FLUVASTATIN 20MG CAPSULES

Active substance: FLUVASTATIN SODIUM

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S563 LEAFLET Lescol 20121205

PACKAGE LEAFLET: INFORMATION FOR THE USER

LESCOL 20mg CAPSULES
(fluvastatin sodium)
Your medicine is known as Lescol 20mg Capsules but will be
referred to as Lescol throughout the following leaflet.
Information for other strength of Lescol i.e. Lescol 40mg Capsules
also may be present in this 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.







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:

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.

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

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

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.

5. How to store Lescol

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.

6. Content of the pack and other information

Lescol and children/adolescents

1. WHAT LESCOL IS AND WHAT IT IS USED FOR

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.

4. Possible side effects

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)

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.

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).

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.

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).

Read the following explanations before you take Lescol.
Do not take Lescol



Rifampicin (an antibiotic).



Phenytoin (a medicine used to treat epilepsy).



if you are allergic (hypersensitive) to fluvastatin or any of the
other ingredients of Lescol listed in section 6 of this leaflet.



Oral anticoagulants like warfarin (medicines used to reduce
blood clotting).



if you currently have liver problems, or if you have unexplained,
persistently high level of certain liver enzymes (transaminases).



Glibenclamide (a medicine used to treat diabetes).



Colchicines (used to treat gout).



if you are pregnant or breast-feeding (see “pregnancy and
breast-feeding”).

Lescol with food and drink



if you are allergic (hypersensitive) to soya or peanut as Lescol
20 mg and 40 mg capsules contain traces of soya lecithin.

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.

You can take Lescol with or without food.
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.
Lescol 20 mg and 40 mg capsules contain soya lecithin. If you
are allergic to peanut or soya do not use this medicinal product.

3. HOW TO TAKE LESCOL

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

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

Common:

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 4week or longer intervals.
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.

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

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



Sexual difficulties



Depression

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



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

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

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



Do not store above 25°C.



The capsules should be left in their original pack and only
removed when it is time for you to take your medicine.

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 use after the expiry date printed on the carton or bottle
label.



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



If your doctor stops your treatment, take any leftover capsules
back to the pharmacy for safe disposal.



Take any capsules which are out of date back to the pharmacy.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

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. 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 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

5. HOW TO STORE LESCOL

6. CONTENT OF THE PACK AND OTHER INFORMATION
What Lescol contains


Each capsule contains 20mg of the active ingredient, fluvastatin
(as the sodium salt).



Lescol Capsules also contain the following inactive ingredients:
magnesium stearate, sodium hydrogen carbonate, talc,
cellulose microcrystalline, sodium dodecylsulphate, maize
starch, calcium carbonate, gelatin, titanium dioxide (E171), iron
oxide red (E172), iron oxide yellow (E172) and shellac.

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.

What Lescol looks like and contents of the pack


Lescol Capsules have a pale-yellow body marked with ‘XU
20mg’ in red and a plain reddish-brown cap.



Lescol Capsules are available in amber glass bottles containing
30, 50 or 100 (2x50) capsules.

Product Licence holder
Procured from within the EU and repackaged by the
Product Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by Novartis Pharma GmbH, 90327
Nurnberg, Germany.
POM

PL No: 19488/0563

Leaflet revision date: 05 December 2012.
Lescol is a registered trademark of Novartis AG, Switzerland.
S563 LEAFLET Lescol 20121205

S563 LEAFLET Fluvastatin 20121205

PACKAGE LEAFLET: INFORMATION FOR THE USER



FLUVASTATIN 20mg CAPSULES
(fluvastatin sodium)

if you have a medical history of muscle diseases yourself or in
your family.



if you had muscle problems with another lipid-lowering
medicine.

Your medicine is known as Fluvastatin 20mg Capsules but will be
referred to as Fluvastatin Capsules throughout the following leaflet.



if you regularly drink large amounts of alcohol.

Information for other strength of Fluvastatin Capsules i.e.
Fluvastatin 40mg Capsules also may be present in this leaflet.



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.

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 Fluvastatin Capsules are and what they are used for
2. What you need to know before you take Fluvastatin Capsules
3. How to take Fluvastatin Capsules
4. Possible side effects
5. How to store Fluvastatin Capsules
6. Content of the pack and other information
1. WHAT FLUVASTATIN CAPSULES ARE AND WHAT THEY
ARE USED FOR
Fluvastatin Capsules contain the active fluvastatin sodium which
belongs to a group of medicines known as statins, which are lipidlowering medicines: they lower the fat (lipids) in your blood. They
are used in patients whose conditions cannot be controlled by diet
and exercise alone.


Fluvastatin Capsules are 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 Fluvastatin Capsules 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
FLUVASTATIN CAPSULES
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 Fluvastatin
Capsules.
Do not take Fluvastatin Capsules


if you are allergic (hypersensitive) to fluvastatin or any of the
other ingredients of Fluvastatin Capsules 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 you are allergic (hypersensitive) to soya or peanut as
Fluvastatin 20 mg and 40 mg capsules contain traces of soya
lecithin.



