Lescol XL (Fluvastatin)

Lescol XL 80 mg prolonged-release tablets. Fluvastatin

WHAT LESCOL XL IS AND WHAT IT IS USED FOR

Lescol XL contains the active fluvastatin sodium which belongs to a group of medicines known as statins, which are lipid-lowering medicines: they lower the fat (lipids) in your blood. They are used in patients whose conditions cannot be controlled by diet and exercise alone.

Lescol XL is a medicine used to treat raised levels of fats in the blood

• in adults, in particular total cholesterol and so called “bad” or LDL 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 both cholesterol and triglycerides (another sort of blood lipid)

Your doctor can also prescribe Lescol XL to prevent further serious cardiac events (e.g. heart attack) in patients after they already went through a heart catheterisation, with an intervention in the heart vessel.

BEFORE YOU TAKE LESCOL XL

Follow all instructions given to you by your doctor carefully. They may differ from the information contained in this leaflet.

Read the following explanations before you take Lescol XL.

Do not take Lescol XL

1. if you are allergic (hypersensitive) to fluvastatin or any of the other ingredients of Lescol XL listed in section 6 of this leaflet.
2. if you currently have liver problems, or if you have unexplained, persistently high level of certain liver enzymes (transaminases).
3. if you are pregnant or breast-feeding.

If any of these apply to you, do not take Lescol XL and tell your doctor.

Take special care with Lescol XL

1. if you previously had a liver disease. Liver function tests will normally be done before you start Lescol XL, when your dose is increased and at various intervals during treatment to check for side effects.
2. if you have a kidney disease.
3. if you have a thyroid disease (hypothyroidism).
4. if you have a medical history of muscle diseases yourself or in your family.
5. if you had muscle problems with another lipid-lowering medicine.
6. if you regularly drink large amounts of alcohol.

Check with your doctor or pharmacist before taking Lescol XL: if you have severe respiratory failure

If any of these apply to you, tell your doctor before you take Lescol XL. Your doctor will take a blood test before prescribing Lescol XL.

Lescol XL and people over 70 years

If you are over 70 years your doctor may want to check if you have risk factors for muscular diseases. You may need specific blood tests.

Lescol XL and children/adolescents

Lescol XL has not been investigated and is not intended for the use in children below 9 years. For dose information in children and adolescents over 9 years, see section 3.

There is no experience with the use of Lescol in combination with nicotinic acid, cholestyramine or fibrates in children and adolescents.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained without a prescription.

Lescol XL can be taken on its own or with other cholesterol-lowering medicines prescribed by your doctor.

After intake of a resin, e.g. cholestyramine (primarily used to treat high cholesterol) wait at least 4 hours before taking Lescol XL.

Tell your doctor and pharmacist if you are taking any of the following:

1. Ciclosporin (a medicine used to suppress the immune system).
2. Fibrates (e.g. gemfibrozil), nicotinic acid or bile acid sequestrants (medicines used to
3. lower bad cholesterol levels).
4. Fluconazole (a medicine used to treat fungal infections).
5. Rifampicin (an antibiotic).
6. Phenytoin (a medicine used to treat epilepsy).
7. Oral anticoagulants like warfarin (medicines used to reduce blood clotting).
8. Glibenclamide (a medicine used to treat diabetes).
9. Colchicines (used to treat gout).

Taking Lescol XL with food and drink

You can take Lescol XL with or without food.

Pregnancy and breast-feeding

Do not take Lescol XL if you are pregnant or breast-feeding as the active ingredient may lead to harm to your unborn child, and it is not known whether the active ingredient is excreted in human breast milk. If you are pregnant, consult your doctor or pharmacist before taking Lescol XL. Use reliable contraception for the whole time that you are taking Lescol XL.

If you become pregnant while taking this medicine, stop taking Lescol XL and see your doctor.

Driving and using machines

There is no information on the effects of Lescol XL on your ability to drive and use machines.

HOW TO TAKE LESCOL XL

Follow your doctor’s instructions carefully. Do not exceed the recommended dose.

Your doctor will recommend you to follow a low-cholesterol diet. Stay on this diet while taking Lescol XL.

How much Lescol XL to take

• The dose for adults is 80 mg per day. Dose adjustments may be made by your doctor at 4-week or longer intervals.
• For children (aged 9 years and older) the maximum daily dose is 80 mg. Dose adjustments may be made by your doctor at 6-week intervals.

Your doctor will tell you exactly how many tablets of Lescol XL to take.

