Crestor® 40 mg film-coated tablets – patient leaflet, side effects, dosage

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 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.

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 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.

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.

2) What you need to know before you take Crestor

1. 2. 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 have liver disease.
• If you have severe kidney problems.
• If you have repeated or unexplained muscle aches or pains.

• If you take a drug combination of sofosbuvir/velpatasvir/voxilaprevir (used for viral infection

  of the liver called hepatitis C).

• 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 have or have had myasthenia (a disease with general muscle weakness including in some cases muscles used when breathing), or ocular myasthenia (a disease causing eye muscle weakness) as statins may sometimes aggravate the condition or lead to the occurrence of myasthenia (see section 4).
• If you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking Crestor or other related medicines.
• 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.

Serious skin reactions including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with Crestor treatment. Stop using Crestor and seek medical attention immediately if you notice any of the symptoms described in section 4.

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.

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.

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),
• Belumosudil (used to treat chronic graft-versus-host disease),
• warfarin, clopidogrel or ticagrelor (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),
• regorafenib (used to treat cancer),
• darolutamide (used to treat cancer),
• capmatinib (used to treat cancer),
• Momelotinib (used to treat myelofibrosis, a rare form of blood cancer),
• hormone replacement therapy,
• fostamatinib (used to treat low platelet counts),
• febuxostat (used to treat and prevent high blood levels of uric acid),
• teriflunomide (used to treat multiple sclerosis),

• any of the following drugs used to treat viral infections, including HIV or hepatitis C infection, alone or

  in combination (please see Warnings and precautions): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.

• roxadustat or vadadustat (medicines that increase the number of red blood cells and haemoglobin level in chronic kidney disease patients),
• enasidenib (used to treat acute myeloid leukemia),
• tafamidis (used to treat transthyretin amyloidosis).

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.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this 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 levels.
• 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.

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.effec4) Possible side effects

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).
• Reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

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.

• If you experience muscle rupture.

• If you have lupus-like disease syndrome (including rash, joint disorders and effects on blood

  cells).

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

  1. immediately if you have any unusual aches or pains in your muscles which go on for longer than
  2. expected.
• A severe stomach pain (inflamed pancreas).
• Increase in liver enzymes in the blood.
• Bleeding or bruising more easily than normal due to low level of blood platelets.
• Lupus-like disease syndrome (including rash, joint disorders and effects on blood cells).

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 and breast enlargement in men (gynaecomastia).

Side effects of unknown frequency may include:

• Diarrhoea (loose stools), 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 and muscle weakness that is constant.
• Rash that may occur on the skin or sores in the mouth (lichenoid drug eruption).
• Myasthenia gravis (a disease causing general muscle weakness including in some cases muscles used when breathing), Ocular myasthenia (a disease causing eye muscle weakness). Talk to your doctor if you experience weakness in your arms or legs that worsens after periods of activity, double vision or drooping of your eyelids, difficulty swallowing, or shortness of breath.

Muscle-related side effects

A study that reviewed combined results from multiple clinical trials found that statins can sometimes cause a small increase in mild muscle symptoms in the first year of statin treatment. The study also demonstrated an increase in first episode of muscle pain or weakness symptoms being more likely for intensive statin treatment compared to moderate/less intense statin treatment. However, in more than 90% of cases, the muscle-related symptoms reported were not caused by the statin itself.

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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

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

5. How to store Crestor

• Do not store above 30°C. Store in the original package 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 carton 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.

If your tablets show signs of deterioration or discolouration seek the advice of your pharmacist who will tell you what to do.6)

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6. Contents of the pack and other information

What Crestor contains:

• The active substance in Crestor is rosuvastatin. Each film-coated tablet contains rosuvastatin calcium

  equivalent to 40 mg of rosuvastatin.

• Also contains lactose monohydrate, microcrystalline cellulose, calcium phosphate, crospovidone,

  magnesium stearate, hypromellose, triacetin, titanium dioxide (E171) and red iron oxide (E172).

What Crestor looks like and contents of the pack

Pink, oval, film-coated tablets marked with ‘ZD4522’ on one side and ‘40’ on the reverse.

Available in calendar blisters packs of 28 tablets.

Manufactured by:

AstraZeneca Reims Production, Parc Industriel de la Pompelle, Chemin de Vrilly, 51100 Reims, France or

AstraZeneca AB, S-151 85 Södertälje, Sweden

Procured from within the EU and repackaged by Product Licence Holder Uni Health Distribution Ltd, Unit G4 Riverside Industrial Estate, Riverside Way, Dartford, Kent, DA1 5BS.

PL 45396/0082 POM

Leaflet date: 15 September 2026 Ref: Cr40/UT8

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

Crestor is a registered trademark of AstraZeneca group of companies.

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