Fluvastatin Ratiopharm 80 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Fluvastatina ratiopharm 80 mg prolonged-release tablets EFG

fluvastatin sodium

Read all of this 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 should not be given to other people, even if they have the

same symptoms, as 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.

Contents of this leaflet:

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

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

Fluvastatina ratiopharm contains the active substance fluvastatina sódica, which belongs to a group of medicines called statins, used to lower lipids: they reduce fat (lipids) in the blood. They are used in patients whose condition cannot be controlled by diet and exercise alone.

Fluvastatina 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 lipid) in the blood.

Your doctor may also prescribe Fluvastatina ratiopharm to help prevent other serious heart problems (e.g., a heart attack) in patients who have already undergone heart catheterization or a procedure on the blood vessels of the heart.

If you have any doubts about how Fluvastatina ratiopharm works or why it has been prescribed for you, please consult your doctor.

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

Carefully follow all instructions given by your doctor, even if they differ from the general information included in this leaflet.

Read the following information before taking Fluvastatin ratiopharm.

Do not take Fluvastatin ratiopharm

• 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 an unexplained and persistent increase in the levels 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 ratiopharm and consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Fluvastatin ratiopharm

• 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 ratiopharm may cause serious muscle problems (rhabdomyolysis)
• if you have previously had liver disease. Usually, liver function tests will be performed before starting treatment with Fluvastatin ratiopharm, when the dose is increased, and at various time intervals during treatment to monitor for adverse effects
• if you have kidney disease
• if you have thyroid disease (hypothyroidism)
• if you or a family member has a 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 a severe infection
• if you have very low blood pressure (symptoms may include dizziness, vertigo)
• if you are performing excessive controlled or uncontrolled physical exercise
• if you are about to undergo surgery
• if you have severe metabolic, endocrine, or electrolyte disorders such as poorly controlled 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 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 ratiopharm

• if you have severe respiratory insufficiency

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

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

If, during treatment with Fluvastatin ratiopharm, 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 your doctor immediately.

Fluvastatin ratiopharm and people over 70 years of age

• if you are over 70 years old, your doctor may want to assess your risk of developing muscle-related problems. You may require additional blood tests.

Children and adolescents

Fluvastatin 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 of age and adolescents, see section 3.

There is no experience with the use of Fluvastatin ratiopharm in combination with nicotinic acid, cholestyramine, or fibrates in children and adolescents.

Other medicines and Fluvastatin ratiopharm

Inform 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 using this medicine. Your doctor will advise you when you can restart treatment with Fluvastatin ratiopharm. Using Fluvastatin ratiopharm with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For further information on rhabdomyolysis, see section 4.

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

After taking a resin, e.g. cholestyramine (mainly used to treat high cholesterol), wait at least 4 hours before taking Fluvastatin 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 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 used to treat diabetes)
• Colchicine (used to treat gout)

Fluvastatin ratiopharm with food and drink

You may take Fluvastatin ratiopharm with or without food.

Pregnancy and breastfeeding

Do not take Fluvastatin ratiopharm if you are pregnant or breastfeeding, as the active substance may cause harm to the fetus and it is unknown 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 taking any medicine.

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

You should take appropriate precautions to avoid becoming pregnant while being treated with Fluvastatin ratiopharm.

Driving and using machines

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

Fluvastatin 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 Fluvastatine ratiopharm

Follow exactly the instructions for the administration of Fluvastatine ratiopharm provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Do not exceed the recommended dose.

Your doctor will advise you to follow a low-cholesterol diet. Continue this diet while taking Fluvastatine ratiopharm.

How much Fluvastatine Teva you should take

Usual doses in adults

The recommended dose range of fluvastatine for adults with high levels of fats in the blood is 20 mg to 80 mg daily, depending on the extent of cholesterol reduction required. Your doctor may adjust your dose at intervals of 4 weeks or longer.

Doses in children and adolescents

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

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

When to take Fluvastatine ratiopharm

If you are taking Fluvastatine ratiopharm, take your dose at any time of day.

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

If you take more Fluvastatine ratiopharm than you should

If you have accidentally taken too many Fluvastatine ratiopharm tablets, inform your doctor immediately. You may require medical attention.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Fluvastatine ratiopharm

Take a dose as soon as you remember. However, do not take it if less than 4 hours remain before your next 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 Fluvastatine ratiopharm

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

If you have any further questions about the use of this product, 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 (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 help if you experience any of the following:

• If you experience unexplained muscle pain, tenderness, or weakness. These may be early signs of potentially serious muscle breakdown (rhabdomyolysis). This condition 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).

• If you experience unusual tiredness or fever, yellowing of the skin or eyes, or dark-coloured urine (signs of hepatitis)

• If you develop signs of skin reactions such as rash, blisters, redness, itching, swelling of the face, eyelids, or lips

• If you have skin swelling, difficulty breathing, or dizziness (signs of a severe allergic reaction)

• If you bruise or bleed more easily than normal (signs of reduced blood platelet count)

• If you develop red or purple skin lesions (signs of blood vessel inflammation)

• If 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 systemic lupus erythematosus-like reaction)

• If you have severe pain in the upper part of the stomach (signs of pancreatitis)

If you experience any of these adverse effects, inform your doctor immediately.

Other adverse effects: discuss them with your doctor if they concern you

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 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 difficulty breathing 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 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 the 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 consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fluvastatin ratiopharm

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

Do not store above 30°C.

Store in the original packaging to protect it from moisture.

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

Medicines should not be disposed of via wastewater. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Additional Information

Composition of Fluvastatin ratiopharm

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

The other components are: Tablet core: carrageenan, magnesium stearate.

Tablet coating: hydroxypropyl cellulose, hypromellose 6cP, polyethylene glycol 8000, yellow iron oxide (E-172), red iron oxide.

Appearance of the product and contents of the pack

Fluvastatin ratiopharm 80 mg are prolonged-release yellowish-brown, round, biconvex tablets in aluminum/aluminum blisters.

Pack sizes:

Blister packs containing 20, 28, 30, 50, 56, 60, 90, 98, 100 and 490 tablets.

Only some pack sizes may be marketed.

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:

Pharmathen S.A.,

6 Dervenakion Str,

153 51 Pallini, Attiki (Greece)

Merckle GmbH

Ludwig-Merckle-Strasse 3

89143 Blaubeuren

Germany

Pharmathen Internacional S.A.

Sapes Industrial Park

Block 5 Rodopi

69300 Greece

Date of the most recent revision of this package leaflet: April 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/