Fluvastatin Qualigen 80 mg prolonged-release tablet EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Fluvastatina Qualigen 80 mg prolonged-release tablets EFG

Fluvastatin

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

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• 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 and should not be given to other people, even if they have the same symptoms, as it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

• Leaflet contents:

• 1. What Fluvastatina Qualigen is and what it is used for
• 2. What you need to know before taking Fluvastatina Qualigen
• 3. How to take Fluvastatina Qualigen
• 4. Possible side effects
• 5. How to store Fluvastatina Qualigen

1. Contents of the pack and other information

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

Fluvastatina Qualigen 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.

• Fluvastatina Qualigen is a medicine used to treat elevated levels of fats in the blood in 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 Fluvastatina Qualigen to help prevent other serious heart problems (e.g., a heart attack) in patients who have undergone heart catheterization or a procedure on the blood vessels of the heart.

2. What you need to know before taking Fluvastatin Qualigen

Do not take Fluvastatin Qualigen:

• If you are allergic to fluvastatin or to any of the other ingredients of this medicine (listed in section 6)
• if you have liver problems, or have a persistent, unexplained increase in 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 Qualigen and consult your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Fluvastatin Qualigen

• 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 Qualigen may cause serious muscle problems (rhabdomyolysis).
• if you have previously had liver disease. You will usually have liver function tests before starting treatment with Fluvastatin Qualigen, when your dose is increased, and at various time intervals during treatment to monitor for adverse effects.
• if you have kidney disease.
• if you have a thyroid gland disorder (hypothyroidism).
• if you have personal or family 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 (symptoms may include dizziness, vertigo).
• if you engage 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 potassium levels in the blood.

While you are taking this medicine, your doctor will monitor you for diabetes or risk of developing diabetes. This risk increases if you have high levels of blood sugar and fats, are overweight, or have high blood pressure.

Check with your doctor or pharmacist before taking Fluvastatin Qualigen

• if you have severe respiratory insufficiency.

If you are in any of these situations, inform your doctor before taking Fluvastatin Qualigen. Your doctor may perform a blood test before prescribing Fluvastatin Qualigen.

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests or treatments may be needed to diagnose and manage this condition.

If during treatment with Fluvastatin Qualigen 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 failure. In this case, contact your doctor immediately.

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).

Elderly patients (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 Qualigen 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.

Other medicines and Fluvastatin Qualigen:

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Fluvastatin Qualigen may be taken alone or in combination with other cholesterol-lowering medicines prescribed by your doctor.

After taking a resin such as cholestyramine (used mainly to treat high cholesterol), wait at least 4 hours before taking Fluvastatin Qualigen.

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).
• If you need to take oral fusidic acid to treat a bacterial infection, you must stop using this medicine. Your doctor will advise you when you can restart treatment with Fluvastatin Qualigen. The use of Fluvastatin Qualigen with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For further information on rhabdomyolysis, see section 4.

Pregnancy and breastfeeding:

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Do not take Fluvastatin Qualigen if you are pregnant or breastfeeding, as the active substance may harm the fetus and it is unknown whether it is excreted in breast milk. If you are pregnant, consult your doctor or pharmacist before taking Fluvastatin Qualigen. You must take appropriate precautions to avoid pregnancy while being treated with Fluvastatin Qualigen.

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

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

Driving and using machines:

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

Fluvastatin Qualigen contains sodium

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

3. How to take Fluvastatin Qualigen

Follow exactly the instructions for using Fluvastatin Qualigen provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist before using this medicine.

Do not take a higher dose than indicated.

Your doctor will advise you to follow a low-cholesterol diet. Continue this diet while taking Fluvastatin Qualigen.

How much Fluvastatin Qualigen should you take?

Usual doses in adults

The dose 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 (aged 9 years and older), the usual starting dose is 20 mg of fluvastatin daily. The maximum daily dose is 80 mg. Your doctor may adjust the dose at intervals of 6 weeks.

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 Fluvastatin Qualigen

If you are taking Fluvastatin Qualigen, you may take your dose at any time of day.

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

If you take more Fluvastatin Qualigen than you should

If you have accidentally taken too many Fluvastatin Qualigen tablets, inform your doctor immediately. You may require medical attention.

If you take more Fluvastatin Qualigen than you should, contact your doctor, pharmacist, or call the toxicology information service at 91.562.04.20, indicating the medicine and the amount taken.

It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If you forget to take Fluvastatin Qualigen

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 your next dose at the usual time.

Do not take a double dose to make up for a forgotten dose.

If you stop taking Fluvastatin Qualigen

To maintain the benefits of your treatment, do not stop taking Fluvastatin Qualigen unless instructed by your doctor. You should continue taking Fluvastatin Qualigen as prescribed to maintain low levels of your "bad" cholesterol. Fluvastatin Qualigen will not cure your condition but will help control it. Regular monitoring of your cholesterol levels is necessary to track progress.

If you have any further questions about the use of this product, 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) 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 fluvastatin treatment as soon as possible. These adverse effects have also been observed with similar medicines in this class (statins).
• you experience unusual tiredness or fever, yellowing of the skin or eyes, or dark urine (signs of hepatitis).
• you develop signs of skin reactions such as rash, blisters, redness, itching, swelling of the face, eyelids, or lips.
• you have swelling of the skin, difficulty breathing, or dizziness (signs of a severe allergic reaction).
• you bleed or bruise more easily than normal (signs of a decrease in 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 pancreatitis).

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

Other adverse effects (may affect up to 1 in 10 people): inform your doctor if you are concerned.

Common:

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, respiratory 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 weakness in your arms or legs that worsens 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.

Reporting of adverse effects

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

5. Fluvastatina Qualigen Storage

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and on the 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 from moisture.

Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Package contents and other information

Composition of Fluvastatin Qualigen:

• The active substance is fluvastatin sodium.
• Each tablet of Fluvastatin Qualigen contains 84.2 mg of fluvastatin sodium, equivalent to 80 mg of fluvastatin base.
• The other components are:

Tablet core: Carrageenan, magnesium stearate.

Tablet coating: Hydroxypropyl cellulose, hypromellose 6 cP, yellow iron oxide (E 172), titanium dioxide (E 171), macrogol 8000, and red iron oxide (E 172).

Appearance of the medicinal product and contents of the pack:

Fluvastatin Qualigen tablets are dark yellow, round, and biconvex, and are packaged in alu/alu blisters.

Each pack of Fluvastatin Qualigen contains 7, 28, or 56 tablets.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona - Spain

Manufacturer:

Pharmathen S.A.

6, Dervenakion str.

153 51 Pallini

Athens (Greece)

Date of the most recent revision 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 Health Products (AEMPS) http://www.aemps.gob.es/