Crestor

Leaflet accompanying the packaging: patient information

Crestor, 10 mg, film-coated tablets

Crestor, 20 mg, film-coated tablets

Rosuvastatinum

It is essential to carefully read the contents of the leaflet before taking the medication, as it contains important information for the patient.

• The leaflet should be kept, so it can be re-read if necessary.
• In case of any further doubts, the patient should consult a doctor or pharmacist.
• This medication has been prescribed to a specific person.It should not be given to others. The medication may harm another person, even if the symptoms of their illness are the same.
• If any side effects occur, including those not listed in the leaflet, the patient should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Crestor and what is it used for
• 2. Important information 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 is Crestor and what is it used for

Crestor belongs to a group of medications called statins.

Crestor is recommended for use because:

• The patient has been diagnosed with high cholesterol levels. This means a risk of heart attack (myocardial infarction) or stroke. Crestor is used in adults, adolescents, and children aged 6 years or older to treat high cholesterol levels.
• The doctor has prescribed a statin because dietary changes and increased physical activity have proven insufficient to achieve normal cholesterol levels in the blood. Patients taking Crestor should also follow a low-cholesterol diet and engage in physical exercise.

or

• Crestor is also recommended if the patient has other factors that increase the risk of heart attack (myocardial infarction), stroke, or similar diseases.

Myocardial infarction, stroke, and other problems can be caused by atherosclerosis of the arteries.
Atherosclerosis of the arteries is the result of the deposition of atherosclerotic plaques in the blood vessels.

Why is it essential to take Crestor regularly

Crestor is used to achieve normal levels of fatty substances in the blood. The most common of these is cholesterol.
There are different types of cholesterol in the blood, so-called "bad" cholesterol (LDL-C) and "good" cholesterol (HDL-C).

• Crestor may cause a decrease in "bad" cholesterol and an increase in "good" cholesterol.
• The action of Crestor involves inhibiting the production of "bad" cholesterol in the body. It also helps remove "bad" cholesterol from the blood.

In most people, high cholesterol levels do not affect their well-being, as they do not cause any symptoms. However, if the patient does not receive treatment, fatty deposits accumulate in the walls of blood vessels and narrow them.
Sometimes, a narrowed blood vessel can become blocked, disrupting blood flow to the heart or brain, and leading to a heart attack or stroke. Achieving normal cholesterol levels in the blood reduces the risk of heart attack, stroke, or similar diseases.

Even if the cholesterol level is normal after taking Crestor, the patient should

continue taking it. This prevents the cholesterol level from increasing again, which can lead to the accumulation of fatty substances. The patient should stop taking Crestor if their doctor advises them to do so or if they become pregnant.

2. Important information before taking Crestor

When not to take Crestor

• If the patient is allergic (hypersensitive) to rosuvastatinor any of the other ingredients of Crestor,
• If the patient is pregnantor breastfeeding. If a woman taking Crestor becomes pregnant, she should stop taking the medication immediately and inform her doctor. Women taking Crestor should use effective methods of contraception,
• If the patient has liver disease,
• If the patient has severe kidney disease,
• If the patient experiences frequent or unexplained muscle pain or weakness,
• If the patient is taking a combination of sofosbuvir/velpatasvir/voxilaprevir (used to treat hepatitis C virus infection),
• If the patient is taking cyclosporin(a medication used, for example, after organ transplantation),
• if the patient has ever had a severe skin rash or skin peeling, blisters, and (or) ulcers in the mouth after taking Crestor or other similar medications.

If any of the above situations apply to the patient or if the patient has doubts, they should consult their doctor again.

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

• If the patient has moderately severe kidney disease(in case of doubt, the patient should ask their doctor),
• If the patient has thyroid disease,
• If the patient experiences frequent or unexplained muscle pain or weakness, if the patient or their family members have had muscle diseases or have previously experienced muscle disorders while taking cholesterol-lowering medications,
• If the patient regularly consumes large amounts of alcohol,
• If the patient is of Asian origin(Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian),
• If the patient is taking fibrate medications, i.e., other cholesterol-lowering medications.

If any of the above situations apply to the patient (or if the patient has doubts), they should consult their doctor again.

