Package Insert: Information for the Patient

Fluvastatina Sandoz 20 mg Hard Capsules EFG

Fluvastatina Sandoz 40 mg Hard Capsules EFG

Fluvastatin Sodium

Read this package insert carefully before you start taking this medicine, because it contains important information for you.

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

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

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

3. How to take Fluvastatina Sandoz

4. Possible side effects

5. Storage of Fluvastatina Sandoz

6. Contents of the pack and additional information

Fluvastatina Sandoz 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 by diet and exercise.

• Fluvastatin is a medicine that is usedto treat high levels of fats 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 fluvastatin 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 information included in this prospectus.

Before taking Fluvastatina Sandoz, read the following clarifications.

Do not take Fluvastatina Sandoz

• if you are allergic to fluvastatina or to any of the other components of this medication (including in section 6),
• if you have liver problems, or present an elevation of unknown and persistent levels 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 Sandoz and consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Fluvastatina Sandoz:

• 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 oral or injection route. The combination of fusidic acid and fluvastatina may lead to a severe muscle problem (rhabdomyolysis),
• if you have or have had myasthenia (a disease that runs with generalized muscle weakness that, in some cases, affects the muscles used to breathe) or myasthenia ocular (a disease that causes weakness of the eye muscles), as statins sometimes may worsen the disease or cause myasthenia (see section 4),
• if you have previously had a liver disease. Normally, liver function controls are performed before starting treatment with fluvastatina, when increasing the dose and at different intervals during treatment to control the appearance of adverse effects,
• if you have a 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 medication to lower lipid levels,
• if you habitually drink large amounts of alcohol,
• if you have a severe infection,
• if you have very low blood pressure (with symptoms such as dizziness or headache),
• if you are doing excessive controlled or uncontrolled muscle exercise,
• if you are about to undergo surgery,
• if you have large metabolic, endocrine, or electrolyte alterations such as uncontrolled diabetes or low blood potassium levels,
• while taking this medication, your doctor will check if you have diabetes or risk of developing diabetes. This risk of diabetes increases if you have high blood sugar and fat levels, overweight, and high blood pressure.

Check with your doctor or pharmacist before taking fluvastatina:

• if you have severe respiratory failure.

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

Also inform your doctor if you present constant muscle weakness. Additional tests and medications may be necessary to diagnose and treat this problem.

If during treatment with fluvastatina you develop symptoms or signs such as nausea, vomiting, loss of appetite, yellowing of the skin or eyes, confusion, euphoria or depression, mental slowness, speech alterations, sleep alterations, tremors, easy bleeding or appearance of hematomas, they may be symptoms of liver alterations.Contact your doctor immediately.

Patients 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 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.

No experience has been reported on the use of fluvastatina in combination with nicotinic acid, cholestyramine, or fibrates in children and adolescents.

Use of Fluvastatina Sandoz with other medications

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

If you have to take oral fusidic acid to treat a bacterial infection, you will have to stop taking this medication. Your doctor will indicate when you can restart the treatment with fluvastatina. The use of fluvastatina with fusidic acid may produce muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Fluvastatina Sandoz 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.

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

• ciclosporin (a medication used to suppress the immune system),
• fibrates (for example, 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),
• phenytoin (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 Sandoz with food and drinks

You can take fluvastatina with or without food.

Pregnancy and breastfeeding

Do not take fluvastatina 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.

You will need to take the necessary precautions to avoid becoming pregnant while receiving treatment with fluvastatina.

If you become pregnant while taking this medication, you should stop taking fluvastatina and consult your doctor. Your doctor will discuss with you the potential risk of taking fluvastatina during pregnancy.

Fluvastatina Sandoz contains sodium

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

Driving and using machines

No information is available on the effects of fluvastatina on the ability to drive anduse machines.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist.

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

How Much Fluvastatina Sandoz to Take

• 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.
• 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 capsules of fluvastatina you should take. Depending on how you respond to treatment, your doctor may prescribe a higher or lower dose.

When to Take Fluvastatina Sandoz

Take your fluvastatina dose at night or before bedtime.

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

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

If You Take More Fluvastatina Sandoz Than You Should

If you have taken more Fluvastatina Sandoz than you should, consult your doctor or go to the nearest hospital immediately, or call the Toxicological Information Service. Phone: 91 562 04 20 indicating the medication and the amount ingested, you may need medical attention.

