ROSUVASTATIN 40 MG FILM-COATED TABLETS

Active substance: ROSUVASTATIN CALCIUM

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Patient Information Leaflet

CRESTOR® 40 mg Film-coated Tablets
(rosuvastatin calcium)
The name of your medicine is CRESTOR®
40 mg Film-coated Tablets, but will be referred
to as ‘CRESTOR’ in this leaflet.
Other strengths are also available.
Read all of this leaflet carefully before
you start taking CRESTOR
 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 get serious, or
if you notice any side effects not listed in
this leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1) What is CRESTOR and what is it used for?
2) Before you take CRESTOR
3) How to take CRESTOR
4) Possible side effects
5) How to store CRESTOR
6) Further information

1)

WHAT IS CRESTOR AND WHAT IS IT
USED FOR?

CRESTOR belongs to a group of medicines
called statins.
You have been prescribed CRESTOR because:
 You have a high cholesterol level. This
means you are at risk from a heart attack
or stroke.
You have been advised to take a statin,
because changing your diet and taking more
exercise were not enough to correct your
cholesterol levels. You should continue with
your cholesterol-lowering diet and exercise
while you are taking CRESTOR.
Or
 You have other factors that increase your
risk of having a heart attack, stroke or
related health problems.
Heart attack, stroke and other problems can be
caused by a disease called atherosclerosis.
Atherosclerosis is due to build-up of fatty
deposits in your arteries.
Why is it important to keep taking
CRESTOR?
CRESTOR is used to correct the levels of fatty
substances in the blood called lipids, the most
common of which is cholesterol.
There are different types of cholesterol found in
the blood-‘bad’ cholesterol (LDL-C) and ‘good’
cholesterol (HDL-C).
 CRESTOR can reduce the ‘bad’ cholesterol
and increase the ‘good’ cholesterol.
 It works by helping to block your body’s
production of ‘bad’ cholesterol. It also
improves your body’s ability to remove it
from your blood.
For most people, high cholesterol does not
affect the way they feel because it does not
produce any symptoms. However, if it is left
untreated, fatty deposits can build up in the
walls of your blood vessels causing them to
narrow.
Sometimes, these narrowed blood vessels can
get blocked which can cut off the blood supply
to the heart or brain leading to a heart attack or
a stroke. By lowering your cholesterol levels,
you can reduce your risk of having a heart
attack, a stroke or related health problems.
You need to keep taking CRESTOR, even if it
has got your cholesterol to the right level,
because it prevents your cholesterol levels
from creeping up again and causing build-up
of fatty deposits. However, you should stop if
your doctor tells you to do so, or you have
become pregnant.

2) BEFORE YOU TAKE CRESTOR
Do not take CRESTOR:
 If you have ever had an allergic reaction
to CRESTOR, or to any of its ingredients.
 If you are pregnant or breast-feeding. If you
become pregnant while taking CRESTOR
stop taking it immediately and tell your
doctor. Women should avoid becoming
pregnant while taking CRESTOR by using
suitable contraception.
 If you have liver disease.
 If you have severe kidney problems.
 If you have repeated or unexplained
muscle aches or pains.
 If you take a drug called ciclosporin
(used, for example, after organ transplants)
If any of the above applies to you (or you are in
doubt), please go back and see your doctor.
In addition, do not take CRESTOR 40 mg (the
highest dose):
 If you have moderate kidney problems (if
in doubt, please ask your doctor).
 If your thyroid gland is not working
properly.
 If you have had any repeated or
unexplained muscle aches or pains, a
personal or family history of muscle
problems, or a previous history of muscle
problems when taking other cholesterollowering medicines.
 If you regularly drink large amounts of
alcohol.
 If you are of Asian origin (Japanese,
Chinese, Filipino, Vietnamese, Korean and
Indian).



