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LESCOL XL 80MG TABLETS

Active substance(s): FLUVASTATIN / FLUVASTATIN SODIUM

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Ref: 1235/120514/1/F

®

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 is called Lescol XL 80mg Tablets but will be referred to as
Lescol XL thoughout this leaflet.
What is in this leaflet:
11 What Lescol XL is and what it is used for
22 What you need to know before you take Lescol XL
33 How to take Lescol XL
4 Possible side effects
55 How to store Lescol XL
6.6 Contents 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 breast-feeding”).
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,
light-headedness).
* 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.
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.

Ref: 1235/120514/1/B

®

Lescol XL 80mg Tablets
(Fluvastatin sodium)
Patient Information Leaflet (continued)
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.

4

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, pharmacist or nurse. 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

* KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF
CHILDREN.

* Do not store above 25ºC
* Store in the original package
* Do not take the medicine after the expiry date which is printed on the
outside of the pack.

* If your medicine become discoloured or show any other signs of

deterioration, consult your pharmacist who will tell you what to do.

* If your doctor tells you to stop taking Lescol, please take any unused

tablets back to your pharmacist to be destroyed. Only keep them if the
doctor tells you to. Do not throw them away with your normal household
water or waste. This will help to protect the environment.

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
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. Your doctor may
monitor you while you are taking this medicine

6

Contents of the pack and other information

What this medicine contains:
Each prolonged release tablet contains fluvastatin sodium equivalent to
80mg of fluvastatin.
The other ingredients are: microcrystalline cellulose, hypromellose,
hydroxypropyl cellulose, potassium bicarbonate, povidone, magnesium
stearate, macrogol 8000, iron oxide yellow (E172), titanium dioxide (E171).
What this medicine looks like and contents of the pack
Your tablets are yellow, round, slightly biconvex with bevelled edges and are
marked with “LE” on one side and “NVR” on the other side.
Your medicine comes in a pack size of 28 Tablets.
Manufacturer and Licence Holder
Lescol is manufactured by Novartis s.r.o. Nagano iii, u Nakladoveho Nadrazi
10, Praha 10, Prague CZ-130 00, Czech Republic and is procured from
within the EU and repackaged by the Product Licence Holder: Lexon (UK)
Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/1235 Lescol XL 80mg Tablets

Lescol is a registered trademark of Novartis AG.
Revision date: 12/05/14

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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