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CRESTOR 40 MG FILM-COATED TABLET

Active substance(s): ROSUVASTATIN CALCIUM / ROSUVASTATIN CALCIUM / ROSUVASTATIN CALCIUM

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Package leaflet: information for the patient

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

1) What Crestor is and what it is 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. Crestor is used in adults, adolescents and
children 6 years or older to treat high cholesterol.
You have been advised to take a statin, because changing your diet
and doing 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 it is 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) What you need to know 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.
Warnings and precautions
Talk to your doctor or pharmacist before taking 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 cholesterollowering 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.
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 treat the HIV infection e.g.
ritonavir with lopinavir and/or atazanavir, please see Other
medicines and Crestor.
If you are taking or have taken in the last 7 days a medicine
called fusidic acid (a medicine for bacterial infection), orally or by
injection. The combination of fusidic acid and Crestor can lead to
serious muscle problems (rhabdomyolysis), please see Other
medicines and Crestor.
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.
Children and adolescents
• If the patient is under 6 years old: Crestor should not be given to
children younger than 6 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.
Other medicines and Crestor
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines
Tell your doctor if you are taking any of the following: ciclosporin (used
for example, after organ transplants), warfarin or clopidogrel (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), fusidic acid (an antibiotic –
please see below and Warnings and precautions), an oral contraceptive
(the pill), hormone replacement therapy or anti-viral medications such
as ritonavir with lopinavir and/or atazanavir or simeprevir (used to treat
infections, including HIV or hepatitis C infection – please see Warnings
and precautions). The effects of these medicines could be changed by
Crestor or they could change the effect of Crestor.
If you need to take oral fusidic acid to treat a bacterial infection
you will need to temporarily stop using this medicine. Your doctor
will tell you when it is safe to restart Crestor. Taking Crestor with
fusidic acid may rarely lead to muscle weakness, tenderness or
pain (rhabdomyolysis). See more information regarding
rhabdomyolysis in Section 4.
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.
Crestor contains lactose.
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 Contents of the pack and
other information.

3) How to take Crestor
Always take this medicine as your doctor has told you. 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.
Use in children and adolescents aged 6-17 years
The dose range in children and adolescents aged 6 to 17 years is 5 to
20 mg once daily. The usual start dose is 5 mg per day, and your doctor
may gradually increase your dose to find the right amount of Crestor for
you. The maximum daily dose of Crestor is 10 or 20 mg for children
aged 6 to 17 years depending on your underlying condition being
treated. 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 with or
without food.
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 a forgotten dose.
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.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.

4) Possible side effects
Like all medicines, this medicine 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
Reporting of side effects:
If you get any side effects talk to your doctor or pharmacist. This
includes any side effects not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme Website:
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 Crestor







Keep out of the sight and reach of children.
Do not store above 30°C.
Store in the original package in order to protect from moisture.
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.
If your medicine gets discoloured or shows any other signs of
deterioration, seek the advice of your pharmacist.

6) Contents of the pack and other 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, 68723 Plankstadt,
Germany.
AstraZeneca GmbH, Tinsdaler Weg 183, D-22880, Wedel, Germany.
AstraZeneca Reims, Parc Industriel Pompelle, Chemin de Vrilly, Box
1050, Reims Cedex 2, France.
AstraZeneca AB, S-151085, Sodertalje, Sweden.
AndersonBrecon (UK) Ltd, 2-7 Wye Valley Business Park, Brecon
Road, Hay-on-Wye, Hereford, HR3 5PG, UK.
Procured from within the EU & repackaged by Product Licence
holder: Kosei Pharma UK Ltd., 956 Buckingham Avenue, Slough
Trading Estate, Slough, SL1 4NL, UK

CRESTOR® 40 mg Film-coated Tablets
PL: 39352/0135

POM

Leaflet date: 18/04/2017
Crestor® is a registered trademark of AstraZeneca UK Ltd.
H.E.A.R.T UK – The Cholesterol Charity provides information and
advice for patients through a membership magazine, health and diet
fact sheets and a helpline manned by nurses and dieticians.
To become a member of H.E.A.R.T UK or for further information
contact: H.E.A.R.T UK, 7 North Road, Maidenhead, Berkshire,
SL6 1PE.
Helpline number: 0845 450 5988 open 1000-1600 from Mon-Fri.

