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LESCOL CAPSULES 20MG

Active substance(s): FLUVASTATIN SODIUM

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– Your doctor can also prescribe Lescol 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.

Package leaflet:
Information for the user

2. What you need to know before you take Lescol
Follow all the doctor’s instructions carefully. They may differ
from the general information contained in this leaflet.

Lescol® 20 and 40 mg
hard capsules

Read the following explanations before you take Lescol.

Fluvastatin

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.
What is in this leaflet
1. What Lescol is and what it is used for
2. What you need to know before you take Lescol
3. How to take Lescol
4. Possible side effects
5. How to store Lescol
6. Content of the pack and other information
1. What Lescol is and what it is used for
Lescol 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 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)

Do not take Lescol
– if you are allergic (hypersensitive) to fluvastatin or any of
the other ingredients of Lescol 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 and tell
your doctor.
Warnings and precautions
Talk to you doctor or pharmacist before taking Lescol.
– if you previously had a liver disease. Liver function tests
will normally be done before you start Lescol, 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.

Comp. No. New:
Comp. No. Old:
Format/Dimension:
Tech. Drawing No.:

Production Site:
CTM:
LFT LESCOL HGC 20MG/40MG GB Printing Colours:
(MOCK UP)
1381275_GB
N/A
148 x 297 mm
N/A
Technical Colours:

Min. Font Size Text:
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Version No.: 3

7 pt
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Date: 20 Apr 2015

 Yes /
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Live Text:
WO:
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Braille:



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Both

Barbera
Agustin, Alberto
PANTONE 541 C

Cutting

J.N.: 251124

N/A

! PLEASE TURN OVERPRINTING ON !

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:
– if you have severe respiratory failure
If any of these apply to you, tell your doctor before taking
Lescol. Your doctor will take a blood test before prescribing
Lescol.
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, 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 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 and children/adolescents
Lescol 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
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines including
medicines obtained without a prescription.
Lescol can be taken on its own or with other cholesterollowering 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.

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 with food and drink
You can take Lescol with or without food.
Pregnancy and breast-feeding
Do not take Lescol 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.
Take adequate precaution against pregnancy while taking
Lescol.
If you become pregnant while taking this medicine, stop
taking Lescol and see your doctor.
Your doctor will discuss with you the potential risk of taking
Lescol during pregnancy.
Driving and using machines
There is no information on the effects of Lescol on your
ability to drive and use machines.
3. How to take Lescol
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.
How much Lescol to take
– The dose range for adults is 20 to 80 mg per day and
depends on the extent of cholesterol lowering which
needs to be achieved. Dose adjustments may be made
by your doctor at 4-week or longer intervals.
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– For children (aged 9 years and older) the usual starting
dose is 20 mg per day. 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 capsules of
Lescol to take.
Depending on how you respond to the treatment, your
doctor may suggest a higher or lower dose.
When to take Lescol
Take your Lescol dose in the evening or at bedtime.
If you are taking Lescol twice per day, take one capsule in
the morning and one in the evening or at bedtime.
Lescol can be taken with or without meals. Swallow whole
with a glass of water.
If you take more Lescol than you should
If you have accidentally taken too much Lescol, talk to your
doctor straight away. You may need medical attention.
If you forget to take Lescol
–– 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
To maintain the benefits of your treatment, do not stop
taking Lescol unless your doctor tells you to. You must
continue to take Lescol as directed to keep the levels of
your ‘bad’ cholesterol down. Lescol will not cure your
condition but it does help control it. Your cholesterol levels
need to be checked regularly to monitor your progress.

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.

If you have any further questions on the use of this
product, ask your doctor or pharmacist.

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

4. Possible side effects
Like all medicines, Lescol 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.

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

Comp. No. New:
Comp. No. Old:
Format/Dimension:
Tech. Drawing No.:

Production Site:
CTM:
LFT LESCOL HGC 20MG/40MG GB Printing Colours:
(MOCK UP)
1381275_GB
N/A
148 x 297 mm
N/A
Technical Colours:

Min. Font Size Text:
Font Type:
Version No.: 3

7 pt
News Gothic
Date: 20 Apr 2015

 Yes /
1381275

Live Text:
WO:
Comp. Description:

Braille:



No /



Both

Barbera
Agustin, Alberto
PANTONE 541 C

Cutting

J.N.: 251124

N/A

! PLEASE TURN OVERPRINTING ON !

– 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
– Keep this medicine out of the sight and reach of children.
– Do not use this medicine after the expiry date which is
stated on the pack. The expiry date refers to the last day
of that month.
– Do not store Lescol capsules above 25°C. Store in the
original package in order to protect from light and moisture.
– Do not use this medicine if you notice that the pack is
damaged or shows signs of tampering.
– Leave your Lescol capsule in the blister pack until
required for use, in order to protect from moisture.
– 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.
6. Contents of the pack and other information
What Lescol contains
– The active substance is fluvastatin sodium.
Each Lescol 20 mg capsule contains 21.06 mg fluvastatin
sodium equivalent to 20 mg fluvastatin free acid.
Each Lescol 40 mg capsule contains 42.12 mg fluvastatin
sodium equivalent to 40 mg fluvastatin free acid.
– The other ingredients of Lescol 20 mg and 40 mg
capsules are: magnesium stearate, sodium hydrogen
carbonate, talc, cellulose microcrystalline, pregelatinised
starch, calcium carbonate, titanium dioxide (E 171),
iron oxide red (E 172), gelatin, iron oxide yellow (E 172),
shellac, propylene glycol, potassium hydroxide.

What Lescol looks like and contents of the pack
– Lescol 20 mg capsules have a strong reddish brown
opaque cap and a pale yellow opaque body with the red
inprint “XU 20 mg”.
Lescol 40 mg capsules have a strong reddish brown
opaque cap and a moderate orange yellow opaque body
with the red inprint “XU 40 mg”.
– Bottles: The capsules are supplied in packs of 20
(samples not for sale or parts of hospital packs), 30,
50 or 100 (2 x 50 or 1 x 100) capsules and in hospital
packs of 300 (15 x 20) or 600 (30 x 20) capsules.
– Blisters: The capsules are supplied in packs of 14, 28,
30, 56, 84, 90 or 98 capsules and in hospital packs of
28, 56, 98 or 490 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
For any information about this medicine, please contact the
local representative of the Marketing Authorisation Holder:
The Marketing Authorisation Holder is:
Novartis Pharmaceuticals UK Limited
Trading as:
Sandoz Pharmaceuticals,
Frimley Business Park, Frimley, Camberley, Surrey,
GU16 7SR, United Kingdom.
Lescol capsules are released onto the market by:
Novartis Pharmaceuticals UK Limited,
Frimley Business Park,
Frimley, Camberley, Surrey, GU16 7SR, United Kingdom.
If you would like any more information, or would like
this leaflet in a different format, please contact Medical
Information at Novartis Pharmaceuticals UK Ltd, telephone
number 01276 698370.
This leaflet was last revised in March 2015.

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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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