Fluvastatin Normon 80 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Fluvastatina Normon 80 mg prolonged-release tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because 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 such effects are not listed in this leaflet. See section 4.

Leaflet contents

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

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

Fluvastatina Normon contains the active substance fluvastatin sodium, which belongs to a group of medicines known as statins, used to lower lipids—substances that reduce fat (lipids) in the blood. It is used in patients whose condition cannot be controlled by diet and exercise alone.

• Fluvastatina Normon 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 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 to help prevent serious heart problems (e.g., a heart attack) in patients who have already undergone heart catheterization or procedures on the heart's blood vessels.

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

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

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

Before taking fluvastatin, read the following information.

Do not take Fluvastatin Normon

• 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 an unexplained and persistent 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 fluvastatin and consult your doctor.

Warnings and precautions

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

• if you are taking or have taken within the last 7 days an oral or injectable medicine containing fusidic acid (used to treat bacterial infection). The combination of fusidic acid and Fluvastatin Normon may cause serious muscle problems (rhabdomyolysis).

• if you have previously had liver disease. Your liver function will usually be monitored before starting treatment with fluvastatin, when the dose is increased, and at various time intervals during treatment to check for the appearance of adverse effects.

• if you have kidney disease.

• if you have a thyroid gland disorder (hypothyroidism).

• if you or a family member has a 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 severe infection.

• if you have very low blood pressure (signs may include dizziness, vertigo).

• if you engage in excessive physical exercise, controlled or uncontrolled.

• if you are about to undergo surgery.

• if you have severe 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), since 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 fluvastatin Normon:

? if you have severe respiratory insufficiency

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

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 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 could be signs of liver dysfunction. In such case, contact your doctor immediately.

Fluvastatin Normon 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. Specific blood tests may be required.

Children and adolescents

Fluvastatin 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 Fluvastatin Normon 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.

Fluvastatin Normon 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 Fluvastatin Normon. Your doctor will advise you when you can restart treatment with Fluvastatin Normon. Using Fluvastatin Normon 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 (mainly used 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:

• 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 fluvastatin if you are pregnant or breastfeeding, as the active substance may cause harm to the fetus and it is unknown 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 being treated with fluvastatin.

If you become pregnant while taking this medicine, you must 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 use of machines

There is no information 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 Fluvastatina Normon

Follow exactly the instructions for taking Fluvastatina Normon as given by your doctor. 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 fluvastatin.

How much Fluvastatina Normon to take

Usual doses in adults

• The dosage range of fluvastatin for adults is 20 mg to 80 mg daily, 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 starting dose is 20 mg of fluvastatin per day. The maximum daily dose is 80 mg. Your doctor may adjust your dose at 6-week intervals.

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 Fluvastatina Normon

If you are taking Fluvastatina Normon, you may take your dose at any time of day.

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

If you take more Fluvastatina Normon than you should

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

If you forget to take Fluvastatina Normon

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 missed dose.

If you stop taking Fluvastatina Normon

To maintain the benefits of your treatment, you should not stop taking fluvastatin unless your doctor tells you to. You should continue taking Fluvastatina Normon as prescribed to maintain low levels of your "bad" cholesterol. Fluvastatin 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 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 any of the following occur.

If you experience unexplained muscle pain, tenderness, or weakness, these may be early signs of potentially serious muscle breakdown. This condition 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).

• If you experience unusual tiredness or fever, yellowing of the skin or eyes, or dark-coloured urine (signs of hepatitis).
• If you develop signs of skin reactions such as rash, blisters, redness, itching, or swelling of the face, eyelids, or lips.
• If you have skin swelling, difficulty breathing, or dizziness (signs of a severe allergic reaction).
• If you experience bleeding or bruising more easily than normal (signs of a reduced number of blood platelets).
• If you develop red or purple skin lesions (signs of blood vessel inflammation).
• If 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).
• If 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 you are concerned.

Frequent (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 (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 condition causing generalized muscle weakness which, in some cases, affects the muscles used for breathing).
• Ocular myasthenia (a condition 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 adverse 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 fats in your 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 effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

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

5. Storage of 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 packaging, after EXP. The expiry date refers to the last day of the month indicated.
• Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. 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 tablet of Fluvastatin Normon 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 medicine and contents of the pack

Fluvastatin Normon is presented as dark yellow, round, biconvex tablets, packed in aluminum-aluminum blisters.

Each Fluvastatin Normon pack 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 the most recent review of this leaflet: June 2025

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