FLUVASTATIN 20MG CAPSULES

Active substance: FLUVASTATIN SODIUM

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S174LEAFLET Lescol 20120721

PACKAGE LEAFLET: INFORMATION FOR USER

LESCOL 20mg CAPSULES
(fluvastatin sodium)

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.

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

Check with your doctor or pharmacist before taking Lescol:

Information for other strength of Lescol (Lescol 40mg Capsules) is
also present in this leaflet.

If any of these apply to you, tell your doctor before you take
Lescol. Your doctor will take a blood test before prescribing Lescol.
Lescol and people over 70 years

Read all of this leaflet carefully before you start using this
medicine.



if you have severe respiratory failure

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.



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. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.

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.



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

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

In this leaflet:
1. What Lescol is and what it is used for
2. Before you take Lescol
3. How to take Lescol
4. Possible side effects
5. How to store Lescol

Lescol and children/adolescents

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 cholesterol-lowering
medicines prescribed by your doctor.

6. Further information

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

1. WHAT LESCOL IS AND WHAT IT IS USED FOR

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

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.



Ciclosporin (a medicine used to suppress the immune system).



Fibrates (e.g. gemfi brozil), 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).



in adult patients with high blood levels of cholesterol



Glibenclamide (a medicine used to treat diabetes).



in adult patients with high blood levels of both cholesterol and
triglycerides (another sort of blood lipid)



Colchicines (used to treat gout).

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.

You can take Lescol with or without food.



2. BEFORE YOU TAKE LESCOL
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.
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.

Taking Lescol with food and drink
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. Use reliable contraception for the whole time that you
are taking Lescol.
If you become pregnant while taking this medicine, stop taking
Lescol and see your doctor.
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.

Take special care with Lescol

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



How much Lescol to take

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 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.

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.

if you have a kidney disease.





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

Other possible side effects

Take your Lescol dose in the evening or at bedtime.



Sleep disturbances, including insomnia and nightmares

If you are taking Lescol twice per day, take one capsule in the
morning and one in the evening or at bedtime.



Memory loss



Sexual difficulties

Lescol can be taken with or without meals. Swallow whole with a
glass of water.
If you take more Lescol than you should



Depression



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

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



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 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.

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

Do not take a double dose to make up for the one that you missed.
If you stop taking Lescol

5. HOW TO STORE 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.



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 25°C.



The capsules should be left in the foil, 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 blister
label.



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

4. POSSIBLE SIDE EFFECTS



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

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



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.



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.

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

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.

6. FURTHER INFORMATION

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

What Lescol contains



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 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).

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, maize starch, calcium carbonate,
gelatin, titanium dioxide (E171), iron oxide red (E172), iron
oxide yellow (E172) and shellac.

if you have unusual tiredness or fever, yellowing of the skin and
eyes, dark coloured urine (signs of hepatitis).





What Lescol looks like and contents of the pack


Lescol Capsules are in a half reddish-brown and half paleyellow capsule marked with ‘XU 20mg’ in red



Capsules are available in calendar blister packs of 28 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

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

This product is manufactured by Novartis Farmacéutica SA, 08210
Barbera del Valles, Barcelona, Spain.

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

And

Common:

Novartis Farmaceutica SA, Gran Via de les Corts Catalanes 764,
08013 Barcelona, Spain.

Difficulty in sleeping, headache, stomach discomfort, abdominal
pain, nausea.
Very rare:
Tingling or numbness of the hands or feet, disturbed or decreased
sensitivity.

POM

PL No: 19488/0174

Leaflet revision date: 21 July 2012
Lescol is a registered trademark of Novartis AG, Switzerland.
S174LEAFLET Lescol 20120721

S174LEAFLET Fluvastatin 20120721

PACKAGE LEAFLET: INFORMATION FOR USER

Take special care with Fluvastatin Capsules


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.

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



if you have a kidney disease.

Information for other strength of Fluvastatin Capsules (Fluvastatin
40mg Capsules) is also present in this leaflet.



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.

FLUVASTATIN 20mg CAPSULES
(fluvastatin sodium)

Read all of this leaflet carefully before you start using this
medicine.


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. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.



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

In this leaflet:
1. What Fluvastatin Capsules are and what they are used for
2. Before you take Fluvastatin Capsules
3. How to take Fluvastatin Capsules
4. Possible side effects
5. How to store Fluvastatin Capsules
6. Further 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 medicines 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.

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 you take
Fluvastatin Capsules. Your doctor will take a blood test before
prescribing Fluvastatin Capsules.
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.
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.
Fluvastatin Capsules 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 Fluvastatin
Capsules.
Tell your doctor and pharmacist if you are taking any of the
following:


Ciclosporin (a medicine used to suppress the immune system).


2. BEFORE YOU TAKE FLUVASTATIN CAPSULES

Fibrates (e.g. gemfi brozil), nicotinic acid or bile acid
sequestrants (medicines used to lower bad cholesterol levels).



Fluconazole (a medicine used to treat fungal infections).

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



Rifampicin (an antibiotic).

Read the following explanations before you take Fluvastatin
Capsules.



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).

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

Taking Fluvastatin Capsules with food and drink
You can take Fluvastatin Capsules with or without food.
Pregnancy and breast-feeding
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. Use reliable
contraception for the whole time that you are taking Fluvastatin
Capsules.
If you become pregnant while taking this medicine, stop taking
Fluvastatin Capsules and see your doctor.
Driving and using machines
There is no information on the effects of Fluvastatin Capsules on
your ability to drive and use machines.

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.

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

How much Fluvastatin Capsules to take

Very rare:



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



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.

Your doctor will tell you exactly how many capsules of Fluvastatin
Capsules to take.
Depending on how you respond to the treatment, your doctor may
suggest a higher or lower dose.

Common:

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.

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


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 25°C.



The capsules should be left in the foil, 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 blister
label.



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

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.



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.

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

6. FURTHER INFORMATION

4. POSSIBLE SIDE EFFECTS



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, maize starch, calcium carbonate,
gelatin, titanium dioxide (E171), iron oxide red (E172), iron
oxide yellow (E172) and shellac.

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

Like all medicines, Fluvastatin Capsules can cause side effects,
although not everybody gets them.

What Fluvastatin Capsules contain

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).

What Fluvastatin Capsules look like and contents of the pack


Fluvastatin Capsules are in a half reddish-brown and half paleyellow capsule marked with ‘XU 20mg’ in red



Capsules are available in calendar blister packs of 28 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 Farmacéutica SA, 08210
Barbera del Valles, Barcelona, Spain.
And
Novartis Farmaceutica SA, Gran Via de les Corts Catalanes 764,
08013 Barcelona, Spain.
POM

PL No: 19488/0174

Leaflet revision date: 21 July 2012
S174LEAFLET Fluvastatin 20120721

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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