Fluvastatin Eg

Patient Information Leaflet: Information for the User

Fluvastatin EG 80 mg Prolonged-Release Tablets

Generic Medicine
Please read this leaflet carefully before taking 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, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:

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

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

Fluvastatin EG contains the active substance sodium fluvastatin, which belongs to a group of medicines known as statins, which are lipid-lowering agents: these medicines lower fats (lipids) in the blood.
They are used in patients whose conditions cannot be controlled by diet and exercise alone.
Fluvastatin EG 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 cholesterol levels;
in adult patients with high levels of cholesterol and triglycerides (another type of fat) in the blood.
Your doctor may also prescribe Fluvastatin EG to prevent further serious cardiovascular events (e.g. heart attack) in patients who have already undergone cardiac catheterization with an intervention on the heart vessels.

2. What you need to know before taking Fluvastatin EG

Carefully follow all instructions given by your doctor. They may differ from the general information contained in this leaflet.
Before taking Fluvastatin EG, read the following information.

Do not take Fluvastatin EG
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 have persistent, unexplained high levels of certain liver enzymes (transaminases);
if you are pregnant or breastfeeding (see "Pregnancy and breastfeeding"). If any of these conditions apply to you, do not take Fluvastatin EG and inform your doctor.

Warnings and precautions
Inform your doctor or pharmacist before taking Fluvastatin EG:
if you have or have had myasthenia (a disease characterized by generalized muscle weakness, including in some cases the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen myasthenia or trigger its onset (see section 4);
if you have previously had liver disease. Liver function tests are usually performed before starting treatment with Fluvastatin EG, when the dose is increased, and at various intervals during treatment to monitor for possible adverse effects;
if you have kidney disease;
if you have thyroid disease (hypothyroidism);
if you have or have a family 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 serious infection;
if you have very low blood pressure (symptoms may include dizziness, lightheadedness);
if you perform excessive physical exercise, whether controlled or uncontrolled;
if you are due to undergo surgery;
if you have severe metabolic, endocrine, or electrolyte imbalances 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 and Fluvastatin EG can lead to serious muscle problems (rhabdomyolysis).

During treatment with this medicine, your doctor will carefully 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 EG, check with your doctor or pharmacist:
if you have severe respiratory insufficiency.

If any of these conditions apply to you, inform your doctor before taking Fluvastatin EG. Your doctor will perform blood tests before prescribing Fluvastatin EG.

If, during treatment with Fluvastatin EG, symptoms or signs such as nausea, vomiting, loss of appetite, yellowing of the eyes or skin, confusion, euphoria or depression, mental slowing, difficulty speaking, sleep disturbances, tremors, bruising or bleeding occur, these could be symptoms of liver dysfunction. In such cases, inform your doctor immediately.

Additionally, inform your doctor or pharmacist if you experience persistent muscle weakness. Further tests and medications may be needed to diagnose and treat this condition.

Fluvastatin EG and patients over 70 years of age
If you are over 70 years old, your doctor may want to check for risk factors for muscle disorders. You may require specific blood tests.

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

Other medicines and Fluvastatin EG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will tell you when it is safe to resume treatment with Fluvastatin EG. Taking Fluvastatin EG with fusidic acid may rarely cause muscle weakness, tenderness, or pain (muscular rhabdomyolysis). For further information on rhabdomyolysis, see section 4.

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

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

Inform your doctor and pharmacist if you are taking any of the following medicines:
Ciclosporin (a medicine used to reduce the activity of 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).

Fluvastatin EG with food and drink
Fluvastatin EG may be taken with or without food.

Pregnancy and breastfeeding
Do not take Fluvastatin EG if you are pregnant or breastfeeding, as the active substance may be harmful to the fetus, and it is not known whether the active substance is excreted in human breast milk. If you are pregnant, consult your doctor or pharmacist before taking Fluvastatin EG. Take appropriate precautions to avoid pregnancy while taking Fluvastatin EG.

If you become pregnant while taking this medicine, stop taking Fluvastatin EG and contact your doctor. Your doctor will discuss with you the potential risks associated with taking Fluvastatin EG during pregnancy.

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

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

3. How to take Fluvastatina EG

Follow your doctor's instructions carefully. Do not exceed the recommended dose.
Your doctor will advise you to follow a cholesterol-lowering diet. Continue this diet while taking Fluvastatina EG.

How much Fluvastatina EG to take
For adults, the dose range is 20 to 80 mg daily, depending on the degree of cholesterol reduction required. Your doctor may adjust the dose at intervals of 4 weeks or longer.