If you take other medicines called fibrates
to lower your cholesterol.
If any of the above applies to you (or you are in
doubt), please go back and see your doctor.
Take special care with CRESTOR:





If you have problems with your kidneys.
If you have problems with your liver.
If you have had repeated or unexplained
muscle aches or pains, a personal or
family history of muscle problems, or a
previous history of muscle problems when
taking other cholesterol-lowering medicines.
Tell your doctor immediately if you have
unexplained muscle aches or pains
especially if you feel unwell or have a fever.
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 you regularly drink large amounts of
alcohol.
 If your thyroid gland is not working
properly.
 If you take other medicines called fibrates
to lower your cholesterol. Please read this
leaflet carefully, even if you have taken other
medicines for high cholesterol before.
 If you take medicines used to fight the
HIV infection e.g. lopinavir/ritonavir, please
see Taking other medicines.
 If the patient is under 10 years old:
CRESTOR should not be given to children
younger than 10 years.
 If the patient is below 18 years of age: The
CRESTOR 40 mg tablet is not suitable for
use in children and adolescents below 18
years of age.
 If you are over 70 (as your doctor needs to
choose the right start dose of CRESTOR to
suit you).
 If you have severe respiratory failure.
 If you are of Asian origin – that is
Japanese, Chinese, Filipino, Vietnamese,
Korean and Indian. Your doctor needs to
choose the right start dose of CRESTOR to
suit you.
If any of the above applies to you (or if you are
not sure):
 Do not take CRESTOR 40 mg (the highest
dose) and check with your doctor or
pharmacist before you actually start
taking any dose of CRESTOR.
In a small number of people, statins can affect
the liver. This is identified by a simple test which
looks for increased levels of liver enzymes in the
blood. For this reason, your doctor will usually
carry out this blood test (liver function test)
before and during treatment with CRESTOR.
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.
Taking other medicines
Tell your doctor or pharmacist if you are taking,
or have recently taken, any other medicines
including any you bought without a prescription.
Tell your doctor if you are taking any of the
following: ciclosporin (used for example, after
organ transplants), warfarin (or any other drug
used for thinning the blood), fibrates (such as
gemfibrozil, fenofibrate) or any other medicine
used to lower cholesterol (such as ezetimibe),
indigestion remedies (used to neutralise acid in
your stomach), erythromycin (an antibiotic), an
oral contraceptive (the pill), hormone
replacement therapy or lopinavir/ritonavir (used
to fight the HIV infection – please see Take
special care with CRESTOR). The effects of
these medicines could be changed by
CRESTOR or they could change the effects of
CRESTOR.
Taking CRESTOR with food and drink
You can take CRESTOR with or without food.
Pregnancy and breast-feeding
Do not take CRESTOR if you are pregnant or
breast-feeding. If you become pregnant while
taking CRESTOR stop taking it immediately
and tell your doctor. Women should avoid
becoming pregnant while taking CRESTOR by
using suitable contraception.
Ask your doctor or pharmacist for advice before
taking any medicine.
Driving and using machines
Most people can drive a car and operate
machinery while using CRESTOR – it will not
affect their ability. However, some people feel
dizzy during treatment with CRESTOR. If you
feel dizzy, consult your doctor before attempting
to drive or use machines.
Important information about some of the
ingredients of CRESTOR
If you have been told by your doctor that you
have an intolerance to some sugars (lactose or
milk sugar), contact your doctor before taking
CRESTOR.
For a full list of ingredients please see Further
information below.

3) HOW TO TAKE CRESTOR
Always take CRESTOR as your doctor has told
you. You should check with your doctor or
pharmacist if you are not sure.
Usual doses in adults
If you are taking CRESTOR for high
cholesterol:
Starting dose
Your treatment with CRESTOR must start with
the 5 mg or the 10 mg dose, even if you have
taken a higher dose of a different statin before.