Warnings and precautions

Before starting treatment with Crestor, the patient should consult their doctor or pharmacist,

• If the patient has kidney disease,
• If the patient has liver disease,
• If the patient experiences frequent or unexplained muscle pain or weakness, or if the patient or their family members have had muscle diseases or have previously experienced muscle disorders while taking cholesterol-lowering medications. The patient should immediately consult their doctor if they experience unexplained muscle pain or weakness, especially if accompanied by general malaise and fever. The patient should also inform their doctor if they experience persistent muscle weakness,
• If the patient has or has had myasthenia(a disease that causes general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes exacerbate symptoms of the disease or lead to the development of myasthenia (see section 4),
• If the patient regularly consumes large amounts of alcohol,
• If the patient has thyroid disease,
• If the patient is taking cholesterol-lowering medications from the fibrate group. The patient should read the leaflet carefully, even if they have taken other cholesterol-lowering medications before,
• If the patient is taking medications used to treat HIV, e.g., ritonavir with lopinavir and (or) atazanavir, the patient should refer to the information in the section "Other medications and Crestor",
• If the patient is taking or has taken within the last 7 days an oral or injectable medication containing fusidic acid(an antibiotic used to treat bacterial infections). Taking fusidic acid with Crestor can lead to severe muscle damage (rhabdomyolysis); see the section "Other medications and Crestor",
• If the patient is over 70 years old(as the doctor must determine the appropriate initial dose of Crestor for the patient),
• If the patient has severe respiratory failure,
• If the patient is of Asian origin(Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). For these patients, the doctor will determine the appropriate initial dose of Crestor.

If any of the above situations apply to the patient (or if the patient has doubts):

• The patient should not take Crestor at a dose of 40 mg (the highest dose) and should consult their doctor or pharmacist before taking Crestor at any other dose.

In a small group of patients, statin medications can affect liver function. To confirm this effect, a blood test is performed to check liver enzyme activity. Usually, the doctor recommends performing a liver enzyme activity test in the blood before starting and during treatment with Crestor.
Patients with diabetes or those at risk of developing diabetes will be under close medical supervision while taking this medication. Patients with high blood sugar and fat levels, overweight, and high blood pressure may be at risk of developing diabetes.
Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with Crestor. If any of the symptoms described in section 4 occur, the patient should stop taking Crestor and consult their doctor immediately.

Children and adolescents

• If the patient is under 6 years old: Crestor should not be used in children under 6 years old.
• If the patient is under 18 years old: Crestor at a dose of 40 mg is not suitable for use in children and adolescents under 18 years old.

Other medications and Crestor

The patient should tell their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take.
The patient should inform their doctor if they are taking:

• cyclosporin (used, for example, after organ transplantation),
• warfarin, clopidogrel, or ticagrelor (or any other blood-thinning medication),
• a fibrate medication (such as gemfibrozil, fenofibrate) or any other cholesterol-lowering medication (e.g., ezetimibe),
• medications used to treat indigestion (used to neutralize stomach acid),
• erythromycin (an antibiotic), fusidic acid (an antibiotic - see below and the section "Warnings and precautions"),
• oral contraceptives,
• regorafenib (used to treat cancer),
• darolutamide (used to treat cancer),
• camptothecin (used to treat cancer),
• hormone replacement therapy,
• fostamatinib (used to treat low platelet count),
• febuxostat (used to treat and prevent high uric acid levels in the blood),
• teriflunomide (used to treat multiple sclerosis),
• leflunomide (used to treat rheumatoid arthritis)
• any of the following medications used to treat viral infections, including HIV or hepatitis C virus infection, taken alone or in combination with other medications (see the section "Warnings and precautions"): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir,
• roxadustat (used to treat anemia in patients with chronic kidney disease),
• tafamidis (used to treat a disease called transthyretin amyloidosis),
• momelotinib (used to treat myelofibrosis in adults with anemia). Crestor may affect the action of these medications or these medications may affect the action of Crestor.

If the patient needs to take fusidic acid orally to treat a bacterial infection, they should temporarily stop taking Crestor. The doctor will inform the patient when it is safe to restart taking Crestor. Taking Crestor with fusidic acid can rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.

Taking Crestor with fusidic acid can rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis).
More information on rhabdomyolysis can be found in section 4.

Pregnancy and breastfeeding

Crestor should not be takenduring pregnancy or breastfeeding. If a patient becomes pregnant while taking Crestor, they should stop taking the medication immediately and consult their doctor. While taking Crestor, the patient should avoid becoming pregnant and use effective methods of contraception.
Before taking any medication, the patient should consult their doctor or pharmacist.

Driving and operating machinery

Most people can drive and operate machinery while taking Crestor - it will not affect their abilities. However, some patients may experience dizziness while taking Crestor. If this symptom occurs, the patient should consult their doctor before driving or operating machinery.
Crestor contains lactose.
If the patient has been diagnosed with intolerance to some sugars (lactose, i.e., milk sugar), they should inform their doctor before taking Crestor.
A full list of excipients can be found in the section: Contents of the packaging and other information.

