FLUVASTATIN TEVA 20 mg HARD CAPSULES

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

Follow carefully the instructions given to you by your doctor, they may be different from those contained in this 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 medicine listed in section 6.
• if you have liver problems or have persistent elevated 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 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 medicine 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 had liver disease before. Normally, your doctor will perform blood tests to check your liver function before starting to take Fluvastatin Teva, when increasing the dose, and at regular 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 medicine.
• 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 diseases. You may need additional 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 medicine, 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 elderly patients over 70 years

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

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

If you have to take oral fusidic acid to treat a bacterial infection, you will have to stop using this medicine. 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 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 Teva.

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 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 clotting).
• Glibenclamide (a medicine 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 substance 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 medicine.

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

Driving and using machines

No information is 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 some sugars, consult with them before taking this medicine.

Fluvastatin Teva contains sodium

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

3. How to take Fluvastatin Teva

Follow exactly the administration instructions of this medicine given to you by your doctor or pharmacist. In case of 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 in 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 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 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 telephone 91 562 04 20, indicating the medicine 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 forgotten doses.

If you stop taking 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 keep your "bad" cholesterol levels low. Fluvastatin Teva 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 other questions about 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 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 damage. This can be avoided if your doctor stops your treatment with fluvastatin as soon as possible. These side effects have also been observed with similar medicines in this class (statins).

• if you experience unusual tiredness, fever, yellowing of the skin and eyes, dark-colored urine (signs of hepatitis).
• if you have skin reactions such as 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, 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 have 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 of the hands or feet, altered or decreased sensitivity.

Frequency not known (cannot be estimated from the 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 medicine.
• Tendon inflammation, swelling, and irritation.

Reporting of side effects

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

5. Storage of Fluvastatin Teva

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

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

Store below 30°C.

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

6. Container Content and Additional Information

Composition of Fluvastatina Teva

• The active ingredient is fluvastatina sodium

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

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

• 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 with an opaque ivory color and an opaque pink cap marked with 93/7442.

Fluvastatina Teva 40 mg are hard capsules with an opaque yellow color and an opaque pink cap 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 medication 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 medication 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