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ROSUVASTATIN 5MG FIM-COATED TABLETS

Active substance(s): ROSUVASTATIN CALCIUM

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S1594 LEAFLET Crestor 20150924

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warnings and precautions
Talk to your doctor or pharmacist before taking Crestor.


If you have problems with your kidneys.

(rosuvastatin calcium)



If you have problems with your liver.

Your medicine is known as Crestor 5mg Film-coated Tablets but will
be referred to as Crestor throughout the following leaflet.



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.

CRESTOR®

5mg FILM-COATED TABLETS

Information for other strengths of Crestor (Crestor 10mg, 20mg and
40mg tablets) also may be present in this leaflet.
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.


Keep this leaflet. You may need to read it again.



If you regularly drink large amounts of alcohol.



If you have any further questions, ask your doctor or
pharmacist.



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.



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.

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.

What is in this leaflet:
1. What Crestor is and what it is used for

Children and adolescents

2. What you need to know before you take Crestor



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.

6. Contents of the pack and other information.



If you are over 70 (as your doctor needs to choose the right
start dose of Crestor to suit you)

1. WHAT CRESTOR IS AND WHAT IT IS USED FOR



If you have severe respiratory failure.

Crestor belongs to a group of medicines called statins.



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.

3. How to take Crestor
4. Possible side effects
5. How to store Crestor

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 cholesterollowering 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.

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.

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?

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

Crestor is used to correct the levels of fatty substances in the blood
called lipids, the most common of which is cholesterol.

Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines

There are different types of cholesterol found in the blood – ‘bad’
cholesterol (LDL-C) and ‘good’ cholesterol (HDL-C).

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.



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.

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

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
CRESTOR

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.

Do not take Crestor:

Crestor contains lactose.



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 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.



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):

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.



If you have moderate kidney problems (if in doubt, please
ask your doctor).



If your thyroid gland is not working properly.





Your cholesterol level.

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.



The level of risk you have of experiencing a heart attack or
stroke.





If you regularly drink large amounts of alcohol.

Whether you have a factor that may make you more sensitive to
possible side effects.



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.

The choice of your start dose will depend upon:

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:

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)

Use in children and adolescents aged 6-17 years



Cough

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.



Shortness of breath



Oedema (swelling)



Sleep disturbances, including insomnia and nightmares



Sexual difficulties

Taking your tablets



Depression

Swallow each tablet whole with a drink of water.



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



Tendon injury

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.

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

 Muscle weakness that is constant
Reporting of side effects:

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.

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:

Your doctor may decide to increase your dose so that you are
taking the amount of Crestor that is right for you.

Yellow Card Scheme

If you take more Crestor than you should

By reporting side effects you can help provide more information on
the safety of this medicine.

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.

Website: www.mhra.gov.uk/yellowcard

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.



Do not use Crestor after the expiry date which is stated on the
carton and blister strip. The expiry date refers to the last day of
that 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.

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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Crestor contains


The active substance in Crestor is rosuvastatin.
Each film coated tablet contains 5mg of rosuvastatin (as
rosuvastatin calcium).



The other ingredients are: lactose monohydrate,
microcrystalline cellulose (E460), calcium phosphate,
crospovidone, magnesium stearate, hypromellose, glycerol
triacetate, titanium dioxide (E171), yellow iron oxide (E172).

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

What Crestor looks like and contents of the pack
Crestor tablets are yellow, round tablets engraved ‘ZD4522’ and ‘5’
on one side and plain on the other side.
Crestor is available as calendar blister packs of 28 tablets.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by AstraZeneca Reims, France.
POM

PL 19488/1594

Leaflet revision date: 24 September 2015
Crestor is a registered trademark of AstraZeneca group of
companies.
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.
S1594 LEAFLET Crestor 20150924

S1594 LEAFLET Rosuvastatin 20150924

PACKAGE LEAFLET: INFORMATION FOR THE USER

ROSUVASTATIN 5mg FILM-COATED TABLETS
(rosuvastatin calcium)
Your medicine is known as Rosuvastatin 5mg Film-coated Tablets
but will be referred to as Rosuvastatin Tablet throughout the
following leaflet.

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 Tablet.


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.

Information for other strengths of Rosuvastatin Tablet (Rosuvastatin
10mg, 20mg and 40mg tablets) also may be present in this leaflet.
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.


Keep this leaflet. You may need to read it again.



If you have any further questions, ask your doctor or
pharmacist.



If you regularly drink large amounts of alcohol.





If your thyroid gland is not working properly.

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 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 get any side effects talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.



If you take medicines used to treat the HIV infection e.g.
ritonavir with lopinavir and/or atazanavir, please see Other
medicines and Rosuvastatin Tablet.

What is in this leaflet:



2. What you need to know before you take Rosuvastatin Tablet

If you take antibiotics containing fusidic acid, please see
Other medicines and Rosuvastatin Tablet.
Children and adolescents

3. How to take Rosuvastatin Tablet



If the patient is under 6 years old: Rosuvastatin Tablet should
not be given to children younger than 6 years.



If the patient is below 18 years of age: The Rosuvastatin
Tablet 40 mg tablet is not suitable for use in children and
adolescents below 18 years of age.

