Package Leaflet: Information for the User

Fluvastatina STADA 80 mg prolonged-release tablets EFG

Read this 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. Do not pass it on to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isFluvastatina STADAand what it is used for

2. What you need to know before you start takingFluvastatina STADA

3. How to takeFluvastatina STADA

4. Possible side effects

5. Storage ofFluvastatina STADA

6. Contents of the pack and additional information

Fluvastatina STADA contains 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 with diet and exercise.

• Fluvastatina STADA is a medicine used to treat high levels offat in the blood of 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 lipid) in the blood.

• Your doctor may also prescribe Fluvastatina STADA for the prevention of other serious heart problems (e.g. a heart attack) in patients after undergoing a heart catheterization through an intervention in the heart vessels.

Follow carefully all the instructions given to you by your doctor. These may be different from the general information contained in this prospectus.

Before taking Fluvastatina STADA, read the following clarifications:

DO NOT take Fluvastatina STADA:

• if you are allergic to fluvastatina or to any of the other components of this medication (including those listed in section 6).
• if you have liver problems, or present 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 STADA and consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Fluvastatina STADA.

• if you have previously had a liver disease. Normally, your doctor will perform liver function tests before starting treatment with Fluvastatina STADA, when increasing the dose, and at different intervals during treatment to check for the appearance 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 habitually drink large amounts of alcohol.
• if you have a severe infection.
• if you have very low blood pressure (symptoms may include dizziness, fainting).
• 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.
• if you have taken or are taking, within the last 7 days, a medication called fusidic acid (an antibiotic) orally or by injection. The combination of fusidic acid and Fluvastatina STADA may cause severe muscle problems (rhabdomyolysis).

While you are taking this medication, your doctor will monitor whether 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.

Consult your doctor or pharmacist before taking Fluvastatina STADA if you:

• have severe respiratory failure

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

If during treatment with Fluvastatina STADA you experience symptoms or signs such as nausea, vomiting, loss of appetite, yellow discoloration of the eyes or skin, confusion, euphoria or depression, mental slowing, difficulty speaking, sleep disturbances, tremors, or easy bruising or bleeding, these may be signs of liver insufficiency. In this case, contact your doctor immediately.

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

Fluvastatina STADA and 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.

Fluvastatina STADA and children/adolescents

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

Other medications and Fluvastatina STADA

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

• If you need to take fusidic acid orally for the treatment of a bacterial infection, you will need to temporarily interrupt the use of this medication. Your doctor will indicate when it will be safe to restart Fluvastatina STADA. Taking Fluvastatina STADA with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). See section 4 for more information on rhabdomyolysis.

Fluvastatina STADA 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 STADA.

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).

Fluvastatina STADA and food and beverages

You can take Fluvastatina STADA with or without food.

Pregnancy and breastfeeding

Do not take Fluvastatina STADA if you are pregnant or breastfeeding, as the active ingredient may cause damage to the fetus and it is not known if it is eliminated through breast milk. If you are pregnant, consult your doctor or pharmacist before taking Fluvastatina STADA.

You should take the necessary precautions to avoid becoming pregnant while receiving treatment with Fluvastatina STADA.

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

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

Driving and operating machines

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

Fluvastatina STADA contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor. 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 STADA.

How much Fluvastatina STADA should you take

• The dosage interval for adults is 20 mg to 80 mg per day and depends on the reduction of cholesterol levels that is necessary. Your doctor may adjust your dose at intervals of 4 weeks or more.
• 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 tablets of Fluvastatina STADA you should take.

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

Be aware that you cannot use Fluvastatina STADA 80 mg prolonged-release tablets for all the dosages described above. Fluvastatina STADA 80 mg prolonged-release tablets should not be divided. For lower doses (20 mg and 40 mg), your doctor will prescribe other medications containing fluvastatin.

When should you take Fluvastatina STADA

You can take your dose of Fluvastatina STADA at any time of the day.

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

If you take more Fluvastatina STADA than you should

If you have accidentally taken too much Fluvastatina STADA, inform your doctor immediately. You may need medical attention.

In case of overdose or accidental ingestion,consult your doctor or pharmacist immediatelyor call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Fluvastatina STADA

Take a dose as soon as you remember. However, do not take it if less than 4 hours remain until 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 STADA

To maintain the benefits of your treatment, you should not stop taking Fluvastatina STADA unless your doctor tells you to. You must continue taking Fluvastatina STADA as prescribed to maintain low levels of your "bad" cholesterol. Fluvastatina STADA 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) could be severe: 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 reactions such as skin rash, blisters, redness, itching, swelling of the face, eyelids, and lips.
• If you experience skin swelling, difficulty breathing, dizziness (signs of a severe allergic reaction).
• If you experience bleeding or bruising more easily than normal (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: inform your doctor if you are concerned.

Frequent (may affect up to 1 in 10 people):

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.

Unknown (frequency cannot be estimated from available data):

• Impotence.
• Constant muscle weakness
• Respiratory problems, including persistent cough and/or difficulty breathing or fever
• Diarrhea

Other possible side effects:

• Sleep disorders, including insomnia and nightmares
• Memory loss
• Sexual dysfunction
• Depression
• Diabetes. It is more likely if you have high blood sugar and fat levels, obesity, and high blood pressure. Your doctor will monitor you while taking this medicine.
• Tendon problems, sometimes complicated by tendon rupture

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 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 usethis medicationafter the expiration date that appears on the blister pack and on the packaging after CAD. The expiration date is the last day of the month indicated.

• Do not store at a temperature above 30°C.
• Store in the original packaging to protect it from light.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy.Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Fluvastatina STADA

• The active ingredient is fluvastatin.

Each prolonged-release tablet contains 80 mg of fluvastatin (as fluvastatin sodium).

• The other components are:

- Tablet core: povidone, microcrystalline cellulose, hydroxyethylcellulose, mannitol, magnesium stearate.

- Tablet coating: hypromellose 50, macrogol 6000, yellow iron oxide (E172), titanium dioxide (E171).

Appearance of the product and content of the container

Fluvastatina STADA are biconvex, round, and yellow prolonged-release tablets.

Container size:

Blister (OPA/Al/PVC-Al): 7, 20, 28, 30, 50, 56, 98, 100, and 120 prolonged-release tablets.

Only some container sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern

(Barcelona)

[email protected]

Responsible for manufacturing:

Actavis Ltd.

BLB016, Belebel Industrial Estate,

Zejtun ZTN 3000

Malta

or

Actavis ehf.

Reykjavikurvegi 78,

IS-222 Hafnarfjordur

Islandia

or

STADA Arzneimittel AG

Stadastrasse 2-18, 61118 Bad Vilbel

Alemania

Last review date of this leaflet: October 2018

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