Lescol Xl 80mg Tablets
1811
08.08.16[15]
Lescol® XL 80mg Tablets
(fluvastatin sodium)
PATIENT INFORMATION LEAFLET
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Your medicine will be referred to as Lescol XL in this leaflet.
What is in this leaflet
1. What Lescol XL is and what it is used for
2. What you need to know before you take Lescol XL
3. How to take Lescol XL
4. Possible side effects
5. How to store Lescol XL
6. Content of the pack and other information
1. 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.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LESCOL XL
Follow all the doctor's instructions carefully. They may differ from the general information contained in this leaflet.
Read the following explanations before you take Lescol XL.
Do not take Lescol XL
- if you are allergic (hypersensitive) to fluvastatin or any of the other ingredients of Lescol XL listed in section 6 of this leaflet.
- if you currently have liver problems, or if you have unexplained, persistently high level of certain liver enzymes (transaminases).
- if you are pregnant or breast-feeding (see “pregnancy and breastfeeding”).
If any of these apply to you, do not take Lescol XL and tell your doctor. Warnings and precautions
Talk to you doctor or pharmacist before taking Lescol XL.
- 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.
- if you have a kidney disease.
- if you have a thyroid disease (hypothyroidism).
- if you have a medical history of muscle diseases yourself or in your family.
- if you had 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 (signs may include dizziness, lightheadedness).
- if you have controlled or uncontrolled excessive muscle exercise.
- if you are about to have an operation.
- if you have severe metabolic, endocrine or electrolyte disorders such as decompensated diabetes and low blood potassium.
While you are on this medicine your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes. You are likely to be at risk of developing diabetes if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure.
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 taking Lescol XL.
Your doctor will take a blood test before prescribing Lescol XL.
Also tell your doctor or pharmacist if you have a muscle weakness that is constant. Additional tests and medicines may be needed to diagnose and treat this.
If during treatment with Lescol XL, you develop symptoms or signs such as nausea, vomiting, loss of appetite, yellow eye or skin, confusion, euphoria or depression, mental slowing, slurred speech, sleep disturbance, tremors or easy bruising or bleeding, these may be signs of liver failure. In such case contact a doctor immediately.
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.
Other medicines and Lescol XL
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:
- Ciclosporin (a medicine used to suppress the immune system).
- Fibrates (e.g. gemfibrozil), nicotinic acid or bile acid sequestrants (medicines used to lower bad cholesterol levels).
- Fluconazole (a medicine used to treat fungal infections).
- Rifampicin (an antibiotic).
- Phenytoin (a medicine used to treat epilepsy).
- Oral anticoagulants like warfarin (medicines used to reduce blood clotting).
- Glibenclamide (a medicine used to treat diabetes).
- Colchicines (used to treat gout).
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.
Take adequate precaution against pregnancy while taking Lescol XL.
If you become pregnant while taking this medicine, stop taking Lescol XL and see your doctor.
Your doctor will discuss with you the potential risk of taking Lescol XL during pregnancy.
Driving and using machines
There is no information on the effects of Lescol XL on your ability to drive and use machines.
3. 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.
POM
PL 20636/1811
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.
4. 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 side 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, abnormal blood test values for muscle and liver.
Very rare:
- Tingling or numbness of the hands or feet, disturbed or decreased sensitivity.
Not known:
- Impotence, muscle weakness that is constant.
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
- Diabetes. This is more likely if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure. You doctor may monitor you while you are taking this medicine
- Inflammation, swelling, and irritation of a tendon.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE LESCOL XL
Do not store above 25°C. Store in the original package.
Keep all medicines out of the sight and reach of children.
Do not take the medicine after the expiry date which is printed on the outside of the pack.
If the medicine become discoloured or shows any other signs of deterioration, consult your pharmacist who will tell you what to do.
Medicines should not be disposed of via wastewater or household waste. Ask you pharmacist how to dispose of medicine no longer required.
These measures will help to protect the environment
6. CONTENT OF THE PACK AND OTHER INFORMATION
The active ingredient in Lescol XL is fluvastatin sodium.
Each tablet contains 80 mg of fluvastatin (as fluvastatin sodium) in a modified release formulation.
The tablets also contain the following inactive ingredients: microcrystalline cellulose, hypromellose, hyprolose, potassium hydrogen carbonate, povidone, magnesium stearate, macrogol 8000, iron oxide yellow (E 172) and titanium dioxide (E 171).
What Lescol XL looks like and contents of the Pack
Lescol XL 80mg Tablets are available as yellow round slightly biconvex with bevelled edges and marked with "LE" on one side and "NVR" on the other side of the tablet.
Lescol XL comes in plastic bottles of 30 and 50 tablets.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Manufactured by: Novartis Pharma GmbH., 90327 Nurnberg, Germany. Procured from the EU by Product Licence holder Star Pharmaceuticals Ltd.,
5 Sandridge Close, Harrow, Middlesex, HA1 1XD. Repackaged by Servipharm Ltd.
Leaflet revision and issue date (Ref) 08.08.16[15] Lescol is a registered trademark of Novartis AG.