Crestor

Leaflet accompanying the packaging: patient information

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

Crestor, 10 mg, film-coated tablets

Rosuvastatinum

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

• The leaflet should be kept so that it can be read again if necessary.
• In case of any further doubts, the patient should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for this patient.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 patient should tell their 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 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 regularly.

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 essential 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 remove "bad" cholesterol from the blood.

In most people, high cholesterol levels do not change their well-being because 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 can become blocked, disrupting blood flow to the heart or brain, and consequently leading 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, the patient should

continue taking it. This prevents the cholesterol level from increasing again, which can lead to the accumulation of fatty substances. The patient should stop taking Crestor if the doctor recommends it or if the patient becomes pregnant.

2. Important information before taking Crestor

When not to take Crestor:

• If the patient has been found to be hypersensitive (allergic) to rosuvastatinor any of the other ingredients of Crestor,
• If the patient is pregnantor 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 to prevent pregnancy,
• If the patient has liver disease,
• If the patient has severe kidney disease,
• If the patient experiences frequent or unexplained muscle pain or weakness,
• if the patient is taking a combination of sofosbuvir/velpatasvir/voxilaprevir (used to treat hepatitis C virus infection)

Warnings and precautions

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

• If the patient has kidney disease,
• If the patient has liver disease,
• If the patient experiences frequent or unexplained muscle pain or weakness, or if the patient or their family members have had muscle diseases in the past, or if the patient has 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,
• If the patient has or has had myasthenia (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),
• If the patient regularly consumes large amounts of alcohol,
• If the patient has thyroid disease,
• If the patient is taking cholesterol-lowering medicines from the fibrate group. The patient should read the leaflet carefully, even if they have taken other cholesterol-lowering medicines before,
• If the patient is taking medicines used to treat HIV infection, e.g., ritonavir with lopinavir and/or atazanavir, the patient should refer to the information in the section: "Other medicines and Crestor",
• If the patient is taking or has taken within the last 7 days an oral or injectable medicine containing fusidic acid (an antibiotic). Taking fusidic acid with Crestor can lead to severe muscle damage (rhabdomyolysis); see the section "Other medicines and Crestor",
• If the patient is over 70 years old(as the doctor will need to choose the appropriate initial dose of Crestor for the patient),
• If the patient has severe respiratory failure,
• If the patient is of Asian origin(Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). In 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):

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

In a small group of patients, statin medicines 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. 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. 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, the patient should stop taking Crestor and consult 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, clopidogrel, or ticagrelor (or any other blood-thinning medicine),
• a fibrate medicine (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 infection, given 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 condition called transthyretin amyloidosis),
• blood-thinning medicines, e.g., warfarin, acenocoumarol, or fluindione (their blood-thinning effect and the risk of bleeding may be increased when taken with Crestor), 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.

Crestor should not be takenduring pregnancy or breastfeeding. If the patient becomes pregnant while taking Crestor, they should stop taking it immediately and consult their doctor. While taking Crestor, the patient should avoid becoming pregnant and use effective methods to prevent pregnancy. 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 consult their doctor before driving a vehicle or operating machinery.

Crestor contains lactose monohydrate

If the patient has been found to be intolerant to some sugars (lactose, or milk sugar), they should inform their doctor before taking Crestor. A full list of excipients is found in the section: Contents of the pack and other information. The patient can also ask their pharmacist for this information.

3. How to take Crestor

This medicine should always be taken exactly as the doctor has instructed. If the patient is unsure, they should consult their doctor or pharmacist. Crestor is available in the following strengths: 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 the patient having a heart attack or stroke,
• the presence of factors that increase the patient's susceptibility to side 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 starts 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 starts 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, 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's 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 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 help remember it.

Cholesterol checks

To ensure that cholesterol levels have decreased and are normal, the patient should regularly attend check-ups 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 the patient has taken a higher dose of Crestor than recommended, they should consult their doctor or go to the nearest hospital. If the patient is in the hospital or 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 treatment with Crestor

The patient should tell their doctor if they want to stop taking Crestor. Cholesterol levels may increase again if treatment with Crestor is stopped. If the patient has any further doubts about taking this medicine, they 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 what 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 skin, 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 fever, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

The patient should stop taking Crestor and consult their doctor immediately if they experience:

• 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, 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 disease, 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 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 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 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 they have had an allergic reaction, they should stop taking Crestor immediately and seek medical help.
• Muscle damage in adults, the patient should exercise caution, i.e., stop taking Crestor and consult their doctor immediately if they 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 bruising due to low platelet count.
• Symptoms of a lupus-like syndrome (such as rash, joint disease, 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 to 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, shallow breathing, swelling, sleep disturbances (insomnia and nightmares), sexual dysfunction, depression, breathing difficulties (persistent cough and/or shallow breathing 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). The patient should talk to their doctor if they experience weakness in their arms or legs, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. 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 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 they no longer use. 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 film-coated tablet contains 10 mg of rosuvastatin in the form of rosuvastatin calcium. The other ingredients of Crestor 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 is available in blisters in a cardboard box containing 28 tablets. The contents of the pack are pink, round tablets marked "ZD4522" and "10" on one side, and the other side is smooth.

Marketing authorization holder in Spain, the country of export:

Grünenthal GmbH, Zieglerstraße 6, 52078 Aachen, Germany

Manufacturer:

AstraZeneca Reims Production, Parc industriel de la Pompelle, Chemin de Vrilly, 51100 Reims, France Grünenthal GmbH, Zieglerstraße 6, 52078 Aachen, Germany AstraZeneca AB, S-152 57, Södertälje, Sweden

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

Marketing authorization number in Spain, the country of export: 661872.1

This medicinal product is authorized in the Member States of the European Economic Area under the following names: Crestor 10 mg (NL, AT, BE, DE, DK, GR, ES, FI, FR, IS, IE, IT, LU, PL, NO, PT, SE, UK)

Translation of the days of the week symbols on the blister pack:

lun

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

Date of leaflet approval: 17.12.2024

[Information about the trademark]