Prospecto: Information for the User

Fluvastatina Teva20mghard capsules EFG

Fluvastatina Teva40mghard capsules EFG

Read this prospectus carefully before starting to take the medication, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

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

2.What you need to know before starting to take Fluvastatina Teva

3.How to take Fluvastatina Teva

4.Possible adverse effects

5Storage of Fluvastatina Teva

6Contents of the package and additional information

Fluvastatina Teva contains the active ingredient fluvastatin sodium, which belongs to a group of medicines called 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 Teva is a medicine that is used

• to treat high levels of fats in the blood in adults, particularly total cholesterol and the so-called "bad" 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 fat) in the blood.

Your doctor may also prescribe Fluvastatina Teva for the prevention of other serious heart problems (e.g. a heart attack) in patients who have already had a heart catheterization through an intervention in the heart vessels.

If you have any doubts about how Fluvastatina Teva works or why you have been prescribed this medicine, contact your doctor.

Follow carefully the instructions given by your doctor, which may be different from those listed in this leaflet.

Read the following explanations before taking Fluvastatina Teva.

Do not take Fluvastatina Teva:

• if you are allergic to fluvastatin or any of the other ingredients of this medicine listed in section 6.
• if you have liver problems or have a persistent and unexplained 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 Fluvastatina Teva and consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Fluvastatina Teva

• if you are taking or have taken in the last 7 days a medicine containing fusidic acid (used for the treatment of bacterial infections) by mouth or by injection. The combination of fusidic acid and Fluvastatina Teva may cause severe muscle problems (rhabdomyolysis).
• if you have had liver disease in the past. Normally, you will have blood tests to check your liver function before starting to take Fluvastatina Teva, when increasing the dose and at various intervals during treatment to check for any adverse effects.
• if you have kidney disease.
• if you have a 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 severe respiratory failure.
• if you are over 70 years old, your doctor may want to clarify whether you are at risk of developing muscle disorders. You may need additional blood tests.
• if you have a severe infection.
• if you have very low blood pressure (the signs may include dizziness, confusion).
• if you have 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 potassium levels in the blood.
• 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 can sometimes worsen the disease or cause myasthenia (see section 4).

While taking this medicine, your doctor will closely monitor you if you have diabetes or are at risk of developing diabetes. You are likely to be at risk of developing diabetes if you have high blood sugar or fat levels, are overweight, or have high blood pressure.

Consult your doctor or pharmacist before taking Fluvastatina Teva

• if you have severe respiratory failure

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

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

If 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 a doctor immediately.

Fluvastatina Teva and people over 70 years old

If you are over 70 years old, your doctor may want to check if you are at risk of developing muscle disorders. You may need specific blood tests.

Children and adolescents

Fluvastatina Teva 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 of the use of Fluvastatina Teva in combination with nicotinic acid, cholestyramine or fibrates in children and adolescents.

Use of other medicines with Fluvastatina Teva

Inform your doctor or pharmacist if you are taking/using or have taken/used recently other medicines or may need to take/use any other medicine, including over-the-counter medicines.

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 the treatment with Fluvastatina Teva. The use of Fluvastatina Teva with fusidic acid may cause muscle weakness, sensitivity or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Fluvastatina Teva can be taken alone or with other medicines 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 Teva.

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 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)

Taking Fluvastatina Teva with food and drinks

You can take Fluvastatina Teva with or without food.

Pregnancy and breastfeeding

Do not take Fluvastatina Teva if you are pregnant or breastfeeding as the active ingredient may cause harm to the fetus and it is not known if it is excreted in breast milk.

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medicine.

You will need to take the necessary precautions to avoid becoming pregnant while receiving treatment with Fluvastatina Teva. If you become pregnant while taking this medicine, stop taking Fluvastatina Teva and consult your doctor. Your doctor will discuss with you the potential risk of taking Fluvastatina Teva during pregnancy.

Driving and operating machines

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

Fluvastatina Teva contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Fluvastatina Teva contains sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Do not exceed the recommended dose.

