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CRESTOR 10MG FILM COATED TABLETS

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

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Crestor® 10mg film-coated Tablets /
Rosuvastatin 10mg film-coated Tablets
Crestor® 20mg film-coated Tablets /
Rosuvastatin 20mg film-coated Tablets
(rosuvastatin calcium)
This medicine is available using any of the above names but will be referred to as Crestor
throughout this leaflet. Please note Crestor is also available in other strengths (Crestor 5mg
and 40mg Tablets).
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

Warnings and precautions
By kariri
at 10:50 am, May 22, 2017
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)
▪ 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.
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.

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
cholesterol-lowering diet and exercise while you are taking Crestor.

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

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.

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

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.

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.

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.

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.

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.

Ask your doctor or pharmacist for advice before taking any medicine.

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.

2. What you need to know before you take Crestor

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.

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).

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 any of the above applies to you (or you are in doubt), please go back and see your
doctor.

Usual doses in adults

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.

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.

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.
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.
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.





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.
5. How to store Crestor






Keep out of the sight and reach of children.
Do not use Crestor 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 store above 30°C. Store in the original package in order to protect from moisture.
If the tablets become discoloured or show signs of any deterioration, consult your doctor
or pharmacist who will tell you what to do.
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 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.

6. Contents of the pack and other information

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.

What Crestor contains:
The active substance in Crestor is rosuvastatin.
®
Crestor 10mg film-coated Tablets: Each film-coated tablet contains 10mg of
rosuvastatin (as rosuvastatin calcium).
®
Crestor 20mg film-coated Tablets: Each film-coated tablet contains 20mg of
rosuvastatin (as rosuvastatin calcium).
Crestor also contains the following the inactive ingredients: lactose monohydrate,
microcrystalline cellulose, calcium phosphate, crospovidone, magnesium stearate,
hypromellose, triacetate, titanium dioxide (E171) and red iron oxide (E172).

Stop taking Crestor and seek medical help immediately if you have any of the following
allergic reactions:
▪ Difficulty in breathing, with or without swelling of the face, lips, tongue and/or throat.
▪ Swelling of the face, lips, tongue and/or throat, which may cause difficulty in swallowing.
▪ Severe itching of the skin (with raised lumps).

What Crestor looks like and contents of the pack
®
Crestor 10mg film-coated Tablets are pink, round film-coated tablet and marked with
"ZD4522" and "10" on one side and plain on the reverse.
®
Crestor 20mg film-coated Tablets are pink, round film-coated tablet and marked with
"ZD4522" and "20" on one side and plain on the reverse.

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.

Manufacturers
Crestor is manufactured by:
− AstraZeneca UK Ltd, Silk Road Business Park, Macclesfield, Cheshire, SK10 2NA. UK
− AndersonBrecon (UK) Ltd, Hereford, UK.
− Corden Pharma GmbH, Otto-Hahn-Strasse, 68723 Plankstadt, Germany.
− AstraZeneca GmbH, Tinsdaler Weg 183, 22880, Wedel, Germany.
− AstraZeneca Reims, Parc Industriel Pompelle, Chemin de Vrilly, Box 1050, Reims
Cedex 2, France.
− AstraZeneca AB, S-151 085, Sodertalje, Sweden.

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

Crestor is supplied in blister packs of 30 and 60 tablets.

Crestor is procured from within the EU and repackaged by the Product Licence Holder:
O.P.D. Laboratories Ltd., Unit 6 Colonial Way, Watford, Herts WD24 4PR.
POM
PL No: 15814/1126
®
Crestor 10mg film-coated Tablets / Rosuvastatin 10mg film-coated Tablets
PL No: 15814/1127
®
Crestor 20mg film-coated Tablets / Rosuvastatin 20mg film-coated Tablets
Crestor is a registered Trade Mark of IPR Pharmaceuticals Inc.
Leaflet revision and issue date (Ref.) 18.04.2017.
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

To request a copy of this leaflet in Braille, large
print or audio please call 01923 332 796.

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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