Digaril ProLib 80 mg prolonged-release tablets

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Digaril Prolib 80 mg prolonged-release tablets

Fluvastatin

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Digaril Prolib contains the active substance fluvastatin sodium, which belongs to a group of medicines known as statins, which are lipid-lowering agents: they reduce 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 elevated levels of fats in the blood of adults, particularly total cholesterol and so-called "bad" cholesterol or LDL-cholesterol, which is associated with an increased 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 previously undergone heart catheterization with an intervention on the heart's blood vessels.

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

2. What you need to know before taking Digaril Prolib

Carefully follow all instructions given by your doctor, even if they differ from the general information included in this leaflet.

Before taking Digaril Prolib, read the following information.

Do not take Digaril Prolib

• if you are allergic (hypersensitive) to fluvastatin or to any of the other components of this medicine (listed in section 6).
• if you have liver problems, or have a persistent and unexplained increase in the levels of certain liver enzymes (transaminases).
• 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

Talk to your doctor or pharmacist before starting to take Digaril Prolib if:

• you are taking or have taken within the last 7 days an oral or injectable medicine containing fusidic acid (used to treat bacterial infection). The combination of fusidic acid and Digaril Prolib may cause serious muscle problems (rhabdomyolysis).
• you have previously had liver disease. Liver function tests are usually performed before starting treatment with Digaril Prolib, when the dose is increased, and at various intervals during treatment to monitor for adverse effects.
• you have kidney disease.
• you have a thyroid gland disorder (hypothyroidism).
• you have a personal or family history of muscle disorders.
• you have experienced muscle problems with another lipid-lowering medicine.
• you regularly drink large amounts of alcohol.
• you have a severe infection.
• you have very low blood pressure (symptoms may include dizziness, vertigo).
• you engage in excessive controlled or uncontrolled physical exercise.
• you are about to undergo surgery.
• you have severe metabolic, endocrine, or electrolyte disorders such as uncontrolled diabetes or low blood potassium levels.
• you have or have had myasthenia (a disease characterized by generalized muscle weakness that, in some cases, affects the muscles used for breathing) or ocular myasthenia (a condition causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).

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

Check with your doctor or pharmacist before taking Digaril Prolib:

• if you have severe respiratory insufficiency.

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

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests or treatments may be needed to diagnose and manage this condition.

If, during treatment with Digaril Prolib, you experience symptoms 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 such cases, contact your doctor immediately.

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

Digaril Prolib and elderly patients over 70 years of age

If you are over 70 years old, your doctor may want to assess whether you have risk factors for muscle disorders. Specific blood tests may be required.

Children and adolescents

Digaril Prolib has not been studied and is not indicated in children under 9 years of age. For information on dosing in children over 9 years of age 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 medicines

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

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

If you need to take oral fusidic acid to treat a bacterial infection, you must stop using Digaril Prolib. Your doctor will advise you when you can restart treatment with Digaril Prolib. Using Digaril Prolib with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For further information on rhabdomyolysis, see section 4.

After taking a resin such as 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 medicines:

• Cyclosporine (a medicine used to suppress the immune system).
• Fibrates (e.g., gemfibrozil), nicotinic acid, or bile acid sequestrants (medicines used to lower levels of bad cholesterol).
• 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 cause harm to the fetus and it is unknown whether it is excreted in breast milk.

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. You must take appropriate precautions to avoid pregnancy while being treated with Digaril Prolib.

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

Your doctor will discuss with you the potential risks of taking Digaril Prolib during pregnancy.

Driving and using machines

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

3. How to take Digaril Prolib

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again. Do not take a higher dose than prescribed.

Your doctor will recommend that you follow a low-cholesterol diet. Continue this diet while taking Digaril Prolib.

How much Digaril Prolib to take

Usual doses in adults

The fluvastatin dose range for adults is 20 mg to 80 mg per day, depending on the required reduction in cholesterol levels. Your doctor may adjust your dose at intervals of 4 weeks or longer.

