Package leaflet: Information for the patient

Warning! Keep this leaflet. 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.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

Keep this leaflet so that you can read it again if necessary.
Consult your doctor or pharmacist if you have any further questions.
This medicine has been prescribed for a specific individual only. Do not give it to others. This medicine may harm another person, even if their symptoms are the same.
If any side effects occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

What Crestor is and what it is used for
Important information before taking Crestor
How to take Crestor
Possible side effects
How to store Crestor
Contents of the pack and other information

1. What Crestor is and what it is used for

Crestor belongs to a group of medicines called statins.
Crestor is recommended because:

The patient has been diagnosed with high cholesterol levels. This indicates an increased risk of heart attack (myocardial infarction) or stroke. Crestor is used in adults, adolescents, and children aged 6 years and older to treat high cholesterol levels.
The doctor has recommended taking a statin because dietary changes and increased physical activity have not been sufficient to achieve normal blood cholesterol levels. Patients taking Crestor should also follow a cholesterol-lowering diet and engage in regular physical exercise.

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

Heart attack, stroke, and other related problems may be caused by atherosclerosis. Atherosclerosis
results from the buildup of atherosclerotic plaques in blood vessels.
Why it is important to take Crestor regularly
Crestor is used to achieve normal levels of blood lipids (fats). The most common of these is cholesterol.
There are different types of cholesterol in the blood, known as "bad" cholesterol (LDL-C) and "good" cholesterol (HDL-C).

Crestor may reduce levels of "bad" cholesterol and increase levels of "good" cholesterol.
Crestor works by inhibiting the production of "bad" cholesterol in the body. It also helps remove "bad" cholesterol from the blood.

In most people, high cholesterol does not cause any noticeable symptoms. However, if left untreated, fatty deposits build up in the walls of blood vessels, leading to narrowing.
Sometimes, a narrowed blood vessel may become completely blocked, interrupting blood flow to the heart or brain, resulting in a heart attack or stroke. Achieving normal cholesterol levels reduces the risk of heart attack, stroke, or similar conditions.
Even if cholesterol levels become normal after using Crestor, you must continue taking it. This prevents cholesterol levels from rising again, which could lead to the re-accumulation of fatty deposits. You should stop taking the medicine only if your doctor advises you to do so, or if you become pregnant.

2. Important information before using Crestor

When not to use Crestor:

if the patient has a known allergy (hypersensitivity) to rosuvastatin or any of the other ingredients of Crestor,
if the patient is pregnant or breastfeeding. If a woman taking Crestor becomes pregnant, she should immediately stop taking the medicine and inform her doctor. Women of childbearing potential taking Crestor should use effective contraceptive methods,
if the patient has liver disease,
if the patient has severe kidney disease,
if the patient experiences frequent or unexplained muscle pain or discomfort,
if the patient is taking the combination of sofosbuvir/velpatasvir/voxilaprevir (used to treat a viral liver infection known as hepatitis C),
if the patient is taking cyclosporine (a medicine used, for example, after organ transplantation),
if the patient has previously experienced severe skin rash, skin peeling, blisters and/or oral ulcers after taking Crestor or other similar medicines. If any of the above situations apply to the patient or if the patient has any doubts, they should contact their doctor again.

Additionally, do not use Crestor 40 mg (the highest dose):

if the patient has moderate kidney disease (if in doubt, consult the doctor),
if the patient has thyroid disease,
if the patient experiences frequent or unexplained muscle pain or discomfort, or if the patient or their family members have a history of muscle disorders or previously experienced muscle-related side effects while taking lipid-lowering medicines,
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 fibrates, i.e. other cholesterol-lowering medicines. If any of the above situations apply to the patient (or if the patient has any doubts), they should contact their doctor again.

