Vadadotin ProLib 80 mg prolonged-release tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Vaditon 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 others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet Contents

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

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

Vaditon 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.

• Vaditon 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 Vaditon 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 heart's blood vessels.

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

2. What you need to know before starting to take Vaditon Prolib

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

Before taking Vaditon Prolib, read the following information.

Do not take Vaditon 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, unexplained elevation in 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 Vaditon Prolib and consult your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Vaditon Prolib:

• if you are currently 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 Vaditon Prolib may cause serious muscle problems (rhabdomyolysis).
• if you have previously had liver disease. You will usually have liver function tests before starting treatment with Vaditon Prolib, when the dose is increased, and at various 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 previously experienced 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, vertigo).
• if you are engaging in excessive controlled or uncontrolled physical exercise.
• if you are about to undergo surgery.
• if you have serious metabolic, endocrine or electrolyte disorders such as uncontrolled diabetes or low levels of potassium 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 of diabetes is higher 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 Vaditon Prolib:

• if you have severe respiratory insufficiency.

If you are in any of these situations, inform your doctor before taking Vaditon 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 treatments may be needed to diagnose and manage this condition.

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, speech difficulties, sleep disturbances, tremors, or easy bruising or bleeding, these may be signs of liver dysfunction. In such a case, contact your doctor immediately.

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

Vaditon Prolib and people 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. You may require specific blood tests.

Children and adolescents

Vaditon 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 Vaditon Prolib with other medicines

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

Vaditon 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 Vaditon Prolib. Your doctor will advise you when you can restart treatment with Vaditon Prolib. Using Vaditon Prolib with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For further information on rhabdomyolysis, see section 4.

After taking a resin, e.g. cholestyramine (used mainly to treat high cholesterol), wait at least 4 hours before taking Vaditon 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 clotting).
• Glibenclamide (a medicine used to treat diabetes).
• Colchicine (used to treat gout).

Pregnancy and breastfeeding

Do not take Vaditon Prolib if you are pregnant or breastfeeding, as the active ingredient 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 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 receiving treatment with Vaditon Prolib.

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

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

Driving and using machines

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

3. How to take Vaditon Prolib

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If 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 this diet while taking Vaditon Prolib.

How much Vaditon Prolib to take

Usual doses in adults

The dosage range of fluvastatin 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 (9 years of age and older), the usual initial 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 how you respond to treatment, your doctor may prescribe a higher or lower dose.

When to take Vaditon Prolib

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

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

If you take more Vaditon Prolib than you should

If you have accidentally taken too many Vaditon 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 Vaditon 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 forgotten doses.

If you stop taking Vaditon Prolib

To maintain the benefits of your treatment, you should not stop taking Vaditon Prolib unless your doctor tells you to. You should continue taking Vaditon Prolib as prescribed to maintain low levels of your "bad" cholesterol. Vaditon 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 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 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 side 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-coloured urine (signs of hepatitis).
• you develop signs of skin reactions such as rash, blistering, redness, itching, swelling of the face, eyelids, or lips.
• you have swelling of the skin, difficulty breathing, dizziness (signs of a severe allergic reaction).
• you experience bleeding or bruising more easily than normal (signs of a reduced number of blood platelets).
• 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, or loss of appetite (signs of a lupus-like reaction).
• you have severe pain in the upper abdomen (signs of inflammation of the pancreas).

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

Other side effects: inform 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 reduced 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 the arms or legs 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 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 side effects you experience to be severe, or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Vaditon 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 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 Vaditon 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. Return unused medicines and their containers to your pharmacy’s SIGRE collection point. If you are unsure how to dispose of unused medicines or their packaging, please consult your pharmacist. This will help protect the environment.

6. Contents of the pack and other information

Composition of Vaditon Prolib

• The active substance is fluvastatin sodium.

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

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

Prolonged-release Vaditon Prolib 80 mg tablets are yellow, round, slightly biconvex, with bevelled edges. On one side they bear 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 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 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 on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/