Fluvastatin Teva 40 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Fluvastatina Teva 20 mg hard capsules EFG

Fluvastatina Teva 40 mg hard capsules EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask 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. 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 Fluvastatina Teva is and what it is used for
2. What you need to know before taking Fluvastatina Teva
3. How to take Fluvastatina Teva
4. Possible side effects
5. How to store Fluvastatina Teva
6. Contents of the pack and other information

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

Fluvastatina Teva contains the active substance fluvastatin sodium, which belongs to a group of medicines called statins, used to lower lipids—substances that reduce fat (lipids) in the blood. It is used in patients whose condition cannot be controlled by diet and exercise alone.

Fluvastatina Teva 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 fat) in the blood.

Your doctor may also prescribe Fluvastatina Teva to prevent serious heart problems (e.g., a heart attack) in patients who have already undergone heart catheterization or an intervention on the heart's blood vessels.

If you have any questions about how Fluvastatina Teva works or why it has been prescribed for you, please contact your doctor.

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

Carefully follow the instructions provided by your doctor, as they may differ from those included in this leaflet.

Read the following information before taking Fluvastatin Teva.

Do not take Fluvastatin Teva:

• 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 a persistent, unexplained increase in 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 currently 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 Teva may cause serious muscle problems (rhabdomyolysis).
• if you have previously had liver disease. You will usually have tests to check your liver function before starting Fluvastatin Teva, when the dose is increased, and at regular intervals during treatment to monitor for possible adverse effects.
• if you have kidney disease.
• if you have thyroid disease (hypothyroidism).
• if you have a 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 severe respiratory insufficiency.
• if you are over 70 years of age, your doctor may want to assess whether you are at risk of muscle-related problems. You may require additional blood tests.
• if you have a serious infection.
• if you have very low blood pressure (symptoms may include dizziness, lightheadedness).
• if you have excessive controlled or uncontrolled physical exertion.
• if you are about to undergo surgery.
• if you have severe metabolic, endocrine, or electrolyte disorders, such as uncontrolled diabetes or low blood potassium levels.
• 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 condition causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of 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 levels of sugar or fats 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 insufficiency.

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

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

If, during treatment with Fluvastatin Teva, you develop 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 such a case, contact a doctor immediately.

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

Using other medicines with Fluvastatin Teva

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those not requiring a prescription.

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 treatment with Fluvastatin Teva. The use of Fluvastatin Teva with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For further information on rhabdomyolysis, see section 4.

Fluvastatin Teva may be taken alone or together with other cholesterol-lowering medicines prescribed by your doctor.

If you take a resin, e.g., cholestyramine (used mainly to treat high cholesterol), wait at least 4 hours before taking Fluvastatin Teva.

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 levels of 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 for treating diabetes).
• Colchicine (used to treat gout).

Taking Fluvastatin Teva with food and drinks

You may 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 harm the unborn baby and it is not known whether 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 must take appropriate precautions to avoid pregnancy while being treated 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 risks 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 or operate machinery.

Fluvastatin Teva contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

Fluvastatin Teva contains sodium

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

3. How to take Fluvastatin Teva

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Do not exceed the recommended dose.

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

How much Fluvastatin Teva should you take?

Recommended dose in adults

The dosage range for adults is 20 mg to 80 mg daily, depending on the degree of cholesterol reduction required. Your doctor may adjust your dose at intervals of 4 weeks or longer.

Use in children and adolescents

In children (aged 9 years and older), the usual starting dose is 20 mg daily. 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 Teva you should take.

Depending on your response to treatment, your doctor may prescribe a higher or lower dose.

When to take Fluvastatin Teva

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

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

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

If you take more Fluvastatin Teva than you should

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

If you forget to take Fluvastatin Teva

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

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

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 maintain low levels of your "bad" cholesterol. Fluvastatin Teva will not cure your condition but will help you control it. Regular monitoring of your cholesterol levels is necessary to track 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) can be serious: seek immediate medical help if:

• You experience unexplained muscle pain, tenderness, or muscle weakness. These may be early signs of potentially serious muscle breakdown. This 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 and eyes, or dark-coloured urine (signs of hepatitis).

• You develop skin reactions such as redness, itching, or swelling of the face, eyelids, and 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 a reduced number of blood platelets).

• 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 inflammation of the pancreas – pancreatitis).

If you have any of these symptoms, consult your doctor immediately.

Other possible adverse effects: Talk to 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 parameters.

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

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

Frequency not known (cannot be estimated from available data):

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

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, drooping eyelids, difficulty swallowing, or difficulty breathing.

Other possible adverse effects:

• Sleep disturbances, including insomnia and nightmares.
• Memory loss
• Sexual difficulties
• Depression
• Diabetes. This is more likely if you have high levels of sugar and fats 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 a tendon.

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 Medicines: https://www.notificaram.es. By reporting adverse 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 drains. Dispose of unused containers and medicines at the SIGRE Point located at the pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fluvastatin Teva

• The active substance is fluvastatin sodium.

Each 20 mg capsule contains 20 mg of fluvastatin (as fluvastatin sodium).

Each 40 mg capsule contains 40 mg of fluvastatin (as fluvastatin sodium).

• The other components are: monohydrate lactose, 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 contents of the pack

Fluvastatin Teva 20 mg are hard capsules with an opaque ivory body and an opaque pink cap, marked with 93/7442.

Fluvastatin Teva 40 mg are hard capsules with an opaque yellow body and an opaque pink cap, marked with 93/7443.

Pack sizes:

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

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

Bottles: 100, 250 and 500 capsules.

Only certain pack sizes may be marketed.

The capsule should be carefully pushed out of the blister as shown in the picture, to avoid damaging it.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Teva Pharma, S.L.U.

Anabel Segura, 11. Edificio Albatros B - 1st floor.

28108 Alcobendas-Madrid

Manufacturer:

Pharmachemie B.V.

Swensweg 5, Postbus 552, 2003 RN Haarlem

The 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 most recent revision of this leaflet: March 2022

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

You can access detailed and up-to-date information about this medicine by scanning the QR code included on the outer 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