The choice of your start dose will depend upon:
 Your cholesterol level.
 The level of risk you have of experiencing a
heart attack or stroke.
 Whether you have a factor that may make
you more sensitive to possible side effects.
Please check with your doctor or pharmacist
which start dose of CRESTOR will best suit you.
Your doctor may decide to give you the lowest
dose (5 mg) if:
 You are of Asian origin (Japanese,
Chinese, Filipino, Vietnamese, Korean and
Indian)
 You are over 70 years of age.
 You have moderate kidney problems.
 You are at risk of muscle aches and pains
(myopathy).
Increasing the dose and maximum daily
dose
Your doctor may decide to increase your dose.
This is so that you are taking the amount of
CRESTOR that is right for you. If you started
with a 5 mg dose, your doctor may decide to
double this to 10 mg, then 20 mg and then 40
mg if necessary. If you started on 10 mg, your
doctor may decide to double this to 20 mg and
then 40 mg if necessary. There will be a gap of
four weeks between every dose adjustment.
The maximum daily dose of CRESTOR is
40 mg. It is only for patients with high
cholesterol levels and a high risk of heart
attacks or stroke whose cholesterol levels are
not lowered enough with 20 mg.
If you are taking CRESTOR to reduce your
risk of having a heart attack, stroke or
related health problems:
The recommended dose is 20 mg daily.
However, your doctor may decide to use a lower
dose if you have any of the factors mentioned
above.
Usual doses in children aged 10-17 years
The usual start dose is 5 mg. Your doctor may
increase your dose to find the right amount of
CRESTOR for you. The maximum daily dose of
CRESTOR is 20 mg. Take your dose once a
day. CRESTOR 40 mg tablet should not be
used by children.
Taking your tablets
Swallow each tablet whole with a drink of water.
Take CRESTOR once daily. You can take it at
any time of the day.
Try to take your tablet at the same time every
day to help you to remember it.
Regular cholesterol checks
It is important to go back to your doctor for
regular cholesterol checks, to make sure your
cholesterol has reached and is staying at the
correct level.
Your doctor may decide to increase your dose
so that you are taking the amount of CRESTOR
that is right for you.
If you take more CRESTOR than you should
Contact your doctor or nearest hospital for
advice.
If you go into hospital or receive treatment for
another condition, tell the medical staff that
you’re taking CRESTOR.
If you forget to take CRESTOR
Don’t worry, just take your next scheduled dose
at the correct time. Do not take a double dose to
make up for the one you have missed.
If you stop taking CRESTOR
Talk to your doctor if you want to stop taking
CRESTOR. Your cholesterol levels might
increase again if you stop taking CRESTOR.

4) POSSIBLE SIDE EFFECTS
Like all medicines, CRESTOR can cause side
effects, although not everybody gets them.
It is important that you are aware of what these
side effects may be. They are usually mild and
disappear after a short time.
Stop taking CRESTOR and seek medical
help immediately if you have any of the
following allergic reactions:
 Difficulty in breathing, with or without
swelling of the face, lips, tongue and/or
throat
 Swelling of the face, lips, tongue and/or
throat, which may cause difficulty in
swallowing.
 Severe itching of the skin (with raised
lumps).
Also, stop taking CRESTOR and talk to your
doctor immediately if you have any unusual
aches or pains in your muscles which go on for
longer than you might expect. Muscle symptoms
are more common in children and adolescents
than in adults. As with other statins, a very small
number of people have experienced unpleasant
muscle effects and rarely these have gone on to
become a potentially life threatening muscle
damage known as rhabdomyolysis.
Common possible side effects (these may
affect between 1 in 10 and 1 in 100 patients):
 Headache
 Stomach pain
 Constipation
 Feeling sick
 Muscle pain
 Feeling weak
 Dizziness
 An increase in the amount of protein in the
urine – this usually returns to normal on its
own without having to stop taking your
CRESTOR tablets (only CRESTOR 40 mg)



