Lipaxan

Package Leaflet: Information for the User

Lipaxan 80 mg prolonged-release tablets

Fluvastatin
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, as it may 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 Lipaxan 80 mg prolonged-release tablets are and what they are used for
2. What you need to know before taking Lipaxan 80 mg prolonged-release tablets
3. How to take Lipaxan 80 mg prolonged-release tablets
4. Possible side effects
5. How to store Lipaxan 80 mg prolonged-release tablets
6. Contents of the pack and other information

1. What Lipaxan 80 mg prolonged-release tablets are and what they are used for

Lipaxan 80 mg prolonged-release tablets contain the active substance fluvastatin sodium, which belongs to a group of medicines known as statins, or 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.

• Lipaxan 80 mg prolonged-release tablets are 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 both cholesterol and triglycerides (another type of fat) in the blood.
• Your doctor may also prescribe Lipaxan 80 mg prolonged-release tablets to prevent further serious cardiac events (e.g., heart attack) in patients who have already undergone cardiac catheterization with an intervention on the heart vessels.

If you have any questions about how Lipaxan 80 mg prolonged-release tablets work or why this medicine has been prescribed for you, consult your doctor.

2. What you need to know before taking Lipaxan 80 mg prolonged-release tablets

Follow carefully all instructions given by your doctor, even if they differ from the information contained in this leaflet.
Before taking Lipaxan 80 mg prolonged-release tablets, read the following information.

Do not take Lipaxan 80 mg prolonged-release tablets

• if you are allergic (hypersensitive) to fluvastatin or to any of the other ingredients of this medicine listed in section 6.
• if you currently have liver problems or if you have persistently elevated and unexplained 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 Lipaxan 80 mg prolonged-release tablets and inform your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Lipaxan 80 mg prolonged-release tablets:

• if you are currently taking or have taken within the last 7 days, orally or by injection, a medicine called fusidic acid (a medicine used to treat bacterial infections). The combination of fusidic acid and Lipaxan 80 mg prolonged-release tablets may cause serious muscle problems (rhabdomyolysis).
• if you have previously had liver disease. Liver function tests are usually performed before starting treatment with Lipaxan 80 mg prolonged-release tablets, when the dose is increased, and at various intervals during treatment to monitor for side effects.
• if you have kidney disease.
• if you have a thyroid disorder (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 severe infection.
• if you have very low blood pressure (symptoms may include dizziness, lightheadedness).
• if you perform 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 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).

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, if you are overweight, or if you have high blood pressure.

Before taking Lipaxan 80 mg prolonged-release tablets, consult your doctor or pharmacist:

• if you have severe respiratory insufficiency.

If any of these conditions apply to you, inform your doctor before taking Lipaxan 80 mg prolonged-release tablets. Your doctor will perform blood tests before prescribing Lipaxan 80 mg prolonged-release tablets.
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.
If during treatment with Lipaxan 80 mg prolonged-release tablets 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.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

Lipaxan 80 mg prolonged-release tablets and people 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.

Children/adolescents
Lipaxan 80 mg prolonged-release tablets have 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 Lipaxan 80 mg prolonged-release tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those not requiring a prescription.

If you need to take fusidic acid orally to treat a bacterial infection, you must temporarily stop taking Lipaxan 80 mg prolonged-release tablets. Your doctor will tell you when it is safe to restart Lipaxan 80 mg prolonged-release tablets. Taking Lipaxan 80 mg prolonged-release tablets with fusidic acid may rarely cause muscle weakness, pain or tenderness (rhabdomyolysis). Read more about rhabdomyolysis in section 4.

Lipaxan 80 mg prolonged-release tablets may be taken alone or together 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 Lipaxan 80 mg prolonged-release tablets.

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).

Pregnancy and breastfeeding
Do not take Lipaxan 80 mg prolonged-release tablets 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 milk.
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Use adequate contraceptive precautions while taking Lipaxan 80 mg prolonged-release tablets.
If you become pregnant while taking this medicine, stop taking Lipaxan 80 mg prolonged-release tablets and consult your doctor.
Your doctor will discuss with you the potential risks associated with using Lipaxan 80 mg prolonged-release tablets during pregnancy.

Driving and using machines
There is no information available on the effects of Lipaxan 80 mg prolonged-release tablets on the ability to drive vehicles or operate machinery.

