Fluvastatin Teva-Ratiopharm 80 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Fluvastatina Teva-ratiopharm 80 mg prolonged-release tablets EFG

fluvastatin sodium

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 personally and you should not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if the side effects are not listed in this leaflet. See section 4.

What is in this leaflet

1. What Fluvastatina Teva-ratiopharm is and what it is used for
2. What you need to know before taking Fluvastatina Teva-ratiopharm
3. How to take Fluvastatina Teva-ratiopharm
4. Possible side effects
5. How to store Fluvastatina Teva-ratiopharm
6. Contents of the pack and other information

1. What Fluvastatin Teva-ratiopharm is and what it is used for

Fluvastatin Teva-ratiopharm contains the active substance fluvastatin sodium, which belongs to a group of medicines called 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 Teva-ratiopharm 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 Fluvastatin Teva-ratiopharm to help prevent other serious heart problems (e.g. a heart attack) in patients following a heart catheterization procedure involving intervention on the heart's blood vessels.

If you have any questions about how this medicine works or why it has been prescribed for you, please consult your doctor.

2. What you need to know before taking Fluvastatin Teva-ratiopharm

Carefully follow all instructions given by your doctor, as they may differ from those contained in this leaflet.

Read the following information before taking Fluvastatin Teva-ratiopharm.

Do not take Fluvastatin Teva-ratiopharm

• if you are allergic (hypersensitive) to fluvastatin or to any of the other ingredients of Fluvastatin Teva-ratiopharm 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-ratiopharm and consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Fluvastatin Teva-ratiopharm.

• if you are currently taking or have taken within the last 7 days a medicine containing fusidic acid (used to treat bacterial infection) by mouth or injection. The combination of fusidic acid and Fluvastatin Teva-ratiopharm may cause serious muscle problems (rhabdomyolysis).
• if you have previously had liver disease. You will usually have blood tests to check your liver function before starting treatment with Fluvastatin Teva-ratiopharm, when the dose is increased, and at different 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 previously experienced muscle problems with another lipid-lowering medicine.
• if you regularly drink large amounts of alcohol.
• if you have a serious infection.
• if you have low blood pressure (these signs may include dizziness, feeling faint).
• if you perform excessive controlled or uncontrolled physical exercise.
• if you are due to undergo surgery.
• if you have had severe metabolic, endocrine or electrolyte disorders such as uncontrolled diabetes or low potassium levels in the blood.
• if you have or have had myasthenia (a disease characterized by generalized muscle weakness that, 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).

While taking this medicine, your doctor will monitor you closely 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.

Check with your doctor or pharmacist before taking Fluvastatin Teva-ratiopharm

• if you have severe respiratory insufficiency.

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

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

If, during treatment with Fluvastatin Teva-ratiopharm, you develop symptoms or signs such as nausea, vomiting, loss of appetite, yellowing of the eyes or skin, confusion, euphoria, depression, mental slowness, slurred speech, sleep disturbances, tremors, bruising or bleeding, these may be signs of liver failure. In such cases, contact your doctor immediately.

Fluvastatin Teva-ratiopharm 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/adolescents

Fluvastatin Teva-ratiopharm has not been studied 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-ratiopharm in combination with nicotinic acid, colestyramine, or fibrates in children and adolescents.

Other medicines and Fluvastatin Teva-ratiopharm

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without 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-ratiopharm. Taking Fluvastatin Teva-ratiopharm with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For further information on rhabdomyolysis, see section 4.

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

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

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 reduce 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 used to treat diabetes)
• Colchicine (used to treat gout)

Taking Fluvastatin Teva-ratiopharm with food and drink

You may take Fluvastatin Teva-ratiopharm with or without food.

Pregnancy and breastfeeding

Do not take Fluvastatin Teva-ratiopharm if you are pregnant or breastfeeding, as the active substance may cause harm to the fetus 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.

Take appropriate precautions to avoid becoming pregnant while receiving treatment with Fluvastatin Teva-ratiopharm.

If you become pregnant while taking this medicine, you must stop taking Fluvastatin Teva-ratiopharm and consult your doctor.

Your doctor will discuss with you the potential risks of taking Fluvastatin Teva-ratiopharm during pregnancy.