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

When to take Lescol XL

You can take your Lescol XL dose at any time of the day.

Lescol XL can be taken with or without meals. Swallow whole with a glass of water.

If you take more Lescol XL than you should

If you have accidentally taken too much Lescol XL, talk to your doctor straight away. You may need medical attention.

If you forget to take Lescol XL

Take one dose as soon as you remember. However, do not take it if there is less than 4 hours before your next dose. In this case take your next dose at the usual time. Do not take a double dose to make up for the one that you missed.

If you stop taking Lescol XL

To maintain the benefits of your treatment, do not stop taking Lescol XL unless your doctor tells you to. You must continue to take Lescol XL as directed to keep the levels of your ‘bad’ cholesterol down. Lescol XL will not cure your condition but it does help control it. Your cholesterol levels need to be checked regularly to monitor your progress. If you have any further questions on the use of this product, ask your doctor or pharmacist.

POSSIBLE SIDE EFFECTS

Like all medicines, Lescol XL can cause side effects, although not everybody gets them.

• Very common: affects more than 1 user in 10
• Common: affects 1 to 10 users in 100 Uncommon: affects 1 to 10 users in 1,000
• Rare: affects 1 to 10 users in 10,000
• Very rare: affects less than 1 user in 10,000
• Not known: frequency cannot be estimated from the available data.

Some rare or very rare effects could be serious: get medical help immediately.

• if you have unexplained muscle pain, tenderness or weakness. These might be early signs of a potentially severe muscle degradation. This can be avoided if your doctor stops your treatment with fluvastatin as quickly as possible. These side effects have also been found with similar medicines of this class (statins).
• if you have unusual tiredness or fever, yellowing of the skin and eyes, dark coloured urine (signs of hepatitis).
• if you have signs of skin reactions such as skin rash, hives, redness, itching, swelling of  the face, eyelids, and lips.
• if you have skin swelling, difficulty in breathing, dizziness (signs of severe allergic reaction).
• if you bleed or bruise more easily than normal (signs of decreased number of blood platelets).
• if you have red or purple skin lesions (signs of blood vessel inflammation).
• if you have red blotchy rash mainly on the face which may be accompanied by fatigue, fever, nausea, loss of appetite (signs of lupus erythematous-like reaction).
• if you have severe upper stomach pain (signs of inflamed pancreas). If you experience any of these, tell your doctor straight away.

Other side effects: tell your doctor if they worry you.

Common:

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

Very rare:

Tingling or numbness of the hands or feet, disturbed or decreased sensitivity.

Other possible side effects

• Sleep disturbances, including insomnia and nightmares
• Memory loss
• Sexual difficulties
• Depression
• Breathing problems including persistent cough and/or shortness of breath or fever

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

HOW TO STORE LESCOL XL

Keep your tablets in their original pack at a temperature below 30°C. Keep Lescol XL out of the reach and sight of children.

Do not use Lescol XL after the expiry date which is stated on the carton and blister. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

FURTHER INFORMATION

What Lescol XL contains

The active substance is fluvastatin sodium

Each Lescol XL 80 mg tablet contains 84.24 mg fluvastatin sodium equivalent to 80 mg fluvastatin free acid.

The tablets also contain the inactive ingredients microcrystalline cellulose, hypromellose, hydroxypropyl cellulose, potassium hydrogen carbonate, povidone, magnesium stearate, yellow iron oxide (E172), titanium dioxide (E171) and macrogol 8000.

What Lescol XL looks like and contents of the pack

Lescol XL 80 mg prolonged release tablets are round, yellow tablets marked ‘LE’ on one side and ‘NVR’ on the other. They come in packs of 28 tablets.

This medicinal product is authorised in the Member States of the EEA under the following names:

Member State	Medicinal Product
Estonia, Bulgaria, Cyprus, Czech Republic, Greece, Hungary, Ireland, Latvia, Lithuania, Malta, Netherlands, Poland, Portugal, Romania, Slovak Republic, Slovenia, United Kingdom	Lescol XL
Demark, Finland, Iceland, Norway, Sweden	Lescol Depot
Austria, Germany	Fluvastatin Novartis
Austria	Lescol MR
Belgium	Lescol Exel
France	Lescol LP
Germany, Luxembourg	Locol
Italy	Lescol, Lipaxin, Primesin
Portugal	Cardiol XL, Canef
Spain	Lescol Prolib, Leposit Prolib, Vaditon Prolib, Digaril Prolib