Skip to Content

UK Edition. Click here for US version.

CRESTOR 5MG FILM COATED TABLETS

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

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

Assessed against UK PIL dated November 2016
Package leaflet: information for the patient
®

Crestor 5mg film-coated tablets
(rosuvastatin calcium)
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.
The name of your medicine is Crestor 5mg film-coated tablets but will
be referred to as Crestor throughout this leaflet. Please note that this
leaflet also contains information about other strengths Crestor 10mg,
20mg and 40mg film-coated tablets.
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 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.
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 40mg (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 or 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.

mock up

By Carthika Kanagasabai at 1:50 pm, Apr 19, 2017





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 or 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 40mg (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 40mg
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 monohydrate.
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 5mg or the 10mg
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 (5mg) if:
 You are of Asian origin (Japanese, Chinese, Filipino,
Vietnamese, Korean or 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 5mg dose, your doctor may decide to double this to 10mg,
then 20mg and then 40mg if necessary. If you started on 10mg,
your doctor may decide to double this to 20mg and then 40mg if
necessary. There will be a gap of four weeks between every dose
adjustment.

The maximum daily dose of Crestor is 40mg. 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
20mg.
If you are taking Crestor to reduce your risk of having a heart
attack, stroke or related health problems:
The recommended dose is 20mg 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 20mg once daily. The usual start dose is 5mg 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 20mg for children aged 6 to 17 years depending on your
underlying condition being treated. Take your dose once a day.
Crestor 40mg 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 (only Crestor 40mg)
 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 (only Crestor 5mg, 10mg and 20mg).
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, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You
can also report any side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information
on the safety of this medicine.
HU

UH

5) How to store Crestor








Keep out of the sight and reach of children.
Do not store above 30°C.
Store in the original pack
Do not take the tablets after the expiry date which is stated on
the carton and blister labels after ‘Exp’. The expiry date refers
to the last day of that month.
If the tablets become discoloured or show any signs of
deterioration, seek the advice of your pharmacist.
Remember if your doctor tells you to stop taking this medicine,
return any unused medicine to your pharmacist for safe
disposal. Only keep this medicine if your doctors tells you to.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

6) Contents of the pack and other information
What Crestor contains:
Each film-coated tablet contains 5mg rosuvastatin (as rosuvastatin
calcium).
The other ingredients are lactose monohydrate, microcrystalline
cellulose, calcium phosphate, crospovidone, magnesium stearate,
hypromellose, glycerol triacetate, titanium dioxide (E171) and
yellow iron oxide (E172).
What Crestor looks like and contents of the pack:
Crestor is a yellow, round film-coated tablet marked with ‘ZD4522’
and ‘5’ on one side and plain on the other side.
Crestor is available in carton blister pack containing 60 tablets.
Manufactured by: AstraZeneca UK Ltd, Macclesfield, Cheshire,
UK. OR
Brecon Pharmaceuticals Ltd, Hereford, UK. OR
Corden Pharma GmbH, Plankstadt, Germany. OR
AstraZeneca GmbH, Wedel, Germany. OR
AstraZeneca Reims, France. OR
AstraZeneca AB, Sodertalje, Sweden.
Procured from within the EU and repackaged by the Product
Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK.
POM
®
Crestor 5mg film-coated tablets; PL 18799/2060
Leaflet date: 10.04.2017
Crestor is a registered trademark of the AstraZeneca group of
companies.

Blind or partially sighted?
Is this leaflet hard to see or
read?
Call 0208 515 3763 to obtain the
leaflet in a format suitable for
you.

For more information about Cholesterol and health contact
HEART UK The Cholesterol Charity
HEART UK Cholesterol Helpline
T: 0345 450 5988 Monday–Friday 10am–3pm
E: ask@heartuk.org.uk
HEART UK Website
W: www.heartuk.org.uk
Patient Community
W: www.healthunlocked.com/heartuk

Package leaflet: information for the patient

Rosuvastatin 5mg film-coated tablets
(rosuvastatin calcium)
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.
The name of your medicine is Rosuvastatin 5mg film-coated tablets
but will be referred to as Rosuvastatin throughout this leaflet. Please
note that this leaflet also contains information about other strengths
Rosuvastatin 10mg, 20mg and 40mg film-coated tablets.
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 cholesterollowering 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 40mg (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 or 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
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 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 or 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 40mg (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
40mg 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 monohydrate.
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 5mg or the
10mg 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 (5mg) if:
 You are of Asian origin (Japanese, Chinese, Filipino,
Vietnamese, Korean or 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 5mg dose, your doctor may decide to double this to
10mg, then 20mg and then 40mg if necessary. If you started on
10mg, your doctor may decide to double this to 20mg and then
40mg if necessary. There will be a gap of four weeks between
every dose adjustment.
The maximum daily dose of Rosuvastatin is 40mg. 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
20mg.
If you are taking Rosuvastatin to reduce your risk of having a
heart attack, stroke or related health problems:
The recommended dose is 20mg 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 20mg once daily. The usual start dose is 5mg 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 20mg for children aged 6 to 17 years
depending on your underlying condition being treated. Take your
dose once a day. Rosuvastatin 40mg 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.

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, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You
can also report any side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information
on the safety of this medicine.
HU

UH

5) How to store Rosuvastatin







Keep out of the sight and reach of children.
Do not store above 30°C.
Store in the original pack
Do not take the tablets after the expiry date which is stated on
the carton and blister labels after ‘Exp’. The expiry date refers
to the last day of that month.
If the tablets become discoloured or show any signs of
deterioration, seek the advice of your pharmacist.
Remember if your doctor tells you to stop taking this medicine,
return any unused medicine to your pharmacist for safe
disposal. Only keep this medicine if your doctors tells you to.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

If you 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.

6) Contents of the pack and other information

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 (only Rosuvastatin 40mg)
 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 (only Rosuvastatin 5mg, 10mg and 20mg).
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

What Rosuvastatin contains:
Each film-coated tablet contains 5mg rosuvastatin (as rosuvastatin
calcium).
The other ingredients are lactose monohydrate, microcrystalline
cellulose, calcium phosphate, crospovidone, magnesium stearate,
hypromellose, glycerol triacetate, titanium dioxide (E171) and
yellow iron oxide (E172).
What Rosuvastatin looks like and contents of the pack:
Rosuvastatin is a yellow, round film-coated tablet marked with
‘ZD4522’ and ‘5’ on one side and plain on the other side.
Rosuvastatin is available in carton blister pack containing 60
tablets.
Manufactured by: AstraZeneca UK Ltd, Macclesfield, Cheshire,
UK. OR
Brecon Pharmaceuticals Ltd, Hereford, UK. OR
Corden Pharma GmbH, Plankstadt, Germany. OR
AstraZeneca GmbH, Wedel, Germany. OR
AstraZeneca Reims, France. OR
AstraZeneca AB, Sodertalje, Sweden.
Procured from within the EU and repackaged by the Product
Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK.
POM
Rosuvastatin 5mg film-coated tablets; PL 18799/2060
Leaflet date: 10.04.2017

Blind or partially sighted?
Is this leaflet hard to see or
read?
Call 0208 515 3763 to obtain the
leaflet in a format suitable for
you.

For more information about Cholesterol and health contact
HEART UK The Cholesterol Charity
HEART UK Cholesterol Helpline
T: 0345 450 5988 Monday–Friday 10am–3pm
E: ask@heartuk.org.uk
HEART UK Website
W: www.heartuk.org.uk
Patient Community
W: www.healthunlocked.com/heartuk

Expand Transcript

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.

Hide