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CRESTOR 5MG FILM COATED TABLETS

Active substance: ROSUVASTATIN CALCIUM

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P039665

CRESTOR® 5 mg film-coated tablets
CRESTOR® 10 mg film-coated tablets
CRESTOR® 20 mg film-coated tablets
CRESTOR® 40 mg film-coated tablets
rosuvastatin

Read all of this leaflet carefully before
you start taking this medicine because it
contains important information for you.
• Keep this leaflet. You may need to read
it again.
• If you have any further questions, ask your
doctor or pharmacist.
• This medicine has been prescribed for
you only. Do not pass it on to others. It may
harm them, even if their signs of illness are
the same as yours.
• If you get any side effects talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet:
1) What CRESTOR is and what it is used for
2) What you need to know before you take
CRESTOR
3) How to take CRESTOR
4) Possible side effects
5) How to store CRESTOR
6) Contents of the pack and other information
1) WHAT CRESTOR IS AND WHAT IT IS
USED FOR
CRESTOR belongs to a group of medicines
called statins.
You have been prescribed CRESTOR
because:
• You have a high cholesterol level. This
means you are at risk from a heart attack
or stroke. CRESTOR is used in adults,
adolescents and children 6 years or older to
treat high cholesterol.

• 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.

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.

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.

Or

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.

• 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.

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).
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.

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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.

5) HOW TO STORE CRESTOR
• Blisters: Store below 30°C. Store in the
original package in order to protect from
moisture.
• Containers: Store below 30°C. Keep the
bottle tightly closed in order to protect from
moisture.
• Keep this medicine out of the sight and
reach of children.
• Do not use this medicine after the expiry date
which is stated on the box/blisters/label after
EXP. The expiry date refers to the last day of
the month.
• Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines
you no longer use. These measures will help
protect the environment.
6) CONTENTS OF THE PACK AND OTHER
INFORMATION
What CRESTOR contains:
The active substance in CRESTOR is
rosuvastatin. CRESTOR film-coated tablets
contain rosuvastatin calcium equivalent to
5 mg, 10 mg, 20 mg or 40 mg of rosuvastatin.
The other ingredients are: lactose
monohydrate, microcrystalline cellulose,
calcium phosphate, crospovidone, magnesium
stearate, hypromellose, triacetin, titanium
dioxide (E171). CRESTOR 10 mg, 20 mg and
40 mg film-coated tablets also contain red iron
oxide (E172). CRESTOR 5 mg film-coated
tablets also contain yellow iron oxide (E172).
What CRESTOR looks like and contents of
the pack
CRESTOR comes in blister packs containing
7, 14, 15, 20, 28, 30, 42, 50, 56, 60, 84, 90,
98 and 100 tablets and plastic containers with
30 and 100 tablets (Not all packs are available
in every country).
CRESTOR comes in four tablet strengths:
CRESTOR 5 mg film-coated tablets are yellow,
round and marked with ZD4522 and 5 on
one side and plain on the reverse.

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

CRESTOR 10 mg film-coated tablets are pink,
round and marked with ZD4522 and 10 on
one side and plain on the reverse.

4) POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause
side effects, although not everybody gets them.

CRESTOR 20 mg film-coated tablets are pink,
round and marked with ZD4522 and 20 on
one side and plain on the reverse.

It is important that you are aware of what these
side effects may be. They are usually mild and
disappear after a short time.

CRESTOR 40 mg film-coated tablets are pink,
oval and marked with ZD4522 on one side and
40 on the reverse.

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).

Marketing Authorisation Holder and
Manufacturer
The Marketing Authorisations for CRESTOR
are held by AstraZeneca UK Ltd,
600 Capability Green, Luton, LU1 3LU, UK.

