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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.

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.

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 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.

•    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.

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.

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.

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

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

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 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.

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 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).

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.qov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisations for CRESTOR are held by AstraZeneca UK Ltd,

600 Capability Green, Luton, LU1 3LU, UK.

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 Sodertalje, 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

HEART UK - The Cholesterol Charity -

VI    provides information and

advice for patients through H-E-A-R.-T UK a membership magazine, the cholesterol charity health and diet fact sheets

and a helpline manned by nurses and dieticians.

To become a member of HEART UK or for further information contact:

HEART UK 7 North Road Maidenhead Berkshire SL6 1PE

Helpline number: 0845 450 5988 open 1000-1600 from Mon-Fri.

AstraZeneca

P039665