Crestor

Leaflet accompanying the packaging: patient information

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

Crestor, 5 mg, film-coated tablets

Rosuvastatinum

It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any further doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person.It should not be given to others. The medicine 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 doctor, pharmacist, or nurse should be informed. 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. Package contents 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 because diet changes and increased physical activity have been insufficient to achieve normal cholesterol levels in the blood. The 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.

Heart attack, stroke, and other problems can be caused by atherosclerosis of the arteries. Atherosclerosis is the result of the deposition of atherosclerotic plaques in 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. 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 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, fatty deposits accumulate in the walls of blood vessels and narrow them. Sometimes, a narrowed blood vessel may become blocked, disrupting blood flow to the heart or brain, and resulting in 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, it should still

be taken. This prevents the cholesterol level from rising again, which causes the accumulation of fatty substances. The use of Crestor should be stopped if the doctor so advises or if the patient becomes 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,
• ,
• ,
• ,

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• (a medicine used, for example, after organ transplantation),
• if the patient has ever had a severe skin rash or peeling of the skin, blisters, and (or) ulcers in the mouth after taking Crestor or other similar medicines.

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

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

• (in case of doubts, the doctor should be consulted),
• ,
• , if the patient or their family members have had muscle diseases or have had muscle disorders while taking cholesterol-lowering medicines,
• ,
• (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian),
• , i.e., other cholesterol-lowering medicines.

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

Warnings and precautions

Before starting to take Crestor, the patient should consult their doctor or pharmacist:

• ,
• ,
• , or if the patient or their family members have had muscle diseases or have had muscle disorders while taking cholesterol-lowering medicines. The patient should contact their doctor immediately if they experience muscle pain or weakness of unknown origin, especially if accompanied by general malaise and fever. The patient should also inform their doctor if they experience persistent muscle weakness,
• ,
• ,
• . The patient should read the leaflet carefully, even if they have taken other cholesterol-lowering medicines before,
• , e.g., ritonavir with lopinavir and (or) atazanavir, the patient should read the information in the section: "Other medicines and Crestor",
• (a medicine used to treat bacterial infections). Taking fusidic acid at the same time as Crestor may lead to severe muscle damage (rhabdomyolysis); see the section "Other medicines and Crestor",
• (because the doctor must choose the appropriate initial dose of Crestor for the patient),
• ,
• (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 the patient has doubts):

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

In a small group of patients, statin medicines may affect liver function. To confirm such an 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 medicine. Patients with high blood sugar and fat levels, overweight, and high blood pressure may be at risk of developing diabetes. With the use of Crestor, severe skin reactions, including Stevens-Johnson syndrome and drug rash with eosinophilia and systemic symptoms (DRESS), have been reported. If any of the symptoms described in section 4 occur, the patient should stop taking Crestor and contact 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 medicines and Crestor

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

• cyclosporin (used, for example, after organ transplantation),
• warfarin or clopidogrel (or any other blood-thinning medicine),
• a fibrate medicine (such as gemfibrozil, fenofibrate) or any other cholesterol-lowering medicine (e.g., ezetimibe),
• medicines 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),
• hormone replacement therapy,
• any of the following medicines used to treat viral infections, including HIV or hepatitis C virus infection, given alone or in combination with other medicines (see "Warnings and precautions"): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir,
• blood-thinning medicines, e.g., warfarin, acenocoumarol, or fluindione (their blood-thinning effect and risk of bleeding may be increased when taken 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, they should temporarily stop taking Crestor. The doctor will inform the patient when they 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.

Crestor should not be takenduring pregnancy or breastfeeding. If the patient becomes pregnant while taking Crestor, they should stop taking it immediately and contact their doctor. While taking Crestor, the patient should avoid pregnancy and use effective methods of contraception. Before taking any medicine, the patient should consult their 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, the patient should contact their doctor before driving a vehicle or operating machines.

Crestor contains lactose monohydrate

If the patient has been found to be intolerant to some sugars (lactose, i.e., milk sugar), they should inform their doctor before taking Crestor. A full list of excipients is included in the section: "Package contents and other information".

3. How to take Crestor

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist. Crestor is available in the following doses: 5 mg, 10 mg, 20 mg, 40 mg.

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 taken higher doses of other statins before. 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 muscle diseases (myopathy).

Increasing the dose and maximum daily dose

The doctor may decide to increase the dose so that it is suitable for 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, 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, 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, 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 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 5 to 20 mg once daily. The usual initial dose is 5 mg once daily, and the doctor may gradually increase the dose so that it is suitable 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 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 to make it easier to remember.

Cholesterol checks

To ensure that cholesterol levels have decreased and are normal, regular check-ups and blood tests should be performed. The doctor may decide to increase the dose of Crestor so that it is suitable for 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 contact their doctor or go to the nearest hospital. If the patient is in the hospital or is 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 Crestor treatment

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

4. Possible side effects

Like all medicines, Crestor can cause side effects, although not everybody gets them. It is essential for the patient to know which side effects can occur. They are usually mild and disappear shortly after starting treatment. The patient should stop taking Crestor immediately and seek medical helpif 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 lumps),
• red, flat, plate-like, or round patches on the torso, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes. The occurrence of this type of severe skin rash may 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 contact their doctor immediately if they 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 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 disappears on its own and does not require stopping Crestor (only for 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 doctor will monitor patients at risk while they are 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 disappears on its own and does not require stopping Crestor (for 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 lumps). If the patient suspects an allergic reaction, they should stop taking Crestor immediately and seek medical help.
• Muscle damage in adults, the patient should stop taking Crestor and contact their doctor immediately if they 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 disturbances (insomnia and nightmares), sexual dysfunction, depression, breathing problems (persistent cough and (or) shortness of breath or fever), tendon damage, persistent muscle weakness.

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should inform their 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, more information can be collected on the safety of the medicine.

5. How to store Crestor

• Do not store above 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 month stated.
• Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Crestor contains

The active substance of Crestor is rosuvastatin. Each film-coated tablet contains 5 mg of rosuvastatin in the form of rosuvastatin calcium. Other ingredients of Crestor are lactose monohydrate, microcrystalline cellulose, calcium phosphate, crospovidone, magnesium stearate, hypromellose, triacetin, titanium dioxide (E 171), yellow iron oxide (E 172).

What Crestor looks like and contents of the pack

Crestor, blisters in a cardboard box containing 28 tablets. The package contains yellow, round tablets marked "ZD4522" and "5" on one side, the other side is smooth. For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Spain, the country of export:

AstraZeneca Farmacéutica Spain, S.A. C/ Serrano Galvache, 56 - Edificio Álamo 28033 Madrid Spain

Manufacturer:

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

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 Authorization number in Spain, the country of export: 661858.5

Parallel import authorization number: 8/21

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, IC, IE, IT, LU, MT, NO, PL, PT, SE, UK) and 5 mg, 10 mg, and 20 mg (DE, ES, FR).

Translation of day symbols on the packaging:

lun

• Monday mar
• Tuesday mié
• Wednesday jue
• Thursday vie
• Friday sáb
• Saturday dom
• Sunday

Date of leaflet approval: 14.01.2022
[Information about the trademark]