FLUVASTATIN STADA 80 mg PROLONGED-RELEASE TABLETS

2. What you need to know before taking Fluvastatin STADA

Follow your doctor's instructions for taking this medication carefully. They may be different from the general information contained in this package leaflet.

Before taking Fluvastatin STADA, read the following clarifications:

DO NOT take Fluvastatin STADA:

• if you are allergic to fluvastatin or any of the other components of this medication (listed in section 6).
• if you have liver problems or present an unexplained and persistent elevation of certain liver enzyme levels (transaminases).
• if you are pregnant or breastfeeding (see "Pregnancy and breastfeeding").

If you are in any of these situations, do not take Fluvastatin STADA and consult your doctor.

Warnings and precautions

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

• if you have previously had liver disease. Normally, you will undergo liver function tests before starting treatment with Fluvastatin STADA, when the dose is increased, and at different time intervals during treatment to check for adverse effects.
• if you have kidney disease.
• if you have 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, fainting).
• 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 uncontrolled diabetes and low blood potassium levels.
• if you are taking or have taken, during the last 7 days, a medication called fusidic acid (an antibiotic) orally or by injection. The combination of fusidic acid and Fluvastatin STADA can rarely cause serious muscle problems (rhabdomyolysis).

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 levels of sugars and fats in the blood, are overweight, and have high blood pressure.

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

• have severe respiratory failure

If you are in any of these situations, tell yourdoctor before takingFluvastatin STADA. Your doctor will perform a blood test before prescribing Fluvastatin STADA.

If during treatment with Fluvastatin STADA 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.

Also, inform your doctor or pharmacist if you experience constant muscle weakness. Additional tests and medications may be needed to diagnose and treat muscle weakness.

Fluvastatin 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.

Fluvastatin STADA and children/adolescents

Fluvastatin has not been investigated and is not 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 fluvastatin in combination with nicotinic acid, cholestyramine, or fibrates in children and adolescents.

Other medications and Fluvastatin STADA

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

• If you need to take fusidic acid orally for the treatment of a bacterial infection, you should temporarily stop taking this medication. Your doctor will tell you when it is safe to restart Fluvastatin STADA. Taking Fluvastatin STADA with fusidic acid can rarely cause serious muscle problems (rhabdomyolysis). See section 4 for more information on rhabdomyolysis.

Fluvastatin STADA can be taken alone or with other cholesterol-lowering medications prescribed by your doctor.

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

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

• Cyclosporine (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).
• Fluconazole (a medication used to treat fungal infections).
• Rifampicin (an antibiotic).
• Phenytoin (a medication used to treat epilepsy).
• Oral anticoagulants such as warfarin (medications used to reduce blood clots).
• Glibenclamide (a medication used to treat diabetes).
• Colchicine (used to treat gout).

Taking Fluvastatin STADA with food and drinks

You can take Fluvastatin STADA with or without food.

Pregnancy and breastfeeding

Do not take Fluvastatin STADA if you are pregnant or breastfeeding, as the active ingredient 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 Fluvastatin STADA.

You should take adequate precautions to avoid becoming pregnant while receiving treatment with Fluvastatin STADA.

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

Your doctor will discuss the potential risk of taking Fluvastatin STADA during pregnancy.

Driving and using machines

There is no information available on the effects of Fluvastatin STADA on the ability to drive and use machines.

Fluvastatin STADA contains sodium

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

3. How to take Fluvastatin STADA

Follow your doctor's instructions for taking this medication exactly. 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 Fluvastatin STADA.

How much Fluvastatin STADA should you take

• The dosage range 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.
• In children (9 years old and older), the initial dose is usually 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 Fluvastatin STADA tablets you should take.

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

Note that you cannot use Fluvastatin STADA 80 mg prolonged-release tablets for all the dosages described above. Fluvastatin 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 to take Fluvastatin STADA

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

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

If you take more Fluvastatin STADA than you should

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

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

If you forget to take Fluvastatin STADA

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 Fluvastatin STADA

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication 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 attention immediately.

• if you experience unexplained muscle pain, sensitivity, or weakness. These can be early signs of potentially serious muscle degradation. This can be avoided if your doctor stops your treatment with fluvastatin as soon as possible. These side effects have also been observed in similar medications of this class (statins).
• if you experience unusual tiredness or fever, yellowing of the skin and eyes, dark urine (signs of hepatitis).
• if you have skin reactions such as rash, blisters, redness, itching, swelling of the face, eyelids, and lips.
• if you have skin swelling, difficulty breathing, dizziness (signs of a severe allergic reaction).
• if you have bleeding or bruising more easily than normal (signs of a decrease in blood platelet count).
• if you have red or purple skin lesions (signs of blood vessel inflammation).
• if you have a skin rash with red spots mainly on the face, which 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: inform your doctor if you are concerned.

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

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

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

Numbness or tingling in 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. 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 medication.
• Tendon problems, sometimes complicated by tendon rupture

Reporting 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 Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Fluvastatin STADA

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

• Do not use this medication after the expiration date shown on the blister pack and carton after EXP. The expiration date is the last day of the month indicated.

• Do not store above 30°C.
• Keep in the original packaging to protect from light.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and unused medications at the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Fluvastatin STADA

• The active ingredient is fluvastatin.

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

• Other components are:

• Core of the tablet: 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 package contents

Fluvastatin STADA are biconvex, round, yellow prolonged-release tablets.

Package size:

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

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern

(Barcelona)

[email protected]

Manufacturer:

Actavis Ltd.

BLB016, Belebel Industrial Estate,

Zejtun ZTN 3000

Malta

or

Actavis ehf.

Reykjavikurvegi 78,

IS-222 Hafnarfjordur

Iceland

or

STADA Arzneimittel AG

Stadastrasse 2-18, 61118 Bad Vilbel

Germany

Date of the last revision of this package leaflet:October 2018

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/