Fluvastatin Sandoz 40 mg hard capsules EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the Patient

Fluvastatin Sandoz 20 mg Hard Capsules EFG

Fluvastatin Sandoz 40 mg Hard Capsules EFG

Sodium Fluvastate

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, 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 must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents:

1. What Fluvastatin Sandoz is and what it is used for
2. What you need to know before taking Fluvastatin Sandoz
3. How to take Fluvastatin Sandoz
4. Possible adverse effects
5. How to store Fluvastatin Sandoz
6. Contents of the pack and other information

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

Fluvastatina Sandoz contains the active substance fluvastatin sodium, which belongs to a group of medicines known as statins, used to lower lipids: they reduce fat (lipids) in the blood. It is used in patients whose condition cannot be controlled by diet and exercise alone.

• Fluvastatin is a medicine used to treat high levels of fats in the blood in adults, particularly total cholesterol and so-called "bad" cholesterol or LDL-cholesterol, which is associated with an increased risk of heart disease and stroke:
• in adult patients with high blood cholesterol levels,
• in adult patients with high levels of both cholesterol and triglycerides (another type of lipid) in the blood.
• Your doctor may also prescribe fluvastatin to help prevent serious heart problems (e.g. a heart attack) in patients after undergoing heart catheterization or a procedure on the blood vessels of the heart.

2. What you need to know before taking Fluvastatin Sandoz

Carefully follow all instructions given to you by your doctor. These may differ from the information contained in this leaflet.

Before taking Fluvastatin Sandoz, read the following information.

Do not take Fluvastatin Sandoz

• if you are allergic to fluvastatin or to any of the other ingredients of this medicine (listed in section 6),
• if you have liver problems, or have an unexplained and persistent increase in levels 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 Fluvastatin Sandoz and consult your doctor.

Warnings and precautions

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

• if you are taking or have taken within the last 7 days a medicine containing fusidic acid (used to treat bacterial infection) taken orally or by injection. The combination of fusidic acid and fluvastatin may lead to a serious muscle problem (rhabdomyolysis),
• if you have or have had myasthenia (a disease characterized by generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4),
• if you have previously had liver disease. Liver function tests are usually performed before starting fluvastatin treatment, when the dose is increased, and at various intervals during treatment to monitor for adverse effects,
• if you have kidney disease,
• if you have thyroid gland disease (hypothyroidism),
• if you have personal or family history of muscle disorders,
• if you have experienced muscle problems with another lipid-lowering medicine,
• if you regularly drink large amounts of alcohol,
• if you have a severe infection,
• if you have very low blood pressure (with symptoms such as dizziness or throbbing headache),
• if you perform excessive controlled or uncontrolled physical exercise,
• if you are undergoing surgery,
• if you have significant metabolic, endocrine, or electrolyte disturbances such as uncontrolled diabetes or low blood potassium levels,
• while taking this medicine, your doctor will monitor you for diabetes or risk of developing diabetes. This risk is higher if you have high blood sugar and fat levels, are overweight, or have high blood pressure.

Check with your doctor or pharmacist before taking fluvastatin:

• if you have severe respiratory insufficiency.

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

Also inform your doctor if you experience persistent muscle weakness. Additional tests and treatments may be needed to diagnose and manage this condition.

If, during treatment with fluvastatin, 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 disturbances, sleep disturbances, tremors, or easy bruising or bleeding, these may be symptoms of liver dysfunction. In such cases, contact your doctor immediately.

Elderly patients (over 70 years of age)

If you are over 70 years old, your doctor may want to assess whether you have risk factors for muscle disorders. You may require specific blood tests.

Children and adolescents

Fluvastatin has not been studied and is not indicated in children under 9 years of age. For information on dosing in children over 9 years of age 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.

Taking Fluvastatin Sandoz with other medicines

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

If you need to take oral fusidic acid to treat a bacterial infection, you must stop taking this medicine. Your doctor will advise you when you can restart fluvastatin treatment. Using fluvastatin with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For further information on rhabdomyolysis, see section 4.

Fluvastatin Sandoz may be taken alone or together with other cholesterol-lowering medicines 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.

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

• cyclosporine (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).

Fluvastatin Sandoz with food and drink

You may take fluvastatin with or without food.

Pregnancy and breastfeeding

Do not take fluvastatin if you are pregnant or breastfeeding, as the active substance may harm the fetus and it is not known whether it is excreted in breast milk. If you are pregnant, consult your doctor or pharmacist before taking fluvastatin.

You must take appropriate precautions to avoid becoming pregnant while receiving fluvastatin treatment.

If you become pregnant while taking this medicine, you must stop taking fluvastatin and consult your doctor. Your doctor will discuss with you the potential risks of taking fluvastatin during pregnancy.

Fluvastatin Sandoz contains sodium

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

Driving and using machines

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

3. How to take Fluvastatine Sandoz

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine.

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

How much Fluvastatine Sandoz should you take

• The dosage range for adults is 20 mg to 80 mg per day and depends on the required reduction in cholesterol levels. Your doctor may adjust your dose at intervals of 4 weeks or longer.
• In children (9 years of age and older), the usual starting 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 fluvastatin you should take. Depending on your response to treatment, your doctor may prescribe a higher or lower dose.

When to take Fluvastatine Sandoz

Take your dose of fluvastatin at night or before bedtime.

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

Fluvastatin may be taken with or without food. Swallow the capsule whole with a glass of water.