For children (9 years and older), 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 capsules or tablets of Fluvastatina EG to take. Depending on your response to treatment, your doctor may increase or decrease the dose.

Please note that Fluvastatina EG 80 mg prolonged-release tablets cannot be used for all the dosage strengths listed above. Fluvastatina EG 80 mg prolonged-release tablets must not be divided. For lower doses (20 mg and 40 mg), your doctor will prescribe other fluvastatin-containing medicines.

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

If you take more Fluvastatina EG than you should
If you have accidentally taken too much Fluvastatina EG, inform your doctor immediately. You may require medical treatment.

If you forget to take Fluvastatina EG
Take the missed dose as soon as you remember. However, do not take it if less than 4 hours remain before your next scheduled dose. In that 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 Fluvastatina EG
To maintain the benefits of treatment, do not stop taking Fluvastatina EG unless instructed by your doctor. You should continue taking Fluvastatina EG as prescribed to keep your "bad" cholesterol levels low. Fluvastatina EG does not cure the condition but helps to control it. Your cholesterol levels should be monitored regularly to assess improvement. If you have any questions about using this medicine, consult 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 may be serious: seek immediate medical help if you experience any of the following:

• if you have unexplained muscle pain, tenderness to touch, or muscle weakness. These could be early signs of potentially severe muscle breakdown. This can be avoided if your doctor stops treatment with fluvastatin as soon as possible. These side effects have also been reported with similar medicines in this class (statins);
• if you experience unexplained tiredness or fever, yellowing of the skin or eyes, or 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 have skin swelling, difficulty breathing, or dizziness (signs of a severe allergic reaction);
• if you bleed or bruise more easily than normal (signs of a reduced platelet count in the blood);
• if you develop red or purple skin lesions (signs of blood vessel inflammation);
• if you develop a red rash, especially on the face, which may be accompanied by tiredness, fever, nausea, or loss of appetite (signs of a lupus erythematosus-like reaction);
• if you have severe pain in the upper part of the stomach (signs of pancreas inflammation).
  If you experience any of these side effects, contact your doctor immediately.

Other side effects: contact your doctor if they concern you.
Common (may affect up to 1 in 10 people):

• difficulty sleeping, headache, stomach discomfort, abdominal pain, nausea, abnormal blood test results for liver and muscle function.

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

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

Not known (frequency cannot be determined from available data):

• impotence;
• persistent muscle weakness;
• breathing problems, including persistent cough and/or shortness of breath or fever;
• diarrhoea;
• myasthenia gravis (a condition causing generalized muscle weakness, which in some cases may affect muscles used for breathing);
• ocular myasthenia (a condition causing weakness of the eye muscles).

Contact your doctor if you experience worsening weakness in the arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing, or breathlessness.

Other possible side effects:

• sleep disorders, including insomnia and nightmares;
• memory loss;
• sexual difficulties;
• depression;
• diabetes. This is more likely if you have high levels of sugar and fats in the blood, are overweight, and have high blood pressure. Your doctor will monitor you during treatment with this medicine;
• tendon problems, sometimes complicated by tendon rupture.

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 EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the outer carton following the wording
EXP. The expiry date refers to the last day of that month.
Do not store above 30°C.
Keep the blisters in the outer carton to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Fluvastatina EG contains
The active substance is fluvastatin sodium. Each prolonged-release tablet contains 80 mg of
fluvastatin (as fluvastatin sodium).
The other components are:
Tablet core:
povidone, microcrystalline cellulose, hydroxyethylcellulose, mannitol, magnesium stearate.
Coating:
hypromellose 50, macrogol 6000, yellow iron oxide (E172), titanium dioxide (E171).
Description of the appearance of Fluvastatina EG and package contents
Fluvastatina EG contains yellow, round, biconvex prolonged-release tablets.
Pack sizes:
Blister (OPA/Alu/PVC-Alu): 20, 28, 30, 50, 56, 98 and 100 prolonged-release tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
EG S.p.A. Via Pavia, 6 - 20136 Milan, Italy
Manufacturers
ACTAVIS LTD BLB015-016 Bulebel Industrial Estate, Zejtun ZTN 3000 (Malta)
STADA ARZNEIMITTEL AG Stradastrasse 2-18, D-61118 Bad Vilbel (Germany)
PHARMA CO DANE APS Marielundvej 46 A, DK – 2730 Herlev (Denmark)