Package Insert: Information for the User

Fluvastatina Qualigen 80 mg prolonged-release tablets EFG

Fluvastatina

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

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• Keep this package insert, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to others, 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 not listed in this package insert. See section 4.

• Package Insert Content:
• 1. What is Fluvastatina Qualigen and for what it is used
• 2.What you need to know before taking Fluvastatina Qualigen
• 3. How to take Fluvastatina Qualigen
• 4. Possible adverse effects
• 5. Storage of Fluvastatina Qualigen

6.Contents of the package and additional informationl

Fluvastatina Qualigencontains 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 by diet and exercise.

• Fluvastatina Qualigenis a medicine that is usedto 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 prescribeFluvastatina Qualigenfor the prevention of other serious heart problems (e.g. a heart attack) in patients who have undergone a heart catheterization through an intervention in the heart vessels.

Do not take Fluvastatina Qualigen:

• If you are allergic to fluvastatina or any of the other components of this medication (including those listed in section 6)
• 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 find yourself 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 medication that contains fusidic acid, (used for the treatment of bacterial infection) by mouth or injection. The combination of fusidic acid and Fluvastatina Qualigen may cause severe muscle problems (rhabdomyolysis).
• If you have had a liver disease in the past. Normally, your doctor will perform liver function tests before starting treatment with Fluvastatina Qualigen, 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 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 medication.
• 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 about to undergo surgery.
• If you have severe metabolic, endocrine, or electrolyte disorders such as uncontrolled diabetes and low blood potassium levels.

While you are taking this medication, your doctor will check if you have diabetes or are at risk of developing diabetes. This risk of diabetes increases if you have high blood sugar and fat levels, obesity, and high blood pressure.

Check with your doctor or pharmacist before taking Fluvastatina Qualigen

• If you have severe respiratory failure.

If you find yourself in any of these situations, inform your doctor before taking Fluvastatina Qualigen. Your doctor will perform a blood test before prescribing Fluvastatina Qualigen.

Also inform your doctor or pharmacist if you experience persistent 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, speech difficulties, sleep disturbances, tremors, or easy bruising or bleeding, these may be signs of liver insufficiency. 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 myasthenia gravis (a disease that causes weakness of the eye muscles), as statins may 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 or indicated in children under 9 years old. For information on dosing in children over 9 years old 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 medications and Fluvastatina Qualigen:

Inform your doctor or pharmacist if you are using or have used recently other medications, even those purchased without a prescription.

Fluvastatina Qualigen can be taken alone or with other medications to lower cholesterol that your doctor prescribes.

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

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

• Ciclosporina (a medication used to suppress the immune system).
• Fibrates (e.g. gemfibrozil), nicotinic acid, or bile acid sequestrants (medications used to lower bad cholesterol levels).
• Fluconazol (a medication used to treat fungal infections).
• Rifampicina (an antibiotic).
• Fenitoína (a medication used to treat epilepsy).
• Oral anticoagulants such as warfarin (medications used to reduce blood clots).
• Glibenclamida (a medication used to treat diabetes).
• Colchicina (used to treat gout)
• If you need to take fusidic acid orally to treat a bacterial infection, you will need to stop taking this medication. Your doctor will indicate when you can restart treatment with Fluvastatina Qualigen. The use of Fluvastatina Qualigen with fusidic acid may cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Pregnancy and breastfeeding:

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

Do not take Fluvastatina Qualigen if you are pregnant or breastfeeding, as the active ingredient may cause damage to 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 the necessary precautions to avoid becoming pregnant while taking Fluvastatina Qualigen.

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

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

Driving and operating machines:

There is no information on the effects of Fluvastatina Qualigen on the ability to drive and operate machines.

Fluvastatina Qualigen contains sodium

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

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

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 be taken

Usual doses in adults

The dosage interval for fluvastatin in 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 usual initial dose is 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 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 tablets of Fluvastatina Qualigen, inform your doctor immediately. You may need medical attention.

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

It is recommended to bring the packaging and the medication leaflet 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 less than 4 hours are left for 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 with 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 maintain low levels of your "bad" cholesterol. Fluvastatina Qualigen will not cure your disease but will help you 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, this medicine can cause side 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 medical help immediately.

• If you experience unexplained muscle pain, sensitivity, or weakness. These may be early signs of a potentially severe muscle degradation. This can be prevented if your doctor stops your fluvastatin treatment as soon as possible. These side effects have also been observed in similar medications of this class (statins).
• If you experience unusual fatigue 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 swelling in the skin, difficulty breathing, dizziness (signs of a severe allergic reaction).
• If you experience bleeding or bruising more easily than usual (signs of a decrease in blood platelet count).
• If you experience red or purple skin lesions (signs of blood vessel inflammation).
• If you experience a skin rash with red patches mainly on the face that may be accompanied by fatigue, fever, nausea, loss of appetite (signs of lupus erythematosus-like reaction).
• If you experience intense 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 you are concerned.

Common:

Difficulty sleeping, headache, stomach discomfort, abdominal pain, nausea, altered muscle and liver parameters in blood tests.

Very rare (may affect up to 1 in 10,000 people):

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

Frequency not known (the 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), 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 disturbances, including insomnia and nightmares
• Memory loss
• Sexual problems
• Depression

• Diabetes. It is more likely if you have high blood sugar and fat levels, obesityand high blood pressure. Your doctor will monitor you while you are taking this medicine.
• Tendon inflammation, swelling, and irritation.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, 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 Vigilance of Medicines for Human Use:http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and on the blister pack after “CAD”. The expiration date is the last day of the month indicated.

Do not store above30ºC.

Store in the original packaging to protect it from moisture.

Do not use this medication if you observe that the packaging is damaged or shows signs of deterioration.

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Fluvastatina Qualigen:

• The active ingredient is fluvastatinasodium.
• Each Fluvastatina Qualigen tabletcontains84.2 mg of fluvastatina sodium equivalent to80 mg of fluvastatina base.
• The other components are:

Tablet core: Carrageenan, magnesium stearate.

Tablet 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 packaging:

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 will be marketed.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona - Spain

Responsible manufacturer:

Pharmathen S.A.

6, Dervenakion str.

153 51 Pallini

Athens (Greece)

Last review date of this leaflet: April 2023

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