Crestor (rosuvastatin)

• Cholesterol-lowering medicine (statin)
• Tablet for oral use
• Not to be used while pregnant or breastfeeding

CRESTOR contains rosuvastatin, which belongs to a group of medicines called statins. This medicine lowers LDL cholesterol levels in the blood. Fatty deposits, such as LDL cholesterol, can build up in the walls of your blood vessels causing them to narrow (atherosclerosis). Atherosclerosis increases the risk of cardiovascular diseases. CRESTOR reduces cholesterol levels in the blood and thus the risk of atherosclerosis.

You have been prescribed CRESTOR because:

• You have a high cholesterol level.
• You have other factors that increase your risk of heart attack or stroke due to atherosclerosis.

Take the tablet with a drink of water, preferably at the same time each day to avoid missing any. 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.

Dosage

Dosage varies per person and is determined by a doctor depending on the symptoms. The recommended dose in adults is:

For high cholesterol:

• Your recommended starting dose is 5 mg or 10 mg. The doctor may decide to increase this dose after a few weeks. The maximum daily dose of CRESTOR is 40 mg.

To reduce your risk of having a heart attack, stroke or related health problems:

• The recommended dose is 20 mg once daily. However, your doctor may decide to use a lower dose.

Use in children and adolescents aged 10-17 years:

• The usual starting dose is 5 mg. The doctor may gradually increase your dose to find the right amount of CRESTOR for you. The maximum daily dose of CRESTOR is 20 mg. Take your dose once a day. CRESTOR 40mg tablets should not be used by children.

For more information on dosage, see the package leaflet.

Alcohol/driving

Reduce or stop alcohol consumption while taking this medicine.

CRESTOR may cause dizziness. You should avoid driving until the symptoms have passed if you are affected.

If you use too much/forget to use/stop using CRESTOR

If you take more tablets than you were told to, consult your doctor or pharmacist.

If you forget to take CRESTOR, just take your next scheduled dose at the correct time. Do not take a double dose to make up for a forgotten one.

Talk to your doctor if you want to stop taking CRESTOR. Your cholesterol levels might increase again if you stop taking CRESTOR.

Do not take CRESTOR if:

• You are allergic to any of the ingredients of CRESTOR.
• You are pregnant or breastfeeding (see section 'Pregnancy and breastfeeding’).
• You have a liver disease.
• You have severe kidney problems.
• You have repeated or unexplained muscle aches or pains.
• You take a drug called ciclosporin.

In addition, do not take CRESTOR 40 mg (the highest dose) if:

• You have moderate kidney problems (if in doubt, please ask your doctor).
• Your thyroid gland is not working properly.
• 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 cholesterollowering medicines.
• You regularly drink large amounts of alcohol.
• You are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean or Indian).
• You take other medicines called fibrates to lower your cholesterol.

Always consult a doctor if you fall into one of the above-mentioned categories.

When should this medicine be used with caution?

Talk to your doctor or pharmacist before taking CRESTOR if:

• You have problems with your kidneys or liver.
• 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 cholesterollowering medicines. Tell your doctor immediately if you have unexplained muscle aches or pains, especially if you feel unwell or have a fever.
• You regularly drink large amounts of alcohol.
• Your thyroid gland is not working properly.
• You are taking certain medicines (see section ‘Other medicines and CRESTOR’).
• If the patient is below 18 years of age: CRESTOR 40mg tablets are not suitable for use in children and adolescents below 18 years of age.
• You are over 70 years.
• You have severe respiratory failure.
• You are of Asian origin – that is Japanese, Chinese, Filipino, Vietnamese, Korean or Indian.

Talk to your doctor before you start taking this medicine. For more information, see the package leaflet.

Pregnancy and breastfeeding

Do not take CRESTOR if you are pregnant or breastfeeding.

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.

Other medicines and CRESTOR

Tell your doctor if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines.

The effects of the following medicines could be changed by CRESTOR or they could change the effect of CRESTOR:

• Cyclosporine (used for example after transplantation).
• Warfarin (or other medicines 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 (HRT).
• Lopinavir/ritonavir (used to treat HIV infections).

Check with your doctor if you are taking any of these medicines.

Like all medicines, this medicine can cause side effects, although some people may not experience any. Side effects that are known to be associated with CRESTOR include:

Common (may affect up to 1 in 10 patients):

• Headache.
• Abdominal pain.
• Constipation.
• Feeling unwell.
• Muscle ache.
• 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.

Uncommon (may affect up to 1 in 100 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).

For a list of rare side effects, see the package leaflet. Consult a doctor or pharmacist if the side effects are severe or bothersome.

Stop taking CRESTOR and seek medical help immediately if you have any severe side effects, such as a severe allergic reaction or any unusual aches or pains in your muscles which go on for longer than

you might expect (see the package leaflet for more information).

The active substance is rosuvastatin. CRESTOR film-coated tablets contain rosuvastatin calcium equivalent to 5 mg, 10 mg, 20 mg or 40 mg of rosuvastatin.

Read the package leaflet before use. The official package leaflet of CRESTOR is available for download here.