FLUVASTATIN QUALIGEN 80 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Fluvastatina Qualigen 80 mg prolonged-release tablets EFG

Fluvastatina

Read the package leaflet carefully before starting to take the medicine, as it contains important information for you.

.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed to you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

• Contents of the package leaflet:
• 1. What is Fluvastatina Qualigen and what is it used for
• 2. What you need to know before taking Fluvastatina Qualigen
• 3. How to take Fluvastatina Qualigen
• 4. Possible side effects
• 5. Storage of Fluvastatina Qualigen

1. Package contents and additional information

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

Fluvastatina Qualigen contains the active substance fluvastatina sodium, which belongs to a group of medicines known as statins, which are lipid-lowering medicines: they reduce the 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 high levels of fat in the blood of adults, in particular 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 Qualigen to prevent other serious heart problems (e.g. a heart attack) in patients who have undergone a heart catheterization through an intervention in the heart vessels.

2. What you need to know before taking Fluvastatina Qualigen

Do not take Fluvastatina Qualigen:

• If you are allergic to fluvastatina or any of the other components of this medicine (listed in section 6)
• if you have liver problems, or have an elevation of unknown and persistent cause 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 Fluvastatina Qualigen and consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Fluvastatina Qualigen

• if you are taking or have taken in the last 7 days a medicine that contains fusidic acid, (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and Fluvastatina Qualigen can cause serious muscle problems (rhabdomyolysis).
• if you have previously suffered from liver disease. Normally, you will have liver function tests before starting treatment with Fluvastatina Qualigen, 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 potassium levels in the blood.

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 Fluvastatina Qualigen

• if you have severe respiratory failure.

If you are in any of these situations, tell your doctor before takingFluvastatina Qualigen. Your doctor will perform a blood test before prescribing Fluvastatina Qualigen.

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 Fluvastatina 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, difficulty speaking, 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 that causes generalized muscle weakness that, in some cases, affects 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).

People over 70 years old

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

Fluvastatina Qualigen has not been investigated and is not indicated in children under 9 years of age. For information on the dose in children over 9 years and adolescents, see section 3

There is no experience with the use of fluvastatina in combination with nicotinic acid, cholestyramine or fibrates in children and adolescents.

Other medicines and Fluvastatina Qualigen:

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

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

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

Tell 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 "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)
• If you need to take oral fusidic acid to treat a bacterial infection, you will need to stop using this medicine. Your doctor will tell you when you can restart treatment with Fluvastatina Qualigen. The use of Fluvastatina Qualigen with fusidic acid can cause muscle weakness, sensitivity or pain (rhabdomyolysis). For more 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 Fluvastatina Qualigen 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, consult your doctor or pharmacist before taking Fluvastatina Qualigen. You should take adequate precautions to avoid becoming pregnant while being treated with Fluvastatina Qualigen.

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

Your doctor will discuss with you the potential risk of taking Fluvastatina Qualigen during pregnancy.

Driving and using machines:

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

Fluvastatina Qualigen contains sodium

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

3. How to take Fluvastatina Qualigen

Follow the administration instructions of Fluvastatina Qualigen indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist before using this medicine.

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 Qualigen.

How much Fluvastatina Qualigen should you take

Usual doses in adults

The dose range of fluvastatina 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 fluvastatina 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 fluvastatina you should take.

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

When to take Fluvastatina Qualigen

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

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

If you take more Fluvastatina Qualigen than you should

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

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

It is recommended to take the package and package leaflet of the medicine to the healthcare professional.

If you forget to take Fluvastatina Qualigen

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 Fluvastatina Qualigen

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

If you have any other questions about the use of this product, 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 a potentially serious muscle breakdown. This can be avoided if your doctor stops your treatment with fluvastatina 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 platelets in the blood).
• if you have red or purple skin lesions (signs of inflammation of blood vessels).
• 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 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 (may affect up to 1 in 10 people): inform your doctor if they worry you.

Common:

Difficulty sleeping, headache, stomach upset, abdominal pain, nausea, altered values in 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, in some cases, affects 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.

Reporting of side effects

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

5. Storage of Fluvastatina Qualigen

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date is 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 should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to 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. Package contents and additional information

Composition of Fluvastatina Qualigen:

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

Core of the tablet: Carrageenan, magnesium stearate.

Coating of the tablet: 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 package contents:

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

Each package of Fluvastatina Qualigen contains 7, 28 or 56 tablets.

It is possible that only some package sizes are marketed.

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 last revision of this package leaflet: April 2023

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.gob.es/