Fluvastatina ratiopharm 80 mg comprimidos de liberacion prolongada efg

Prospect: Information for the User

Fluvastatina ratiopharm 80 mg prolonged-release tablets EFG

fluvastatina sódica

Read this prospect carefully before starting to take the medicine because it contains important information for you

- Keep this prospect as you may need to read it again.

- If you have any doubts, consult your doctor or pharmacist.

- This medicine has been prescribed only to you and should not be given to other people, even if they have the same symptoms, as it may harm them.

- If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

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

3.How to take Fluvastatina ratiopharm

4.Possible adverse effects

5.Storage of Fluvastatina ratiopharm

6.Contents of the package and additional information

Fluvastatina ratiopharm contains the active ingredient fluvastatina sodium, which belongs to a group of medicines called statins, which are medicines to reduce lipids: decrease the fat (lipids) in the blood. They are used in patients whose condition cannot be controlled solely with diet and exercise.

Fluvastatina is a medicine that is usedto treat high levels of fats in the blood of adults, particularly total cholesterol and the so-called "bad" or LDL-cholesterol, which is associated with a high risk of heart disease and stroke

Your doctor may also prescribe Fluvastatina ratiopharm for the prevention of other serious heart problems (e.g. a heart attack) in patients who have already undergone a heart catheterization through an intervention in the heart vessels.

If you have any doubts about how Fluvastatina ratiopharm works or why you have been prescribed this medicine, consult your doctor.

Follow carefully all the instructions given to you by your doctor, even if they differ from the general information included in this prospectus.

Read the following explanations before taking Fluvastatina ratiopharm.

Do not takeFluvastatina ratiopharm

• if you are allergic to fluvastatin or to any of the other components of this medication included in section 6
• if you have liver problems, or present an elevation of unknown and persistent 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 Fluvastatina ratiopharm and consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Fluvastatina ratiopharm

• if you are taking or have taken in the last 7 days a medication that contains fusidic acid, (used for the treatment of bacterial infection) by oral or injection route. The combination of fusidic acid and Fluvastatina ratiopharm may produce severe muscle problems (rhabdomyolysis)
• if you have previously suffered from liver disease. Normally, liver function controls will be performed before starting treatment with Fluvastatina ratiopharm, when the dose is increased and at different intervals of time during treatment to control the appearance of adverse 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 habitually drink large amounts of alcohol.
• if you have a severe infection.
• If you have very low blood pressure (the signs may include dizziness, vertigo),
• If you engage in 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 blood potassium levels.
• if you have or have had myasthenia (a disease that is characterized by 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 may 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 probably at risk of developing diabetes if you have high blood sugar or fat levels, are overweight, or have high blood pressure.

Consult your doctor or pharmacist before taking Fluvastatina ratiopharm

• if you have severe respiratory failure

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

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

If during treatment with Fluvastatina 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 insufficiency. In this case, contact your doctor immediately.

Fluvastatina ratiopharm and people over 70 years old

• if you are over 70 years old, your doctor may want to clarify whether you are at risk of suffering from muscle disorders. You may need additional blood tests.

Children and adolescents

Fluvastatina ratiopharm has not been investigated or indicated in children under 9 years old. For information on the dose in children over 9 years old and adolescents, see section 3.

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

Other medications and Fluvastatina ratiopharm

Inform your doctor or pharmacist if you are taking or have taken recently other medications or may need to take any other medication, even those acquired 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 indicate when you can restart treatment with Fluvastatina ratiopharm. The use of Fluvastatina ratiopharm with fusidic acid may produce muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Fluvastatina ratiopharm can be taken alone or with other medications to lower cholesterol that your doctor prescribes.

After taking a resin, for example, cholestyramine (used mainly to treat high cholesterol), wait at least 4 hours before taking Fluvastatina ratiopharm.

Inform your doctor and pharmacist if you are taking any of the following medications:

• Ciclosporin (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).

