Crestor

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep this leaflet, information on the outer packaging in a foreign language!
Crestor
20 mg, coated tablets
Rosuvastatin
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• 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 another person, even if their symptoms are the same.
• If any side effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

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 for use 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.
• The doctor has recommended taking a statin because dietary changes and increased physical activity have not been sufficient to achieve normal cholesterol levels in the blood. Patients taking Crestor should also follow a cholesterol-lowering diet and engage in regular physical exercise.

or

• Crestor is also 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 related problems may be caused by atherosclerosis.
Atherosclerosis results from the buildup of atherosclerotic plaques in blood vessels.
Why it is 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, known as "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 affect how they feel, as it causes no symptoms. However, if untreated, fatty deposits build up in the walls of blood vessels, leading to narrowing.
Sometimes, a narrowed blood vessel may become completely blocked, interrupting blood flow to the heart or brain, resulting in a heart attack or stroke. Achieving normal cholesterol levels reduces the risk of heart attack, stroke, or similar conditions.
Even if cholesterol levels become normal after using Crestor, continue taking it. This prevents cholesterol levels from rising again, which could lead to further fatty deposits. You should stop taking the medicine 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 it 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 experiences frequent or unexplained muscle pain or discomfort,
• if the patient is taking the combination of sofosbuvir/velpatasvir/voxilaprevir (used in the treatment of viral hepatitis C),
• if the patient is taking cyclosporine (a medicine used, for example, after organ transplantation),
• if the patient has previously experienced severe skin rash, skin peeling, blisters and/or oral 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 experiences frequent or unexplained muscle pain or discomfort, or if the patient or their 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 cholesterol-lowering 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.
Warnings and precautions

Before starting treatment with Crestor, 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 discomfort, or if the patient or their family has 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 and fever. The doctor should also be informed if persistent muscle weakness occurs,
• if the patient has or has had myasthenia gravis (a disease causing general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease causing weakness of eye muscles), as 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, other cholesterol-lowering medicines. Read the package 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 taking or has taken within the last 7 days, orally or by injection, a medicine containing fusidic acid (a medicine used for bacterial infections). Concomitant use of fusidic acid with Crestor may lead to severe muscle damage (rhabdomyolysis); see section "Other medicines and Crestor",
• if the patient is over 70 years of age (as the doctor must select an appropriate starting dose of Crestor),
• if the patient has severe respiratory failure,
• if the patient is of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, and Indian). The doctor will determine the appropriate starting dose of Crestor for these patients.

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, consult a doctor or pharmacist.

In a small number of patients, statins may affect liver function. To confirm this effect, blood tests are performed to check liver enzyme activity. 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 increased risk of developing diabetes.
Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during treatment with Crestor. If any of the symptoms described in section 4 occur, treatment with Crestor should be stopped immediately and the patient should contact their doctor without delay.
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 you are currently taking, have recently taken, or plan to take.
Inform your doctor if you are 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 (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 in cancer treatment),
• darolutamide (used in cancer treatment),
• capmatinib (used in cancer treatment),
• hormone replacement therapy,
• fostamatinib (used in the treatment of low platelet count),
• febuxostat (used in the treatment and prevention of high blood uric acid levels),
• teriflunomide (used in the treatment of 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 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 a disease called transthyretin amyloidosis),
• 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 for a bacterial infection,
Crestor should be temporarily discontinued. The doctor will inform the patient when it is safe to restart
Crestor. Concomitant use of 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 the patient becomes pregnant while taking Crestor, treatment should be stopped immediately and the patient should contact their 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 monohydrate lactose.
If the patient has been diagnosed with 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 exactly 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 be initiated with a dose of 5 mg or 10 mg, even if the patient has previously
taken 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 you.
Your doctor may decide to start treatment with a 5 mg 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 moderate kidney impairment,
• the patient is at risk of developing muscle disorders or muscle pain (myopathy).