1. What Rosuvastatin Tablet is and what it is used for

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


1. WHAT ROSUVASTATIN TABLET IS AND WHAT IT IS USED
FOR

If you are over 70 (as your doctor needs to choose the right
start dose of Rosuvastatin Tablet to suit you)



If you have severe respiratory failure.

Rosuvastatin Tablet belongs to a group of medicines called statins.



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 Tablet to suit you.

You have been prescribed Rosuvastatin Tablet because:


You have a high cholesterol level. This means you are at risk
from a heart attack or stroke. Rosuvastatin Tablet 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 cholesterollowering diet and exercise while you are taking Rosuvastatin Tablet.
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 Tablet?
Rosuvastatin Tablet 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 Tablet 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 Tablet, 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 TABLET
Do not take Rosuvastatin Tablet:


If you have ever had an allergic reaction to Rosuvastatin
Tablet, or to any of its ingredients.



If you are pregnant or breast-feeding. If you become pregnant
while taking Rosuvastatin Tablet stop taking it immediately
and tell your doctor. Women should avoid becoming pregnant
while taking Rosuvastatin Tablet 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 Tablet 40 mg (the highest
dose):

If any of the above applies to you (or if you are not sure):


Do not take Rosuvastatin Tablet 40 mg (the highest dose)
and check with your doctor or pharmacist before you
actually start taking any dose of Rosuvastatin Tablet.

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 Tablet.
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 Tablet
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 Tablet or they
could change the effects of Rosuvastatin Tablet.
Pregnancy and breast-feeding
Do not take Rosuvastatin Tablet if you are pregnant or breastfeeding. If you become pregnant while taking Rosuvastatin Tablet
stop taking it immediately and tell your doctor. Women should
avoid becoming pregnant while taking Rosuvastatin Tablet 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 Tablet – it will not affect their ability. However, some
people feel dizzy during treatment with Rosuvastatin Tablet. If you
feel dizzy, consult your doctor before attempting to drive or use
machines.
Rosuvastatin Tablet 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 Tablet.
For a full list of ingredients please see Contents of the pack and
other information.
3. HOW TO TAKE ROSUVASTATIN TABLET
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 Tablet for high cholesterol:
Starting dose
Your treatment with Rosuvastatin Tablet must start with the 5 mg or
the 10 mg dose, even if you have taken a higher dose of a different
statin before.



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).

Please check with your doctor or pharmacist which start dose of
Rosuvastatin Tablet will best suit you.



If you take other medicines called fibrates to lower your
cholesterol.

Your doctor may decide to give you the lowest dose (5 mg) if:

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.



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 Tablet
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.



Muscle damage in adults – as a precaution, stop taking
Rosuvastatin Tablet 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

The maximum daily dose of Rosuvastatin Tablet 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.



Damage to the nerves of your legs and arms (such as
numbness)



Joint pain

If you are taking Rosuvastatin Tablet to reduce your risk of
having a heart attack, stroke or related health problems:



Memory loss

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.

 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

Taking your tablets



Sexual difficulties

Swallow each tablet whole with a drink of water.



Depression

Take Rosuvastatin Tablet once daily. You can take it at any time
of the day with or without food.



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

Try to take your tablet at the same time every day to help you to
remember it.



Tendon injury

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 Tablet for you. The
maximum daily dose of Rosuvastatin Tablet 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 Tablet 40 mg tablet should not
be used by children.

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 Tablet that is right for you.
If you take more Rosuvastatin Tablet 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 Tablet.

 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:
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.

If you forget to take Rosuvastatin Tablet

5. HOW TO STORE ROSUVASTATIN TABLET

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.



Keep out of the sight and reach of children.



Do not store above 30°C.

If you stop taking Rosuvastatin Tablet



Store in the original package.

Talk to your doctor if you want to stop taking Rosuvastatin Tablet.
Your cholesterol levels might increase again if you stop taking
Rosuvastatin Tablet. If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.



Do not use Rosuvastatin Tablet after the expiry date which is
stated on the carton and blister strip. The expiry date refers to
the last day of that 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.

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 Tablet 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 Tablet 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 Tablet (only Rosuvastatin Tablet 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):


What Rosuvastatin Tablet contains


The active substance in Rosuvastatin Tablet is rosuvastatin.
Each film coated tablet contains 5mg of rosuvastatin (as
rosuvastatin calcium).



The other ingredients are: lactose monohydrate,
microcrystalline cellulose (E460), calcium phosphate,
crospovidone, magnesium stearate, hypromellose, glycerol
triacetate, titanium dioxide (E171), yellow iron oxide (E172).

What Rosuvastatin Tablet looks like and contents of the pack
Rosuvastatin Tablets are yellow, round tablets engraved ‘ZD4522’
and ‘5’ on one side and plain on the other side.
Rosuvastatin Tablet is available as calendar blister packs of 28
tablets.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by AstraZeneca Reims, France.
POM

PL 19488/1594

Leaflet revision date: 24 September 2015
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.

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 Tablet (only Rosuvastatin Tablet 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):


6. CONTENTS OF THE PACK AND OTHER INFORMATION

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 Tablet and seek medical help immediately

S1594 LEAFLET Rosuvastatin 20150924

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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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