Warnings and precautions
Before starting treatment with Crestor, consult a doctor or pharmacist if:

the patient has kidney disease,
the patient has liver disease,
the patient experiences frequent or unexplained muscle pain or discomfort, or if the patient or their family has a history of muscle disorders, or if the patient previously experienced muscle-related side effects while taking lipid-lowering medicines. The patient should contact their doctor immediately if they develop unexplained muscle pain, especially if accompanied by general malaise and fever. The doctor should also be informed if persistent muscle weakness occurs,
the patient has or has had myasthenia gravis (a disease causing general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease causing weakness of eye muscles), as statins may sometimes worsen symptoms or trigger the onset of myasthenia (see section 4),
the patient regularly consumes large amounts of alcohol,
the patient has thyroid disease,
the patient is taking fibrates, other cholesterol-lowering medicines. The package leaflet should be read carefully, even if the patient has previously taken other cholesterol-lowering medicines,
the patient is taking medicines used to treat HIV infection, e.g. ritonavir with lopinavir and/or atazanavir; refer to the section: "Other medicines and Crestor",
the patient is taking or has taken within the last 7 days an oral or injectable medicine containing fusidic acid (a medicine used for bacterial infections). Concomitant use of fusidic acid with Crestor may lead to severe muscle damage (rhabdomyolysis); see section "Other medicines and Crestor",
the patient is over 70 years of age (as the doctor must determine the appropriate starting dose of Crestor),
the patient has severe respiratory insufficiency,
the patient is of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). In these patients, the doctor will determine the appropriate starting dose of Crestor.

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

the patient should not take Crestor 40 mg (the highest dose), and should consult a doctor or pharmacist before taking Crestor at any other dose. In a small number of patients, statins may affect liver function. To monitor this, blood tests measuring liver enzyme activity may be performed. Usually, the doctor will recommend checking liver enzyme levels in the blood before 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 increased risk of developing diabetes.

Serious skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during treatment with Crestor. If any of the symptoms described in section 4 occur, treatment with Crestor should be stopped immediately and the patient should contact their doctor without delay.

Children and adolescents

if the patient is under 6 years of age: Crestor should not be used in children under 6 years of age.
if the patient is under 18 years of age: Crestor 40 mg is not appropriate for use in children and adolescents under 18 years of age.

Other medicines and Crestor
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.

Tell your doctor if you are taking:

cyclosporine (used, for example, after organ transplantation),
warfarin, clopidogrel, or ticagrelor (or any other anticoagulant),
a fibrate (such as gemfibrozil, fenofibrate) or any other medicine that lowers blood cholesterol (e.g. ezetimibe),
medicines used for indigestion (used to neutralize stomach acid),
erythromycin (an antibiotic), fusidic acid (an antibiotic - see below and section "Warnings and precautions"),
oral contraceptives,
regorafenib (used to treat cancer),
darolutamide (used to treat cancer),
capmatinib (used to treat cancer),
hormone replacement therapy,
fostamatinib (used to treat low platelet count),
febuxostat (used to treat and prevent high blood levels of uric acid),
teriflunomide (used to treat multiple sclerosis),
any of the following antiviral medicines used to treat viral infections, including HIV or hepatitis C virus, used alone or in combination with other medicines (see section "Warnings and precautions"): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir,
roxadustat (used to treat anaemia in patients with chronic kidney disease),
tafamidis (used to treat a disease called transthyretin amyloidosis),
anticoagulants such as warfarin, acenocoumarol, or fluindione (their anticoagulant effect and risk of bleeding may be increased when used concomitantly with this medicine), ticagrelor or clopidogrel. Crestor may affect the action of these medicines or these medicines may affect the action of Crestor.

If the patient needs to take fusidic acid orally to treat a bacterial infection,
Crestor should be temporarily discontinued. The doctor will inform the patient when it is safe to restart
Crestor. Concomitant use of Crestor with fusidic acid may rarely lead to muscle weakness, tenderness, or pain
(rhabdomyolysis). More information on rhabdomyolysis is provided in section 4.

