FLUVASTATIN TEVA 40 mg HARD CAPSULES

2. What you need to know before taking Fluvastatin Teva

Follow your doctor's instructions carefully, as they may differ from those listed in this package leaflet.

Read the following explanations before taking Fluvastatin Teva.

Do not take Fluvastatin Teva:

• if you are allergic to fluvastatin or any of the other ingredients of this medication listed in section 6.
• if you have liver problems or have an unexplained and persistent elevation 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 Teva and consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Fluvastatin Teva

• if you are taking or have taken in the last 7 days a medication containing fusidic acid (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and Fluvastatin Teva can cause serious muscle problems (rhabdomyolysis).
• if you have previously had liver disease. Normally, your doctor will perform blood tests to check your liver function before starting Fluvastatin Teva, when increasing the dose, and at various time intervals during treatment to check for possible side effects.
• if you have kidney disease.
• if you have thyroid 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 severe respiratory failure.
• if you are over 70 years old, your doctor may want to check if you have risk factors for muscle disease. You may need specific blood tests.
• if you have a severe infection.
• if you have very low blood pressure (symptoms may include dizziness, fainting).
• if you have 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 potassium levels in the blood.
• If you have or have had myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects 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).

While taking this medication, your doctor will closely monitor you if you have diabetes or are at risk of developing diabetes. You are likely to be at risk of developing diabetes if you have high sugar or fat levels in your blood, are overweight, or have had high blood pressure.

Consult your doctor or pharmacist before taking Fluvastatin Teva

• if you have severe respiratory failure

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

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

If, during treatment with Fluvastatin Teva, you experience symptoms or signs such as nausea, vomiting, loss of appetite, yellowing of the eyes or skin, confusion, euphoria or depression, mental slowness, difficulty speaking, sleep disturbances, tremors, or easy bruising or bleeding, these may be signs of liver failure. In this case, contact a doctor immediately.

Fluvastatin Teva 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 disease. You may need specific blood tests.

Children and adolescents

Fluvastatin Teva 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 Teva in combination with nicotinic acid, colestyramine, or fibrates in children and adolescents.

Use of other medications with Fluvastatin Teva

Tell your doctor or pharmacist if you are taking or have recently taken any other medications or may need to take any other medication, including those without a prescription.

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

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

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

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 Teva with food and drinks

You can take Fluvastatin Teva with or without food.

Pregnancy and breastfeeding

Do not take Fluvastatin Teva if you are pregnant or breastfeeding, as the active ingredient may cause harm to the fetus, and it is not known if it is excreted in breast milk.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

You should take adequate precautions to avoid becoming pregnant while receiving treatment with Fluvastatin Teva. If you become pregnant while taking this medication, stop taking Fluvastatin Teva and consult your doctor. Your doctor will discuss the potential risk of taking Fluvastatin Teva during pregnancy.

Driving and using machines

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

Fluvastatin Teva contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Fluvastatin Teva contains sodium

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

3. How to take Fluvastatin Teva

Follow your doctor's or pharmacist's instructions for taking this medication exactly. If in doubt, consult your doctor or pharmacist again. Do not exceed the recommended dose.

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

How much Fluvastatin Teva to take

Recommended dose for adults

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.

Use in children and adolescents

In children (9 years old 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 Fluvastatin Teva capsules to take.

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

When to take Fluvastatin Teva

If you are taking Fluvastatin Teva once a day, take your dose at night or before bedtime.

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

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

If you take more Fluvastatin Teva than you should

If you have accidentally taken many Fluvastatin Teva capsules, inform your doctor immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medication and the amount taken. You may need medical attention.

If you forget to take Fluvastatin Teva

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 missed doses.

If you stop treatment with Fluvastatin Teva

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

If you have any other doubts 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 can be serious: seek medical help 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 fatigue or fever, yellowing of the skin and eyes, dark urine (signs of hepatitis).
• if you have skin reactions such as 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, which 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 symptoms, consult your doctor directly.

Other possible side effects:discuss with your doctor if you are concerned.

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

Difficulty sleeping, headache, stomach upset, abdominal pain, nausea, abnormal blood test values for muscle and liver parameters.

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

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

Frequency not known (cannot be estimated from available data)

Impotence, constant muscle weakness, breathing problems including persistent cough and/or shortness of breath or fever.

Diarrhea

Severe myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects 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 disturbances, including insomnia and nightmares.
• Memory loss
• Sexual difficulties
• Depression
• Diabetes. This is more likely if you have high sugar and fat levels in your blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medication.
• Tendon inflammation, swelling, and irritation.

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Fluvastatin Teva

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

Do not use Fluvastatin Teva after the expiration date stated on the packaging, after the EXP date. The expiration date is the last day of the month indicated.

Store below 30°C.

Medications should not be disposed of through wastewater or household waste. Place the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Container Content and Additional Information

Composition of Fluvastatina Teva

• The active ingredient is sodium fluvastatine

Each 20 mg capsule contains 20 mg of fluvastatine (as sodium fluvastatine)

Each 40 mg capsule contains 40 mg of fluvastatine (as sodium fluvastatine)

• The other components are: lactose monohydrate, anhydrous colloidal silica, crospovidone, magnesium stearate, red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172), titanium dioxide (E171), gelatin, shellac, and propylene glycol.

Appearance of the Product and Container Content

Fluvastatina Teva 20 mg are hard capsules of opaque ivory color and the cap of opaque pink color marked with 93/7442.

Fluvastatina Teva 40 mg are hard capsules of opaque yellow color and the cap of opaque pink color marked with 93/7443.

Package sizes:

Blister packs:1, 14, 15, 20, 28, 30, 50, 50x2, 56, 60, 84, 90, 98, and 100 hard capsules.

Clinical trial blister packs:1, 50, and 100 hard capsules.

Bottles:100, 250, and 500 capsules

Only some package sizes may be marketed.

The capsule should be removed from the blister pack by carefully pushing it out as shown in the drawing, in order not to damage it.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

Anabel Segura, 11. Edificio Albatros B - 1ª planta.

28108 Alcobendas-Madrid

Manufacturer:

Pharmachemie B.V.

Swensweg 5, Postbus 552, 2003 RN Haarlem

Netherlands

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

Merckle GmbH

Ludwig-Merckle-Straße 3, 89143 Blaubeuren

Germany

Date of the Last Revision of this Prospectus:March 2022

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

You can access detailed and updated information about this medicinal product by scanning the QR code included in the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/69981/P_69981.html