If You Forget to Take Fluvastatina Sandoz

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

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

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

Rare or very rare side effects (may affect up to 1 in 1,000 people) or may be severe: seek immediate medical assistance.

• If you experience unexplained muscle pain, sensitivity, or weakness. These may be early signs of a potentially severe muscle degradation that 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 skin swelling, difficulty breathing, dizziness (signs of a severe allergic reaction),
• If you have bleeding or bruising more easily than usual (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 that may be accompanied by fatigue, fever, nausea, loss of appetite (signs of lupus erythematosus-like reaction),
• If you have intense upper stomach pain (signs of pancreatitis inflammation).

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 analytical values.

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

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

Not known(the frequency cannot be estimated from available data):

• Impotence, constant muscle weakness, diarrhea.
• Myasthenia gravis (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, eyelid drooping, difficulty swallowing, or difficulty breathing.

Other possible side effects:

• Sleep disturbances, including insomnia and nightmares,
• Memory loss,
• Sexual problems,
• Depression,
• Respiratory problems including persistent cough and/or difficulty breathing or fever,
• 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 medication,
• Tendon inflammation, swelling, and irritation.

Reporting of 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 through the Spanish System for the 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 this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

For Fluvastatina Sandoz packaged in OPA/ Al/ PVC/ Al blister: Do not store at a temperature above 25?°C.

For Fluvastatina Sandoz packaged in HDPE bottle: Do not store at a temperature above 25°C.

After the first opening of the HDPE bottle: 4 months

Store in the original packaging to protect it from light.

Medicines should not be throwndown the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Fluvastatina Sandoz

Fluvastatina Sandoz 20 mg: the active ingredient is fluvastatina sodium and each hard capsule contains an amount of 21.06 mg of fluvastatina sodium equivalent to 20 mg of fluvastatina.

Fluvastatina Sandoz 40 mg: the active ingredient is fluvastatina sodium and each hard capsule contains an amount of 42.12 mg of fluvastatina sodium equivalent to 40 mg of fluvastatina.

The other components are:

Hard capsule content:Calcium carbonate, microcrystalline cellulose, pregelatinized cornstarch (cornstarch), talc, sodium hydrogen carbonate, magnesium stearate.Hard gelatin capsule:Gelatin, titanium dioxide (E 171), iron oxide red (E 172), sodium lauryl sulfate

Appearance of the product and contents of the package

Fluvastatina Sandoz are hard brown capsules containing a white to pale yellow powder.

Fluvastatina Sandoz may be packaged in blisters (OPA/ Al/ PVC/ Al) or HDPE bottles (high-density polyethylene) with polypropylene (PP) closures in various formats.

OPA/ Al/ PVC/ Al blister: 14, 20, 28, 30, 50, 56, 84, 90, 98, 100, 490 hard capsules. HDPE bottle with PP closure: 98 hard capsules.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible manufacturer

Lek Pharmaceuticals d.d.

Verovskova 57

1526 Ljubljana

Slovenia

O

S. C. Sandoz, S.R.L. Str.Livezeni nr. 7A

RO-540472 Targu-Mures

Romania

O

Salutas Pharma GmbH Otto von Guericke Allee 1

39179 Barleben

Germany

O

Lek S.A.

Ul. Domaniewska 50C

02-672 Warzawa

Poland

O

Lek Pharmaceuticals d.d,

Trimlini 2 D,

9220 Lendava

Slovenia

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Austria:Fluvastatin Sandoz 20 mg – Hard capsules

Fluvastatin Sandoz 40 mg - Hard capsules

Belgium:Fluvastatine Sandoz 40 mg hard capsules

Denmark:Fluvastatin Sandoz

France:FLUVASTATINE SANDOZ 20 mg, gel

FLUVASTATINE SANDOZ 40 mg, gel

Netherlands:Fluvastatine Sandoz 20 mg, hard capsules

Portugal:FLUVASTATINA Sandoz 20 mg CAPSULES

FLUVASTATINA Sandoz 20 mg CAPSULES

United Kingdom:FLUVASTATIN 20 MG CAPSULES

Last review date of this leaflet: April 2023

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