Patient Information Leaflet

Warning! Keep this leaflet – the outer packaging contains information in a foreign language!
Crestor
10 mg, film-coated tablets
Rosuvastatin
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 someone else, even if their symptoms are the same.
If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

What Crestor is and what it is used for
What you need to know 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 prescribed because:

You have been diagnosed with high cholesterol levels. This increases the 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. While taking Crestor, you should continue to follow a cholesterol-lowering diet and maintain regular physical activity.

Crestor may also be prescribed if you have other risk factors that increase the likelihood of heart attack (myocardial infarction), stroke, or similar cardiovascular diseases.

Heart attack, stroke, and related conditions 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 lipid is cholesterol.
There are different types of cholesterol in the blood: so-called "bad" cholesterol (LDL-C) and "good" cholesterol (HDL-C).

Crestor can 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 bloodstream.

In most people, high cholesterol does not cause noticeable symptoms or changes in how you feel.
However, if left untreated, fatty deposits can 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 cardiovascular events.
Even if your cholesterol levels become 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 taking Crestor

When not to take 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 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 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 take Crestor 40 mg (the highest dose):

if the patient has moderately severe 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 ever had muscle disorders, or if muscle-related side effects occurred previously during treatment with 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 experiences frequent or unexplained muscle pain or discomfort, or if the patient or a family member has previously had 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 general 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 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 fibrate-class 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). 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 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, 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, statin-class medicines may affect liver function. To confirm this effect, a blood test is performed to check liver enzyme activity. Usually, the doctor will recommend checking liver enzyme activity 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 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, the patient should stop taking Crestor and contact their 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 for use.
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-class 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 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),
leflunomide (used in the treatment of rheumatoid arthritis),
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 in the treatment of anaemia in patients with chronic kidney disease),
tafamidis (used in the treatment of transthyretin amyloidosis),
momelotinib (used in the treatment of myelofibrosis in adults with anaemia). 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 the treatment of 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 used.
Before taking any medicine, consult a doctor or pharmacist.
Driving and using machines
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 full 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 directed by your doctor. If in doubt, consult your doctor or pharmacist.
Crestor is available in the following doses: 10 mg, 20 mg.
Adults
Use of Crestor to lower cholesterol levels
Starting dose
Treatment should be initiated at 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 use a starting dose of 5 mg 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 to severe 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 the patient's needs.
If treatment is initiated at 5 mg, your doctor may decide to increase the dose to 10 mg, then to 20 mg or 40 mg, if necessary. If treatment is initiated at 10 mg, your doctor may decide to increase the dose to 20 mg, then to 40 mg, if necessary.
The treatment period with a fixed dose between each dose increase should last 4 weeks.
The maximum daily dose of Crestor is 40 mg. This dose is used in patients with high cholesterol levels and 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 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 your doctor may gradually increase the dose as appropriate for the patient. The maximum daily dose of Crestor in children 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, 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 follow-up visits and blood tests are necessary.
Your doctor may decide to increase the dose of Crestor as appropriate for the patient.
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 being treated for another condition, they should inform the doctor or medical staff about taking Crestor.
Missed 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
Inform your doctor if you wish to stop taking Crestor. Cholesterol levels may rise again if Crestor is discontinued.
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 everybody 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 should 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 spots on the trunk, often with blisters in the centre, peeling of the skin, oral, throat, nasal, genital or ocular ulcers. These potentially life-threatening skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome),
extensive rash, high fever 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 risk of developing diabetes is higher in patients with high blood glucose and lipid levels, obesity 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 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 5 mg, 10 mg and 20 mg doses).

Rare adverse reactions (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 skin itching (with lumps). If the patient suspects an allergic reaction, they should stop taking Crestor immediately and seek medical help.
Muscle damage in adults – caution is required, i.e. stop taking Crestor and contact a 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).

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 of upper and lower limbs (felt as numbness), joint pain, memory loss, breast enlargement in men (gynaecomastia).

Adverse reactions with unknown frequency include:

Diarrhoea (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). Patients should speak to their 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 reactions occur, including any 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 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 provide more information 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.
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. These 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: 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 supplied in Al/Al blisters in a cardboard carton containing 14 or 28 tablets.
Crestor 10 mg coated tablets, pink, round tablets marked “ZD4522” and “10” on one side, the other side smooth.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Spain, country of export:
Grünenthal GmbH
Zieglerstraße 6
52078 Aachen
Germany
Manufacturer:
Farmaceutici Formenti S.p.A.
Via Di Vittorio 2
21040 Origgio (VA)
Italy
AstraZeneca AB
S-152 57, Södertälje
Sweden
Grünenthal GmbH
Zieglerstraße 6
52078 Aachen
Germany
Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
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 authorised for marketing in the Member States of the European Economic Area under the following names:
Crestor 10 mg (NL, AT, BE, DK, GR, FI, IS, IE, IT, LU, NO, PT, SE, DE, ES, FR, PL).
Marketing authorisation number in Spain, country of export: 661872.1
Parallel import authorisation number: 303/23
Translation of the weekday symbols printed next to each tablet on the immediate packaging:
lun – Monday
mar – Tuesday
mié – Wednesday
jue – Thursday
vie – Friday
sáb – Saturday
dom – Sunday