Package leaflet: Information for the patient

Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
Crestor (Crestor 10), 10 mg, film-coated tablets
Rosuvastatin
Crestor and Crestor 10 are different brand names for the same medicine.
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 others, even if their symptoms are the same.
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet:

What Crestor is and what it is used for
Important information before taking Crestor
How to take Crestor
Possible side effects
How to store Crestor
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.
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.

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 related problems may result from atherosclerosis. Atherosclerosis
is caused by 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: 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. However, if left untreated, fatty deposits build up in the walls of blood vessels, leading to narrowing.
Sometimes, a narrowed blood vessel may become completely blocked, cutting off 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 diseases.
Even if cholesterol levels become normal after using Crestor, continue taking it. This prevents cholesterol levels from rising again, which could lead to further accumulation of 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 has a known allergy (hypersensitivity) to rosuvastatin or any of the other ingredients of Crestor,
if the patient is pregnant or breastfeeding. If a woman becomes pregnant while taking Crestor, she must immediately stop taking the medicine and inform her doctor. Women of childbearing potential taking Crestor should use effective contraceptive methods,
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, they should contact their doctor again.

In addition, 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 a family member has 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, or Indian),
if the patient is taking fibrates, 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 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 a family member 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 develop unexplained muscle pain or discomfort, especially if accompanied by malaise or fever. The patient should also inform the doctor 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), because statins may sometimes worsen symptoms or trigger the onset 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, i.e. other cholesterol-lowering medicines. The patient should read the leaflet carefully, even if they have 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 an oral or injectable 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 (because the doctor must select an appropriate starting dose of Crestor),
if the patient has severe respiratory insufficiency,
if the patient is of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). In 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 monitor this, blood tests to assess liver enzyme activity are performed. Usually, the doctor will recommend checking liver enzyme levels in 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 lipid levels, overweight, and high blood pressure may be at increased 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 immediately and contact a doctor without delay.

Children and adolescents

if the patient is under 6 years of age: Crestor must 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
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
Tell 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 (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 in cancer treatment),
darolutamide (used in cancer treatment),
capmatinib (used in cancer treatment),
hormone replacement therapy,
fostamatinib (used to treat low platelet count),
febuxostat (used to treat and prevent 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, used 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 anaemia in patients with chronic kidney disease),
tafamidis (used to treat a disease called transthyretin amyloidosis),
anticoagulants such as warfarin, acenocoumarol, or fluindione (their blood-thinning effect and risk of bleeding may be increased when used concomitantly 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 must not be used during pregnancy or breastfeeding. If a woman becomes pregnant while taking Crestor, treatment must be stopped immediately and the doctor should be contacted. While taking Crestor, pregnancy must be avoided and effective contraception used.
Before taking any medicine, consult a doctor or pharmacist.

Driving and operating machinery
Most people can drive and operate machinery while taking Crestor – the medicine does not impair these 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 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 exactly as your doctor has instructed. If you are unsure, consult your doctor or pharmacist.
Crestor is available in the following doses: 10 mg, 20 mg.
Adults
Taking Crestor to lower cholesterol levels
Starting dose
Treatment should begin with a 5 mg or 10 mg dose, even if the patient previously took 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 in the patient that increase susceptibility to adverse effects. Ask your doctor which starting dose of Crestor is most appropriate for you.

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 moderate kidney disease,
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 your individual needs.
If treatment was started at 5 mg, your doctor may increase the dose to 10 mg, and then to 20 mg or 40 mg, if necessary. If treatment was started at 10 mg, your doctor may increase the dose to 20 mg, and then to 40 mg, if necessary. A treatment period of 4 weeks at a given dose should elapse before any dose increase.
The maximum daily dose of Crestor is 40 mg. This dose is used in patients with high cholesterol and a high risk of heart attack or stroke, in whom the 20 mg dose was insufficient to reduce cholesterol levels.
Taking Crestor to reduce the risk of heart attack, stroke, or similar health problems
The recommended daily dose is 20 mg; however, your doctor may decide to reduce this dose if any of the factors described above apply to you.
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. 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 of day, 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 your individual needs.
If you take more Crestor than you should
If you take more Crestor than prescribed, contact your doctor or go to the nearest hospital immediately.
If you are admitted to hospital or are being treated for another condition, inform your doctor or medical staff that you are taking Crestor.
If you miss 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 Crestor treatment is stopped.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
It is important for the patient to know which adverse effects may occur. Usually, they are
mild and resolve shortly after starting treatment.
You 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, skin peeling, mouth ulcers, throat, nose, genital organs and around the eyes. Such severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome);
widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

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

muscle pain or other muscle symptoms persist longer than expected. Muscle-related symptoms occur more frequently in children and adolescents than in adult patients. As with other statins, in a very small number of patients, adverse effects on muscles have been observed. 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).

Adverse effects occurring frequently (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 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.

Adverse effects occurring uncommonly (in more than 1 in 1,000 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).

Adverse effects occurring rarely (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 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 required, i.e. stop taking Crestor and contact your doctor immediately if muscle pain or other muscle symptoms persist longer than expected.
Severe abdominal pain (pancreatitis).
Increased liver enzyme levels in blood.
Increased tendency to bleed or bruise due to low platelet count.
Symptoms of lupus-like syndrome (such as rash, joint disorders and hematological changes).

Adverse effects occurring very rarely (in less than 1 in 10,000 patients)

Jaundice (yellowing of the skin and eyes), hepatitis, blood in urine, damage to nerves of upper and lower limbs (felt as numbness), joint pain, memory loss, breast enlargement in men (gynecomastia).

Adverse effects 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 eye muscles). You should talk to your doctor if you experience weakness in arms or legs that worsens with activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath.

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring 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 effects helps to gather more information about 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 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 specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Crestor contains
The active substance is rosuvastatin. Each coated tablet contains 10 mg of rosuvastatin in the form of rosuvastatin calcium.
Other ingredients are monohydrate lactose, microcrystalline cellulose, calcium phosphate, crospovidone, magnesium stearate, hypromellose, triacetin, titanium dioxide (E 171), red iron oxide (E 172).

What Crestor looks like and contents of the pack
Crestor is available in blisters within a cardboard box containing 30 tablets.
Crestor 10 mg are pink, round, film-coated tablets marked with "ZD4522" and "10" on one side, the other side is smooth.

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

Marketing Authorisation Holder in the Netherlands, the country of export:
Grünenthal B.V.
De Corridor 21K
3621 ZA Breukelen
The Netherlands

Manufacturer:
AstraZeneca AB
Gärtunavägen
152-57 Södertälje
Sweden
Grünenthal GmbH
Zieglerstraße 6
52078 Aachen
Germany
Farmaceutici Formenti S.p.A.
Via Di Vittorio 2
21040 Origgio (VA)
Italy

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 the Netherlands, the country of export: RVG 26872
Parallel Import Authorisation number: 174/25

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