Fluvastatin Zentiva

PACKAGE LEAFLET: INFORMATION FOR THE USER

Fluvastatin Zentiva 80 mg prolonged-release tablets

Read this leaflet carefully before using 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT FLUVASTATIN ZENTIVA IS AND WHAT IT IS USED FOR

Fluvastatin Zentiva contains the active substance fluvastatin sodium, which belongs to a group of medicines known as statins, lipid-lowering agents: these medicines reduce fats (lipids) in the blood.
They are used in patients whose conditions cannot be controlled by diet and exercise alone.
Fluvastatin Zentiva is a medicine used to treat elevated levels of fats in the blood in adults, particularly total cholesterol and LDL cholesterol, also known as "bad cholesterol", which is associated with an increased risk of heart disease and stroke.

• In adult patients with high blood levels of cholesterol.
• In adult patients with high blood levels of cholesterol and triglycerides (another type of blood lipid). Your doctor may also prescribe Fluvastatin Zentiva to prevent further serious cardiac events (for example, a heart attack) in patients who have already undergone cardiac catheterization, through an intervention on the blood vessels of the heart.

2. WHAT YOU NEED TO KNOW BEFORE TAKING FLUVASTATIN ZENTIVA

Follow all your doctor's instructions carefully. They may differ from the general information contained in this leaflet.
Read the following information before taking Fluvastatin Zentiva.

Do not take Fluvastatin Zentiva

• if you are allergic to fluvastatin or to any of the other ingredients of this medicine (listed in section 6);
• if you currently have liver problems or if your levels of certain liver enzymes (transaminases) are unexplainedly and persistently elevated;
• if you are pregnant or breastfeeding (see “Pregnancy, breastfeeding and fertility”).

If any of these conditions apply to you, do not take Fluvastatin Zentiva and inform your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Fluvastatin Zentiva

If you have previously had liver disease. Liver function tests are usually performed before starting Fluvastatin Zentiva, when the dose is increased, and at various intervals during treatment to monitor for adverse effects;

• If you have kidney disease;
• If you have a thyroid disease (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 regularly drink large amounts of alcohol;
• If you have a severe infection;
• If you have very low blood pressure (symptoms may include dizziness, lightheadedness);
• If you engage in excessive controlled or uncontrolled physical exercise;
• If you are about to undergo surgery;
• If you have serious metabolic, endocrine or electrolyte disorders such as uncontrolled diabetes or low potassium levels in the blood;
• 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 with Fluvastatin Zentiva can lead to serious muscle problems (rhabdomyolysis);
• If you have or have had myasthenia gravis (a disease characterized by generalized muscle weakness, including in some cases the muscles used for breathing) or ocular myasthenia (a condition causing weakness of the eye muscles), as statins may sometimes worsen myasthenia or trigger its onset (see section 4). During treatment with this medicine, your doctor will closely monitor whether you have diabetes or are at risk of developing diabetes. You are at risk of developing diabetes if you have high levels of sugar and fats in the blood, are overweight, and have high blood pressure.

Before taking Fluvastatin Zentiva, check with your doctor or pharmacist:

• if you have severe respiratory insufficiency.

Additionally, inform your doctor or pharmacist if you have persistent muscle weakness. Further tests and medications may be needed to diagnose and treat this condition.
If any of these conditions apply to you, inform your doctor before taking Fluvastatin Zentiva. Your doctor will perform a blood test before prescribing Fluvastatin Zentiva to you.
If, during treatment with Fluvastatin Zentiva, you experience signs or symptoms such as nausea, vomiting, loss of appetite, yellowing of the eyes or skin, confusion, euphoria or depression, mental slowing, difficulty speaking, sleep disturbances, tremors, or easy bruising or bleeding, these may be signs of liver failure. In such a case, contact a doctor immediately.

Fluvastatin Zentiva and people 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. You may need specific blood tests.

Children and adolescents
Fluvastatin Zentiva has not been studied and should not be used in children under 9 years of age. For information on dosing in children and adolescents over 9 years of age, see section 3.
There is no experience with the use of Fluvastatin Zentiva in combination with nicotinic acid, cholestyramine, or fibrates in children and adolescents.

Other medicines and Fluvastatin Zentiva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Fluvastatin Zentiva may be taken alone or together with other cholesterol-lowering medicines prescribed by your doctor.
After taking a resin such as cholestyramine (mainly used to treat high cholesterol levels), wait at least 4 hours before taking Fluvastatin Zentiva.
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 clotting);
• Glibenclamide (a medicine used to treat diabetes);
• Colchicine (used to treat gout).
• Fusidic acid – If you need to take fusidic acid orally to treat a bacterial infection, you will need to temporarily stop treatment with this medicine. Your doctor will tell you when it is safe to resume taking Fluvastatin Zentiva. Taking Fluvastatin Zentiva with fusidic acid can rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). See section 4 for more information on rhabdomyolysis.

Fluvastatin Zentiva with food and drink
You may take Fluvastatin Zentiva with or without food.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take Fluvastatin Zentiva if you are pregnant or breastfeeding, as the active substance may cause harm to your unborn baby, and it is unknown whether the active substance is excreted in human breast milk.
Use adequate contraceptive precautions while taking Fluvastatin Zentiva. If you become pregnant while taking this medicine, stop taking Fluvastatin Zentiva and consult your doctor.
Your doctor will discuss with you the potential risks associated with using Fluvastatin Zentiva during pregnancy.