Dose escalation and maximum daily dose
Your doctor may decide to increase the dose as appropriate for the patient's needs.
If treatment was initiated with a 5 mg dose, your doctor may decide to increase it to 10 mg, then to 20 mg or 40 mg, if necessary. If treatment was initiated with a 10 mg dose, your doctor may decide to increase it to 20 mg, then to 40 mg, if necessary. The treatment period with a given dose between each dose increase should be 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 the dose if any of the factors described above are present.
Use in children and adolescents aged 6-17 years
The dose range for children and adolescents aged 6 to 17 years is 5 to 20 mg once daily. The usual starting dose is 5 mg once daily, and your doctor may gradually increase the dose as appropriate for the patient. The maximum daily dose of Crestor in children and adolescents aged 6 to 17 years is 10 mg or 20 mg, depending on the condition being treated.
Crestor should be taken once daily. Crestor 40 mg should not be used in children.
How to take the medicine
The tablet should be swallowed 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 remain within the target range, regular check-ups and blood tests are necessary.
Your doctor may decide to increase the dose of Crestor as appropriate for the patient.
Accidentally taking more Crestor than prescribed
If you have taken more Crestor than prescribed, contact your doctor or go to the nearest hospital immediately.
If you are in hospital or being treated for another condition, inform your doctor or medical staff that you are taking Crestor.
Missing a dose of Crestor
Take the next dose at your usual time. Do not take a double dose to make up for a missed dose.
Stopping Crestor
Tell your doctor if you wish 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 be aware of the possible adverse reactions. 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),
• Reddish, flat, disc-shaped or round rashes on the trunk, often with blisters in the center, peeling of the skin, ulceration in the mouth, 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 body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

The patient should stop taking Crestor and contact a doctor immediately if the following occur:

• Muscle pain or other muscle 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 small number of patients have experienced adverse effects on muscles. Rarely, this may lead to 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 (applies only to the 40 mg dose).
• Diabetes. The likelihood of developing diabetes is higher in patients with high blood sugar and lipid levels, overweight, and high blood pressure. The treating physician will monitor patients at risk during treatment with 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 (applies only to doses of 5 mg, 10 mg, and 20 mg).

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 stop taking Crestor immediately and seek medical help.
• Muscle damage in adults – caution is required; stop taking Crestor and contact a doctor immediately if muscle pain or other muscle symptoms occur that 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.
• Symptoms of lupus-like syndrome (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, presence of blood in urine, damage to nerves of 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, 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 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 adverse reactions not listed in this leaflet, the patient should inform their doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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 provide more information on the safety of the medicine.

5. How to store Crestor

• Store below 30°C. Keep in the original packaging to protect from moisture.
• Keep the medicine 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 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. Each coated tablet contains 20 mg of rosuvastatin in the form of rosuvastatin calcium.
Other ingredients in the medicine are monohydrate lactose, microcrystalline cellulose, calcium phosphate, crospovidone, magnesium stearate, hypromellose, triacetin, titanium dioxide (E 171), and red iron oxide (E 172).

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

For further information, please contact the responsible party or the parallel importer.

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

Manufacturer:
AstraZeneca UK Ltd.
Silk Road Business Park
Macclesfield, Cheshire
SK102NA
United Kingdom
Grünenthal GmbH
Zieglerstraße 6
52078 Aachen
Germany
AstraZeneca Reims Production
Parc Industriel Pompelle
Chemin de Vrilly
Reims 51100
France
AstraZeneca AB
Gärtunavägen, S-151 85 Södertälje
Sweden

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Relabelled and repackaged by:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

This medicinal product is authorised for marketing in the Member States of the European Economic Area under the following trade names:
Crestor 20 mg (NL, AT, BE, DK, GR, FI, IC, IE, IT, LU, MT, NO, PL, PT, SE, UK, DE, ES, FR).

Translation of the 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

Belgium (country of export) Marketing Authorisation Number: BE250223
Parallel Import Authorisation Number: 5/24