Pregnancy and breastfeeding
Crestor must not be used during pregnancy or while breastfeeding. If a woman becomes pregnant while taking Crestor, treatment should be stopped immediately and the doctor contacted. Effective contraception must be used to avoid pregnancy while taking Crestor.

Before taking any medicine, consult a doctor or pharmacist.

Driving and operating machinery
Most people can drive and operate machinery while taking Crestor – the medicine does not impair these abilities. However, some patients may experience dizziness during treatment with Crestor. If this occurs, the patient should contact their doctor before driving or operating machinery.

Crestor contains lactose monohydrate
If the patient has been diagnosed with an intolerance to certain sugars [lactose (milk sugar)], they should inform their doctor before taking Crestor.

A full list of excipients is provided in section: Contents of the pack and other information.

3. How to take Crestor

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
Crestor is available in the following doses: 10 mg, 20 mg.
Adults
Use of Crestor for lowering cholesterol levels
Starting dose
Treatment should be initiated with a dose of 5 mg or 10 mg, even if the patient has previously taken
higher doses of other statins. The choice of starting dose depends on:

cholesterol levels,
the patient's risk level for heart attack or stroke,
the presence of factors increasing the patient's susceptibility to adverse effects. Ask your doctor which starting dose of Crestor is most appropriate for you.

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

the patient is of Asian origin (Japan, China, Philippines, Vietnam, Korea or India),
the patient is over 70 years of age,
the patient has moderate kidney impairment,
the patient is at risk of developing muscle disorders or muscle pain (myopathy).

Dose escalation and maximum daily dose
Your doctor may decide to increase the dose as appropriate for the patient's needs.
If the patient started treatment with a 5 mg dose, the doctor may increase it to 10 mg, then to 20 mg or 40 mg, if necessary. If the patient started treatment with a 10 mg dose, the doctor may increase it to 20 mg, then to 40 mg, if necessary. The treatment period at a given dose between each dose increase should last 4 weeks.
The maximum daily dose of Crestor is 40 mg. This dose is used in patients with high cholesterol levels and a high risk of heart attack or stroke, in whom a 20 mg dose was insufficient to reduce cholesterol levels.
Use of Crestor to reduce the risk of heart attack or stroke or similar health problems
The recommended daily dose is 20 mg; however, your doctor may decide to reduce it if the patient has any of the risk factors described above.
Use in children and adolescents aged 6–17 years
The dose range for children and adolescents aged 6 to 17 years is 5 to 20 mg once daily. The usual starting dose is 5 mg once daily, and the doctor may gradually increase the dose as appropriate for the patient. The maximum daily dose of Crestor in children aged 6 to 17 years is 10 mg or 20 mg, depending on the type of disease being treated. The medicine should be taken once daily. Crestor 40 mg should not be used in children.
How to take the medicine
The tablet should be swallowed whole with water.
Crestor should be taken once daily, at any time, with or without food.
It is recommended to take the medicine at the same time each day to help remember it.
Regular cholesterol monitoring
To ensure that cholesterol levels have decreased and remain within the target range, regular check-ups and blood tests are necessary.
Your doctor may decide to increase the dose of Crestor as appropriate for the patient.
Taking more Crestor than prescribed
If you take more Crestor than prescribed, contact your doctor or go to the nearest hospital immediately.
If you are in hospital or being treated for another condition, inform your doctor or medical staff that you are taking Crestor.
Missing a dose of Crestor
Take the next dose at the usual time. Do not take a double dose to make up for a missed dose.
Stopping Crestor
Tell your doctor if you wish to stop taking Crestor. Cholesterol levels may rise again if treatment with Crestor is stopped.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
It is important for the patient to be aware of which adverse reactions may occur. Usually, they are
mild and resolve shortly after starting treatment.
You must stop taking Crestor immediately and seek medical help if the following allergic
reactions occur:

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 swallowing;
severe skin itching (with hives);
red, flat, disc-shaped or round spots on the trunk, often with blisters in the center, peeling of the skin, mouth ulcers, ulcers in the throat, nose, genitals, and around the eyes. Such severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome);
widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

You must stop taking Crestor and contact your doctor immediately if the following occur:

muscle pain or other muscle-related symptoms that persist longer than expected. Muscle-related 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, this has led to potentially life-threatening muscle damage (rhabdomyolysis);
muscle rupture;
symptoms of lupus-like syndrome (such as rash, joint disorders, and hematological changes).

