Fluvastatin Kern Pharma 80 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Fluvastatina Kern Pharma 80 mg prolonged-release tablets EFG

Read the entire 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 and you should not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Fluvastatina Kern Pharma is and what it is used for
2. What you need to know before taking Fluvastatina Kern Pharma
3. How to take Fluvastatina Kern Pharma
4. Possible side effects
5. How to store Fluvastatina Kern Pharma
6. Contents of the pack and other information

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

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

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

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

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

Before taking Fluvastatin Kern Pharma, read the following information.

Do not take Fluvastatin Kern Pharma

• If you are allergic to fluvastatin or to any of the other components of this medicine (listed in section 6).
• If you have liver problems, or have a persistent and unexplained increase 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 Kern Pharma and consult your doctor.

Warnings and precautions

Talk to 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, which 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 have previously had liver disease. Your liver function will usually be monitored before starting treatment with fluvastatin, when the dose is increased, and at regular intervals during treatment to detect possible adverse effects.
• If you have kidney disease.
• If you have a thyroid gland disorder (hypothyroidism).
• If you have personal or family history of muscle disorders.
• If you have previously experienced muscle problems with another lipid-lowering medicine.
• If you have persistent muscle weakness. Additional tests and treatments may be needed to diagnose and manage this condition.
• If you regularly drink large amounts of alcohol.
• If you are taking or have taken within the last 7 days an oral or injectable medicine containing fusidic acid (used to treat bacterial infections). The combination of fusidic acid and Fluvastatin Kern Pharma may cause serious muscle problems (rhabdomyolysis).

Check with your doctor or pharmacist before taking Fluvastatin Kern Pharma:

• If you have severe respiratory insufficiency.

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

Fluvastatin Kern Pharma 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 Kern Pharma and children/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 Fluvastatin in combination with nicotinic acid, cholestyramine, or fibrates in children and adolescents.

Use of other medicines

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

Fluvastatin Kern Pharma may be taken alone or in combination with other cholesterol-lowering medicines prescribed by your doctor.

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

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 (a medicine 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 you can restart treatment with Fluvastatin Kern Pharma. Using Fluvastatin Kern Pharma with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For further information on rhabdomyolysis, see section 4.

Taking Fluvastatin Kern Pharma with food and drink

You may take Fluvastatin with or without food.

Pregnancy and breastfeeding

Do not take Fluvastatin if you are pregnant or breastfeeding, as the active substance may cause harm to 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 must take appropriate precautions to avoid becoming pregnant while receiving treatment with Fluvastatin.

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

Driving and using machines

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

3. How to take Fluvastatina Kern Pharma

Follow exactly the administration instructions for Fluvastatina as 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 this diet while taking Fluvastatina.

How much Fluvastatina Kern Pharma you should take

• The dosage range for adults is 20 mg to 80 mg per day and depends 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 initial 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 inform you exactly how many tablets of Fluvastatina Kern Pharma you should take.

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

When to take Fluvastatina Kern Pharma

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

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

If you take more Fluvastatina Kern Pharma than you should

If you have accidentally taken too much Fluvastatina, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested. You may require medical attention.

If you forget to take Fluvastatina Kern Pharma

If you forget to take a dose, take it as soon as you remember. However, do not take it if less than 4 hours remain before your next 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 Fluvastatina Kern Pharma

To maintain the benefits of your treatment, you should not stop taking Fluvastatina unless instructed by your doctor. You should continue taking Fluvastatina Kern Pharma as prescribed to maintain low levels of your "bad" cholesterol. Fluvastatina 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 experiences 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 immediate medical attention 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 fluvastatin treatment 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 or eyes, or dark 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 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 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.

Common:

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

Very rare:

• Tingling or numbness in the hands or feet, altered or reduced sensation.

Frequency not known:

• Persistent muscle weakness

• Diarrhea

• Myasthenia gravis (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 worsening weakness in the arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

Other possible adverse 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 adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a side 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 Kern Pharma

Keep out of sight and reach of children.

Do not store above 30°C.

Do not use this medicine after the expiry date stated on the packaging, after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Fluvastatin Kern 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 components are: povidone, microcrystalline cellulose, hydroxyethylcellulose, mannitol (E-421), magnesium stearate, hypromellose 50, macrogol 6000, yellow iron oxide (E172), and titanium dioxide (E171).

Product appearance and package contents

This medicine is presented as prolonged-release tablets, yellow, round and biconvex in shape.

This medicine is available in a pack (blister) containing 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 the most recent review of this leaflet: May 2023

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