FLUVASTATIN NORMON 80 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Fluvastatin Normon 80 mg prolonged-release tablets EFG

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

1. What is Fluvastatin Normon and what is it used for

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

• Fluvastatin Normon is a medicine used to treat high levels of fat in the blood in adults, in particular total cholesterol and so-called "bad" 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 Fluvastatin Normon to prevent other serious heart problems (e.g. a heart attack) in patients who have already undergone heart catheterization through an intervention in the heart vessels.

If you have any questions about how Fluvastatin Normon works or why it has been prescribed for you, ask your doctor.

2. What you need to know before you take Fluvastatin Normon

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

Before taking fluvastatin, read the following information.

Do not take Fluvastatin Normon

• 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 persistent.
• If you are pregnant or breastfeeding (see "Pregnancy and breastfeeding").

If you are in any of these situations, do not take fluvastatin and consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Fluvastatin Normon:

• 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 Fluvastatin Normon can cause serious muscle problems (rhabdomyolysis).

• if you have previously suffered from liver disease. Normally, your doctor will perform liver function tests before starting treatment with fluvastatin, 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 a 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, vertigo).
• 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 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 sugars and fats in the blood, are overweight, and have high blood pressure.

Check with your doctor or pharmacist before taking fluvastatin Normon:

if you have severe respiratory failure

If you are in any of these situations, tell your doctor before takingFluvastatin Normon. Your doctor will perform a blood test before prescribing fluvastatin.

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 Fluvastatin Normon 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.

Fluvastatin Normon 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

Fluvastatin 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 Fluvastatin Normon 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.

Fluvastatin Normon 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 fluvastatin Normon. Your doctor will tell you when you can restart treatment with Fluvastatin Normon. The use of Fluvastatin Normon 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 fluvastatin.

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 clots).
• Glibenclamide (a medicine used to treat diabetes).
• Colchicine (used to treat gout).

Pregnancy and breastfeeding

Do not take fluvastatin if you are pregnant or breastfeeding, as the active substance may cause harm to 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 should take adequate precautions to avoid becoming pregnant while receiving treatment with fluvastatin.

If you become pregnant while taking this medicine, stop taking Fluvastatin Normon and consult your doctor.

Your doctor will discuss with you the potential risks of taking Fluvastatin Normon during pregnancy.

Driving and using machines

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

Fluvastatin Normon contains sodium

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

3. How to take Fluvastatin Normon

Follow exactly the instructions for administration of Fluvastatin Normon given to you by your doctor. 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 fluvastatin.

How much Fluvastatin Normon to take

Usual dose 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 to take.

Depending on how you respond to treatment, your doctor may prescribe a higher or lower dose.

When to take Fluvastatin Normon

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

Fluvastatin Normon can be taken with or without food. Swallow it whole with a glass of water.

If you take more Fluvastatin Normon than you should

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

If you forget to take Fluvastatin Normon

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 Fluvastatin Normon

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

If you have any further questions on 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 suffer from 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 suffer from unusual tiredness or fever, yellowing of the skin and eyes, dark-colored urine (signs of hepatitis).
• If you have signs of 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 that 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.

Common (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 of 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 sugars and fats 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 consider that any of the side effects you are experiencing is serious or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible that they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Fluvastatin Normon

• Keep Fluvastatin Normon out of the reach and sight of children.
• Do not store above 30°C.
• Do not use Fluvastatin Normon after the expiry date stated on the carton, after EXP. The expiry date is the last day of the month stated.
• Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fluvastatin Normon

The active substance is fluvastatin sodium. Each Fluvastatin Normon tablet contains 84.2 mg of fluvastatin sodium, equivalent to 80 mg of fluvastatin base.

The other ingredients are: Core: Viscarin GP-209 NF, gelcarin GP-379 NF, and magnesium stearate. Coating: Hydroxypropylcellulose, hypromellose 6cP, yellow iron oxide (E-172), titanium dioxide (E-171), macrogol 8000, and red iron oxide (E-172).

Appearance of the product and pack contents

Fluvastatin Normon is presented in the form of dark yellow, round, and biconvex tablets, and is packaged in aluminum-aluminum blisters.

Each pack of Fluvastatin Normon contains 28 tablets.

Marketing authorization holder and manufacturer:

Marketing authorization holder:

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Manufacturers:

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of last revision of this leaflet:June 2025

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