Crestor

Leaflet accompanying the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Crestor (Crestor 20), 20 mg, film-coated tablets

Rosuvastatinum
Crestor and Crestor 20 are different trade names for the same medicine.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• You should consult a doctor or pharmacist if you have any further doubts.
• This medicine has been prescribed specifically for you.Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including those not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. 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 medicines called statins.

Crestor is recommended for use because:

• The patient has been found to have 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 recommended taking a statin, as dietary changes and increased physical activity have proven insufficient to achieve normal cholesterol levels in the blood. A patient taking Crestor should also follow a low-cholesterol diet and 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 is the result of the deposition of atherosclerotic plaques in the blood vessels.

Why is it important to take Crestor regularly

Crestor is used to achieve normal levels of fatty substances in the blood. The most common of these is cholesterol.
In the blood, there are different types of cholesterol, 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 to remove "bad" cholesterol from the blood.

In most people, high cholesterol levels do not change their well-being, as they do not cause any symptoms. However, if the patient does not receive treatment, it leads to the deposition of fatty deposits in the walls of blood vessels and their narrowing.
Sometimes, it may lead to the blockage of a narrowed blood vessel, disruption of blood flow to the heart or brain, and consequently to a heart attack or stroke. Achieving normal cholesterol levels in the blood reduces the risk of a heart attack, stroke, or similar diseases.

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

take it. This prevents the cholesterol level from increasing again, which causes the deposition of fatty substances. You should stop taking the medicine if your doctor advises you to do so or if you become pregnant.

2. Important information before taking Crestor

When not to take Crestor:

• or any of the other ingredients of Crestor,
• or breastfeeding. If a woman taking Crestor becomes pregnant, she should stop taking it immediately and inform her doctor. Women taking Crestor should use effective methods of contraception,
• ,
• ,
• ,
• if you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir (used to treat viral hepatitis C infection)

Warnings and precautions

Before starting to take Crestor, you should consult a doctor or pharmacist:

• ,
• ,
• , or if you or your family members have had muscle diseases in the past or had muscle disorders while taking cholesterol-lowering medicines. You should contact your doctor immediately if you experience muscle pain or weakness of unknown origin, especially if accompanied by general malaise and fever. You should also inform your doctor if you experience persistent muscle weakness,
• (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 the symptoms of the disease or lead to the development of myasthenia (see section 4),
• ,
• ,
• . You should read the leaflet carefully, even if you have taken other cholesterol-lowering medicines before,
• , e.g., ritonavir with lopinavir and/or atazanavir, you should refer to the information in the section: "Other medicines and Crestor",
• (an antibiotic used to treat bacterial infections). Taking fusidic acid with Crestor can lead to severe muscle damage (rhabdomyolysis); see the section "Other medicines and Crestor",
• (as your doctor will need to choose the right starting dose of Crestor for you),
• ,
• (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor will determine the appropriate starting dose of Crestor for you.

If any of the above situations apply to you (or if you have any doubts):

• do not take Crestor at a dose of 40 mg (the highest dose) and before taking Crestor at any other dose, consult your doctor or pharmacist.In a small group of patients, statins may affect liver function. To confirm this effect, a blood test is performed to check liver enzyme activity. Usually, your doctor will recommend a liver enzyme activity test 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 medicine. Patients with high blood sugar and fat levels, overweight, and high blood pressure may be at risk of developing diabetes.
In connection with the use of Crestor, severe skin reactions have been reported, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS). If you experience any of the symptoms described in section 4, you should stop taking Crestor and seek medical attention immediately.

Children and adolescents

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

Crestor at a dose of 40 mg should not be used in children.

Other medicines and Crestor

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
You should tell your doctor if you are taking:

• cyclosporin (used, for example, after organ transplantation),
• warfarin, clopidogrel, or ticagrelor (or any other blood-thinning medicine),
• a medicine from the fibrate group (such as gemfibrozil, fenofibrate) or any other cholesterol-lowering medicine (e.g., ezetimibe),
• medicines used for 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,
• fosfomycin (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),
• any of the following medicines used to treat viral infections, including HIV or hepatitis C virus, alone or in combination with other medicines (see the section "Warnings and precautions"): ritonavir, lopinavir, atazanavir, sofosbuvir, velpatasvir, 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),
• blood-thinning medicines, e.g., warfarin, acenocoumarol, or fluindion (their blood-thinning effect and the risk of bleeding may be increased when taken with this medicine), ticagrelor, or clopidogrel. Crestor may change the effect of these medicines or these medicines may change the effect of Crestor.

If you need to take fusidic acid orally to treat a bacterial infection, you should temporarily stop taking Crestor. Your doctor will tell you when you can safely start taking Crestor again. Taking Crestor with fusidic acid can rarely lead to muscle weakness, tenderness, or pain

(rhabdomyolysis). More information about rhabdomyolysis can be found in section 4.

Pregnancy and breastfeeding

Crestor should not be takenduring pregnancy or breastfeeding. If a woman taking Crestor becomes pregnant, she should stop taking it immediately and consult her doctor. While taking Crestor, you should avoid becoming pregnant and use effective methods of contraception.
Before taking any medicine, you should consult a doctor or pharmacist.

Driving and using machines

Most people can drive and use machines while taking Crestor - it will not affect their ability. However, some patients may experience dizziness while taking Crestor. If this symptom occurs, you should consult your doctor before driving a vehicle or operating machinery.

