Lescol ProLib 80 mg prolonged-release tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Lescol Prolib 80 mg prolonged-release tablets

Fluvastatin

Read the entire leaflet carefully before you start taking this medicine, as 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, and you should not give it to other people, 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 Lescol Prolib is and what it is used for
2. What you need to know before taking Lescol Prolib
3. How to take Lescol Prolib
4. Possible adverse effects
5. How to store Lescol Prolib
6. Contents of the pack and other information

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

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

• Lescol Prolib is a medicine used to treat high 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 Lescol Prolib to help prevent other serious heart problems (e.g., a heart attack) in patients who have already undergone heart catheterization or a procedure on the blood vessels of the heart.

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

2. What you need to know before taking Lescol Prolib

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

Before taking Lescol Prolib, read the following information.

Do not take Lescol Prolib

• if you are allergic (hypersensitive) to fluvastatin or to any of the other ingredients of this medicine (listed in section 6).
• if you have liver problems, or have a persistent, 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 Lescol Prolib and consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Lescol Prolib:

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

While you are 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 Lescol Prolib:

• if you have severe respiratory insufficiency.

If you are in any of these situations, inform your doctor before taking Lescol Prolib. Your doctor will perform a blood test before prescribing Lescol 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 Lescol 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 (1 mmol) per prolonged-release tablet; therefore, it is essentially “sodium-free.”

Lescol Prolib and people over 70 years of age

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

Children and adolescents

Lescol 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 Lescol Prolib with other medicines

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

Lescol Prolib may be taken alone or together 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 Lescol Prolib. Your doctor will advise you when you can restart treatment with Lescol Prolib. Using Lescol 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 Lescol 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 Lescol Prolib if you are pregnant or breastfeeding, as the active substance may harm the unborn baby and it is not known whether 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 must take appropriate precautions to avoid pregnancy while receiving treatment with Lescol Prolib.

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

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

Driving and using machines

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

3. How to take Lescol 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 Lescol Prolib.

How much Lescol Prolib to take

Usual doses in adults

The usual dose range of fluvastatin for adults is 20 mg to 80 mg daily, depending on the degree of cholesterol reduction required. 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 daily. 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 Lescol Prolib

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

Lescol Prolib may be taken with or without food. Swallow the tablet whole with a glass of water.

If you take more Lescol Prolib than you should

If you accidentally take too many Lescol Prolib tablets, inform your doctor immediately or call the Toxicology Information Service at 91 562 04 20, stating the medication and the amount taken. You may require medical attention.

If you forget to take Lescol Prolib

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

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

If you stop taking Lescol Prolib

To maintain the benefits of your treatment, you must not stop taking Lescol Prolib unless your doctor tells you to. You should continue taking Lescol Prolib as prescribed to keep your "bad" cholesterol levels low. Lescol Prolib will not cure your condition but will help you manage it. It is necessary to check your cholesterol levels regularly to monitor 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 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).
• you experience unusual tiredness or fever, yellowing of the skin or eyes, dark urine (signs of hepatitis).
• you develop signs of skin reactions such as rash, blisters, redness, itching, swelling of the face, eyelids, or lips.
• you have skin swelling, difficulty breathing, dizziness (signs of a severe allergic reaction).
• you experience bleeding or bruising more easily than normal (signs of a decrease in blood platelet count).
• you develop red or purple skin lesions (signs of blood vessel inflammation).
• you develop a skin rash with red spots mainly on the face, possibly accompanied by fatigue, fever, nausea, loss of appetite (signs of a lupus-like reaction).
• you have severe pain in the upper abdomen (signs of pancreatitis).

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

Other adverse effects: inform your doctor if they concern you.

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

Difficulty sleeping, headache, stomach discomfort, abdominal pain, nausea, abnormal results in blood tests 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.
• Diarrhoea
• Myasthenia gravis (a disease causing generalized muscle weakness which, in some cases, affects the muscles used for breathing).
• Ocular myasthenia (a disease causing weakness of the eye muscles).

Consult your doctor if you experience worsening weakness in 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
• Depression
• Diabetes. This is more likely if you have high levels of sugars and fats in the blood, 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 effect not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult 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 Lescol 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 it from moisture.
• Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
• Keep Lescol Prolib tablets in the blister pack until the time of use in order to protect them from moisture.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and packaging that you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Lescol Prolib

• The active substance is fluvastatin sodium.

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

• The other components of Lescol 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 Lescol Prolib and contents of the pack

Lescol 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 of 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 of 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 and in the United Kingdom (Northern Ireland) under the following names:

Prolonged-release tablets of 80 mg

Date of the last revision of this leaflet: April 2023

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