3. How to take Crestor

This medication should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.

Adults

Taking Crestor to lower cholesterol levels

Initial dose

Treatment should be started with a dose of 5 mg or 10 mg, even if the patient has previously taken higher doses of other statins. The size of the initial dose depends on:

• cholesterol levels,
• the degree of risk of heart attack or stroke in the patient,
• the presence of factors that increase the patient's susceptibility to adverse effects.

The patient should ask their doctor which initial dose of Crestor is most suitable for them.
The doctor may decide to use a dose of 5 mg as the initial dose if:

• the patient is of Asian origin(Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian),
• the patient is over 70 years old,
• the patient has moderately severe kidney disease,
• the patient is at risk of developing muscle diseases (myopathy).

Increasing the dose and maximum daily dose

The doctor may decide to increase the dose to suit the patient's needs.
If the patient started treatment with a dose of 5 mg, the doctor may decide to increase it to 10 mg, and then to 20 mg or 40 mg if necessary. If the patient started treatment with a dose of 10 mg, the doctor may decide to increase it to 20 mg, and then to 40 mg if necessary. The treatment period with a fixed dose between each dose increase is 4 weeks.
The maximum daily dose of Crestor is 40 mg. It is used in patients with high cholesterol levels and a high risk of heart attack or stroke, for whom a dose of 20 mg was insufficient to lower cholesterol levels.

Taking Crestor to reduce the risk of heart attack or stroke or similar health problems

The recommended daily dose is 20 mg, but the doctor may decide to reduce it if the patient has the factors mentioned above.

Taking Crestor in children and adolescents aged 6-17 years

The dose range for children and adolescents aged 6-17 years is 5-20 mg once daily. The usual initial dose is 5 mg once daily, and the doctor may gradually increase the dose to suit the patient's needs. The maximum daily dose of Crestor in children aged 6-17 years is 10 mg or 20 mg, depending on the disease being treated.
The medication should be taken once daily. Crestor at a dose of 40 mg should not be usedin children.

Taking the medication

The tablet should be swallowed whole, with water.
Crestor should be taken once dailyat any time, with or without food.
It is recommended to take the medication at the same time every day to make it easier to remember.

Cholesterol control tests

To ensure that cholesterol levels have decreased and are normal, the patient should regularly attend follow-up appointments and have blood tests.
The doctor may decide to increase the dose of Crestor to suit the patient's needs.

Taking a higher dose of Crestor than recommended

In case of taking a higher dose of Crestor than recommended, the patient should consult their doctor or go to the nearest hospital.
If the patient is in the hospital or being treated for another illness, they should inform their doctor or other medical staff that they are taking Crestor.

Missing a dose of Crestor

The patient should take the next dose at the usual time. They should not take a double dose to make up for the missed dose.

Stopping treatment with Crestor

The patient should inform their doctor if they want to stop taking Crestor. Cholesterol levels may increase again if treatment with Crestor is stopped.
In case of any further doubts about taking this medication, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medications, Crestor can cause side effects, although not everyone will experience them.
It is essential for the patient to know which side effects can occur. Usually, they are mild and disappear shortly after starting treatment.
The patient should stop taking Crestor immediately and seek medical attentionif they experience the following allergic reactions:

• difficulty breathing with swelling of the face, lips, tongue, and (or) throat, with or without,
• swelling of the face, lips, tongue, and (or) throat, which can cause difficulty swallowing,
• severe itching of the skin (with hives),
• red, flat, round, or oval patches on the torso, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, and (or) eyes. The occurrence of this type of severe skin rash can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome),
• widespread rash, high fever, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

The patient should stop taking Crestor and consult their doctor immediately if they experience:

• muscle pain or other muscle symptomsthat persist longer than expected. Muscle symptoms occur more frequently in children and adolescents than in adult patients. As with other statins, a small number of patients have experienced adverse effects on muscles. Rarely, these patients have developed potentially life-threatening muscle damage (rhabdomyolysis).
• muscle rupture
• symptoms of a lupus-like syndrome(such as rash, joint diseases, and hematological changes)

Common side effects (occurring in more than 1 in 100 but less than 1 in 10 patients)

• headache, abdominal pain, constipation, nausea, muscle pain, weakness, dizziness.
• increased protein in the urine. This symptom usually resolves on its own and does not require stopping Crestor (applies only to a dose of 40 mg).
• diabetes. The risk of developing diabetes is higher if the patient has high blood sugar and fat levels, is overweight, and has high blood pressure. The treating doctor will monitor patients at risk while they are taking this medication.