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 will monitor you while you are
taking this medicine.
Uncommon possible side effects (these may
affect between 1 in 100 and 1 in 1,000
patients):
 Rash, itching or other skin reactions
 An increase in the amount of protein in the
urine – this usually returns to normal on its
own without having to stop taking your
CRESTOR tablets (only CRESTOR 5 mg, 10
mg and 20 mg).
Rare possible side effects (these may affect
between 1 in 1,000 and 1 in 10,000 patients):
 Severe allergic reaction – signs include
swelling of the face, lips, tongue and/or
throat, difficulty in swallowing and breathing,
a severe itching of the skin (with raised
lumps). If you think you are having an
allergic reaction, then stop taking
CRESTOR and seek medical help
immediately.
 Muscle damage in adults – as a precaution,
stop taking CRESTOR and talk to your
doctor immediately if you have any
unusual aches or pains in your muscles
which go on for longer than expected.
 A severe stomach pain (inflamed pancreas)
 Increase in liver enzymes in the blood.
Very rare possible side effects (these may
affect less than 1 in 10,000 patients):
 Jaundice (yellowing of the skin and eyes)
 Hepatitis (an inflamed liver)
 Traces of blood in your urine
 Damage to the nerves of your legs and arms
(such as numbness)
 Joint pain
 Memory loss
 Breast enlargement in men (gynaecomastia)
Side effects of unknown frequency may
include:
 Diarrhoea (loose stools)
 Stevens-Johnson syndrome (serious
blistering condition of the skin, mouth, eyes
and genitals)
 Cough
 Shortness of breath
 Oedema (swelling)
 Sleep disturbances, including insomnia and
nightmares
 Sexual difficulties
 Depression
 Breathing problems, including persistent
cough and/or shortness of breath or fever
 Tendon injury
 Muscle weakness that is constant.
If any of the side effects become troublesome,
or if you experience any side effects not listed in
this leaflet, please tell your doctor or pharmacist.

5) HOW TO STORE CRESTOR








Keep out of the sight and reach of children.
Do not use CRESTOR after the expiry date
which is stated on the label after EXP. The
expiry date refers to the last day of the
month.
Tablets should not be thrown in your bin or
put down the drain. If they are out of date, or
no longer suitable for you, return them to
your pharmacist.
Do not store above 30°C. Store in the
original package.
If your medicine gets discoloured or shows
any other signs of deterioration, seek the
advice of your pharmacist.

6) FURTHER INFORMATION
What CRESTOR contains:
The active substance in CRESTOR is
rosuvastatin.
Each film-coated tablet contains 40 mg
rosuvastatin (as rosuvastatin calcium). The
other ingredients are: lactose monohydrate,
microcrystalline cellulose, calcium phosphate,
crospovidone, magnesium stearate,
hypromellose, triacetin, titanium dioxide (E171),
red iron oxide (E172).
What CRESTOR looks like and contents of
the pack
CRESTOR comes in blister packs containing 14
& 28 tablets.
CRESTOR 40 mg film-coated tablets are pink,
oval and marked with ‘ZD4522’ on one side and
‘40’ on the other side.
Manufacturer: AstraZeneca UK Ltd., Silk Road
Business Park, Macclesfield, Cheshire,
SK10 2NA, UK.
Corden Pharma GmbH, Otto Hahn Strasse,
D-68723 Plankstadt, Germany.
AstraZeneca GmbH, Tinsdaler Weg 183,
D-22880, Wedel, Germany.
AstraZeneca Reims SAS, Parc Industriel
Pompelle, Chemin de Vrilly, BP 1050, Reims
Cedex 2,F-51689, France.
NV AstraZeneca SA, Schaessestraat 15,
Destelbergen,B-9070, Belgium.
AstraZeneca Farmaceutica Spain S.A, LA
RELVA S/N, O Porrino, Pontevedra, E-36400,
Spain.
AstraZeneca AB, 19, Forskargatan, S-15185,
Sodertalje, Sweden.
Procured from within the EU & repackaged
by Product Licence holder:
Kosei Pharma UK Ltd., 956 Buckingham
Avenue, Slough Trading Estate, Slough,
SL1 4NL
CRESTOR® 40 mg Film-coated Tablets,
PL: 39352/0135
POM
Leaflet date: 21.02.2013
CRESTOR® is a registered trademark of
AstraZeneca UK Ltd.