3. How to take Lipaxan 80 mg prolonged-release tablets

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure,
please consult your doctor or pharmacist.
Do not exceed the recommended dose.
Your doctor will have advised you to follow a cholesterol-lowering diet. Continue this diet while taking
Lipaxan 80 mg prolonged-release tablets.
How much Lipaxan 80 mg prolonged-release tablet to take
Recommended doses in adults
In adults, the fluvastatin dose range is 20 to 80 mg daily, depending on the extent of cholesterol reduction required.
Your doctor may adjust the dose at intervals of 4 weeks or longer.
Use in children and adolescents
For children (9 years and older), the usual starting dose is 20 mg of fluvastatin daily. The maximum daily dose is 80 mg.
Dose adjustments may be made by the doctor every 6 weeks.
Your doctor will tell you exactly how much fluvastatin to take.
Depending on your response to treatment, your doctor may recommend a higher or lower dose.
When to take Lipaxan 80 mg prolonged-release tablets
You may take Lipaxan 80 mg prolonged-release tablets at any time of day.
Lipaxan 80 mg prolonged-release tablets may be taken with or without food. Swallow the tablet whole with a glass of water.
If you take more Lipaxan 80 mg prolonged-release tablets than you should
If you accidentally take too many Lipaxan 80 mg prolonged-release tablets, inform your doctor immediately.
You may require medical treatment.
If you forget to take Lipaxan 80 mg prolonged-release tablets
Take the missed dose as soon as you remember. However, if less than 4 hours remain before your next scheduled dose,
skip the missed dose and 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 Lipaxan 80 mg prolonged-release tablets
To maintain the benefits of treatment, do not stop taking Lipaxan 80 mg prolonged-release tablets unless instructed by your doctor.
Continue taking Lipaxan 80 mg prolonged-release tablets as prescribed to keep "bad" cholesterol levels low.
Lipaxan 80 mg prolonged-release tablets will not cure the condition, but will help control it.
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 can be serious: seek immediate medical attention if you experience any of the following:

• Unexplained muscle pain, tenderness or weakness. These could be early signs of potentially severe muscle breakdown. This can be prevented if your doctor stops treatment with fluvastatin as soon as possible. Such side effects have also been reported with similar medicines in this class (statins).
• Unexplained tiredness or fever, yellowing of the skin or eyes, dark-coloured urine (signs of hepatitis).
• Signs of skin reactions such as rash, hives, redness, itching, swelling of the face, eyelids or lips.
• Skin swelling, difficulty breathing, dizziness (signs of a severe allergic reaction).
• Bleeding or bruising more easily than normal (signs of reduced platelet count in the blood).
• Red or purple-coloured skin lesions (signs of inflammation of blood vessels).
• Red, blotchy rash, especially on the face, possibly accompanied by tiredness, fever, nausea, loss of appetite (signs of a lupus erythematosus-like reaction).
• Severe pain in the upper abdomen (signs of inflammation of the pancreas). If you experience any of these 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 muscle and liver 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 estimated 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 the muscles used for breathing).
• Ocular myasthenia (a condition causing weakness of the eye muscles).

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

Other possible side effects:

• Sleep disturbances, including insomnia and nightmares
• Memory loss
• Sexual dysfunction
• Depression
• 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 will monitor you during treatment with this medicine.
• Inflammation, swelling and irritation of a tendon.

If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

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 Lipaxan 80 mg prolonged-release tablets

• 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.
• Do not store Lipaxan 80 mg prolonged-release tablets above 30°C. Store in the original packaging to protect the medicine from moisture.
• Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
• Store Lipaxan 80 mg prolonged-release tablets in the blister pack until the time of use to protect the medicine from moisture.
• 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. Package Contents and Other Information

What Lipaxan 80 mg Extended-Release Tablets Contain

• The active substance is fluvastatin sodium. Each 80 mg Lipaxan tablet contains 84.24 mg of fluvastatin sodium, equivalent to 80 mg of free acid fluvastatin.
• The excipients of Lipaxan 80 mg extended-release tablets are: microcrystalline cellulose, hypromellose, hydroxypropylcellulose, potassium bicarbonate, povidone, magnesium stearate, macrogol 8000, yellow iron oxide (E172), titanium dioxide.

Description of the Appearance of Lipaxan 80 mg Extended-Release Tablets and Package Contents
Lipaxan 80 mg extended-release tablets are yellow, round, slightly biconvex with bevelled edges, marked with "LE" on one side.

• Bottles: extended-release tablets are available in packs of 28, 30, 50, 98 or 100 (2x50 or 1x100) tablets and in hospital packs of 300 (15x20) or 600 (30x20) tablets.
• Blister Packs: extended-release tablets are available in packs of 7, 14, 28, 28 (in divisible blister for single doses), 30, 42, 49, 56, 70, 84, 90 and 98 tablets and in hospital packs of 28, 56, 98 or 490 tablets.

Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
For further information on this medicinal product, please contact the marketing authorization holder:
Marketing Authorization Holder
ETHYX PHARMACEUTICALS
7 avenue du Fort
92120 Montrouge
France
Manufacturer
SIEGFRIED BARBERA S.L.
Ronda Santa Maria 158
08210 Barbera Del Valles
Spain
This medicinal product is authorized in the Member States of the European Economic Area under the following
names:
Extended-release tablets 80 mg