FLUVASTATIN KERN PHARMA 80 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Fluvastatin Kern Pharma80 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 Kern Pharma and what is it used for
2. What you need to know before you take Fluvastatin Kern Pharma
3. How to take Fluvastatin Kern Pharma
4. Possible side effects
5. Storage of Fluvastatin Kern Pharma
6. Contents of the pack and further information

1. What is Fluvastatin Kern Pharma and what is it used for

Fluvastatin Kern Pharma 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 Kern Pharma 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 Kern Pharma to prevent other serious heart problems (e.g. a heart attack) in patients after they have undergone a heart catheterization procedure.

2. What you need to know before you take Fluvastatin Kern Pharma

Follow carefully all instructions given by your doctor. These may be different from the information contained in this leaflet.

Before taking Fluvastatin Kern Pharma, read the following clarifications.

Do not takeFluvastatinKern Pharma

• 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 Kern Pharma and consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Fluvastatin Kern Pharma.

• 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 that causes weakness of the eye muscles), as statins can sometimes exacerbate the disease or cause myasthenia to appear (see section 4).
• If you have previously had liver disease. Normally, you will have liver function tests before starting treatment with fluvastatin, 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 have constant muscle weakness. Additional tests and medications may be necessary to diagnose and treat this problem.
• If you regularly drink large amounts of alcohol.
• If you are taking or have taken in the last 7 days a medicine containing fusidic acid (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and Fluvastatin Kern Pharma can cause serious muscle problems (rhabdomyolysis).

Check with your doctor or pharmacist before taking FluvastatinKern Pharma:

• If 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.

Fluvastatin Kern Pharma and 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.

Fluvastatin Kern Pharma and children/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.

Use of other medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

Fluvastatin Kern Pharma 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.

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 (a medicine used to treat gout).

If you need 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 Kern Pharma. The use of Fluvastatin Kern Pharma with fusidic acid can cause serious muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

TakingFluvastatinKern Pharmawith food and drinks

You can take Fluvastatin with or without food.

Pregnancy and breastfeeding

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. If you are pregnant, consult your doctor or pharmacist before taking Fluvastatin. You should take adequate 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.

Driving and using machines

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

3. How to take Fluvastatin Kern Pharma

Follow exactly the administration instructions of Fluvastatin indicated by your doctor. Consult your doctor or pharmacist if you have any doubts. 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 Kern Pharma to take

• The dosage range 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.
• In children (9 years of age and older) the initial dose is usually 20 mg 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 many Fluvastatin Kern Pharma tablets to take.

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

When to take Fluvastatin Kern Pharma

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

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

If you take moreFluvastatinKern Pharmathan you should

If you have accidentally taken too much Fluvastatin, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested. You may need medical attention.

If you forget to takeFluvastatinKern Pharma

If you forget to take a dose, 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 takingFluvastatinKern Pharma

To maintain the benefits of your treatment, do not stop taking Fluvastatin unless your doctor tells you to. You should continue taking Fluvastatin Kern Pharma 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 your progress.

If you have any further questions on 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.

• Very common: may affect more than 1 in 10 people,
• Common: may affect up to 1 in 10 people,
• Uncommon: may affect up to 1 in 100 people,
• Rare: may affect up to 1 in 1,000 people,
• Very rare: may affect up to 1 in 10,000 people,
• Frequency not known: frequency cannot be estimated from the available data.

Some rare or very rare side effects could be serious: seek medical attention immediately.

• if you experience unexplained muscle pain, tenderness, 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 with similar medicines in this class (statins).
• if you experience unusual tiredness or fever, yellowing of the skin and eyes, dark-colored urine (signs of hepatitis).
• if you have 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 can 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, tell your doctor immediately.

Other side effects: tell your doctor if you are concerned.

Common:

• Difficulty sleeping, headache, stomach upset, abdominal pain, nausea.

Very rare:

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

Frequency not known:

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

Myasthenia(a disease that causes weakness of the eye muscles).

• Tell 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
• Respiratory problems, including persistent cough and/or difficulty breathing or fever

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency's Pharmacovigilance System for Human Use: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Fluvastatin Kern Pharma

Keep 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 refers to the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition ofFluvastatinKern Pharma

• The active substance is fluvastatin sodium. Each tablet contains 84.48 mg of fluvastatin sodium, equivalent to 80 mg of fluvastatin base.
• The other ingredients are: povidone, microcrystalline cellulose, hydroxyethylcellulose, mannitol (E-421), magnesium stearate, hypromellose 50, macrogol 6000, yellow iron oxide (E172), and titanium dioxide (E171).

Appearance of the product and pack contents

This medicinal product is presented in the form of prolonged-release tablets, yellow, circular, and biconvex.

This medicine is available in a pack (blister) of 28 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

Actavis Limited

BLB015-016 Bulebel Industrial Estate (Zejtun)

ZTN3000 Malta

Date of last revision of this leaflet: May 2023

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