Patient Information Leaflet

Rosuvastatin 40 mg Film-coated Tablets
(rosuvastatin calcium)
The name of your medicine is Rosuvastatin
40 mg Film-coated Tablets, but will be referred
to as ‘Rosuvastatin’ in this leaflet. Other
strengths are also available.
Read all of this leaflet carefully before you
start taking Rosuvastatin
 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 get serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1) What is Rosuvastatin and what is it used
for?
2) Before you take Rosuvastatin
3) How to take Rosuvastatin
4) Possible side effects
5) How to store Rosuvastatin
6) Further information

1)

WHAT IS ROSUVASTATIN AND
WHAT IS IT USED FOR?

Rosuvastatin belongs to a group of medicines
called statins.
You have been prescribed Rosuvastatin
because:
 You have a high cholesterol level. This
means you are at risk from a heart attack
or stroke.
You have been advised to take a statin,
because changing your diet and taking more
exercise were not enough to correct your
cholesterol levels. You should continue with
your cholesterol-lowering diet and exercise
while you are taking Rosuvastatin.
Or
 You have other factors that increase your
risk of having a heart attack, stroke or
related health problems.
Heart attack, stroke and other problems can be
caused by a disease called atherosclerosis.
Atherosclerosis is due to build-up of fatty
deposits in your arteries.
Why is it important to keep taking
Rosuvastatin?
Rosuvastatin is used to correct the levels of fatty
substances in the blood called lipids, the most
common of which is cholesterol.
There are different types of cholesterol found in
the blood-‘bad’ cholesterol (LDL-C) and ‘good’
cholesterol (HDL-C).
 Rosuvastatin can reduce the ‘bad’
cholesterol and increase the ‘good’
cholesterol.
 It works by helping to block your body’s
production of ‘bad’ cholesterol. It also
improves your body’s ability to remove it
from your blood.
For most people, high cholesterol does not
affect the way they feel because it does not
produce any symptoms. However, if it is left
untreated, fatty deposits can build up in the
walls of your blood vessels causing them to
narrow.
Sometimes, these narrowed blood vessels can
get blocked which can cut off the blood supply
to the heart or brain leading to a heart attack or
a stroke. By lowering your cholesterol levels,
you can reduce your risk of having a heart
attack, a stroke or related health problems.
You need to keep taking Rosuvastatin, even if
it has got your cholesterol to the right level,
because it prevents your cholesterol levels
from creeping up again and causing build-up
of fatty deposits. However, you should stop if
your doctor tells you to do so, or you have
become pregnant.

2) BEFORE YOU TAKE ROSUVASTATIN
Do not take Rosuvastatin:
 If you have ever had an allergic reaction
to Rosuvastatin, or to any of its ingredients.
 If you are pregnant or breast-feeding. If you
become pregnant while taking Rosuvastatin
stop taking it immediately and tell your
doctor. Women should avoid becoming
pregnant while taking Rosuvastatin by using
suitable contraception.
 If you have liver disease.
 If you have severe kidney problems.
 If you have repeated or unexplained
muscle aches or pains.
 If you take a drug called ciclosporin
(used, for example, after organ transplants)
If any of the above applies to you (or you are in
doubt), please go back and see your doctor.
In addition, do not take Rosuvastatin 40 mg
(the highest dose):
 If you have moderate kidney problems (if
in doubt, please ask your doctor).
 If your thyroid gland is not working
properly.
 If you have had any repeated or
unexplained muscle aches or pains,
 a personal or family history of muscle
problems, or a previous history of muscle
problems when taking other cholesterollowering medicines.
 If you regularly drink large amounts of
alcohol.
 If you are of Asian origin (Japanese,
Chinese, Filipino, Vietnamese, Korean and
Indian).