Driving and using machines

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

Fluvastatin Teva-ratiopharm contains Sodium

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

3. How to take Fluvastatin Teva-ratiopharm

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

Do not take a higher dose than prescribed.

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

How much Fluvastatin Teva-ratiopharm should you take?

Usual doses in adults

The usual dose range of fluvastatin for adults is 20 mg to 80 mg daily, depending on the required reduction in cholesterol levels. 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 the dose at intervals of 6 weeks.

Your doctor will inform you exactly how much fluvastatin you should take.

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

Fluvastatin Teva-ratiopharm is only available as 80 mg prolonged-release tablets. For lower doses (20 mg and 40 mg), your doctor will prescribe other fluvastatin-containing medicines.

When to take Fluvastatin Teva-ratiopharm

If you are taking Fluvastatin Teva-ratiopharm 80 mg prolonged-release tablets EFG, you may take your dose at any time of day.

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

If you take more Fluvastatin Teva-ratiopharm than you should

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

If you forget to take Fluvastatin Teva-ratiopharm

Take the missed dose as soon as you remember. However, if less than 4 hours remain before your next scheduled dose, do not take the missed dose. Instead, take the next dose at your usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Fluvastatin Teva-ratiopharm

To maintain the benefits of your treatment, do not stop taking Fluvastatin Teva-ratiopharm unless instructed by your doctor. You should continue taking Fluvastatin Teva-ratiopharm as prescribed to maintain low levels of your "bad" cholesterol. Fluvastatin Teva-ratiopharm will not cure your condition but will help 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 experiences them.

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

• You experience unexplained muscle pain, tenderness, or weakness. These may be the first 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 reported with other medicines in the same class (statins).
• You experience unusual tiredness or fever, yellowing of the skin or eyes, or dark-colored urine (signs of hepatitis).
• You develop signs of skin reactions such as rash, blisters, redness, itching, or swelling of the face, eyelids, or lips.
• You have swelling of the skin, difficulty breathing, or dizziness (signs of a severe allergic reaction – anaphylactic reaction).
• You experience bleeding or bruising more easily than normal (signs of reduced platelet count).
• You develop red or purple skin lesions (signs of blood vessel inflammation – vasculitis). This adverse effect is very rare.
• You develop a skin rash with red patches, mainly on the face, possibly accompanied by fatigue, fever, nausea, or loss of appetite (signs of a systemic lupus erythematosus-type reaction).
• You have severe pain in the upper abdomen (signs of inflammation of the pancreas – 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 related to muscle and liver parameters.

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

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

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

• Impotence, persistent muscle weakness, respiratory problems including persistent cough and/or difficulty breathing or fever.
• Diarrhea
• 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 arm or leg weakness that worsens with activity, double vision or 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 previously had high levels of sugar and fats in your blood, are overweight, or have high blood pressure. Your doctor will monitor you while you are taking this medicine.
• Inflammation, swelling, and irritation of a tendon.

If you think any of the adverse effects you experience are serious, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

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-ratiopharm

Keep out of the sight and reach of children.

Do not store above 30°C.

Blister packs:

Keep in the original packaging to protect from light.

Vial (glass vial and HDPE):

Keep the container tightly closed to protect from moisture and light.

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

Medicines must not be disposed of via wastewater. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the container and additional information

Composition of Fluvastatin Teva-ratiopharm

The active substance is fluvastatin sodium, equivalent to 80 mg of fluvastatin.

The other components are:

Tablet core:

Povidone, microcrystalline cellulose, hydroxyethylcellulose, magnesium stearate, mannitol (E421), magnesium stearate.

Tablet coating:

Hypromellose 50, macrogol 6000, yellow iron oxide (E172), titanium dioxide (E171).

Appearance of the medicinal product and contents of the container

Fluvastatin Teva-ratiopharm 80 mg are prolonged-release, biconvex, round, yellow tablets.

Pack sizes:

Blister (OPA/Aluminum/PVC-Aluminum): 10, 20, 28, 30, 50, 60 and 100 prolonged-release tablets.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1st floor.

28108 Alcobendas, Madrid

Manufacturer:

Actavis Ltd.

BLB015-016, Belebel Industrial Estate,

Zejtun ZTN 3000

Malta

Date of the most recent review of this summary: March 2023

Detailed and up-to-date information on this medicinal product 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 with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/70161/P_70161.html

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