5 mg, 10 mg, 20 mg, 40 mg film-coated tablets 
rosuvastatin

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Crestor is and what it is used for 
2. What you need to know before taking Crestor 
3. How to take Crestor 
4. Possible side effects 
5. How to store Crestor 
6. Contents of the packaging 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 that you have an increased risk of having a heart attack or stroke. Crestor is used in adults, adolescents, and children from 6 years of age to treat high cholesterol.
  • You have been advised to take a statin because dietary changes and increased exercise were not enough to correct your cholesterol levels. You should continue your cholesterol-lowering diet and exercise while taking Crestor.

Or

  • You have other factors that increase the risk of heart attack, stroke, or other health problems related to heart vessels.

Myocardial infarction, stroke, and other heart vessel-related health problems may be caused by a condition called atherosclerosis (arteriosclerosis). The cause of atherosclerosis is the accumulation of fat in the artery engines.

Why it’s important to keep taking Crestor

Crestor is used to correct the concentration of certain fats in the blood, so-called lipids. The most common of these is cholesterol.

There are different types of cholesterol in the blood, the “bad” cholesterol ( LDL-C ) and the “good” cholesterol ( HDL-C ).

  • Crestor can lower the “bad” cholesterol and increase the “good” cholesterol.
  • It works by helping your body reduce the production of “bad” cholesterol and improve your body’s ability to remove it from your blood.

For most people, high cholesterol levels do not affect how they feel because high cholesterol levels do not cause any symptoms. If left untreated, however, fat deposits can settle on the walls of your blood vessels and make them narrower.

Sometimes these narrow blood vessels can be blocked and then shut off the blood supply to the heart or brain, which can lead to a heart attack or a stroke. By lowering your cholesterol levels, you can reduce the risk of having a heart attack, stroke, or other related health problems.

You need to keep taking CRESTOR, even if your cholesterol has reached the right level because it prevents your cholesterol levels increased IgE n order to accumulate fat. However, you should stop if your doctor advises you to do so, or if 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 any of the other ingredients.
  • if you are pregnant or breastfeeding. If you become pregnant while taking Crestor, stop taking Crestor immediately and consult a doctor. Women should avoid becoming pregnant while taking Crestor by using appropriate contraception.
  • if you have liver disease.
  • if you have severe kidney problems.
  • if you have repeated or unexplained muscle aches or pain.
  • if you are taking a combination therapy with sofosbuvir / velpatasvir / voxilaprevir (used to treat a viral infection in the liver called hepatitis C).
  • if you are taking a medicine called ciclosporin (used for example in organ transplantation).

If any of the above apply to you (or you are not sure) contact your doctor.

Note that you should not take Crestor 40 mg (the highest dose one):

  • if you have moderate kidney problems (ask your doctor if you are unsure).
  • if you have thyroid problems.
  • if you have had recurrent or unexplained muscle aches or pains, previous muscle disease, heredity for muscle disease, or have had muscle pain when using other cholesterol-lowering medicines.
  • if you regularly drink large amounts of alcohol.
  • if you are of Asian descent (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
  • if you are taking another type of cholesterol-lowering drug called fibrates.

If any of the above apply to you (or you are not sure) contact your doctor.

Warnings and cautions

Talk to your doctor or pharmacist before taking Crestor:

  • if you have problems with your kidneys.
  • if you have a problem with your liver.
  • if you have had recurrent or unexplained muscle aches or pains, previous muscle disease, heredity for muscle disease, or muscle aches when using other cholesterol-lowering medicines. Tell your doctor immediately if you have unexplained muscle aches or pain, especially if you feel sick or have a fever. Also, tell your doctor or pharmacist if you have long-term muscle weakness.
  • if you regularly drink large amounts of alcohol.
  • if you have thyroid problems.
  • if you are taking other cholesterol-lowering drugs called fibrates. Read all of this leaflet carefully if you have taken other medicines for high cholesterol before.
  • if you are taking medicines used to treat HIV infection, such as ritonavir with lopinavir and/or atazanavir, see «Other medicines and Crestor ».
  • if you are taking or have been taking a medicine called fusidic acid (a medicine for bacterial infection ) in the last 7 days, either by mouth or as an injection. The combination of fusidic acid and Crestor can lead to serious muscle problems ( rhabdomyolysis ), see «Other medicines and Crestor ».
  • if you are over 70 years old (then your doctor will need to choose the right starting dose of Crestor that is right for you).
  • if you suffer from severe respiratory failure.
  • If you are of Asian descent (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian) your doctor will need to choose the right starting dose of Crestor that is right for you.

If any of the above is true for you (or if you are unsure):

  • Do not take Crestor 40 mg (the highest dose one) and talk to your doctor or pharmacist before taking any dose of Crestor.