Uncommon side effects (occurring in more than 1 in 1,000 but less than 1 in 100 patients)

• skin rash, itching, or other skin reactions.
• increased protein in the urine. This symptom usually resolves on its own and does not require stopping Crestor (applies to doses of 5 mg, 10 mg, and 20 mg).

Rare side effects (occurring in more than 1 in 10,000 but less than 1 in 1,000 patients)

• severe allergic reactions - symptoms include swelling of the face, lips, tongue, and (or) throat, difficulty swallowing and breathing, severe itching of the skin (with hives). If the patient suspects an allergic reaction, they should stop taking Crestor immediately and seek medical attention.
• muscle damage in adults, the patient should exercise caution, i.e., stop taking Crestor and consult their doctor immediately if they experience muscle pain or other muscle symptomsthat persist longer than expected.
• severe abdominal pain (pancreatitis).
• increased liver enzyme levels in the blood.
• increased tendency to bleed or bruise due to low platelet count.
• symptoms of a lupus-like syndrome (such as rash, joint diseases, and hematological changes).

Very rare side effects (occurring in less than 1 in 10,000 patients)

• jaundice (yellowing of the skin and eyes), liver inflammation, blood in the urine, nerve damage in the arms and legs (felt as numbness), joint pain, memory loss, breast enlargement in men (gynecomastia).

Side effects with unknown frequency:

• diarrhea (loose stools), cough, shortness of breath, swelling, sleep disturbances (insomnia and nightmares), sexual dysfunction, depression, breathing problems (persistent cough and (or) shortness of breath or fever), tendon damage, persistent muscle weakness.

(persistent cough and (or) shortness of breath or fever), muscle weakness, or myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing), ocular myasthenia (a disease that causes weakness of the eye muscles). The patient should discuss with their doctor if they experience weakness in their arms or legs, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.

• Myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing), ocular myasthenia (a disease that causes weakness of the eye muscles). The patient should talk to their doctor if they experience weakness in their arms or legs, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49-21-301, fax: +48 22 49-21-309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or their representative.
Reporting side effects will help collect more information on the safety of the medication.

5. How to store Crestor

• Blister packs: store at a temperature below 30°C. The medication should be stored in its original packaging to protect it from moisture.
• Bottles: store at a temperature below 30°C. The bottle should be tightly closed to protect it from moisture.
• The medication should be stored out of sight and reach of children.
• The medication should not be used after the expiration date stated on the packaging/ blister/ label after the words "Expiration date" (EXP). The expiration date refers to the last day of the specified month.
• Medications should not be disposed of in wastewater or household waste. The patient should ask their pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Crestor contains

The active substance of Crestor is rosuvastatin. Crestor film-coated tablets contain calcium rosuvastatin in a dose equivalent to 10 mg or 20 mg of rosuvastatin. Other ingredients of Crestor are lactose monohydrate, microcrystalline cellulose, calcium phosphate, crospovidone, magnesium stearate, hypromellose, triacetin, titanium dioxide (E171), iron oxide red (E172).

What Crestor looks like and contents of the pack

Crestor is available in blister packs in a cardboard box containing 7, 14, 15, 20, 28, 30, 42, 50, 56, 60, 84, 90, 98, and 100 tablets, and in plastic bottles containing 30 or 100 tablets. (Not all pack sizes are available in every country).
Crestor is available in two strengths:

• Crestor, 10 mg, film-coated tablets, pink, round tablets marked "ZD4522" and "10" on one side, the other side is smooth.
• Crestor, 20 mg, film-coated tablets, pink, round tablets marked "ZD4522" and "20" on one side, the other side is smooth.

Marketing authorization holder

Grünenthal GmbH
Zieglerstraße 6
52078 Aachen
Germany

Manufacturer

AstraZeneca AB
S-152 57 Södertälje
Sweden
Grünenthal GmbH
Zieglerstraße 6
52078 Aachen
Germany
Phone: +49 (0) 241 569 0
Farmaceutici Formenti S.p.A.
Via Di Vittorio 2
21040 Origgio (VA)
Italy
Phone: +39 02 969581
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Crestor 5 mg, 10 mg, 20 mg, and 40 mg (NL, AT, BE, DK, GR, FI, IS, IE, IT, LU, NO, PT, SE), 5 mg, 10 mg, and 20 mg (DE, ES, FR), and 10 mg and 20 mg (PL).

Date of last revision of the leaflet: 04/2025