FLUVASTATIN SANDOZ 40 mg HARD CAPSULES

2. What you need to know before you take Fluvastatin Sandoz

Follow carefully all instructions given by your doctor. These may be different from the information contained in this leaflet.

Before taking Fluvastatin Sandoz, read the following carefully.

Do not take Fluvastatin Sandoz

• 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 if you have a persistent increase in liver enzymes (transaminases) of unknown cause,
• 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 in the last 7 days a medicine containing fusidic acid (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and fluvastatin can lead to a serious muscle problem (rhabdomyolysis),
• if you have or have had myasthenia (a disease characterized by generalized muscle weakness that can affect the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes worsen the disease or cause myasthenia (see section 4),
• if you have previously had liver disease. Normally, liver function tests are performed before starting treatment with fluvastatin, when increasing the dose, and at regular intervals during treatment to monitor the occurrence of side 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 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 pounding headache),
• if you engage in excessive controlled or uncontrolled muscle exercise,
• if you are going to undergo surgery,
• if you have significant metabolic, endocrine, or electrolyte disorders, such as uncontrolled diabetes or low potassium levels in the blood,
• while taking this medicine, 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 sugar and fat in the blood, are overweight, and have high blood pressure.

Check with your doctor or pharmacist before taking fluvastatin:

• if you have severe respiratory failure.

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

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

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 disorders, sleep disorders, tremors, easy bruising or bleeding, these may be symptoms of liver damage. In these cases, contact your doctor immediately.

Elderly 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

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, colestyramine, or fibrates in children and adolescents.

Use of Fluvastatin Sandoz with other medicines

Tell your doctor or pharmacist that you are taking, have recently taken, or may take any other medicines.

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

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

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

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

• cyclosporin (a medicine used to suppress the immune system),
• fibrates (e.g. gemfibrozil), nicotinic acid, or bile acid sequestrants (medicines used to lower "bad" cholesterol),
• 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 drinks

You can 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 if it is excreted in breast milk. If you are pregnant, consult your doctor or pharmacist before taking fluvastatin.

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

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

Fluvastatin Sandoz contains sodium

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

Driving and using machines

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

3. How to take Fluvastatin Sandoz

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist.

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

How much Fluvastatin Sandoz to take

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

When to take Fluvastatin 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 one at night or before bedtime.

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

If you take more Fluvastatin Sandoz than you should

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

If you forget to take Fluvastatin Sandoz

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 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 keep your "bad" cholesterol levels low. Fluvastatin will not cure your condition but will help control it. It is necessary to check your cholesterol levels regularly to monitor your progress.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 a potentially serious muscle degradation that can be avoided if your doctor stops your treatment with fluvastatin as soon as possible. These side effects have also been observed in similar medicines of this class (statins),
• if you experience unusual tiredness, 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 swelling of the skin, difficulty breathing, dizziness (signs of a severe allergic reaction),
• if you have bleeding or bruising more easily than normal (signs of a decrease in the number of blood platelets),
• 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 can 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 they worry you.

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

Difficulty sleeping, headache, stomach upset, abdominal pain, nausea, altered muscle and liver test results.

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

Numbness or tingling of the hands or feet, altered or decreased sensitivity.

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

• Impotence, constant muscle weakness, diarrhea.
• Severe myasthenia (a disease that causes generalized muscle weakness that can affect the muscles used for breathing).
• Ocular myasthenia (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 drooping eyelids, difficulty swallowing, or difficulty breathing.

Other possible side effects:

• sleep disorders, 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 levels of sugar and fat in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine,
• inflammation, swelling, and irritation of the tendons.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Information System: https://www.notificaram.es. By reporting side 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 pack after EXP. The expiry date refers to the last day of the month stated.

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

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

After opening the HDPE bottle: 4 months

Store in the original packaging to protect from light.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Packaging Contents and Additional Information

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:

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

Product Appearance and Packaging Contents

Fluvastatina Sandoz are hard capsules of brown color that contain a white to pale yellow powder.

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

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

Only some packaging sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek Pharmaceuticals d.d.

Verovskova 57

1526 Ljubljana

Slovenia

Or

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

RO-540472 Targu-Mures

Romania

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 Member States of the European Economic Area under 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, capsule

FLUVASTATINE SANDOZ 40 mg, capsule

Netherlands: Fluvastatine Sandoz 20 mg, hard capsules

Portugal: FLUVASTATINA Sandoz 20 mg CAPSULES

FLUVASTATINA Sandoz 20 mg CAPSULES

United Kingdom: FLUVASTATIN 20 MG CAPSULES

Date of the last revision of this leaflet: April 2023

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