If you take other medicines called fibrates
to lower your cholesterol.
If any of the above applies to you (or you are in
doubt), please go back and see your doctor.
Take special care with Rosuvastatin:
 If you have problems with your kidneys.
 If you have problems with your liver.
 If you have had repeated or unexplained
muscle aches or pains, a personal or
family history of muscle problems, or a
previous history of muscle problems when
taking other cholesterol-lowering medicines.
Tell your doctor immediately if you have
unexplained muscle aches or pains
especially if you feel unwell or have a fever.
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 you regularly drink large amounts of
alcohol.
 If your thyroid gland is not working
properly.
 If you take other medicines called fibrates
to lower your cholesterol. Please read this
leaflet carefully, even if you have taken other
medicines for high cholesterol before.
 If you take medicines used to fight the
HIV infection e.g. lopinavir/ritonavir, please
see Taking other medicines.
 If the patient is under 10 years old:
Rosuvastatin should not be given to children
younger than 10 years.
 If the patient is below 18 years of age: The
Rosuvastatin 40 mg tablet is not suitable for
use in children and adolescents below 18
years of age.
 If you are over 70 (as your doctor needs to
choose the right start dose of Rosuvastatin
to suit you).
 If you have severe respiratory failure.
 If you are of Asian origin – that is
Japanese, Chinese, Filipino, Vietnamese,
Korean and Indian. Your doctor needs to
choose the right start dose of Rosuvastatin
to suit you.
If any of the above applies to you (or if you are
not sure):
 Do not take Rosuvastatin 40 mg (the
highest dose) and check with your doctor
or pharmacist before you actually start
taking any dose of Rosuvastatin.
In a small number of people, statins can affect
the liver. This is identified by a simple test which
looks for increased levels of liver enzymes in the
blood. For this reason, your doctor will usually
carry out this blood test (liver function test)
before and during treatment with Rosuvastatin.
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.
Taking other medicines
Tell your doctor or pharmacist if you are taking,
or have recently taken, any other medicines
including any you bought without a prescription.
Tell your doctor if you are taking any of the
following: ciclosporin (used for example, after
organ transplants), warfarin (or any other drug
used for thinning the blood), fibrates (such as
gemfibrozil, fenofibrate) or any other medicine
used to lower cholesterol (such as ezetimibe),
indigestion remedies (used to neutralise acid in
your stomach), erythromycin (an antibiotic), an
oral contraceptive (the pill), hormone
replacement therapy or lopinavir/ritonavir (used
to fight the HIV infection – please see Take
special care with Rosuvastatin). The effects of
these medicines could be changed by
Rosuvastatin or they could change the effects of
Rosuvastatin.
Taking Rosuvastatin with food and drink
You can take Rosuvastatin with or without food.
Pregnancy and breast-feeding
Do not take Rosuvastatin if you are pregnant
or breast-feeding. If you become pregnant while
taking Rosuvastatin stop taking it immediately
and tell your doctor. Women should avoid
becoming pregnant while taking Rosuvastatin by
using suitable contraception.
Ask your doctor or pharmacist for advice before
taking any medicine.
Driving and using machines
Most people can drive a car and operate
machinery while using Rosuvastatin – it will not
affect their ability. However, some people feel
dizzy during treatment with Rosuvastatin. If you
feel dizzy, consult your doctor before attempting
to drive or use machines.
Important information about some of the
ingredients of Rosuvastatin
If you have been told by your doctor that you
have an intolerance to some sugars (lactose or
milk sugar), contact your doctor before taking
Rosuvastatin.
For a full list of ingredients please see Further
information below.

3) HOW TO TAKE ROSUVASTATIN
Always take Rosuvastatin as your doctor has
told you. You should check with your doctor or
pharmacist if you are not sure.
Usual doses in adults
If you are taking Rosuvastatin for high
cholesterol:
Starting dose
Your treatment with Rosuvastatin must start with
the 5 mg or the 10 mg dose, even if you have
taken a higher dose of a different statin before.

