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CRESTOR 5MG TABLETS

Active substance(s): ROSUVASTATIN / ROSUVASTATIN CALCIUM

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Ref: 1081/070715/1/F

Crestor ® 5mg Tablets
(rosuvastatin calcium)
Patient Information Leaflet
Your medicine is called Crestor 5mg Tablets but will be referred to as Crestor
throughout this leaflet.

*

Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
* Keep this leaflet. You may need to read it again.
* If you have any further questions, ask your doctor or pharmacist.
* 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 is Crestor and what is it 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 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. 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
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

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 cholesterol-lowering 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 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.
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 take antibiotics containing fusidic acid, please see Other
medicines and Crestor.

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.
* 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.
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 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 effects of Crestor.
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).

Ref: 1081/070715/1/B

Crestor ® 5mg Tablets
(rosuvastatin calcium)
Patient Information Leaflet (continued)
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 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 10
mg for children aged 6 to 9 years and 20 mg for children aged
10 to 17 years. 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.

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

the sight and reach of children.
* Keep out ofthis medicine after the expiry date which is stated on the pack.
* Do not use above 30°C.
* Do notinstoreoriginal package.
the
* Store tablets become discoloured or show signs of any deterioration, you
* If the seek the advice of your pharmacist who will advise you what to do.
should
Medicines should not be
via wastewater
* Ask your pharmacist howdisposed of of medicines no or household waste.
to dispose
longer required.
These measures will help to protect the environment.

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).

6

Contents of the pack and other information

What this medicine contains:
The active substance in Crestor is rosuvastatin.
Crestor 5mg Tablets are film-coated and contain rosuvastatin calcium
equivalent to 5 mg of rosuvastatin.
The other ingredients are: lactose monohydrate, microcrystalline cellulose,
calcium phosphate, crospovidone, magnesium stearate, hypromellose,
triacetin, titanium dioxide (E171), ferric oxide yellow (E172).
What this medicine looks like and contents of the pack
Crestor comes in blister packs containing 28, 30, 84 or 90 tablets.
The tablets are yellow and round and marked with ZD4522 and 5 on the one
side and are plain on the reverse.
Manufacturer and Licence Holder
This medicine is manufactured by AstraZeneca Reims, Chemin de Vrilly,
BP 1050, 51689 Reims Cedex 2, France and is procured from within the EU
and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/1081 Crestor 5mg Tablets

Crestor is a registered trademark of IPR Pharmaceuticals, Inc.
Revision date: 07/07/15

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.
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 memeber 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.

Ref: 1081/070715/2/F

Rosuvastatin 5mg Tablets
Patient Information Leaflet
Your medicine is called Rosuvastatin 5mg Tablets but will be referred to as
Rosuvastatin throughout this leaflet.

*

Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
* Keep this leaflet. You may need to read it again.
* If you have any further questions, ask your doctor or pharmacist.
* 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 is Rosuvastatin and what is it used for

*

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.
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 take antibiotics containing fusidic acid, please see Other medicines
and Rosuvastatin.

2 What you need to know before you take Rosuvastatin

Rosuvastatin belongs to a group of medicines called statins.

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.
* 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.

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.

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.

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.

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.

3 How to take Rosuvastatin
4 Possible side effects
5 How to store Rosuvastatin
6 Contents of the pack and other information

1

What is Rosuvastatin and what is it used for

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

What you need to know before you take 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.
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 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 effects of Rosuvastatin.
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.

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.

Rosuvastatin contains lactose.

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 cholesterol-lowering 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.

Usual doses in adults
If you are taking Rosuvastatin for high 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 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.

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.

Ref: 1081/070715/2/B

Rosuvastatin 5mg Tablets
Patient Information Leaflet (continued)
* 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 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 10 mg for children aged 6 to 9 years and 20 mg for children
aged 10 to 17 years. 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.

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

the sight and reach of children.
* Keep out ofthis medicine after the expiry date which is stated on the pack.
* Do not use above 30°C.
* Do notinstoreoriginal package.
the
* Store tablets become discoloured or show signs of any deterioration, you
* If the seek the advice of your pharmacist who will advise you what to do.
should
Medicines should not be
via wastewater
* Ask your pharmacist howdisposed of of medicines no or household waste.
to dispose
longer required.
These measures will help to protect the environment.

If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.
6
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.

How to store Rosuvastatin

Contents of the pack and other information

What this medicine contains:
The active substance in Rosuvastatin is rosuvastatin.
Rosuvastatin 5mg Tablets are film-coated and contain rosuvastatin calcium
equivalent to 5 mg of rosuvastatin.
The other ingredients are: lactose monohydrate, microcrystalline cellulose,
calcium phosphate, crospovidone, magnesium stearate, hypromellose,
triacetin, titanium dioxide (E171), ferric oxide yellow (E172).
What this medicine looks like and contents of the pack
Rosuvastatin comes in blister packs containing 28, 30, 84 or 90 tablets.
The tablets are yellow and round and marked with ZD4522 and 5 on the one
side and are plain on the reverse.
Manufacturer and Licence Holder
This medicine is manufactured by AstraZeneca Reims, Chemin de Vrilly,
BP 1050, 51689 Reims Cedex 2, France and is procured from within the EU
and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM
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).

PL 15184/1081 Rosuvastatin 5mg Tablets

Revision date: 07/07/15

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.
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 memeber 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.

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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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