In a small number of people, statins can affect the liver. This is detected by a simple test that examines increased levels of liver enzymes in the blood. For this reason, doctors will usually perform this blood test (liver function test) before and during treatment with Crestor.

During treatment with this medicine, your doctor will closely monitor you if you have diabetes or are at high risk for diabetes. You are more likely to be at risk for diabetes if you have high blood sugar and blood fat levels, are overweight and have high blood pressure.

Children and young people

  • if the patient is under 6 years of age: Crestor should not be given to children under 6 years of age.
  • if the patient is under 18 years of age: Crestor 40 mg tablet is not suitable for children and adolescents under 18 years of age.

Other drugs and Crestor

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

  • cyclosporine (used for example in organ transplantation)
  • warfarin or clopidogrel (or other blood thinners)
  • fibrates (eg gemfibrozil, fenofibrate), other cholesterol-lowering drugs (eg ezetimibe)
  • certain medicines for heartburn and acid reflux
  • erythromycin ( antibiotics ), fusidic acid ( antibiotics – see below and Warnings and Precautions)
  • birth control pills
  • regorafenib (used to treat cancer)
  • darolutamide (used to treat cancer)
  • hormone replacement drugs
  • any of the following medicines used to treat viral infections, including HIV or hepatitis C infection, alone or in combination (see Warnings and Precautions): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, Graz elbasvir, glekaprevir, pibrentasvir.

The effects of these medicines may be affected by Crestor or they may affect the effect of Crestor.

If you have to take fusidic acid by mouth to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will tell you when it is safe to take Crestor again. The use of Crestor in combination with fusidic acid may in rare cases lead to muscle weakness, tenderness, or pain ( rhabdomyolysis ). See more information regarding rhabdomyolysis in section 4.

Pregnancy and breastfeeding

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 appropriate contraception.

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

Driving and using machines

Crestor does not affect the ability to drive or use machines of most people. However, some people feel dizzy while using Crestor. If you feel dizzy, talk to your doctor before trying to drive or use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

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 complete list of ingredients, see Package Contents and Other Information.

3. How to take Crestor

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

The usual dose for adults

If you take Crestor for high cholesterol:

Starting dose

Your treatment with Crestor should start with 5 mg or 10 mg, even if you have taken a higher dose of another statin before. The choice of starting dose for you depends on:

  • your cholesterol levels
  • the risk level you have for having a heart attack or stroke
  • if you have a factor that may make you more sensitive to possible side effects.

Ask your doctor or pharmacist for advice on which starting dose Crestor is best for you.

Your doctor may decide to give you the lowest dose (5 mg) if:

  • you are of Asian descent (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian)
  • you are over 70 years old
  • you have moderate kidney problems
  • you are at risk for muscle aches and pains ( myopathy ).

Increase of dose one and a maximum daily dose

Your doctor may decide to increase your dose. This is so that you can take the dose of Crestor that is right for you. If you started with 5 mg, your doctor may decide to double this dose to 10 mg, then to 20 mg, and then to 40 mg if necessary. If you started with 10 mg, your doctor may decide to double this dose to 20 mg and then to 40 mg if necessary. There will be four weeks between each 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 attack or stroke whose cholesterol levels are not lowered enough by 20 mg.

If you take Crestor to reduce the risk of heart attack, stroke, or other heart vessel-related health problems:

The recommended dose is 20 mg/day. However, your doctor may decide that you should use a lower dose if you have any of the factors mentioned above.

Use for children and adolescents aged 6–17 years

The usual dose range for children and adolescents aged 6–17 years is 5–20 mg once daily. The usual starting dose is 5 mg daily and your doctor may gradually increase the dose to find the right dose of Crestor for you. The maximum daily dose of Crestor is 10 or 20 mg for children aged 6-17 years, depending on the underlying condition you are being treated for. Take a dose once a day. Crestor 40 mg tablet should not be used in children.

Tablet intake

Swallow each tablet whole with a glass of water.

Take Crestor once daily. You can take the tablet any time you want, with or without food. Try to take the same time each day to make it easier to remember.

Regular cholesterol checks

You must see your doctor for regular cholesterol checks that ensure that your cholesterol has reached and stays at the right level.

Your doctor may decide to increase your dose so that you take the dose of Crestor that is right for you.

If you take more Crestor than you should

If you have ingested too much medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you go to a hospital or receive treatment for any other condition, tell your healthcare provider that you are taking Crestor.

If you forget to take Crestor

Do not worry but take the next dose as planned at the right 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 may rise again if you stop taking Crestor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. You must be 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 get any of the following allergic reactions:

  • difficulty 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 skin itching (with raised lumps).

