Lescol

Package Leaflet: Information for the User

Lescol 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 effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

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

• Lescol 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 blood cholesterol and triglyceride levels (another type of fat).
• Your doctor may also prescribe Lescol 80 mg prolonged-release tablets to prevent further serious cardiac events (e.g. heart attack) in adult patients who have already undergone cardiac catheterization with a procedure on the heart vessels.

If you have any questions about how Lescol 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 Lescol 80 mg prolonged-release tablets

Follow carefully all instructions given by your doctor, even if they differ from the information
provided in this patient leaflet.
Before taking Lescol 80 mg prolonged-release tablets, read the following information.
Do not take Lescol 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 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 Lescol 80 mg prolonged-release tablets and inform your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Lescol 80 mg prolonged-release tablets.

• If you are currently taking or have taken within the last 7 days, either orally or by injection, a medicine called fusidic acid (a medicine used to treat bacterial infections). The combination of fusidic acid and Lescol 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 Lescol 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 severe metabolic, endocrine or electrolyte disturbances 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 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 Lescol 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 Lescol 80 mg prolonged-release tablets. Your doctor will perform blood tests before prescribing Lescol 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 Lescol 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’.
Lescol 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 need specific blood tests.
Children and adolescents
Lescol 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, colestyramine, or fibrates in children and adolescents.
Other medicines and Lescol 80 mg prolonged-release tablets
Inform 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 Lescol 80 mg prolonged-release tablets. Your doctor will tell you when it is safe to restart Lescol 80 mg prolonged-release tablets. Taking Lescol 80 mg prolonged-release tablets with fusidic acid may rarely cause muscle weakness, pain, or tenderness (rhabdomyolysis). Read more information about rhabdomyolysis in section 4.
Lescol 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 colestyramine (used mainly to treat high cholesterol), wait at least 4 hours before taking Lescol 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 Lescol 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 Lescol 80 mg prolonged-release tablets.
If you become pregnant while taking this medicine, stop taking Lescol 80 mg prolonged-release tablets and contact your doctor.
Your doctor will discuss with you the potential risks associated with using Lescol 80 mg prolonged-release tablets
during pregnancy.
Driving and using machines
There is no information available on the effects of Lescol 80 mg prolonged-release tablets on the ability to drive
vehicles or operate machinery.

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

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure,
ask your doctor or pharmacist.
Do not exceed the recommended dose.
Your doctor will recommend that you follow a cholesterol-lowering diet. Continue this diet while you are
taking Lescol 80 mg prolonged-release tablets.
How much Lescol 80 mg prolonged-release tablet to take
Recommended doses in adults
For adults, the fluvastatin 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.
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 at intervals of 6 weeks.
Your doctor will tell you exactly how much fluvastatin to take.
Depending on your response to treatment, your doctor may suggest a higher or lower dose.
When to take Lescol 80 mg prolonged-release tablets
If you are taking Lescol 80 mg prolonged-release tablets, you may take the dose at any time of
the day.
Lescol 80 mg prolonged-release tablets can be taken with or without food. Swallow the tablet whole with a
glass of water.
If you take more Lescol 80 mg prolonged-release tablets than you should
If you have accidentally taken too many Lescol 80 mg prolonged-release tablets, inform your
doctor immediately. You may need medical treatment.
If you forget to take Lescol 80 mg prolonged-release tablets
Take the missed dose as soon as you remember. However, if it is less than 4 hours before your next dose,
do not take the missed dose. Take the next dose at your usual time.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Lescol 80 mg prolonged-release tablets
To maintain the benefits of treatment, do not stop taking Lescol 80 mg prolonged-release
tablets unless your doctor tells you to. You should continue taking Lescol 80 mg prolonged-release
tablets as prescribed to keep your "bad" cholesterol levels low. Lescol 80 mg
prolonged-release tablets will not cure the condition, but will help control it. Your cholesterol
levels need to be checked regularly to monitor 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.
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:

• 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 prevented 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 number of platelets in the blood).
• If you develop red or purple skin lesions (signs of inflammation of blood vessels).
• If you develop a red, blotchy 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 inflammation of the pancreas). If you experience any of these side effects, contact your doctor immediately.

Other side effects: contact your doctor if you are concerned.
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 the available data):
• Impotence, persistent muscle weakness, breathing problems including persistent cough and/or shortness of breath or fever.
• 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 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 difficulties
• 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 Lescol 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 packaging. The expiry date refers to the last day of the month.
• Do not store Lescol 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.
• Keep Lescol 80 mg prolonged-release tablets in the blister 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 no longer required. This will help protect the environment.

6. Package contents and other information

What Lescol 80 mg prolonged-release tablets contain

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

Description of the appearance of Lescol 80 mg prolonged-release tablets and pack contents
Lescol 80 mg prolonged-release tablets are yellow, round, slightly biconvex with bevelled edges, and engraved with "LE" on one side.

• Bottles: prolonged-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: prolonged-release tablets are available in packs of 7, 14, 28, 28 (in divisible blister for single dose), 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 Authorisation Holder and Manufacturer
For further information about this medicinal product, please contact the Marketing Authorisation Holder:
Marketing Authorisation 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 authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following name:
Prolonged-release tablets 80 mg