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CRESTOR 20MG TABLETS

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

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Product
Licence
Holder
and
Manufacturer
CRESTOR is manufactured by either of the
following manufacturers:
List of manufacturers:
a. AstraZeneca UK Ltd., Silk Road
Business Park, Macclesfield, Cheshire,
SK10 2NA, UK.
b. AstraZeneca GmbH, Tinsdaler Weg 183,
22880, Wedel, Germany
c. AstraZeneca Reims, Parc Industriel
Pompelle, Chemin de Vrilly, Box 1050,
Reims Cedex 2, France
d. AstraZeneca AB, S-151 85, Sodertalje,
Sweden
e. AndersonBrecon (UK) Ltd, Hereford,
UK.
Product Licence Holder:
CRESTOR is procured from within the EU
by the PL Holder: Swinghope Ltd,
Commerce Way, Edenbridge TN8 6ED, UK
and Repackaged by YMD Pharma Limited,
Commerce Way, Edenbridge TN8 6ED, UK.

T06829

CRESTOR® 10 mg tablets
CRESTOR® 20 mg tablets
(rosuvastatin calcium)

This product is available as the above
names/strengths but will be referred to as
CRESTOR throughout the leaflet.
CRESTOR is available in four strengths:
5 mg, 10 mg, 20 mg and 40 mg.
Patient Information Leaflet
Read all of this leaflet carefully before
you start taking this medicine because it
contains important information for you.
• Keep this leaflet. You may need to read it
again.
• If you have any further questions, ask
your doctor or pharmacist.
• This medicine has been prescribed
for you only. Do not pass it on to
others. It may harm them, even if their
signs of illness are the same as yours.
• If you get any side effects talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet. See section 4.

POM
PL No: 10380/1134
CRESTOR® 20 mg tablets/
Rosuvastatin 20 mg tablets
PL No: 10380/1135
CRESTOR® 10 mg tablets/
Rosuvastatin 10 mg 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

Leaflet revision date: 18/07/2017
Crestor® is a registered trademark of the
AstraZeneca group of companies.
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

1. WHAT CRESTOR IS AND WHAT IT IS
USED FOR
CRESTOR belongs to a group of medicines
called statins.

HEART UK Website
W: www.heartuk.org.uk

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.

Patient Community
W: www.healthunlocked.com/heartuk

Blind or partially
sighted?
Is this leaflet hard to
see or read?
Call 02030969700 to
obtain the leaflet in a
format suitable for
you.

You have been advised to take a statin,
because changing your diet and doing more
exercise were not enough to correct your
cholesterol levels. You should continue with
your cholesterol-lowering diet and exercise
while you are taking CRESTOR.
Or
• You have other factors that increase your
risk of having a heart attack, stroke or
related health problems.
Heart attack, stroke and other problems can
be caused by a disease called
atherosclerosis. Atherosclerosis is due to
build up of fatty deposits in your arteries.
Why it is important to keep taking
CRESTOR
CRESTOR is used to correct the levels of
fatty substances in the blood called lipids,
the most common of which is cholesterol.
There are different types of cholesterol
found in the blood – ‘bad’ cholesterol
(LDL-C) and ‘good’ cholesterol (HDL-C).
• CRESTOR can reduce the ‘bad’
cholesterol and increase the ‘good’
cholesterol.
• It works by helping to block your body’s
production of ‘bad’ cholesterol. It also
improves your body’s ability to remove
it from your blood.
For most people, high cholesterol does not
affect the way they feel because it does not
produce any symptoms. However, if it is left
untreated, fatty deposits can build up in the
walls of your blood vessels causing them to
narrow.

Fold

Sometimes, these narrowed blood vessels
can get blocked which can cut off the blood
supply to the heart or brain leading to a heart
attack or a stroke. By lowering your
cholesterol levels, you can reduce your risk
of having a heart attack, a stroke or related
health problems.

You need to keep taking CRESTOR, even if
it has got your cholesterol to the right level,
because it prevents your cholesterol
levels from creeping up again and
causing build up of fatty deposits. However,
you should stop if your doctor tells you to do
so, or you have become pregnant.

2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE CRESTOR
Do not take CRESTOR:
• If you have ever had an allergic
reaction to CRESTOR, or to any of its
ingredients.
• If you are pregnant or breast-feeding. If
you become pregnant while taking
CRESTOR stop taking it immediately
and tell your doctor. Women should
avoid becoming pregnant while taking
CRESTOR
by
using
suitable
contraception.
• If you have liver disease.
• If you have severe kidney problems.
• If you have repeated or unexplained
muscle aches or pains.
• If you take a drug called ciclosporin
(used, for example, after organ
transplants)
If any of the above applies to you (or you are
in doubt), please go back and see your
doctor.
In addition, do not take CRESTOR 40 mg
(the highest dose):
• If you have moderate kidney problems
(if in doubt, please ask your doctor).
• If your thyroid gland is not working
properly.
• If you have had any repeated or
unexplained muscle aches or pains, a
personal or family history of muscle
problems, or a previous history of
muscle problems when taking other
cholesterol-lowering medicines.
• If you regularly drink large amounts
of alcohol.
• If you are of Asian origin (Japanese,
Chinese, Filipino, Vietnamese, Korean
and Indian).
• If you take other medicines called
fibrates to lower your cholesterol.
If any of the above applies to you (or you are
in doubt), please go back and see your
doctor.
Warnings and precautions
Talk to your doctor or pharmacist before
taking CRESTOR.
• If you have problems with your
kidneys.
• If you have problems with your liver.
• If you have had repeated or
unexplained muscle aches or pains, a
personal or family history of muscle
problems, or a previous history of
muscle problems when taking other
cholesterol-lowering medicines. Tell
your doctor immediately if you have
unexplained muscle aches or pains
especially if you feel unwell or have a
fever. Also tell your doctor or pharmacist
if you have a muscle weakness that is
constant.
• If you regularly drink large amounts of
alcohol.
• If your thyroid gland is not working
properly.
• If you take other medicines called
fibrates to lower your cholesterol.
Please read this leaflet carefully, even if
you have taken other medicines for high
cholesterol before.
• If you take medicines used to treat the
HIV infection e.g. ritonavir with lopinavir
and/or atazanavir, please see Other
medicines and CRESTOR.
• If you 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)

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If any of the above applies to you (or if you
are not sure):
• Do not take CRESTOR 40 mg (the
highest dose) and check with your
doctor or pharmacist before you
actually start taking any dose of
CRESTOR.
In a small number of people, statins can
affect the liver. This is identified by a simple
test which looks for increased levels of liver
enzymes in the blood. For this reason, your
doctor will usually carry out this blood test
(liver function test) before and during
treatment with CRESTOR.
While you are on this medicine your doctor
will monitor you closely if you have diabetes
or are at risk of developing diabetes. You
are likely to be at risk of developing diabetes
if you have high levels of sugars and fats in
your blood, are overweight and have high
blood pressure.
Children and adolescents
• If the patient is under 6 years old:
Crestor should not be given to children
younger than 6 years.
• If the patient is below 18 years of age:
The Crestor 40 mg tablet is not suitable
for use in children and adolescents
below 18 years of age.
Other medicines and CRESTOR
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines.
Tell your doctor if you are taking any of the
following: ciclosporin (used for example,
after organ transplants), warfarin or
clopidogrel (or any other drug used for
thinning the blood), fibrates (such as
gemfibrozil, fenofibrate) or any other
medicine used to lower cholesterol (such as
ezetimibe), indigestion remedies (used to
neutralise
acid
in
your
stomach),
erythromycin (an antibiotic), fusidic acid (an
antibiotic – please see below and Warnings
and precautions), an oral contraceptive (the
pill), hormone replacement therapy or
anti-viral medications such as ritonavir with
lopinavir and/or atazanavir or simeprevir
(used to treat infections, including HIV or
hepatitis C infection – please see Warnings
and precautions). The effects of these
medicines could be changed by CRESTOR
or they could change the effects of
CRESTOR.
If you need to take oral fusidic acid to
treat a bacterial infection you will need to
temporarily stop using this medicine.
Your doctor will tell you when it is safe to
restart Crestor. Taking Crestor with
fusidic acid may rarely lead to muscle
weakness,
tenderness
or
pain
(rhabdomyolysis). See more information
regarding rhabdomyolysis in Section 4.
Pregnancy and breast-feeding
Do not take CRESTOR if you are pregnant
or breast-feeding. If you become pregnant
while taking CRESTOR stop taking it
immediately and tell your doctor. Women
should avoid becoming pregnant while
taking CRESTOR by using suitable
contraception.
Ask your doctor or pharmacist for advice
before taking any medicine.
Driving and using machines
Most people can drive a car and operate
machinery while using CRESTOR – it will
not affect their ability. However, some
people feel dizzy during treatment with
CRESTOR. If you feel dizzy, consult your
doctor before attempting to drive or use
machines.
CRESTOR contains lactose.
If you have been told by your doctor that you
have an intolerance to some sugars (lactose
or milk sugar), contact your doctor before
taking CRESTOR.