Fluvastatina ratiopharm with food and drinks

You can take Fluvastatina ratiopharm with or without food.

Pregnancy and breastfeeding

Do not takeFluvastatina ratiopharmif you are pregnant or breastfeeding, as the active ingredient may cause damage to the fetus and it is not known if it is excreted in breast milk.

If you are pregnant or breastfeeding, consult your doctor or pharmacist before taking any other medication.

If you become pregnant while taking this medication, you should stop taking Fluvastatina ratiopharm and consult your doctor.

You will need to take the necessary precautions to avoid becoming pregnant while receiving treatment with Fluvastatina ratiopharm.

Driving and operating machines

There is no information on the effects of Fluvastatina ratiopharm on the ability to drive and operate machines.

Fluvastatina ratiopharm contains sodium

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

Follow exactly the administration instructions for Fluvastatina ratiopharm indicated 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 Fluvastatina ratiopharm.

How much Fluvastatina Teva you should take

Usual doses in adults

The recommended dosage interval for adults with high levels of blood fats 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.

Doses in children and adolescents

In children (9 years of age and older), the usual initial dose is 20 mg of fluvastatina 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 much fluvastatina you should take.

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

When to take Fluvastatina ratiopharm

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

Fluvastatina ratiopharm can be taken with or without food. Swallow it whole with a glass of water.

If you take more Fluvastatina ratiopharm than you should

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

In case of overdose or accidental ingestion,consult your doctor or pharmacist immediatelyor call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Fluvastatina ratiopharm

Take a dose as soon as you remember. However, do not take it if less than 4 hours remain until the next dose. In this case, take the next dose at the usual time. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Fluvastatina ratiopharm

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

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medicines, this medicine 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 could be serious; seek immediate medical assistance.

• If you experience unexplained muscle pain, sensitivity, or muscle weakness. These may be early signs of a potentially severe muscle breakdown (rhabdomyolysis). This can be prevented if your doctor stops your fluvastatin treatment 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, yellow skin and eyes, dark urine (signs of hepatitis)
• If you have skin reaction signs such as skin rash, blisters, redness, itching, hives on the face, eyelids, and lips.
• If you have skin swelling, difficulty breathing, dizziness (signs of a severe allergic reaction).

• If you experience bleeding or bruising more easily than normal (signs of a decrease in blood platelet count).
• If you experience skin lesions that are red or purple (signs of blood vessel inflammation).
• If you experience a skin rash with red patches, mainly on the face, which may be accompanied by fatigue, fever, nausea, loss of appetite (signs of systemic lupus erythematosus-like reaction).
• If you experience intense pain in the upper abdomen (signs of pancreatitis).

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

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

Frequent(may affect 1 in 10 people):

Difficulty sleeping, headache, stomach discomfort, abdominal pain, nausea, altered muscle and liver parameters in blood tests.

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

Tickling or numbness in the hands or feet, altered or decreased sensitivity.

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

• Impotence, constant muscle weakness, respiratory problems including persistent cough and/or difficulty breathing or fever
• Diarrhea.
• Myasthenia gravis (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing).
• Myasthenia ocular (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, eyelid drooping, 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 had high blood sugar and fat levels, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.
• Tendon inflammation, swelling, and irritation

If you consider any of the side effects you are experiencing to be severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting side effects

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

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

Do not store at a temperature above30°C.

Store in the original packaging to protect it from moisture.

Do not usethis medication after the expiration date that appears on the box and on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Fluvastatina ratiopharm

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

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

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

Appearance of the product and contents of the package

Fluvastatina ratiopharm 80 mg are prolonged-release yellow-brown colored, round, biconvex tablets in aluminum/aluminum blisters.

Package sizes:

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

Only some package sizes may be commercially marketed.

Marketing authorization holder and responsible manufacturer:

Marketing authorization holder:

Teva Pharma, S.L.U.

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

28108 Alcobendas Madrid

Responsible 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 Grecia

Last review date of this leaflet: April 2023

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http: //www.aemps.gob.es/