Driving and using machines
There is no information available on the effects of Fluvastatin Zentiva on the ability to drive vehicles or operate machinery.

Fluvastatin Zentiva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3. HOW TO TAKE FLUVASTATIN ZENTIVA

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.
Follow your doctor's instructions carefully. Do not exceed the recommended dose.
Your doctor will advise you to follow a low-cholesterol diet. Continue this diet during treatment with Fluvastatin Zentiva.

How much fluvastatin to take

• The usual dose range for adults is 20–80 mg daily, depending on the degree of cholesterol reduction required. Dose adjustments may be made by your doctor at intervals of 4 weeks or more.
• For children (from 9 years of age onwards), the usual starting dose is 20 mg daily. The maximum daily dose is 80 mg. Dose adjustments may be made by your doctor at intervals of 6 weeks.

Your doctor will tell you exactly how many fluvastatin tablets to take. Depending on your response to treatment, your doctor may recommend a higher or lower dose.

When to take Fluvastatin Zentiva
You may take your dose of Fluvastatin Zentiva at any time of day.
Fluvastatin Zentiva may be taken with or without food. Swallow the tablets whole with a glass of water.

If you take more Fluvastatin Zentiva than you should
If you have taken too much Fluvastatin Zentiva by accident, contact your doctor immediately. You may require medical treatment.

If you forget to take Fluvastatin Zentiva
Take the missed dose as soon as you remember. However, do not take it if less than 4 hours remain before the 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 forgotten dose.

If you stop taking Fluvastatin Zentiva
To maintain the benefits of treatment, do not stop taking Fluvastatin Zentiva unless your doctor tells you to. You should continue taking Fluvastatin Zentiva as directed to keep your "bad" cholesterol levels low. Fluvastatin Zentiva does not cure your condition but helps to control it.
Your cholesterol levels should be monitored periodically to assess improvement.

If you have any questions about how to use 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.
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 from 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
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 any of the following.

• If you experience unexplained muscle pain, tenderness or weakness. These could be early signs of a potentially serious muscle breakdown. This can be prevented if your doctor stops treatment with fluvastatin as soon as possible. These side effects have also been reported with other medicines in this class (statins).
• If you experience unusual tiredness or fever, yellowing of the skin or eyes, dark-coloured urine (signs of hepatitis).
• If you develop signs of skin reactions such as rash, hives, redness, itching, swelling of the face, eyelids or lips.
• If you experience swelling of the skin, difficulty breathing, dizziness (signs of a severe allergic reaction).
• If you notice bleeding or bruising more easily than normal (signs of reduced platelet count in the blood).
• If you develop red or purple skin lesions (signs of inflammation of blood vessels).
• If you develop red rash-like spots, especially on the face, possibly accompanied by tiredness, fever, nausea, loss of appetite (signs of a lupus erythematosus-like reaction).
• If you experience severe pain in the upper abdomen (signs of inflammation of the pancreas). If any of these occur, consult your doctor immediately.

Other side effects: consult your doctor if you are concerned.
Common:
Difficulty sleeping, headache, stomach discomfort, abdominal pain, nausea, abnormal blood test results for muscle and liver.
Very rare:
Tingling or numbness in the hands or feet, altered or reduced sensation.
Not known:
Impotence, persistent muscle weakness, diarrhoea, myasthenia gravis (a disease causing generalized muscle weakness, which in some cases may affect the muscles used for breathing), ocular myasthenia (a disease causing weakness of the eye muscles).
Contact your doctor if you experience weakness in the arms or legs that worsens with activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath.

Other possible side effects

• Sleep disorders, including insomnia and nightmares
• Memory loss
• Sexual dysfunction
• Depression
• Respiratory problems including persistent cough and/or shortness of breath or fever
• Diabetes. This is more likely if you have high levels of sugar and fats in your blood, are overweight, and have high blood pressure. Your doctor may monitor you during treatment with this medicine.
• Inflammation, swelling and irritation of a tendon.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE FLUVASTATIN ZENTIVA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack. The expiry date refers to the last day of the month.
Store below 30°C.
Keep in the original packaging.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Fluvastatin Zentiva contains:
The active substance is:
sodium fluvastatin.
Each prolonged-release tablet contains 84.2 mg of sodium fluvastatin (equivalent to 80 mg of fluvastatin).
The other components are:
Viscarin GP-209NF, gelcarin GP-379NF, magnesium stearate, hydroxypropylcellulose, hypromellose 6cP, yellow iron oxide, titanium dioxide, macrogol 8000, red iron oxide.
Description of the appearance of Fluvastatin Zentiva and pack contents:
Round, dark yellow, convex tablets on both sides.
Fluvastatin Zentiva is available in packs containing 10, 20, 28, 30, 42, 50, 56, 98 and 100 prolonged-release tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Zentiva Italia S.r.l. Via P. Paleocapa 7, 20121 Milan, Italy
Responsible manufacturer for batch release
Pharmathen S.A.
6, Dervenakion str. - 153 51 Pallini, Attikis (Greece)
This medicinal product is authorized in the European Economic Area countries under the following names: