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ROSUVASTATIN 5MG FILM COATED TABLETS

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

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PACKAGE LEAFLET: INFORMATION FOR THE USER

CRESTOR® 5MG FILM-COATED TABLETS
(rosuvastatin calcium)

2. What you need to know before you take
Crestor
Do not take Crestor:


The name of your medicine is Crestor 5mg Film-coated
Tablets but will be referred to as Crestor throughout this
leaflet.
Other strengths 10mg, 20mg & 40mg are also available.



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.
2.
3.
4.
5.
6.

What Crestor is and what it is used for
What you need to know before you take Crestor
How to take Crestor
Possible side effects
How to store Crestor
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 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.

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):








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?

Warnings and precautions
Talk








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.

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.

Or


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).

to your doctor or pharmacist before taking Crestor.
If you have problems with your kidneys.
If you have problems with your liver.
If you have had repeated or unexplained muscle
aches or pains, a personal or family history of muscle
problems, or a previous history of muscle problems
when taking other cholesterol-lowering medicines. Tell
your doctor immediately if you have unexplained muscle
aches or pains especially if you feel unwell or have a
fever. Also tell your doctor or pharmacist if you have a
muscle weakness that is constant.
If you regularly drink large amounts of alcohol.
If your thyroid gland is not working properly.
If you take other medicines called fibrates to lower
your cholesterol. Please read this leaflet carefully, even
if you have taken other medicines for high cholesterol
before.
If you take medicines used to treat the HIV
infection e.g. ritonavir with lopinavir and/or atazanavir,
please see Other medicines and Crestor.
If you take antibiotics containing fusidic acid,
please see Other medicines and Crestor.

Children and adolescents






If the patient is under 6 years old: Crestor should
not be given to children younger than 6 years.
If the patient is below 18 years of age: The Crestor
40mg 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 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.

Page 1 of 2

While you are on this medicine your doctor will monitor you
closely if you have diabetes or are at risk of developing
diabetes. You are likely to be at risk of developing diabetes if
you have high levels of sugars and fats in your blood, are
overweight and have high blood pressure.

Other medicines and Crestor

Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
Tell your doctor if you are taking any of the following:
ciclosporin (used for example, after organ transplants),
warfarin or clopidogrel (or any other drug used for thinning
the blood), fibrates (such as gemfibrozil, fenofibrate) or any
other medicine used to lower cholesterol (such as ezetimibe),
indigestion remedies (used to neutralise acid in your
stomach), erythromycin (an antibiotic), fusidic acid (an
antibiotic – please see Warnings and precautions), an oral
contraceptive (the pill), hormone replacement therapy or
anti-viral medications such as ritonavir with lopinavir and/or
atazanavir or simeprevir (used to treat infections, including
HIV or hepatitis C infection – please see Warnings and
precautions). The effects of these medicines could be
changed by Crestor or they could change the effects of
Crestor.

Pregnancy and breast-feeding

Do not take Crestor if you are pregnant or breast-feeding.
If you become pregnant while taking Crestor stop taking it
immediately and tell your doctor. Women should avoid
becoming pregnant while taking Crestor by using suitable
contraception.
Ask your doctor or pharmacist for advice before taking any
medicine.

Driving and using machines

Most people can drive a car and operate machinery while
using Crestor – it will not affect their ability. However, some
people feel dizzy during treatment with Crestor. If you feel
dizzy, consult your doctor before attempting to drive or use
machines.

Crestor contains lactose 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.
There is a memory aid on the blister packs for the daily
intake.
The translations of the days of the week are as follows:
lun

mar

mer

jeu

ven

sam

dim

Mon

Tue

Wed

Thu

Fri

Sat

Sun

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 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 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 usual start dose is 5mg. Your doctor may increase your
dose to find the right amount of Crestor for you. The
maximum daily dose of Crestor is 10mg for children aged 6 to
9 years and 20mg for children aged 10 to 17 years. Take your
dose once a day. Crestor 40mg tablet should not be used by
children.

Common possible side effects (these may affect
between 1 in 10 and 1 in 100 patients):

5. How to store Crestor















Uncommon possible side effects (these may affect
between 1 in 100 and 1 in 1,000 patients):





Swallow each tablet whole with a drink of water.



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

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 5mg,
10mg and 20mg).

Rare possible side effects (these may affect
between 1 in 1,000 and 1 in 10,000 patients):

Taking your tablets

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

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 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.




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)

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

Side effects of unknown frequency may include:

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).













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.









Keep out of the sight and reach of children.
Do not use Crestor after the expiry date printed on the
box and blister labels. The expiry date refers to the last
day of the 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.
Store in the original package. Do not store above 30°C.
If your tablets come in a plastic bottle, keep the lid
tightly closed.
Keep your tablets in the container you received them in.
If your tablets appear to be discoloured or show any
other signs of deterioration, take them to your
pharmacist who will advise you.
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 ingredient in Crestor is rosuvastatin.
Each film-coated tablet contains 5mg of 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

Each film-coated tablet is yellow, round and marked with
‘ZD4522’ & ‘5’ on one side and plain on the reverse.

Crestor comes in a calendar blister pack containing 28 or
84 tablets in strips of 14 tablets. Crestor is also available in
blister packs containing 30 or 90 tablets in strips of
10 tablets.

Manufacturer

Crestor is manufactured by:
AstraZeneca Reims, Reims, France.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
Product Licence holder:
BR Lewis Pharmaceuticals Ltd., Kirk Sandall, Doncaster,
DN3 1QR.
PL No: 08929/0421

POM

Leaflet issue and revision date (Ref): 14.08.15
CRESTOR® is a registered trademark of the AstraZeneca
group of companies.
To request a copy of this leaflet in Braille, large print or audio
please call 01302 365000 and ask for the Regulatory
Department.
Please be ready to give the following information:
Product name
Crestor 5mg Film-coated Tablets
Reference number
08929/0421
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.

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.

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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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