Crestor contains lactose monohydrate

If you have been found to be intolerant to some sugars (lactose, milk sugar), you should inform your doctor before taking Crestor.
A full list of excipients is included in the section: Contents of the packaging and other information.

3. How to take Crestor

This medicine should always be taken as directed by your doctor. If you are unsure, you should consult your doctor or pharmacist.
Crestor is available in the following doses: 10 mg, 20 mg.

Adults

Taking Crestor to lower cholesterol levels

Starting dose

Treatment should be started with a dose of 5 mg or 10 mg, even if you have taken higher doses of other statins before. The size of the starting dose depends on:

• cholesterol levels,
• the degree of risk of heart attack or stroke,
• the presence of factors that increase the risk of side effects. You should ask your doctor which starting dose of Crestor is most suitable for you.

Your doctor may decide to use a dose of 5 mg as the starting dose if:

• you are of Asian origin(Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian),
• you are over 70 years old,
• you have moderately severe kidney disease,
• you are at risk of muscle diseases (myopathy).

Increasing the dose and maximum daily dose

Your doctor may decide to increase the dose so that it is suitable for your needs.
If you started treatment with a dose of 5 mg, your doctor may decide to increase it to 10 mg, and then to 20 mg or 40 mg if necessary. If you started treatment with a dose of 10 mg, your doctor may decide to increase it to 20 mg, and then to 40 mg if necessary. The treatment period with the established dose between each 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, in 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 your doctor may decide to reduce it if you have the factors described above.

Taking Crestor in children and adolescents aged 6-17 years

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

Taking the medicine

The tablet should be swallowed whole, with a glass of water.
Crestor should be taken once a dayat any time, with or without food.
It is recommended to take the medicine at the same time every day, so it is easier to remember.

Cholesterol checks

To ensure that cholesterol levels have decreased and are normal, you should regularly have check-ups and blood tests.
Your doctor may decide to increase the dose of Crestor to suit your needs.

Taking a higher dose of Crestor than recommended

If you have taken a higher dose of Crestor than recommended, you should consult your doctor or go to the nearest hospital.
If you are in the hospital or being treated for another illness, you should inform your doctor or other medical staff that you are taking Crestor.

Missing a dose of Crestor

You should take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

Stopping treatment with Crestor

You should tell your doctor if you want to stop taking Crestor. Cholesterol levels may increase again if treatment with Crestor is stopped.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Crestor can cause side effects, although not everybody gets them.
It is important for you to know what side effects can occur. They are usually mild and disappear shortly after starting treatment.
You should stop taking Crestor immediately and seek medical attentionif you 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, plate-like, or round patches on the torso, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and 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 body temperature, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).

You should stop taking Crestor and consult your doctor immediately if you experience:

• muscle pain or other muscle symptomsthat last longer than expected. Muscle symptoms occur more frequently in children and adolescents than in adult patients. As with other statins, a very small number of patients have experienced adverse effects on muscles. Rarely, these patients have experienced 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 the medicine (only applies to a dose of 40 mg).
• Diabetes. The risk of developing diabetes is higher if you have high blood sugar and fat levels, are overweight, and have high blood pressure. Your doctor will monitor you if you are at risk while taking this medicine.

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

• Rash, itching, or other skin reactions.
• Increased protein in the urine. This symptom usually resolves on its own and does not require stopping the medicine (only 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 you suspect an allergic reaction, you should stop taking Crestor immediately and seek medical attention.
• Muscle damage in adults, you should take precautions, i.e., stop taking Crestor and consult your doctor immediately if you experience muscle pain or other muscle symptomsthat last 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 disorders (insomnia and nightmares), sexual dysfunction, depression, breathing problems (persistent cough and/or shortness of breath or fever), tendon damage, persistent muscle weakness.
• 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). You should talk to your doctor if you experience weakness in your arms or legs, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49-21-301, fax: +48 22 49-21-309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help gather more information on the safety of this medicine.

5. How to store Crestor

Store at a temperature below 30°C. Store in the original packaging to protect from moisture.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines 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. Each film-coated tablet contains 20 mg of rosuvastatin in the form of rosuvastatin calcium.
Other ingredients of the medicine are lactose monohydrate, microcrystalline cellulose, calcium phosphate, crospovidone, magnesium stearate, hypromellose, triacetin, titanium dioxide (E 171), iron oxide red (E 172).

What Crestor looks like and what the pack contains

Crestor, blisters in a cardboard box containing 30 tablets.
Crestor, 20 mg, are pink, round, film-coated tablets marked "ZD4522" and "20" on one side, the other side is smooth.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in the Netherlands, the country of export:

Grünenthal B.V.
De Corridor 21K
3621 ZA Breukelen
Netherlands

Manufacturer:

AstraZeneca AB
Gärtunavägen
152-57 Södertälje
Sweden
Grünenthal GmbH
Zieglerstraße 6
52078 Aachen
Germany
Farmaceutici Formenti S.p.A.
Via Di Vittorio 2
21040 Origgio (VA)
Italy

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Netherlands marketing authorization number: RVG 26873

Parallel import authorization number: 173/25

This medicine is authorized for marketing in the Member States of the European Economic Area under the following names:
Crestor 20 mg (NL, AT, BE, DE, DK, GR, ES, FI, FR, IS, IE, IT, LU, NO, PL, PT, SE)

Date of leaflet approval: 09.05.2025

[Information about the trademark]