Crestor

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE USER

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!

Crestor

10 mg, coated tablets

Rosuvastatinum

You should carefully read the contents of the leaflet before using 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 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 prescribed 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 blockage of the 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, and 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, you should consult a 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 discomfort or pain of unknown origin, especially if it is 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 myasthenic ophthalmia (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),
• ,
• ,
• . 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",
• (a medicine used to treat bacterial infections). Taking fusidic acid at the same time as Crestor can lead to severe muscle damage (rhabdomyolysis); see section "Other medicines and Crestor",
• (because the doctor must choose the appropriate initial dose of Crestor for the patient),
• ,
• (Japanese, Chinese, Filipino, Vietnamese, Korean, and 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 under close medical supervision 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.
Severe skin reactions, including Stevens-Johnson syndrome and drug rash with eosinophilia and systemic symptoms (DRESS), have been reported with Crestor. If any of the symptoms described in section 4 occur, you should 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

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 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,
• fosfomycin (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, alone or in combination with other medicines (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 transthyretin amyloidosis),
• 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 change the effect of these medicines or these medicines may change the effect 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.

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, 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, the patient should contact their doctor before driving or operating machines.

Crestor contains lactose monohydrate

If the patient has been found to have 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 pack 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: 5 mg, 10 mg, 20 mg, and 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 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 side effects.

You should 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 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, 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 mentioned 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

The tablet should be swallowed 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, you should regularly visit your doctor 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

If you have taken a higher dose of Crestor than recommended, you should contact 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 the patient to know which side effects can occur. Usually, they are mild and disappear shortly after starting treatment.
You should stop taking Crestor and seek medical help immediatelyif you experience any of the following allergic reactions:

• difficulty breathing with swelling of the face, lips, tongue, and (or) throat, 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 or hypersensitivity syndrome).

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

• muscle pain or other muscle discomfortthat lasts 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 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 (only applies 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 treating 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 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 and seek medical help immediately

Crestor and seek medical help.

• Muscle damage in adults, you should be cautious, i.e., stop taking Crestor and contact your doctor immediately if you experience muscle pain or other muscle discomfortthat lasts 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), myasthenic ophthalmia (a disease that causes muscle weakness in the eyes). 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 or pharmacist. 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

• Do not store above 30°C. Store in the original package 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 package. The expiry date refers to the last day of the month stated.
• 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 pack and other information

What Crestor contains

The active substance of Crestor is rosuvastatin. Each coated tablet contains 10 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 contents of the pack

Crestor, Al/Al blisters in a cardboard box containing 14, 28 tablets.
Crestor, 10 mg coated tablets, pink, round tablets marked "ZD4522" and "10" 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 Spain, the country of export:

Grünenthal GmbH
Zieglerstraße 6
52078 Aachen
Germany

Manufacturer:

AstraZeneca UK Ltd.
Silk Road Business Park
Macclesfield
Cheshire, SK10 2NA
United Kingdom
AstraZeneca Reims Production
Parc industriel de la Pompelle
Chemin de Vrilly
REIMS, 51100
France
Grünenthal GmbH
Zieglerstraße 6
52078 Aachen
Germany

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3

91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Crestor 10 mg (NL, AT, BE, DK, GR, FI, IC, IE, IT, LU, MT, NO, PL, PT, SE, UK, DE, ES, FR).
Marketing authorization number in Spain, the country of export: 661872.1
Parallel import authorization number: 303/23

Translation of day-of-the-week symbols on the packaging:

lun – Monday
mar – Tuesday
mié – Wednesday
jue – Thursday
vie – Friday
sáb – Saturday
dom - Sunday

Date of leaflet approval: 25.06.2024

[Information about the trademark]