Crestor

Package leaflet: Information for the user

Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
Crestor, 20 mg, coated tablets
Rosuvastatinum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• 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 other people, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet:

1. What Crestor is and what it is 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 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.
• Your 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.

or

• Crestor may also be 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 complications may result from atherosclerosis. Atherosclerosis
is caused by the buildup of atherosclerotic plaques in blood vessels.
Why is it 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: so-called "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 or changes in well-being. However, if left untreated, fatty deposits can accumulate in the walls of blood vessels, leading to their narrowing.
Sometimes, a narrowed blood vessel may become completely blocked, interrupting blood flow to the heart or brain, which may result in a heart attack or stroke. Achieving normal blood cholesterol levels reduces the risk of heart attack, stroke, or similar conditions.
Even if cholesterol levels return to normal after using Crestor, you must continue taking it. This prevents cholesterol levels from rising again, which could lead to further accumulation of fatty deposits. You should stop taking Crestor 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 is allergic (hypersensitive) 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 taking Crestor should use effective methods of contraception,
• if the patient has liver disease,
• if the patient has severe kidney disease,
• if the patient has frequent or unexplained muscle pain or discomfort,
• if the patient is taking the combination 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 ever developed a severe skin rash, skin peeling, blisters and/or mouth 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,
the patient 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 has frequent or unexplained muscle pain or discomfort, or if the patient or family members have a history of muscle disorders, or if the patient 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, and Indian),
• if the patient is taking medicines from the fibrate group, i.e. other medicines that lower cholesterol levels.

If any of the above situations apply to the patient (or if the patient has any doubts),
the patient should contact their doctor again.
Warnings and precautions
Before starting Crestor, consult a doctor or pharmacist:

• if the patient has kidney disease,
• if the patient has liver disease,
• if the patient has frequent or unexplained muscle pain or discomfort, or if the patient or family members have 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 experience unexplained muscle pain or discomfort, especially if accompanied by general malaise or fever. The doctor should also be informed if persistent muscle weakness occurs,
• if the patient has or has had myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease causing weakness of eye muscles), because statins may sometimes worsen symptoms 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 fibrates, a group of cholesterol-lowering medicines. Read the leaflet carefully, even if the patient has previously taken other cholesterol-lowering medicines,
• if the patient is taking medicines used to treat HIV infection, e.g., ritonavir with lopinavir and/or atazanavir; please refer to the section: "Other medicines and Crestor",
• if the patient is currently taking or has taken within the last 7 days an oral or injectable medicine containing fusidic acid (a medicine used for bacterial infections). Taking fusidic acid together with Crestor may lead to severe muscle damage (rhabdomyolysis); see section "Other medicines and Crestor",
• if the patient is over 70 years of age (because the doctor must determine the appropriate starting dose of Crestor),
• if the patient has severe respiratory insufficiency,
• if the patient is of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, and Indian). For 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):

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

In a small number of patients, statins may affect liver function. To confirm such an effect, a blood test checking liver enzyme activity is performed. Usually, the doctor will recommend checking liver enzyme activity 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 risk of developing diabetes.
Serious skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with the use of Crestor. If any of the symptoms described in section 4 occur, stop taking Crestor and contact a doctor immediately.
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 suitable for use in children and adolescents under 18 years of age.

Other medicines and Crestor
Tell your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
Inform your doctor if the patient is taking:

• cyclosporine (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 medicine that lowers blood cholesterol levels (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 medicines used to treat viral infections, including HIV or hepatitis C virus, administered alone or in combination with other medicines (see: Warnings and precautions): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir,
• anticoagulant medicines such as warfarin, acenocoumarol or fluindione (their blood-thinning effect and risk of bleeding may be increased when taken together with this medicine), ticagrelor or clopidogrel. Crestor may alter the effect of these medicines or these medicines may alter the effect of Crestor.

If the patient needs to take oral fusidic acid to treat a bacterial infection,
Crestor should be temporarily discontinued. The doctor will inform the patient when it is safe to restart Crestor.
Taking Crestor with fusidic acid may 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 used during pregnancy or while breastfeeding. If a woman becomes pregnant while taking Crestor, she should immediately stop taking Crestor and contact her doctor. While taking Crestor, pregnancy should be avoided and effective contraception methods should be used.
Before taking any medicine, consult a doctor or pharmacist.
Driving and operating machinery
Most people can drive and operate machinery while taking Crestor – it will not impair their abilities. However, some patients may experience dizziness during treatment with Crestor. If this symptom 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 complete 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 as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
Crestor is available in the following doses: 5 mg, 10 mg, 20 mg, 40 mg.
Adults
Use of Crestor to lower cholesterol levels
Starting dose
Treatment should begin with a dose of 5 mg or 10 mg, even if the patient previously used
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 the patient.
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 moderately severe kidney disease,
• the patient is at risk of developing muscle disorders and muscle pain (myopathy).