The choice of your start dose will depend upon:
 Your cholesterol level.
 The level of risk you have of experiencing a
heart attack or stroke.
 Whether you have a factor that may make
you more sensitive to possible side effects.
Please check with your doctor or pharmacist
which start dose of Rosuvastatin will best suit
you.
Your doctor may decide to give you the lowest
dose (5 mg) if:
 You are of Asian origin (Japanese,
Chinese, Filipino, Vietnamese, Korean and
Indian)
 You are over 70 years of age.
 You have moderate kidney problems.
 You are at risk of muscle aches and pains
(myopathy).
Increasing the dose and maximum daily
dose
Your doctor may decide to increase your dose.
This is so that you are taking the amount of
Rosuvastatin that is right for you. If you started
with a 5 mg dose, your doctor may decide to
double this to 10 mg, then 20 mg and then 40
mg if necessary. If you started on 10 mg, your
doctor may decide to double this to 20 mg and
then 40 mg if necessary. There will be a gap of
four weeks between every dose adjustment.
The maximum daily dose of Rosuvastatin is
40 mg. It is only for patients with high
cholesterol levels and a high risk of heart
attacks or stroke whose cholesterol levels are
not lowered enough with 20 mg.
If you are taking Rosuvastatin to reduce your
risk of having a heart attack, stroke or
related health problems:
The recommended dose is 20 mg daily.
However, your doctor may decide to use a lower
dose if you have any of the factors mentioned
above.
Usual doses in children aged 10-17 years
The usual start dose is 5 mg. Your doctor may
increase your dose to find the right amount of
Rosuvastatin for you. The maximum daily dose
of Rosuvastatin is 20 mg. Take your dose once
a day. Rosuvastatin 40 mg tablet should not be
used by children.
Taking your tablets
Swallow each tablet whole with a drink of water.
Take Rosuvastatin once daily. You can take it
at any time of the day.
Try to take your tablet at the same time every
day to help you to remember it.
Regular cholesterol checks
It is important to go back to your doctor for
regular cholesterol checks, to make sure your
cholesterol has reached and is staying at the
correct level.
Your doctor may decide to increase your dose
so that you are taking the amount of
Rosuvastatin that is right for you.
If you take more Rosuvastatin than you
should
Contact your doctor or nearest hospital for
advice.
If you go into hospital or receive treatment for
another condition, tell the medical staff that
you’re taking Rosuvastatin.
If you forget to take Rosuvastatin
Don’t worry, just take your next scheduled dose
at the correct time. Do not take a double dose to
make up for the one you have missed.
If you stop taking Rosuvastatin
Talk to your doctor if you want to stop taking
Rosuvastatin. Your cholesterol levels might
increase again if you stop taking Rosuvastatin.



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 will monitor you while you are
taking this medicine.
Uncommon possible side effects (these may
affect between 1 in 100 and 1 in 1,000
patients):
 Rash, itching or other skin reactions
 An increase in the amount of protein in the
urine – this usually returns to normal on its
own without having to stop taking your
Rosuvastatin tablets (only Rosuvastatin 5
mg, 10 mg and 20 mg).
Rare possible side effects (these may affect
between 1 in 1,000 and 1 in 10,000 patients):
 Severe allergic reaction – signs include
swelling of the face, lips, tongue and/or
throat, difficulty in swallowing and breathing,
a severe itching of the skin (with raised
lumps). If you think you are having an
allergic reaction, then stop taking
Rosuvastatin and seek medical help
immediately.
 Muscle damage in adults – as a precaution,
stop taking Rosuvastatin and talk to your
doctor immediately if you have any
unusual aches or pains in your muscles
which go on for longer than expected.
 A severe stomach pain (inflamed pancreas)
 Increase in liver enzymes in the blood.
Very rare possible side effects (these may
affect less than 1 in 10,000 patients):
 Jaundice (yellowing of the skin and eyes)
 Hepatitis (an inflamed liver)
 Traces of blood in your urine
 Damage to the nerves of your legs and arms
(such as numbness)
 Joint pain
 Memory loss
 Breast enlargement in men (gynaecomastia)
Side effects of unknown frequency may
include:
 Diarrhoea (loose stools)
 Stevens-Johnson syndrome (serious
blistering condition of the skin, mouth, eyes
and genitals)
 Cough
 Shortness of breath
 Oedema (swelling)
 Sleep disturbances, including insomnia and
nightmares
 Sexual difficulties
 Depression
 Breathing problems, including persistent
cough and/or shortness of breath or fever
 Tendon injury
 Muscle weakness that is constant.
If any of the side effects become troublesome,
or if you experience any side effects not listed in
this leaflet, please tell your doctor or pharmacist.