If you take more CRESTOR than you
should
Contact your doctor or nearest hospital for
advice.

For a full list of ingredients please see
Contents of the pack and other
information.

3. HOW TO TAKE CRESTOR

If you go into hospital or receive treatment
for another condition, tell the medical staff
that you’re taking CRESTOR.

Always take this medicine as your doctor
has told you. Check with your doctor or
pharmacist if you are not sure.

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.

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.

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.

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

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

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).

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).

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.

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.

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.

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.

If you are taking CRESTOR to reduce
your risk of having a heart attack, stroke
or related health problems:
The recommended dose is 20 mg daily.
However, your doctor may decide to use a
lower dose if you have any of the factors
mentioned above.
Use in children and adolescents aged
6-17 years
The dose range in children and adolescents
aged 6 to 17 years is 5 to 20 mg once daily.
The usual start dose is 5 mg per day, and
your doctor may gradually increase your
dose to find the right amount of Crestor for
you. The maximum daily dose of Crestor is
10 or 20 mg for children aged 6 to 17 years
depending on your underlying condition
being treated. Take your dose once a day.
Crestor 40 mg tablet should not be used by
children.

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).

Taking your tablets
Swallow each tablet whole with a drink of
water.

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

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.

• 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
enlargement
in
men
• Breast
(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 at: www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help
provide more information on the safety of
this medicine.

5. HOW TO STORE CRESTOR
• Keep out of the sight and reach of
children.
• Do not take your tablets after the expiry
date on the container. Take any tablets
that are out of date back to your
pharmacist.
• Do not store your tablets above 30˚C
• Store in the original package in order to
protect from moisture.
• If your doctor tells you to stop taking your
tablets, take any tablets you have left
back to your pharmacist. If your tablets
become discoloured or deformed, take
them back to your pharmacist.
• 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:
The active ingredient in Crestor is
rosuvastatin calcium. Crestor film-coated
tablets contain either 10 mg or 20 mg
rosuvastatin in them.
The other ingredients are: lactose
monohydrate, microcrystalline cellulose,
calcium
phosphate,
crospovidone,
magnesium stearate, hypromellose, glycerol
triacetate, titanium dioxide (E171) and red
iron oxide (172).
What CRESTOR looks like and contents
of the pack
Crestor 10 mg film-coated tablets are pink,
round and marked with “ZD4522 and 10” on
one side and plain on the reverse.
Crestor 20 mg film-coated tablets are pink,
round and marked with “ZD4522 and 20” on
one side and plain on the reverse.
Crestor Tablets come in a calendar blister
pack containing 28 tablets.
T06829

Fold

• 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.

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.

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