Package Leaflet: Information for the User

Fluvastatina NORMON 80 mg prolonged-release tablets EFG

Read this leaflet carefully beforestarting totakethemedicine.

• Keep this leaflet, as you may need to read it again.
  If you have any questions, consult yourdoctororpharmacist.
• This medicine has been prescribed for you only.You must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you think you are having a serious side effect or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

1. What isFluvastatina Normonand what it is used for

2. Before starting totakeFluvastatina Normon

3. How to takeFluvastatina Normon

4. Possible side effects

5. Storage ofFluvastatina Normon

6. Contents of the pack and additional information

Fluvastatina Normon contains the active ingredient fluvastatin sodium, which belongs to a group of medicines known as statins, which are medicines to reduce lipids: they decrease the fat (lipids) in the blood. They are used in patients whose condition cannot be controlled solely with diet and exercise.

• Fluvastatina Normon is a medicine used to treat high levels of fats in the blood of adults, particularly total cholesterol and the so-called "bad" cholesterol or LDL-cholesterol, which is associated with a high risk of heart disease and stroke

• In adult patients with high levels of cholesterol in the blood.
• In adult patients with high levels of both cholesterol and triglycerides (another type of lipid) in the blood.

• Your doctor may also prescribe Fluvastatina Normon for the prevention of other serious cardiac problems (e.g. a heart attack) in patients after undergoing a heart catheterization through an intervention in the heart vessels.

Follow carefully all the instructions given to you by your doctor. These may be different from the information included in this leaflet.

Before taking fluvastatin, read the following warnings.

Do not take Fluvastatina Normon

• If you are allergic (hypersensitive) to fluvastatin or to any of the other components of Fluvastatina Normon listed in section 6 of this leaflet.
• If you have liver problems, or if you have an unexplained and persistent elevation 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 fluvastatin and consult your doctor.

Warnings and precautions

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

• If you are taking or have taken in the last 7 days a medicine that contains fusidic acid, (used for the treatment of bacterial infections) by mouth or by injection. The combination of fusidic acid and Fluvastatina Normon may cause severe muscle problems (rhabdomyolysis).

• If you have had liver disease. Normally, your doctor will perform liver function tests before starting treatment with fluvastatin, when increasing the dose and at different intervals during treatment to monitor the occurrence of adverse effects.
• If you have kidney disease.
• If you have thyroid 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 or have had myasthenia (a disease that is characterized by generalized muscle weakness that, in some cases, affects the muscles used for breathing) or myasthenia gravis (a disease that causes weakness of the eye muscles), as statins may sometimes worsen the disease or cause myasthenia (see section 4).

Consult your doctor or pharmacist before takingFluvastatina Normon if you:

• Have severe respiratory failure.

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 increases if you have high levels of sugar and fat in your blood, being overweight and high blood pressure.

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

Also inform your doctor or pharmacist if you experience persistent muscle weakness. You may need further tests and additional medicines to diagnose and treat this problem.

Fluvastatina Normon and people over 70 years

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

Fluvastatina Normon and children and adolescents

Fluvastatin has not been investigated or indicated in children under 9 years old. For information on the dose in children over 9 years old 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 Fluvastatina Normon with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine.

Fluvastatina Normon can be taken alone or with other medicines for lowering cholesterol that your doctor prescribes.

After taking a resin, e.g. cholestyramine (used mainly to treat high cholesterol), wait at least 4 hours before taking fluvastatin.

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

• Ciclosporin (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).
• If you need to take fusidic acid orally to treat a bacterial infection, you will need to stop taking this medicine. Your doctor will tell you when you can restart treatment with Fluvastatina Normon. The use of Fluvastatina Normon with fusidic acid may cause muscle weakness, sensitivity or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Taking Fluvastatina Normon with food and drinks

Fluvastatin can be taken with or without food.

Pregnancy and breastfeeding

Do not take fluvastatin if you are pregnant or breastfeeding as the active ingredient may cause damage to the fetus and it is not known whether it is excreted in breast milk. If you are pregnant, consult your doctor or pharmacist before taking Fluvastatina Normon. You should take the necessary precautions to avoid becoming pregnant while receiving treatment with fluvastatin.

