Fluvastatin Alter 80 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Fluvastatina Alter 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 you should not give it to others, even if they have the same symptoms as you, because 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 Alter is and what it is used for
2. What you need to know before taking Fluvastatina Alter
3. How to take Fluvastatina Alter
4. Possible side effects
5. How to store Fluvastatina Alter
6. Further information

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

Fluvastatina Alter contains the active substance fluvastatina sódica, which belongs to a group of medicines known as statins, used to lower lipids—substances that reduce fat (lipids) in the blood. These medicines are used in patients whose condition cannot be controlled by diet and exercise alone.

• Fluvastatina Alter is a medicine used to treat high 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 Alter to help prevent other serious heart problems (e.g., a heart attack) in patients who have undergone heart catheterization or a procedure involving the heart's blood vessels.

2. What you need to know before taking Fluvastatina Alter

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

Before taking Fluvastatina Alter, read the following information.

Do not take Fluvastatina Alter

• 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 Fluvastatina Alter and consult your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Fluvastatina Alter.

Take special care:

• if you have previously had liver disease. You will usually have liver function tests before starting treatment with Fluvastatina Alter, 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 a thyroid gland disorder (hypothyroidism).
• if you or a family member has a history of muscle disorders.
• if you have had muscle problems with another lipid-lowering medicine.
• 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 perform 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.
• 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 disease causing weakness of the eye muscles), since statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).

Check with your doctor or pharmacist before taking Fluvastatina Alter:

• If you are 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 Fluvastatina Alter may cause serious muscle problems (rhabdomyolysis).
• if you have severe respiratory insufficiency.

While you are 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 problem.

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

If during treatment with Fluvastatina Alter 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 the appearance of bruises or easy bleeding, these may be signs of liver failure. In this case, contact your doctor immediately.

Fluvastatina Alter and people over 70 years of age

If you are over 70 years old, your doctor may want to check whether you have risk factors for muscle disorders. You may need specific blood tests.

Children and adolescents

Fluvastatin 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 Fluvastatina Alter in combination with nicotinic acid, cholestyramine, or fibrates in children and adolescents.

Taking Fluvastatina Alter with other medicines

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

• 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 Fluvastatina Alter. Using Fluvastatina Alter with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For further information on rhabdomyolysis, see section 4.

Fluvastatina Alter 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 Fluvastatina Alter.

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).

Taking Fluvastatina Alter with food and drinks

You may take Fluvastatina Alter with or without food.

Pregnancy and breastfeeding

Do not take Fluvastatina Alter 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, consult your doctor or pharmacist before taking Fluvastatina Alter. You must take appropriate precautions to avoid becoming pregnant while being treated with Fluvastatina Alter.

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

Your doctor will discuss with you the potential risks of taking Fluvastatina Alter during pregnancy.

Driving and using machines

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

3. How to take Fluvastatina Alter

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, 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 you are taking Fluvastatina Alter.

How much Fluvastatina Alter should you take?

• The dosage range for adults is 20 mg to 80 mg per day, depending on the required reduction in cholesterol levels. Your doctor may adjust your dose at intervals of 4 weeks or longer.
• In children (aged 9 years and older), the usual starting dose is 20 mg per day. The maximum daily dose is 80 mg. Your doctor may adjust the dose at intervals of 6 weeks.

Your doctor will tell you exactly how many Fluvastatina Alter tablets you should take.

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

When to take Fluvastatina Alter

If you are taking Fluvastatina Alter, you may take your dose at any time of day.

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

If you take more Fluvastatina Alter than you should

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

If you forget to take Fluvastatina Alter

Take the missed dose as soon as you remember. However, if it is less than 4 hours before your next scheduled dose, do not take the missed dose. Instead, take the next dose at the usual time.

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

If you stop taking Fluvastatina Alter

To maintain the benefits of your treatment, do not stop taking Fluvastatina Alter unless your doctor tells you to. You should continue taking Fluvastatina Alter as prescribed to keep your "bad" cholesterol levels low. Fluvastatina Alter 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 side effects

Like all medicines, this medicine can cause side effects, although not everyone gets 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 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 side effects have also been observed with similar medicines in this 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).
• 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 pancreatitis).

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

Other side effects: tell 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 the hands or feet, altered or decreased sensation.

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

Impotence, persistent muscle weakness, diarrhea, severe myasthenia (a disease causing generalized muscle weakness which, in some cases, affects the muscles used for breathing), ocular myasthenia (a disease causing weakness of the eye muscles). Consult your doctor if you experience arm or leg weakness that worsens after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

Other possible side effects:

• Sleep disturbances, including insomnia and nightmares
• Memory loss
• Sexual problems
• Respiratory problems including persistent cough and/or difficulty breathing or fever
• Diabetes. This is more likely if you have 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.

Reporting of side effects

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

5. Storage of Fluvastatin Alter

Keep this medicine out of the sight and reach 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 packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your usual pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Additional information

Composition of Fluvastatin Alter

• The active substance is fluvastatin sodium.

Each tablet contains 84.24 mg of fluvastatin sodium, equivalent to 80 mg of fluvastatin base.

• The other components are:
  Tablet core: carrageenan, magnesium stearate.
  Tablet coating: hydroxypropyl cellulose, hypromellose 6 cP, macrogol 8000, yellow iron oxide (E172), red iron oxide (E172), titanium dioxide (E171).

Appearance of the product and contents of the pack

Fluvastatin Alter are dark yellow, round, biconvex tablets in aluminum/aluminum blisters.

Pack sizes: Blister containing 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Alter, S.A.
Mateo Inurria, 30
28036 Madrid (Spain)

Manufacturer

Pharmathen S.A.,
6 Dervenakion Str,
153 51 Pallini, Attiki (Greece)

Date of the most recent revision of this package 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/