Also, talk to your doctor as soon as possible, and stop taking Crestor immediately:

  • if you get any unusual aches or pains in your muscles that sit in longer than you expected. 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 in rare cases, these have developed into a life-threatening muscle disease, rhabdomyolysis.
  • if you get muscle strain.
  • if you get a lupus-like condition (includes skin rash, joint problems, and effects on blood cells ).

Common side effects (affects more than 1 in 100 people but less than 1 in 10 people):

  • headache, abdominal pain, constipation, nausea, muscle aches, weakness, dizziness.
  • increased content of protein in the urine. This usually goes back to normal without you having to stop taking Crestor (Crestor 40 mg only).
  • diabetes. This is more likely if you have high blood sugar and blood fat levels, are overweight and have high blood pressure. Your doctor will check you while you are taking this medicine.

Uncommon side effects (affects more than 1 in 1,000 people but less than 1 in 100 people):

  • skin rash, itching, or other skin reactions.
  • increased content of protein in the urine. This usually returns to normal by itself without you having to stop taking Crestor (Crestor 5 mg, 10 mg, and 20 mg only).

Rare side effects (affects more than 1 user in 10,000 but less than 1 in 1,000):

  • severe allergic reaction – swelling of the face, lips, tongue,e and/or throat, difficulty swallowing and breathing, severe itching of the skin (with raised lumps). If you think you have an allergic reaction, stop taking Crestor and see a doctor immediately.
  • Muscle damage in adults – as a preventative measure, stop taking Crestor immediately and talk to a doctor as soon as possible if you have any unusual aches or pains in your muscles that sit for longer than expected.
  • severe abdominal pain (inflamed pancreas ).
  • increased liver enzymes in the blood
  • bleeding or bruising occur more often than normal due to low platelet levels.
  • lupus-like disease (includes skin rash, joint problems, and effects on blood cells ).

Very rare side effects (affects less than 1 in 10,000 people):

  • jaundice (yellowing of the skin and eyes), hepatitis (inflammation of the liver), blood in the urine, damage to nerves in the legs and arms (for example, numbness), joint pain, memory loss, and enlargement of the mammary glands in men ( gynecomastia ).

Side effects with unknown occurrence include:

  • diarrhea (loose stools), Stevens-Johnson syndrome (a severe condition with blisters that can affect skin, mouth, ey, es, and genitals), cough, shortness of breath, edema(swelling), sleep disorders, including insomnia and nightmares, sexual difficulties, depression, respiratory problems, including persistent cough and/or shortness of breath or fever, tendon damage and prolonged muscle weakness.

5. How to store Crestor

  • Blister: Do not store above 30 ° C. Store in the original package. Moisture sensitive.
  • Plastic cans: Do not store above 30 ° C. Close the lid tightly. Moisture sensitive.
  • 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 expiration date is the last day of the specified month.
  • 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.

6. Contents of the packaging and other information

Content declaration

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 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 the medicine looks like and the contents of the pack

Crestor is available in blister packs containing 7, 14, 15, 20, 28, 30, 42, 50, 56, 60, 84, 90, 98, and 100 tablets, as well as in plastic jars with 30 and 100 tablets. (Not all packaging may be marketed.)

Crestor is available in four tablet strengths:

Crestor 5 mg film-coated tablets are yellow, round, and marked with ZD4522 and 5 on one side and glossy on the other side.

Crestor 10 mg film-coated tablets are pink, round, and marked with ZD4522 and 10 on one side and glossy on the other side.

Crestor 20 mg film-coated tablets are pink, round, and marked with ZD4522 and 20 on one side and glossy on the other side.

Crestor 40 mg film-coated tablets are pink, oval, and marked with ZD4522 on one side and 40 on the other.

Marketing Authorization Holder and Manufacturer

Finland: AstraZeneca Oy, Självstyrelsegränden 4, 02600 Espoo, Finland

Manufacturer:

AstraZeneca UK Ltd., Silk Road Business Park, Macclesfield, Cheshire, SK102NA, United Kingdom

Tel: +44 1625 582828

AndersonBrecon (UK) Ltd, 2-7 Wye Valley Business Park, Brecon Road, Hay-on-Wye, Hereford, HR3 5PG, UK

Tel: +44 1497 820829

AstraZeneca GmbH, Tinsdaler Weg 183, 22880, Wedel, Germany

Tel: +49 41 037 080

Avara Reims Pharmaceutical Services, Pompelle Industrial Park, Chemin de Vrilly, REIMS, 51100, France

Tel: +33 3266 16868

This medicinal product is authorized under the European Economic Area under the names:

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).

Muhammad Nadeem

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