To listen to or request a copy of
this leaflet in Braille, large print
or audio, please call:
01753515054 (UK only)

Package leaflet: information for the patient

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

1)

What Rosuvastatin is and what it is 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. Rosuvastatin is used in adults, adolescents
and children 6 years or older to treat high cholesterol.
You have been advised to take a statin, because changing your diet
and doing 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 it is 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) What you need to know 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.
Warnings and precautions
Talk to your doctor or pharmacist before taking 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 cholesterollowering 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.
• 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 treat the HIV infection e.g.
ritonavir with lopinavir and/or atazanavir, please see Other
medicines and Rosuvastatin.
• If you are taking or have taken in the last 7 days a medicine
called fusidic acid (a medicine for bacterial infection), orally or by
injection. The combination of fusidic acid and Rosuvastatin can lead
to serious muscle problems (rhabdomyolysis), please see Other
medicines and Rosuvastatin.
• 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.
Children and adolescents
• If the patient is under 6 years old: Rosuvastatin should not be
given to children younger than 6 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.
Other medicines and Rosuvastatin
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines
Tell your doctor if you are taking any of the following: ciclosporin (used
for example, after organ transplants), warfarin or clopidogrel (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), fusidic acid (an antibiotic –
please see below and Warnings and precautions), an oral contraceptive
(the pill), hormone replacement therapy or anti-viral medications such
as ritonavir with lopinavir and/or atazanavir or simeprevir (used to treat
infections, including HIV or hepatitis C infection – please see Warnings
and precautions). The effects of these medicines could be changed by
Rosuvastatin or they could change the effect of Rosuvastatin.
If you need to take oral fusidic acid to treat a bacterial infection
you will need to temporarily stop using this medicine. Your doctor
will tell you when it is safe to restart Rosuvastatin. Taking
Rosuvastatin with fusidic acid may rarely lead to muscle
weakness, tenderness or pain (rhabdomyolysis). See more
information regarding rhabdomyolysis in Section 4.
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.
Rosuvastatin contains lactose.
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 Contents of the pack and
other information.

3) How to take Rosuvastatin
Always take this medicine as your doctor has told you. 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.
Use in children and adolescents aged 6-17 years
The dose range in children and adolescents aged 6 to 17 years is 5 to
20 mg once daily. The usual start dose is 5 mg per day, and your doctor
may gradually increase your dose to find the right amount of
Rosuvastatin for you. The maximum daily dose of Rosuvastatin is 10 or
20 mg for children aged 6 to 17 years depending on your underlying
condition being treated. 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
with or without food.
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 a forgotten dose.
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.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.

4) Possible side effects
Like all medicines, this medicine 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)
• 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
Reporting of side effects:
If you get any side effects talk to your doctor or pharmacist. This
includes any side effects not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme Website:
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 Rosuvastatin







Keep out of the sight and reach of children.
Do not store above 30°C.
Store in the original package in order to protect from moisture.
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.
If your medicine gets discoloured or shows any other signs of
deterioration, seek the advice of your pharmacist.

6) Contents of the pack and other information
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, 68723 Plankstadt,
Germany.
AstraZeneca GmbH, Tinsdaler Weg 183, D-22880, Wedel, Germany.
AstraZeneca Reims, Parc Industriel Pompelle, Chemin de Vrilly, Box
1050, Reims Cedex 2, France.
AstraZeneca AB, S-151085, Sodertalje, Sweden.
AndersonBrecon (UK) Ltd, 2-7 Wye Valley Business Park, Brecon
Road, Hay-on-Wye, Hereford, HR3 5PG, UK.
Procured from within the EU & repackaged by Product Licence
holder: Kosei Pharma UK Ltd., 956 Buckingham Avenue, Slough
Trading Estate, Slough, SL1 4NL, UK.

Rosuvastatin 40 mg Film-coated Tablets
PL: 39352/0135
Leaflet date: 18/04/2017

POM

H.E.A.R.T UK – The Cholesterol Charity provides information and
advice for patients through a membership magazine, health and diet
fact sheets and a helpline manned by nurses and dieticians.
To become a member of H.E.A.R.T UK or for further information
contact: H.E.A.R.T UK, 7 North Road, Maidenhead, Berkshire,
SL6 1PE.
Helpline number: 0845 450 5988 open 1000-1600 from Mon-Fri.

To listen to or request a copy of
this leaflet in Braille, large print
or audio, please call:
01753515054 (UK only)

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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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