Adverse reactions occurring frequently (in more than 1 in 100 but less than 1 in 10 patients)

Headache, abdominal pain, constipation, nausea, muscle pain, fatigue, dizziness.
Increased protein in urine. This symptom usually resolves spontaneously and does not require discontinuation of Crestor (applies only to the 40 mg dose).
Diabetes. The likelihood of developing diabetes is higher if the patient has high blood sugar and lipid levels, overweight, and high blood pressure. The treating physician will monitor patients at risk during treatment with this medicine.

Adverse reactions occurring uncommonly (in more than 1 in 1,000 but less than 1 in 100 patients)

Rash, itching, or other skin reactions.
Increased protein in urine. This symptom usually resolves spontaneously and does not require discontinuation of Crestor (applies only to the 5 mg, 10 mg, and 20 mg doses).

Adverse reactions occurring rarely (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 skin itching (with hives). If a patient suspects an allergic reaction, they must immediately stop taking Crestor and seek medical help.
Muscle damage in adults – exercise caution, i.e., stop taking Crestor and contact your doctor immediately if muscle pain or other muscle-related symptoms persist longer than expected.
Severe abdominal pain (pancreatitis).
Increased liver enzyme levels in blood.
Increased tendency to bleed or bruise due to low platelet count.
Symptoms of lupus-like syndrome (such as rash, joint disorders, and hematological changes).

Adverse reactions occurring very rarely (in less than 1 in 10,000 patients)

Jaundice (yellowing of the skin and eyes), hepatitis, blood in urine, nerve damage in upper and lower limbs (felt as numbness), joint pain, memory loss, breast enlargement in men (gynecomastia).

Adverse reactions with unknown frequency include:

Diarrhea (loose stools), cough, shallow breathing, swelling, sleep disturbances (insomnia and nightmares), sexual dysfunction, depression, breathing problems (persistent cough and/or shallow breathing or fever), tendon damage, persistent muscle weakness.
Myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing), ocular myasthenia (a disease causing weakness of eye muscles). You should speak with your doctor if you experience weakness in hands or legs that worsens with activity, double vision or drooping eyelids, difficulty swallowing, or shortness of breath.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, you should inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Reporting adverse reactions helps to collect more information on the safety of this medicine.

5. How to store Crestor

Store below 30°C. Keep in the original packaging to protect from moisture.
Keep the medicine out of the 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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Crestor contains
The active substance is rosuvastatin. Each coated tablet contains 20 mg of rosuvastatin in the form of rosuvastatin calcium.
Other ingredients are monohydrate lactose, microcrystalline cellulose, calcium phosphate, crospovidone, magnesium stearate, hypromellose, triacetin, titanium dioxide (E 171), and red iron oxide (E 172).

What Crestor looks like and contents of the pack
Crestor is available in blisters within a cardboard box containing 30 tablets.
Crestor 20 mg are pink, round, film-coated tablets marked with "ZD4522" and "20" on one side, the other side being smooth.

For more detailed information, please contact the responsible party or the parallel importer.

Responsible party in the Netherlands, country of export:
Grünenthal B.V.
De Corridor 21K
3621 ZA Breukelen
The 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 in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Authorisation number in the Netherlands, country of export: RVG 26873
Parallel import authorisation number: 173/25

This medicinal product is authorised for sale in the European Economic Area countries under the following names:
Crestor 20 mg (NL, AT, BE, DE, DK, GR, ES, FI, FR, IS, IE, IT, LU, NO, PL, PT, SE)