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PACKAGE LEAFLET: INFORMATION FOR THE USER Crestor® 40mg film-coated tablets

(rosuvastatin calcium)

This product will be referred to as Crestor throughout this leaflet.

This product is also available in multiple strengths and all strengths will be referred to throughout this 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.

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

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.

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.

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 eg. ritonavir with lopinavir and/or atazanavir, please see Other medicines and Crestor.

Children and adolescents

•    If the patient is under 10 years old: Crestor should not be given to children younger than 10 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 bl ood test (liver functi on test) befor e and during t reatment 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 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), an oral contraceptive (the pill), hormone replacement therapy or ritonavir with lopinavir and/or atazanavir (used to treat the HIV 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.

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 (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 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 10-17 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 20 mg. T ake 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.

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