Use in children and adolescents

In children (aged 9 years and older), the usual starting dose is 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 your response to treatment, your doctor may prescribe a higher or lower dose.

When to take Digaril Prolib

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

Digaril Prolib may be taken with or without food. Swallow the tablet 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 telephone number 91 562 04 20, indicating the medicine and the amount taken. You may require medical attention.

If you forget to take Digaril Prolib

Take a dose as soon as you remember. However, do not take it if less than 4 hours remain before your next dose. In this case, take the next dose at the usual time.

Do not take a double dose to make up for a missed dose.

If you stop taking Digaril Prolib

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse 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) adverse effects could be serious: seek immediate medical help if you experience any of the following:

• Unexplained muscle pain, tenderness, or weakness. These may be early signs of potentially serious muscle breakdown. This can be prevented if your doctor stops your treatment with fluvastatin as soon as possible. These adverse effects have also been observed with similar medicines in this class (statins).
• Unusual tiredness or fever, yellowing of the skin or eyes, dark-colored urine (signs of hepatitis).
• Signs of skin reactions such as rash, blistering, redness, itching, swelling of the face, eyelids, or lips.
• Skin swelling, difficulty breathing, dizziness (signs of a severe allergic reaction).
• Bleeding or bruising more easily than normal (signs of a reduced number of blood platelets).
• Red or purple skin lesions (signs of blood vessel inflammation).
• A skin rash with red spots mainly on the face, possibly accompanied by fatigue, fever, nausea, or loss of appetite (signs of a lupus-like reaction).
• Severe pain in the upper abdomen (signs of pancreatitis).

If you experience any of these adverse effects, inform your doctor immediately.

Other adverse effects: tell your doctor if you are concerned.

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

Difficulty sleeping, headache, stomach discomfort, abdominal pain, nausea, abnormal blood test results related to muscle and liver parameters.

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

Tingling or numbness in the hands or feet, altered or decreased sensation.

Frequency not known (frequency cannot be estimated from available data):

• Impotence, persistent muscle weakness, breathing problems including persistent cough and/or difficulty breathing or fever.
• Diarrhea
• Myasthenia gravis (a condition causing generalized muscle weakness, which in some cases affects the muscles used for breathing).
• Ocular myasthenia (a condition causing weakness of the eye muscles).

Consult your doctor if you develop worsening weakness in the arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

Other possible adverse effects:

• Sleep disturbances, including insomnia and nightmares
• Memory loss
• Sexual problems
• Diabetes. This is more likely if you have high levels of blood sugar and fats, are overweight, or have high blood pressure. Your doctor will monitor you while you are taking this medicine.
• Inflammation, swelling, and irritation of a tendon.

If you consider any of the adverse effects you experience to be severe or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse 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 expiry date stated on the carton and blister pack after EXP. The expiry date refers to the last day of the month indicated.
• Do not store above 30°C. Keep 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 time of use to protect them from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of packaging and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Digaril Prolib

• The active substance 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 Digaril Prolib and contents of the pack

Digaril Prolib 80 mg prolonged-release tablets are yellow, round, slightly biconvex, with bevelled edges. On one side they are marked with the letters “LE”.

• Bottles: prolonged-release tablets are available in packaging containing 28, 30, 50, 98 or 100 (2 x 50 or 1 x 100) tablets, and in clinical packs containing 300 (15 x 20) or 600 (30 x 20) tablets.
• Blister packs: prolonged-release tablets are available in packaging containing 7, 14, 28 (4 x 7 or 2 x 14), 28 (in a single-dose perforated blister), 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 packs containing 28, 56, 98 or 490 tablets.

Only certain pack sizes may be commercially available.

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 the Member States of the European Economic Area under the following names:

Prolonged-release tablets 80 mg

Date of the most recent review of this leaflet: April 2023

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