Also, stop taking CRESTOR and talk to your
doctor immediately if you have any unusual
aches or pains in your muscles which go on for
longer than you might expect. Muscle symptoms
are more common in children and adolescents
than in adults. As with other statins, a very small
number of people have experienced unpleasant
muscle effects and rarely these have gone on
to become a potentially life threatening muscle
damage known as rhabdomyolysis.
Common possible side effects (these may
affect between 1 in 10 and 1 in 100 patients):
• Headache
• Stomach pain
• Constipation
• Feeling sick
• Muscle pain
• Feeling weak
• Dizziness
• An increase in the amount of protein in the
urine - this usually returns to normal on
its own without having to stop taking your
CRESTOR tablets (only CRESTOR 40 mg)
• Diabetes. This is more likely if you have high
levels of sugars and fats in your blood, are
overweight and have high blood pressure.
Your doctor will monitor you while you are
taking this medicine.
Uncommon possible side effects (these
may affect between 1 in 100 and 1 in
1,000 patients):
• Rash, itching or other skin reactions
• An increase in the amount of protein in the
urine - this usually returns to normal on
its own without having to stop taking your
CRESTOR tablets (only CRESTOR 5 mg,
10 mg and 20 mg).
Rare possible side effects (these may affect
between 1 in 1,000 and 1 in 10,000 patients):
• Severe allergic reaction – signs include
swelling of the face, lips, tongue and/or throat,
difficulty in swallowing and breathing, a
severe itching of the skin (with raised lumps).
If you think you are having an allergic
reaction, then stop taking CRESTOR and
seek medical help immediately
• Muscle damage in adults – as a precaution,
stop taking CRESTOR and talk to your
doctor immediately if you have any
unusual aches or pains in your muscles
which go on for longer than expected
• A severe stomach pain (inflamed pancreas)
• Increase in liver enzymes in the blood
Very rare possible side effects (these may
affect less than 1 in 10,000 patients):
• Jaundice (yellowing of the skin and eyes)
• Hepatitis (an inflamed liver)
• Traces of blood in your urine
• Damage to the nerves of your legs and arms
(such as numbness)
• Joint pain
• Memory loss
• Breast enlargement in men (gynaecomastia)
Side effects of unknown frequency may
include:
• Diarrhoea (loose stools)
• Stevens-Johnson syndrome (serious
blistering condition of the skin, mouth, eyes
and genitals)
• Cough
• Shortness of breath
• Oedema (swelling)
• Sleep disturbances, including insomnia and
nightmares
• Sexual difficulties
• Depression
• Breathing problems, including persistent
cough and/or shortness of breath or fever
• Tendon injury
• Muscle weakness that is constant
Reporting of side effects:
If you get any side effects talk to your doctor or
pharmacist. This includes any side effects not
listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide
more information on the safety of this medicine.

Manufacturers responsible for batch release:
AstraZeneca UK Ltd., Silk Road Business Park
Macclesfield, Cheshire, SK10 2NA, UK
Telephone: +44 1625 582828
AndersonBrecon (UK) Ltd,
2-7 Wye Valley Business Park, Brecon Road,
Hay-on-Wye, Hereford, HR3 5PG, UK
Telephone: +44 1497 820829
Corden Pharma GmbH, Otto-Hahn-Strasse,
68723 Plankstadt, Germany
Telephone: +49 6202 9900
AstraZeneca GmbH, Tinsdaler Weg 183,
22880 Wedel, Germany
Telephone: +49 41 037 080
AstraZeneca Reims, Parc Industriel Pompelle,
Chemin de Vrilly, Box 1050, Reims Cedex 2,
France
Telephone: +33 3266 16868
AstraZeneca AB, S-151 85 Södertälje, Sweden
Telephone: +46 8 553 260 00
This product is authorised in the Member
States of the EEA under the following name(s):
CRESTOR 5 mg, 10 mg, 20 mg and 40 mg
(NL, AT, BE, DK, GR, FI, IC, IE, IT, LU, NO, MT,
PL, PT, SE, UK), and 5 mg, 10 mg and 20 mg
(DE, ES, FR).

To listen to or request a
copy of this leaflet in Braille,
large print or audio please
call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the
following information:
Product name
Reference number
Crestor 5 mg
Film-coated Tablets
17901/0243
Crestor 10 mg
Film-coated Tablets
17901/0201
Crestor 20 mg
Film-coated Tablets
17901/0202
Crestor 40 mg
Film-coated Tablets
17901/0203
This is a service provided
by the Royal National
Institute of Blind People.
This leaflet was last updated in January 2015
CV 14 0203a
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.

P039665

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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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