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

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 Fluvastatin
Capsules:
 if you have severe respiratory failure
If any of these apply to you, tell your doctor before taking
Fluvastatin Capsules. Your doctor will take a blood test before
prescribing Fluvastatin Capsules.
If during treatment with Fluvastatin Capsules, 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.
Fluvastatin Capsules 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.
Fluvastatin Capsules and children/adolescents
Fluvastatin Capsules 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 Fluvastatin Capsules in
combination with nicotinic acid, cholestyramine or fibrates in
children and adolescents.
Other medicines and Fluvastatin Capsules
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines including medicines obtained
without a prescription.
Fluvastatin Capsules 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 Fluvastatin
Capsules.
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).

Warnings and precautions

 Colchicines (used to treat gout).
Fluvastatin Capsules with food and drink

Talk to you doctor or pharmacist before taking Fluvastatin
Capsules.

You can take Fluvastatin Capsules with or without food.
Pregnancy and breast-feeding



if you previously had a liver disease. Liver function tests will
normally be done before you start Fluvastatin Capsules, when
your dose is increased and at various intervals during treatment
to check for side effects.



if you have a kidney disease.

Do not take Fluvastatin Capsules if you are pregnant or breastfeeding 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 Fluvastatin Capsules.



if you have a thyroid disease (hypothyroidism).

Take adequate precaution against pregnancy while taking
Fluvastatin Capsules.

If you become pregnant while taking this medicine, stop taking
Fluvastatin Capsules and see your doctor.



if you bleed or bruise more easily than normal (signs of
decreased number of blood platelets).

Your doctor will discuss with you the potential risk of taking
Fluvastatin Capsules during pregnancy.



if you have red or purple skin lesions (signs of blood vessel
inflammation).

Driving and using machines



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).

Fluvastatin 20 mg and 40 mg capsules contain soya lecithin. If
you are allergic to peanut or soya do not use this medicinal product.



if you have severe upper stomach pain (signs of inflamed
pancreas).

3. HOW TO TAKE FLUVASTATIN CAPSULES

If you experience any of these, tell your doctor straight away.

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

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

Your doctor will recommend you to follow a low-cholesterol diet.
Stay on this diet while taking Fluvastatin Capsules.
How much Fluvastatin Capsules to take

Difficulty in sleeping, headache, stomach discomfort, abdominal
pain, nausea, abnormal blood test values for muscle and liver.



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

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



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 4week or longer intervals.
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.

Common:

Very rare:

Not known:
Impotence
Other possible side effects


Sleep disturbances, including insomnia and nightmares

Your doctor will tell you exactly how many capsules of Fluvastatin
Capsules to take.



Memory loss



Sexual difficulties

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



Depression



Breathing problems including persistent cough and/or shortness
of breath or fever

Take your Fluvastatin Capsules dose in the evening or at bedtime.



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

If you are taking Fluvastatin Capsules twice per day, take one
capsule in the morning and one in the evening or at bedtime.
Fluvastatin Capsules can be taken with or without meals. Swallow
whole with a glass of water.
If you take more Fluvastatin Capsules than you should
If you have accidentally taken too much Fluvastatin Capsules, talk
to your doctor straight away. You may need medical attention.
If you forget to take Fluvastatin Capsules
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 Fluvastatin Capsules
To maintain the benefits of your treatment, do not stop taking
Fluvastatin Capsules unless your doctor tells you to. You must
continue to take Fluvastatin Capsules as directed to keep the levels
of your ‘bad’ cholesterol down. Fluvastatin Capsules 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, Fluvastatin Capsules 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

If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor.
5. HOW TO STORE FLUVASTATIN CAPSULES


Do not store above 25°C.



The capsules should be left in their original pack and only
removed when it is time for you to take your medicine.



Do not use after the expiry date printed on the carton or bottle
label.



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



If your doctor stops your treatment, take any leftover capsules
back to the pharmacy for safe disposal.



Take any capsules which are out of date back to the pharmacy.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

6. CONTENT OF THE PACK AND OTHER INFORMATION
What Fluvastatin Capsules contain


Each capsule contains 20mg of the active ingredient, fluvastatin
(as the sodium salt).



Fluvastatin Capsules also contain the following inactive
ingredients: magnesium stearate, sodium hydrogen carbonate,
talc, cellulose microcrystalline, sodium dodecylsulphate, maize
starch, calcium carbonate, gelatin, titanium dioxide (E171), iron
oxide red (E172), iron oxide yellow (E172) and shellac.
What Fluvastatin Capsules look like and contents of the pack

Not known: frequency cannot be estimated from the available data.



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

Fluvastatin Capsules have a pale-yellow body marked with ‘XU
20mg’ in red and a plain reddish-brown cap.



Fluvastatin Capsules are available in amber glass bottles
containing 30, 50 or 100 (2x50) capsules.



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).

Product Licence holder
Procured from within the EU and repackaged by the
Product Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by Novartis Pharma GmbH, 90327
Nurnberg, Germany.
POM

PL No: 19488/0563

Leaflet revision date: 05 December 2012.
S563 LEAFLET Fluvastatin 20121205

Expand view ⇕

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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