Crestor

Leaflet accompanying the packaging: patient information

Crestor, 5 mg, film-coated tablets

Crestor, 10 mg, film-coated tablets

Crestor, 20 mg, film-coated tablets

Crestor, 40 mg, film-coated tablets

Rosuvastatin

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• Consult your doctor or pharmacist if you have any further questions.
• 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 as yours.
• If you experience any side effects, including those not listed in the leaflet, tell your 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 pack 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 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 of the arteries 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, it leads to the deposition of fatty substance 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 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 Crestor 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,
• ,
• ,
• ,
• (a medicine 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 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 doubt, ask your doctor),
• ,
• , if the patient or their family members have had muscle diseases or previously experienced 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 treatment with Crestor, consult your doctor or pharmacist,

• ,
• ,
• , or if the patient or their family members have had muscle diseases or previously experienced 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. They should also inform their doctor if they 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 muscle weakness in the eyes), as statins can sometimes exacerbate the symptoms of the disease or lead to the development of myasthenia (see section 4),
• ,
• ,
• . Read the leaflet carefully, even if the patient has previously taken other cholesterol-lowering medicines,
• , e.g., ritonavir with lopinavir and (or) atazanavir, see the information in the section "Other medicines and Crestor".
• (a medicine 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 the doctor must choose an 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, statins 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.
People with diabetes or those at risk of developing diabetes will be closely monitored by their doctor while taking this medicine. People who have high sugar and fat levels in the blood, are overweight, and have high blood pressure may be at risk of developing diabetes.
During treatment with 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, stop taking Crestor and contact your doctor 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.

Other medicines and Crestor

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.
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 fibrate (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),
• camptothecin (used to treat cancer),
• hormone replacement therapy,
• fostamatinib (used to treat low platelet count),
• febuxostat (used to treat and prevent high levels of uric acid 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 infection, given alone or in combination with other medicines (see Warnings and precautions): ritonavir, lopinavir, atazanavir, sofosbuvir, velpatasvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir,
• blood-thinning medicines, e.g., warfarin, acenocoumarol, or fluindion (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 on 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 contact her doctor. While taking Crestor, women should avoid becoming pregnant and use effective methods of contraception.
Before taking any medicine, consult your 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 experience dizziness while taking Crestor. If this symptom occurs, the patient should contact their doctor before driving or operating machines.
Crestor contains lactose.
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 can be found in the section: Contents of the pack and other information.

3. How to take Crestor

Take this medicine always as directed by your doctor. In case of doubt, consult your 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.

Ask your doctor which initial dose of Crestor is most suitable for you.
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 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, 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 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 to suit 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

Swallow the tablet whole with 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 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, consult a doctor or go to the nearest hospital.
If the patient is in the hospital or is being treated for another disease, they should inform their doctor or other medical staff that they 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 treatment with Crestor

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, 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 the patient to know which side effects can occur. They are usually mild and disappear shortly after starting treatment.
Stop taking Crestor and seek medical help immediatelyif the following allergic reactions occur:

• 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 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).

Stop taking Crestor and contact your doctor immediately if the following occur:

• 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, in very rare cases, Crestor can cause adverse effects on muscles. Rarely, these patients have experienced potentially life-threatening muscle damage (rhabdomyolysis).
• muscle rupture
• symptoms of 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 sugar and fat levels in the blood, 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 resolves on its own and does not require stopping Crestor (applies only 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 and seek medical help immediately.
• Muscle damage in adults, so stop taking Crestor and contact your doctor immediately if you 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 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 muscle weakness in the eyes). The patient should discuss with their doctor if they experience muscle weakness in their hands or feet, 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, tell your 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, tel.: +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 its representative.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Crestor

• Blister packs: store in a temperature below 30°C. The medicine should be stored in its original packaging to protect it from moisture.
• Bottles: store in a temperature below 30°C. The bottle should be tightly closed to protect it 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 carton/blister/label after EXP. The expiry date refers to the last day of the month stated.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack 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 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin.
Other ingredients of Crestor are lactose monohydrate, microcrystalline cellulose, calcium phosphate, crospovidone, magnesium stearate, hypromellose, triacetin, titanium dioxide (E171). Crestor 10 mg, 20 mg, and 40 mg tablets also contain iron oxide red (E172). Crestor 5 mg tablets also contain iron oxide yellow (E172).

What Crestor looks like and contents of the pack

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

• Crestor, 5 mg, film-coated tablets, yellow, round tablets marked "ZD4522" and "5" on one side, the other side smooth
• Crestor, 10 mg, film-coated tablets, pink, round tablets marked "ZD4522" and "10" on one side, the other side smooth
• Crestor, 20 mg, film-coated tablets, pink, round tablets marked "ZD4522" and "20" on one side, the other side smooth
• Crestor, 40 mg, film-coated tablets, pink, oval tablets marked "ZD4522" on one side and "40" on the other side

Marketing authorization holder

AstraZeneca AB
S-151 85 Södertälje
Sweden

Manufacturer

AstraZeneca AB
S-151 85 Södertälje
Sweden
AstraZeneca UK Ltd.
Silk Road Business Park
Macclesfield
Cheshire SK10 2NA
United Kingdom
AstraZeneca Reims Production
Parc industriel de la Pompelle
Chemin de Vrilly
51100 Reims
France
Tel.: +33 3266 16868
Grünenthal GmbH
Zieglerstraße 6
52078 Aachen
Germany
Tel.: +49 (0) 241 569 0
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).
For more information, contact the representative of the marketing authorization holder:
AstraZeneca Pharma Poland Sp. z o.o.
ul. Postępu 14
02-676 Warsaw
tel: +48 22 245 73 00
fax: +48 22 485 30 07
Date of last revision of the leaflet:March 2023