5) HOW TO STORE ROSUVASTATIN








Keep out of the sight and reach of children.
Do not use Rosuvastatin after the expiry
date which is stated on the label after EXP.
The expiry date refers to the last day of the
month.
Tablets should not be thrown in your bin or
put down the drain. If they are out of date, or
no longer suitable for you, return them to
your pharmacist.
Do not store above 30°C. Store in the
original package.
If your medicine gets discoloured or shows
any other signs of deterioration, seek the
advice of your pharmacist.

6) FURTHER INFORMATION
4) POSSIBLE SIDE EFFECTS
Like all medicines, Rosuvastatin can cause side
effects, although not everybody gets them.
It is important that you are aware of what these
side effects may be. They are usually mild and
disappear after a short time.
Stop taking Rosuvastatin and seek medical
help immediately if you have any of the
following allergic reactions:
 Difficulty in breathing, with or without
swelling of the face, lips, tongue and/or
throat
 Swelling of the face, lips, tongue and/or
throat, which may cause difficulty in
swallowing.
 Severe itching of the skin (with raised
lumps).
Also, stop taking Rosuvastatin and talk to
your doctor immediately if you have any
unusual aches or pains in your muscles which
go on for longer than you might expect. Muscle
symptoms are more common in children and
adolescents than in adults. As with other statins,
a very small number of people have
experienced unpleasant muscle effects and
rarely these have gone on to become a
potentially life threatening muscle damage
known as rhabdomyolysis.
Common possible side effects (these may
affect between 1 in 10 and 1 in 100 patients):
 Headache
 Stomach pain
 Constipation
 Feeling sick
 Muscle pain
 Feeling weak
 Dizziness
 An increase in the amount of protein in the
urine – this usually returns to normal on its
own without having to stop taking your
Rosuvastatin tablets (only Rosuvastatin 40
mg)

What Rosuvastatin contains:
The active substance in Rosuvastatin is
rosuvastatin.
Each film-coated tablet contains 40 mg
rosuvastatin (as rosuvastatin calcium). The
other ingredients are: lactose monohydrate,
microcrystalline cellulose, calcium phosphate,
crospovidone, magnesium stearate,
hypromellose, triacetin, titanium dioxide (E171),
red iron oxide (E172).
What Rosuvastatin looks like and contents
of the pack
Rosuvastatin comes in blister packs containing
14 & 28 tablets.
Rosuvastatin 40 mg film-coated tablets are pink,
oval and marked with ‘ZD4522’ on one side and
‘40’ on the other side.
Manufacturer: AstraZeneca UK Ltd., Silk Road
Business Park, Macclesfield, Cheshire,
SK10 2NA, UK.
Corden Pharma GmbH, Otto Hahn Strasse,
D-68723 Plankstadt, Germany.
AstraZeneca GmbH, Tinsdaler Weg 183,
D-22880, Wedel, Germany.
AstraZeneca Reims SAS, Parc Industriel
Pompelle, Chemin de Vrilly, BP 1050, Reims
Cedex 2, F-51689, France.
NV AstraZeneca SA, Schaessestraat 15,
Destelbergen,B-9070, Belgium.
AstraZeneca Farmaceutica Spain S.A, LA
RELVA S/N, O Porrino, Pontevedra, E-36400,
Spain.
AstraZeneca AB, 19, Forskargatan, S-15185,
Sodertalje, Sweden.
Procured from within the EU & repackaged
by Product Licence holder:
Kosei Pharma UK Ltd., 956 Buckingham
Avenue, Slough Trading Estate, Slough,
SL1 4NL.
Rosuvastatin 40 mg Film-coated Tablets,
PL: 39352/0135
Leaflet date: 21.02.2013

POM

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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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