FLUVASTATIN CINFA 80 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Fluvastatin Cinfa 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Fluvastatin Cinfa and what is it used for

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

• Fluvastatin Cinfa is a medicine used to treat high levels of fat in the blood in adults, in particular total cholesterol and the so-called "bad" cholesterol or LDL-cholesterol, which is associated with a high 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 fluvastatin for the prevention of other serious heart problems (e.g. a heart attack) in patients who have already undergone heart catheterization through an intervention in the heart vessels.

If you have any doubts about how fluvastatin works or why it has been prescribed for you, ask your doctor.

2. What you need to know before you take Fluvastatin Cinfa

Follow carefully all the instructions given to you by your doctor, even if they are different from the general information contained in this leaflet.

Before taking Fluvastatin Cinfa, read the following clarifications.

Do not takeFluvastatin Cinfa

• if you are allergic to fluvastatin or 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 liver enzyme levels (transaminases).
• if you are pregnant or breastfeeding (see "Pregnancy and breastfeeding").

If you are in any of these situations, do not take fluvastatin and consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Fluvastatin Cinfa:

• if you are taking or have taken in the last 7 days a medicine that contains fusidic acid, (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and fluvastatin can cause serious muscle problems (rhabdomyolysis).
• if you have previously suffered from liver disease. Normally, your doctor will perform liver function tests before starting treatment with fluvastatin cinfa, when the dose is increased and at different time intervals during treatment to monitor the appearance of side effects.
• if you have kidney disease.
• if you have thyroid gland disease (hypothyroidism).
• if you have a personal or family history of muscle diseases.
• if you have had 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 engage in excessive controlled or uncontrolled muscle exercise.
• if you are going to undergo surgery soon.
• if you have severe metabolic, endocrine or electrolyte disorders such as uncompensated diabetes and low blood potassium levels.
• if you have or have had myasthenia (a disease that causes 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 can sometimes worsen the disease or cause myasthenia to appear (see section 4).

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

Check with your doctor or pharmacist before takingFluvastatin Cinfaif:

• you have severe respiratory failure

If you are in any of these situations, tell your doctor before takingfluvastatin. Your doctor will perform a blood test before prescribing fluvastatin.

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

If during treatment with fluvastatin 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 Cinfaand people over 70 years of age

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

Children and adolescents

Fluvastatin has not been investigated 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 in combination with nicotinic acid, colestyramine or fibrates in children and adolescents.

Taking fluvastatin cinfa with other medicines

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

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

After taking a resin, e.g. colestyramine (mainly used to treat high cholesterol), wait at least 4 hours before taking fluvastatin.

If you have to take oral fusidic acid to treat a bacterial infection, you will have to stop using this medicine. Your doctor will tell you when you can restart treatment with fluvastatin. The use of fluvastatin with fusidic acid can cause muscle weakness, sensitivity or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Tell your doctor and pharmacist if you are taking any of the following medicines:

• Cyclosporin (a medicine used to suppress the immune system).
• Fibrates (e.g. gemfibrozil), nicotinic acid or bile acid sequestrants (medicines used to lower bad cholesterol levels).
• 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)

Takingfluvastatin cinfawith food and drinks

You can take Fluvastatin Cinfa with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take fluvastatin if you are pregnant or breastfeeding, as the active substance may harm the fetus and it is not known whether it is excreted in breast milk. You must take the necessary precautions to avoid becoming pregnant while receiving treatment with fluvastatin.

If you become pregnant while taking this medicine, stop taking fluvastatin and consult your doctor.

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

Driving and using machines

No information is available on the effects of fluvastatin on the ability to drive and use machines.

Fluvastatin cinfa 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 Cinfa

Follow exactly the administration instructions of this medicine given to you by your doctor or pharmacist. In case of doubt, 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 with this diet while taking fluvastatin.

How much Fluvastatin Cinfa should you take

Recommended doses in adults

• The dose range of fluvastatin for adults 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.

Use in children and adolescents

• In children (9 years of age and older) the initial dose is usually 20 mg of fluvastatin 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 fluvastatin you should take.

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

When to take Fluvastatin Cinfa

If you are taking fluvastatin, you can take your dose at any time of the day.

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

If you take moreFluvastatin Cinfathan you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested.

You may need medical attention.

If you forget to takeFluvastatin Cinfa

Take a dose as soon as you remember. However, do not take it if it is less than 4 hours before the next dose. In this case, take the next dose at the usual time.

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

If you stop takingFluvastatin Cinfa

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

If you have any other 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 everybody 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 medical attention immediately.

• if you suffer from unexplained muscle pain, sensitivity or weakness. These can be early signs of potentially serious muscle damage. This can be avoided if your doctor stops your treatment with fluvastatin as soon as possible. These side effects have also been observed in similar medicines of this class (statins).
• if you suffer from unusual tiredness or fever, yellowing of the skin and eyes, dark-colored urine (signs of hepatitis).
• if you have signs of skin reactions such as rash, blisters, redness, itching, swelling of the face, eyelids and lips.
• if you have swelling of the skin, difficulty breathing, dizziness (signs of a severe allergic reaction).
• if you have bleeding or bruising more easily than normal (signs of a decrease in the number of blood platelets).
• if you have red or purple skin lesions (signs of blood vessel inflammation).
• if you have a skin rash with red spots mainly on the face that may be accompanied by fatigue, fever, nausea, loss of appetite (signs of a lupus-like reaction).
• if 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: inform your doctor if they worry you.

Frequent (may affect up to 1 in 10 people):

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

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

Numbness or tingling of the hands or feet, altered or decreased sensitivity.

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

Impotence, constant muscle weakness, respiratory problems including persistent cough and/or difficulty breathing or fever, diarrhea.

Severe myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing).

Ocular myasthenia (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 or drooping eyelids, difficulty swallowing or difficulty breathing.

Other possible side effects:

• Sleep disturbances, including insomnia and nightmares
• Memory loss
• Sexual problems
• Depression
• Diabetes. This is more likely if you have high levels of sugars and fats in the blood, are overweight, and 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 effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use 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 Cinfa

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

Do not store above 30°C.

Do not use this medicine after the expiry date which is stated on the carton, after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Place the empty packaging and any unused medicinal product in the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and unused medicinal products. This will help protect the environment.

6. Contents of the pack and other information

Composition ofFluvastatin Cinfa

• The active substance is fluvastatin sodium.

Each prolonged-release tablet of Fluvastatin Cinfa 80 mg contains 84.48 mg of fluvastatin sodium equivalent to 80 mg of fluvastatin base.

The other ingredients are: povidone, microcrystalline cellulose, hydroxyethyl cellulose, mannitol (E-421), magnesium stearate, hypromellose 50, macrogol 6000, yellow iron oxide (E-172) and titanium dioxide (E-171).

Appearance of the product and contents of the pack

Fluvastatin Cinfa is presented in the form of prolonged-release tablets, yellow, round and biconvex.

Fluvastatin Cinfa 80 mg tablets are available in a pack (blister) of 28 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta.

31620 Huarte (Navarra) - Spain

Actavis Ltd.

BLB015-016 Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

Date of last revision of this leaflet:May 2023

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/71845/P_71845.html

QR code to: https://cima.aemps.es/cima/dochtml/p/71845/P_71845.html