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

Driving and operating machines

There is no information on the effects of fluvastatin on the ability to drive and use machines.

Fluvastatina Normon contains sodium

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

Follow exactly the administration instructions for Fluvastatina Normon as indicated by your doctor.

Consult your doctor or pharmacist if you have any doubts. 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 fluvastatina.

How much Fluvastatina Normon should you take

• The dosage interval 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.
• In children (9 years of age and older), the usual initial dose is 20 mg 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 many tablets of Fluvastatina Normon you should take.

Depending on your response to treatment, your doctor may prescribe a higher or lower dose.

When should you take Fluvastatina Normon

You can take your dose at any time of the day.

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

If you take moreFluvastatina Normon than you should

If you have accidentally taken too much fluvastatina, inform your doctor immediately. You may need medical attention.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20 (indicating the medication and the amount ingested).

If you forget to takeFluvastatina Normon

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

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment withFluvastatina Normon

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

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

Like all medicines, Fluvastatina Normon may cause side effects, although not everyone will experience them.

Very common: affects more than 1 in 10 patients,

Common: affects between 1 and 10 in 100 patients,

Uncommon: affects between 1 and 10 in 1,000 patients,

Rare: affects between 1 and 10 in 10,000 patients,

Very rare: affects less than 1 in 10,000 patients,

Frequency not known: the frequency cannot be estimated from the available data.

Some rare or very rare side effects could be severe: seek immediate medical assistance:

• Unknown frequency side effects: diarrhea, constant muscle weakness.

If you experience muscle pain without any apparent reason, sensitivity or muscle weakness. These may be early signs of a potentially severe muscle degradation. This can be prevented if your doctor stops your fluvastatina treatment as soon as possible. These side effects have also been observed in similar medications of this class (statins).

• If you experience fatigue that is not usual or fever, yellow skin and eyes, dark urine (signs of hepatitis).
• If you have skin reaction signs such as skin rash, blisters, redness, itching, swelling of the face, eyelids, and lips.
• If you have skin swelling, difficulty breathing, dizziness (signs of a severe allergic reaction).
• If you have bleeding or bruising more easily than usual (signs of a decrease in blood platelet count).
• 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 may be accompanied by fatigue, fever, nausea, loss of appetite (signs of lupus erythematosus-like reaction).
• If you have intense pain in the upper stomach (signs of pancreatitis inflammation).

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

Other side effects: inform your doctor if you are concerned:

Common:

Difficulty sleeping, headache, stomach discomfort, abdominal pain, nausea.

Very rare:

Tickling or numbness of the hands or feet, altered or decreased sensitivity.

Unknown frequency side effects:

• Myasthenia gravis (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing).
• Myasthenia ocular (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 eyelid drooping, difficulty swallowing or difficulty breathing.

Other possible side effects:

• Sleep disorders, including insomnia and nightmares.
• Memory loss.
• Sexual dysfunction.
• Depression.
• Respiratory problems, including persistent cough and/or difficulty breathing or fever.

Diabetes. It is more likely if you have high blood sugar and fat levels, obesity, and high blood pressure. Your doctor will monitor you while taking this medication.

If you consider any of the side effects you experience to be severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting ofside effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep Fluvastatina Normon out of the reach and sight of children.

Do not store at a temperature above 30 °C.

Do not use Fluvastatina Normon after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need.By doing so, you will help protect the environment.

Composition of Fluvastatina Normon

The active ingredient is fluvastatin sodium. Each Fluvastatina Normon tablet contains 84.2 mg of fluvastatin sodium equivalent to 80 mg of fluvastatin base.

The other components 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 contents of the package

Fluvastatina Normon is presented in the form of yellow-brown, round, and biconvex tablets, and are packaged in aluminum-aluminum blisters.

Each package of Fluvastatina Normon contains 28 tablets.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization:

Laboratorios Normon, S.A.

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

Manufacturing responsible:

Laboratorios Normon, S.A.

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

Date of the last review of this prospectus:May 2023

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/.