Dose escalation and maximum daily dose
Your doctor may decide to increase the dose to suit the patient's needs.
If the patient started treatment at 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 at 10 mg, the doctor may decide to increase it to 20 mg, then to 40 mg, if necessary. The treatment period at a given dose between each dose increase is 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 use in children and adolescents aged 6 to 17 years is 5 to 20 mg once
daily. The usual starting dose is typically 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 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
Swallow the tablet 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.
Cholesterol monitoring tests
To ensure that cholesterol levels have decreased and are within the normal range, regular
check-ups and blood tests should be performed.
Your doctor may decide to increase the dose of Crestor to suit the patient's needs.
Taking more than the recommended dose of Crestor
If more than the recommended dose of Crestor has been taken, contact your doctor or go to
the nearest hospital immediately.
If the patient is in hospital or is being treated for another illness, they should inform the
doctor or medical staff about 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 the patient wishes 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 will experience them.
It is important for the patient to know which adverse reactions may occur. Usually they are
mild and resolve shortly after starting treatment.
The patient 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 lumps);
• Red, flat, disc-shaped or round patches on the trunk, often with blisters in the center, peeling of the skin, mouth ulcers, and ulcers in the throat, nose, genital organs and around the eyes. Such potentially life-threatening skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome);
• Widespread rash, high fever and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

The patient must stop taking Crestor and contact a 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 very small number of patients have experienced adverse effects on muscles. Rarely, these patients developed potentially life-threatening muscle damage (rhabdomyolysis);
• Muscle rupture;
• Symptoms of lupus-like syndrome (such as rash, joint disorders and hematological changes).

Common adverse reactions (occurring 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 (occurs only with the 40 mg dose).
• Diabetes. The risk 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 while taking this medicine.

Uncommon adverse reactions (occurring in more than 1 in 1000 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 (occurs only with the 5 mg, 10 mg and 20 mg doses).

Rare adverse reactions (occurring in more than 1 in 10,000 but less than 1 in 1000 patients)

• Severe allergic reactions – symptoms include swelling of the face, lips, tongue and (or) throat, difficulty swallowing and breathing, severe skin itching (with lumps). If the patient suspects an allergic reaction, they must immediately stop taking Crestor and seek medical help.
• Muscle damage in adults – caution is advised; stop taking Crestor and contact a 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 bleeding or bruising due to low platelet count.
• Lupus-like syndrome symptoms (such as rash, joint disorders and hematological changes).

Very rare adverse reactions (occurring in less than 1 in 10,000 patients)

• Jaundice (yellowing of the skin and eyes), hepatitis, blood in urine, damage to nerves 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 the eye muscles). The patient should talk to a doctor if they experience weakness in hands or legs worsening with activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath.

Reporting of adverse reactions
If any adverse symptoms occur, including any not listed in this leaflet, the patient should inform their doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of 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 the medicine 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 stated 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. Crestor film-coated tablets contain rosuvastatin calcium in a dose corresponding to 20 mg of rosuvastatin.
Other ingredients in the medicine are monohydrate lactose, microcrystalline cellulose, calcium phosphate, crospovidone, magnesium stearate in the tablet core; monohydrate lactose, hypromellose, triacetin, titanium dioxide (E 171), iron oxide red (E 172) in the coating.

What Crestor looks like and contents of the pack
Crestor 20 mg are pink, round film-coated tablets marked with "ZD4522" and "20" on one side, the other side is smooth.
The pack contains 14 or 28 tablets in blisters packed in a cardboard box.

For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation holder in Belgium, country of export:
Grünenthal nv/sa
Lenneke Marelaan 8
1932 St-Stevens-Woluwe
Belgium

Manufacturer:
Grünenthal GmbH
Zieglerstraße 6, 52078 Aachen, Germany
AstraZeneca UK Ltd.
Silk Road Business Park, Macclesfield, Cheshire, SK10 2NA, United Kingdom
AstraZeneca Reims Production
Parc Industriel Pompelle, Chemin de Vrilly, Reims 51100, France
AstraZeneca AB
Gärtunavägen, S-151 85 Södertälje, Sweden

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

Marketing authorisation number in Belgium, country of export: BE250223
Parallel import authorisation number: 394/21

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

Translation of weekday symbols printed next to each tablet on the immediate packaging:
Ma, Lu, Mo - Monday
Di, Ma, Di - Tuesday
Wo, Me, Mi - Wednesday
Do, Je, Do - Thursday
Vr, Ve, Fr - Friday
Za, Sa, Sa - Saturday
Zo, Di, So - Sunday