Your doctor will recommend that you follow a low-cholesterol diet. Continue with this diet while taking Fluvastatina Teva.

How much Fluvastatina Teva to take

Recommended dose in adults

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.

Use in children and adolescents

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 Fluvastatina Teva capsules you should take.

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

When to take Fluvastatina Teva

If you are taking Fluvastatina Teva once a day, take your dose at night or before bedtime.

If you are taking Fluvastatina Teva twice a day, take one capsule in the morning and another at night or before bedtime.

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

If you take more Fluvastatina Teva than you should

If you have accidentally taken many Fluvastatina Teva capsules, inform your doctor immediately or call the Toxicological Information Service at phone 91 562 04 20, indicating the medication and the amount taken. You may need medical attention.

If you forget to take Fluvastatina Teva

Take a dose as soon as you remember. However, do not take it if less than 4 hours are left 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 with Fluvastatina Teva

To maintain the benefits of your treatment, do not stop taking Fluvastatina Teva unless your doctor tells you to. You should continue taking Fluvastatina Teva as prescribed to maintain low levels of your "bad" cholesterol. Fluvastatina Teva 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 medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects,although not everyone will experience them.

Serious side effects that are rare (may affect up to 1 in 1,000 people) or very rare (may affect up to 1 in 10,000 people) may occur: seek immediate medical help.

• 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 reactions such as 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 skin lesions that are red or purple (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 severe upper stomach pain (signs of pancreatitis - pancreas inflammation).

If you experience any of these symptoms,consult your doctor directly.

Other possible side effects:consult 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 for muscle and liver parameters.

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

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

Frequency not known (cannot be estimated based on available data)

Impotence, constant muscle weakness, breathing problems including persistent cough and/or labored breathing or fever.

Dyspepsia

Severe myasthenia (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing).

Myasthenia gravis (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:

• Alterations in sleep, including insomnia and nightmares.
• Memory loss
• Sexual difficulties
• Depression
• Diabetes. This is more likely if you have high blood sugar and fat levels, are overweight, and have 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, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly to the Spanish System for 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 medicine.

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

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

Store below 30°C.

Medicines should not be disposed of through drains.Deposit the packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy. In case of doubtask 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 Fluvastatin Teva

• The active ingredient is fluvastatin sodium

Each 20 mg capsule contains 20 mg of fluvastatin (as fluvastatin sodium)

Each 40 mg capsule contains 40 mg of fluvastatin (as fluvastatin sodium)

• The other components are: lactose monohydrate, colloidal anhydrous silica, crospovidone, magnesium stearate, red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172), titanium dioxide (E171), gelatin, shellac, and propylene glycol.

Appearance of the product and contents of the package

Fluvastatin Teva 20 mg are hard, white opaque capsules with a pink opaque cap marked with 93/7442.

Fluvastatin Teva 40 mg are hard, yellow opaque capsules with a pink opaque cap marked with 93/7443.

Packaging sizes:

Blister packs:1, 14, 15, 20,28, 30, 50, 50x2, 56, 60, 84, 90, 98, and 100 hard capsules.

Clinical packs in blister packs:1, 50, and 100 hard capsules.

Bottles:100, 250, and 500 hard capsules.

Only some packaging sizes may be commercially available.

The capsule should be removed from the blister pack carefully, as shown in the drawing, to avoid damaging it.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

Anabel Segura, 11. Edificio Albatros B - 1st floor.

28108 Alcobendas-Madrid

Responsible manufacturer:

Pharmachemie B.V.

Swensweg 5, Postbus 552, 2003 RN Haarlem

Holland

TEVA PharmaceuticalWorks Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

Merckle GmbH

Ludwig-Merckle-Straße 3, 89143 Blaubeuren

Germany

Last review date of this leaflet:March 2022

For detailed information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) at http://www.aemps.gob.es/

You can access detailed and updated information about this medicine by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/69981/P_69981.html