If you take more Fluvastatine Sandoz than you should

If you have taken more Fluvastatine Sandoz than you should, consult your doctor or go to the nearest hospital immediately, or call the Toxicology Information Service. Telephone: 91 562 04 20, indicating the medicine and the amount ingested, as you may require medical attention.

If you forget to take Fluvastatine Sandoz

Take a dose as soon as you remember. However, do not take it if less than 4 hours remain before your next dose. In this case, take your next dose at the usual time.

Do not take a double dose to make up for a missed dose.

If you stop taking Fluvastatine Sandoz

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

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

4. Possible adverse effects

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

Some rare adverse effects (may affect up to 1 in 1,000 people) or very rare adverse effects (may affect up to 1 in 10,000 people) could be serious: seek immediate medical help if:

• you experience unexplained muscle pain, tenderness, or weakness. These may be early signs of potentially serious muscle breakdown, which can be prevented if your doctor stops your treatment with fluvastatin as soon as possible. These adverse effects have also been observed with similar medicines in this class (statins),
• you experience unusual tiredness or fever, yellowing of the skin or eyes, or dark-coloured urine (signs of hepatitis),
• you develop signs of skin reactions such as rash, blisters, redness, or itching,
• swelling of the face, eyelids, or lips,
• you have skin swelling, difficulty breathing, or dizziness (signs of a severe allergic reaction),
• you experience bleeding or bruising more easily than normal (signs of reduced blood platelet count),
• you develop red or purple skin lesions (signs of blood vessel inflammation),
• you develop a skin rash with red spots mainly on the face, possibly accompanied by fatigue, fever, nausea, or loss of appetite (signs of a lupus-like reaction),
• you have severe pain in the upper abdomen (signs of pancreatitis).

If you experience any of these adverse effects, inform your doctor immediately.

Other adverse effects: inform your doctor if you are concerned.

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

Difficulty sleeping, headache, stomach discomfort, abdominal pain, nausea, abnormal blood test results for muscle and liver.

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

Tingling or numbness in the hands or feet, altered or reduced sensation.

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

• Impotence, persistent muscle weakness, diarrhoea.
• Myasthenia gravis (a condition causing generalized muscle weakness, which in some cases affects the muscles used for breathing).
• Ocular myasthenia (a condition causing weakness of the eye muscles).

Consult your doctor if you experience worsening weakness in the arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

Other possible adverse effects:

• Sleep disturbances, including insomnia and nightmares,
• Memory loss,
• Sexual problems,
• Depression,
• Respiratory problems including persistent cough and/or difficulty breathing or fever,
• Diabetes. This is more likely if you have high levels of sugars and fats in the blood, are overweight, or have high blood pressure. Your doctor will monitor you while you are taking this medicine,
• Inflammation, swelling, and irritation of tendons.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fluvastatin Sandoz

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

For Fluvastatin Sandoz packed in OPA/Al/PVC/Al blisters: Do not store above 25°C.

For Fluvastatin Sandoz packed in HDPE bottles: Do not store above 25°C.

After first opening of the HDPE bottle: 4 months

Keep in the original packaging to protect from light.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and waste materials should be returned to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Fluvastatin Sandoz

Fluvastatin Sandoz 20 mg: The active substance is sodium fluvastatin. Each hard capsule contains 21.06 mg of sodium fluvastatin, equivalent to 20 mg of fluvastatin.

Fluvastatin Sandoz 40 mg: The active substance is sodium fluvastatin. Each hard capsule contains 42.12 mg of sodium fluvastatin, equivalent to 40 mg of fluvastatin.

The other components are:

Capsule contents: Calcium carbonate, microcrystalline cellulose, pregelatinized corn starch (corn starch), talc, sodium bicarbonate, magnesium stearate.
Hard gelatin capsule shell: Gelatin, titanium dioxide (E 171), iron oxide red (E 172), sodium lauryl sulfate.

Appearance of the product and contents of the pack

Fluvastatin Sandoz consists of brown hard capsules containing a whitish to pale yellow powder.

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

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

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.
Parque Norte Business Park
Roble Building
C/ Serrano Galvache, 56
28033 Madrid
Spain

Manufacturer

Lek Pharmaceuticals d.d.
Verovskova 57
1526 Ljubljana
Slovenia

Or

Salutas Pharma GmbH
Otto von Guericke Allee 1
39179 Barleben
Germany

Or

Lek S.A.
Ul. Domaniewska 50C
02-672 Warsaw
Poland

Or

Lek Pharmaceuticals d.d.
Trimlini 2 D
9220 Lendava
Slovenia

This medicinal product is authorized in the European Economic Area (EEA) member states under the following names:

Austria: Fluvastatin Sandoz 20 mg – Hartkapseln
Fluvastatin Sandoz 40 mg – Hartkapseln

Belgium: Fluvastatine Sandoz 40 mg harde capsules

Denmark: Fluvastatin Sandoz

France: FLUVASTATINE SANDOZ 20 mg, gélule
FLUVASTATINE SANDOZ 40 mg, gélule

Netherlands: Fluvastatine Sandoz 20 mg, harde capsules

Portugal: FLUVASTATINA Sandoz 20 mg CÁPSULAS
FLUVASTATINA Sandoz 20 mg CÁPSULAS

United Kingdom: FLUVASTATIN 20 MG CAPSULES

Date of the most recent review of this leaflet: April 2023

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