicine 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 is not indicated in children under 9 years of age. For information on dosing in children over 9 years and adolescents, see section 3.

There is no experience with the use of fluvastatin in combination with nicotinic acid, colestyramine, or fibrates in children and adolescents.

Taking Digaril Prolib with other medicines

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

Digaril Prolib can be taken alone or with other cholesterol-lowering medicines prescribed by your doctor.

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

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

Tell your doctor and pharmacist if you are taking any of the following medicines:

• Cyclosporine (a medicine used to suppress the immune system).
• Fibrates (e.g., gemfibrozil), nicotinic acid, or bile acid sequestrants (medicines used to lower "bad" cholesterol levels).
• Fluconazole (a medicine used to treat fungal infections).
• Rifampicin (an antibiotic).
• Phenytoin (a medicine used to treat epilepsy).
• Oral anticoagulants such as warfarin (medicines used to reduce blood clots).
• Glibenclamide (a medicine 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 substance may harm the fetus and it is not known if it is excreted in breast milk.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. You will need to take adequate precautions to avoid becoming pregnant while receiving treatment with Digaril Prolib.

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

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

Driving and using machines

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

3. How to take Digaril Prolib

Follow exactly the administration instructions of this medicine given to you by your doctor or pharmacist. If you are in 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 Digaril Prolib.

How much Digaril Prolib to take

Usual doses in adults

The dose range 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 initial dose is usually 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 how you respond to treatment, your doctor may prescribe a higher or lower dose.

When to take Digaril Prolib

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

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

If you take more Digaril Prolib than you should

If you have accidentally taken too many Digaril Prolib tablets, inform your doctor immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount taken. You may need medical attention.

If you forget to take Digaril Prolib

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 stop taking Digaril Prolib

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 experience unexplained muscle pain, sensitivity, or weakness. These can be early signs of potentially serious muscle damage. This can be avoided if your doctor stops your treatment with fluvastatin as soon as possible. These side effects have also been observed with similar medicines in this class (statins).
• if you experience unusual tiredness, fever, yellowing of the skin and eyes, dark-colored 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 normal (signs of a decrease in the number of blood platelets).
• 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 muscle and liver parameters in blood tests.

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

Numbness or tingling in the hands or feet, altered or decreased sensitivity.

Frequency not known (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).
• 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
• Diabetes. This is more likely if you have high levels of sugar and fat in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.
• Inflammation, swelling, and irritation of a tendon.

If you experience any side effect that you think is serious or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, 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 the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Digaril Prolib

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiration date stated on the carton and blister after EXP. The expiration date is the last day of the month indicated.
• Do not store above 30°C. Store in the original packaging to protect from moisture.
• Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
• Keep Digaril Prolib tablets in the blister pack until use to protect them from moisture.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Container Content and Additional Information

Composition ofDigaril Prolib

• The active ingredient is fluvastatin sodium

Each Digaril Prolib 80 mg prolonged-release 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, yellow iron oxide (E172), titanium dioxide (E171), and macrogol 8000.

Appearanceof DigarilProliband Container Content

The Digaril Prolib 80 mg prolonged-release tablets 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 unit-dose blister pack), 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

Manufacturer

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 under the following names:

Prolonged-release tablets of 80 mg

Date of the last revision of this prospectus:April 2023

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