VADITON PROLIB 80 mg PROLONGED-RELEASE TABLETS

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

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

Before taking Vaditon Prolib, read the following information carefully.

Do not takeVaditon 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.
• 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

Consult your doctor or pharmacist before starting to take Vaditon 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 Vaditon 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 Vaditon Prolib, when the dose is increased, and at different time intervals during treatment to monitor for 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 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 uncontrolled diabetes and low blood potassium levels.
• if you have or have had myasthenia (a disease characterized by generalized muscle weakness that can affect 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 pharmacistbefore takingVaditon Prolib:

• if you have severe respiratory failure

If you are in any of these situations, tell your doctor before takingVaditon Prolib. Your doctor will perform a blood test before prescribing Vaditon 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 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, 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; this is, essentially "sodium-free".

Vaditon Prolib and elderly patients over 70 years

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

Vaditon Prolib has not been investigated and 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 Vaditon Prolib with other medicines

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

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

If you have to take oral fusidic acid to treat a bacterial infection, you will have to stop using Vaditon Prolib. Your doctor will tell you when you can restart treatment with Vaditon Prolib. The use of Vaditon 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 Vaditon Prolib.

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

• Cyclosporin (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 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 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 must take adequate precautions to avoid becoming pregnant while receiving treatment with Vaditon Prolib.

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

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

Driving and using machines

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

3. How to take Vaditon Prolib

Follow exactly the administration instructions of this medicine given to you 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 taking Vaditon Prolib.

How much VaditonProlibto 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 takeVaditonProlib

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

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

If you takemore Vaditon Prolibthan you should

If you have accidentally taken too many Vaditon 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 takeVaditon 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 takingVaditon Prolib

To maintain the benefits of your treatment, do not stop taking Vaditon Prolib unless your doctor tells you to. You should continue taking Vaditon Prolib as prescribed to keep your "bad" cholesterol levels low. Vaditon 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 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 they worry you.

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 can affect 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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects 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 Vaditon 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 the packaging is damaged or shows signs of tampering.
• Keep Vaditon 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 in doubt, 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 ofVaditon Prolib

• The active ingredient is fluvastatin sodium

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

Appearanceof VaditonProliband Container Content

The Vaditon Prolib 80 mg prolonged-release tablets are yellow, round, slightly biconvex, with beveled edges. On one face, 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 underthe following names:

80 mg prolonged-release tablets

Date of the last revision of this leaflet: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/