Fluvastatin Aurovitas Spain 80 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Fluvastatin Aurovitas Spain 80 mg prolonged-release tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. 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 you should not give it to others, 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 Fluvastatin Aurovitas Spain is and what it is used for
2. What you need to know before taking Fluvastatin Aurovitas Spain
3. How to take Fluvastatin Aurovitas Spain
4. Possible side effects
5. How to store Fluvastatin Aurovitas Spain
6. Contents of the pack and other information

1. What Fluvastatina Aurovitas Spain is and what it is used for

Fluvastatina Aurovitas Spain contains the active substance fluvastatin sodium, which belongs to a group of medicines known as statins, which are lipid-lowering agents: they reduce the fat (lipids) in the blood. They are used in patients whose condition cannot be controlled by diet and exercise alone.

• Fluvastatina Aurovitas Spain is a medicine used to treat elevated levels of fats in the blood of 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 Aurovitas Spain to prevent other serious heart problems (e.g. a heart attack) in patients after undergoing heart catheterization or a procedure on the blood vessels of the heart.

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

2. What you need to know before taking Fluvastatin Aurovitas Spain

Carefully follow all instructions given to you by your doctor. These may differ from the information included in this leaflet.

Before taking Fluvastatin Aurovitas Spain, read the following information.

Do not take Fluvastatin Aurovitas Spain

• 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 elevation in 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 Aurovitas Spain and consult your doctor.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Fluvastatin Aurovitas Spain:

• if you have previously had liver disease. You will usually have liver function tests before starting treatment with Fluvastatin Aurovitas Spain, when the dose is increased, and at various intervals during treatment to monitor for adverse effects.
• if you are taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (a medicine used to treat bacterial infections). The combination of fusidic acid and Fluvastatin Aurovitas Spain may cause serious muscle problems (rhabdomyolysis).
• if you have kidney disease.
• if you have a thyroid gland disorder (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 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).
• if you regularly drink large amounts of alcohol.
• if you have a serious infection.
• if you have very low blood pressure (symptoms may include dizziness, vertigo).
• if you engage in excessive controlled or uncontrolled physical exercise.
• if you are about to undergo surgery.
• if you have severe metabolic, endocrine, or electrolyte disorders such as uncontrolled diabetes or low potassium levels in the blood.

Consult your doctor or pharmacist before taking Fluvastatin Aurovitas Spain if you:

• Have severe respiratory insufficiency

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

If during treatment with Fluvastatin Aurovitas Spain 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 dysfunction. In such cases, contact your doctor immediately.

While taking this medicine, your doctor will monitor whether you have diabetes or are at risk of developing diabetes. This risk increases if you have high levels of sugar and fats in the blood, are overweight, or have high blood pressure.

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.

Fluvastatin Aurovitas Spain and patients 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. Specific blood tests may be required.

Fluvastatin Aurovitas Spain and children/adolescents

Fluvastatin Aurovitas Spain 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 Aurovitas Spain in combination with nicotinic acid, cholestyramine, or fibrates in children and adolescents.

Other medicines and Fluvastatin Aurovitas Spain

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Fluvastatin Aurovitas Spain 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 Aurovitas Spain.

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).
• If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will advise you when it is safe to restart treatment with Fluvastatin Aurovitas Spain. Taking fluvastatin with fusidic acid may, in rare cases, lead to muscle weakness, tenderness, or pain (rhabdomyolysis). See further information on rhabdomyolysis in section 4.

Taking Fluvastatin Aurovitas Spain with food and drink

You may take Fluvastatin Aurovitas Spain with or without food.

Pregnancy and breastfeeding

Do not take Fluvastatin Aurovitas Spain if you are pregnant or breastfeeding, as the active substance may harm the fetus and it is unknown whether it is excreted in breast milk. If you are pregnant, consult your doctor or pharmacist before taking Fluvastatin Aurovitas Spain. You must take appropriate precautions to avoid becoming pregnant while receiving treatment with Fluvastatin Aurovitas Spain.

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

Driving and using machines

There is no information available on the effects of Fluvastatin Aurovitas Spain on the ability to drive or operate machinery.

Fluvastatin Aurovitas Spain contains sodium

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

3. How to take Fluvastatin Aurovitas Spain

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

Do not take a higher dose than indicated.

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

How much Fluvastatin Aurovitas Spain should you take?

• The dose range 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.
• In children (9 years of age 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 tablets of Fluvastatin Aurovitas Spain you should take.

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

Fluvastatin Aurovitas Spain is only available as prolonged-release tablets. For lower doses (20 mg and 40 mg), your doctor will prescribe other medications.

When to take Fluvastatin Aurovitas Spain

You may take Fluvastatin Aurovitas Spain at any time of day.

Fluvastatin Aurovitas Spain may be taken with or without food. Swallow the tablet whole with a glass of water.

If you take more Fluvastatin Aurovitas Spain than you should

If you have accidentally taken too much Fluvastatin Aurovitas Spain, 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, stating the medication and the amount ingested. You may require medical attention.

If you forget to take Fluvastatin Aurovitas Spain

Take the missed 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 Aurovitas Spain

To maintain the benefits of your treatment, do not stop taking Fluvastatin Aurovitas Spain unless your doctor tells you to. You should continue taking Fluvastatin Aurovitas Spain as prescribed to maintain low levels of your "bad" cholesterol. Fluvastatin Aurovitas Spain 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 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 (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 unexplained muscle pain, tenderness or 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 signs of skin reactions such as rash, blisters, redness, itching, swelling of the face, eyelids or 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 inflammation of blood vessels).
• 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).

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

Other adverse effects: inform your doctor if you are concerned.

Frequent (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.

Possible adverse effects:

• Sleep disorders, including insomnia and nightmares.
• Memory loss.
• Sexual dysfunction.
• Depression.
• Diabetes. This is more likely if you have high levels of sugars 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 effects 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, 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: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fluvastatin Aurovitas Spain

Keep this medicine out of sight and reach of children.

Do not store above 30°C.

Blister packs: keep in the original packaging to protect from light.

Tablet bottles (glass bottle 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 the carton after EXP. The expiry date refers to the last day of the month indicated.

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

6. Contents of the pack and other information

Composition of Fluvastatin Aurovitas Spain

• The active substance is fluvastatin sodium.

Each tablet of Fluvastatin Aurovitas Spain contains 84.48 mg of fluvastatin sodium, equivalent to 80 mg of fluvastatin base.

• The other components are:

Tablet core: povidone, microcrystalline cellulose, hydroxyethylcellulose, mannitol (E-421), magnesium stearate.

Tablet coating: hypromellose 50, macrogol 6000, yellow iron oxide (E172), titanium dioxide (E171).

Appearance of the medicinal product and contents of the pack

Fluvastatin Aurovitas Spain prolonged-release tablets are biconvex, round, and yellow.

Pack sizes:

Blister (OPA/Aluminium/PVC-Aluminium): 10, 20, 28, 30, 50, 60, 98 and 100 prolonged-release tablets.

HDPE bottle with desiccant and easy-open cap (LDPE) and integrated tamper-evident seal. Pack size of 250 prolonged-release tablets.

Glass bottle with desiccant and HDPE cap: 250 prolonged-release tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

Generis Farmacêutica, S.A.

Rua João de Deus, 19 2700-487

Amadora, Portugal.

Or

Merckle GmbH

Ludwig Merckle-Strasse 3, 89143

Blaubeuren (Germany)

Date of the most recent review of this leaflet: May 2023

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