CRESTOR

Patient Information Leaflet

Caution! Please keep this leaflet. The information on the immediate packaging is in a foreign language.
Crestor, 10 mg, coated tablets
Rosuvastatin
Please read this leaflet carefully before taking this medicine, because 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 any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of 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 known as statins.
Crestor is prescribed because:

• The patient has been diagnosed with high cholesterol levels, which 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 changes in diet 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 related problems may be caused by atherosclerosis. Atherosclerosis
is the result of atherosclerotic plaque buildup 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 the level of "bad" cholesterol and increase the level 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 supply 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 taking 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 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 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 experiences 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 had 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 the doctor again.
In addition, do not use 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 fibrates (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 the 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 the doctor immediately if unexplained muscle pain or discomfort occurs, especially if accompanied by 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 the eye muscles), as statins may sometimes worsen symptoms or trigger 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 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 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 old (as 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, contact the doctor or pharmacist.

In a small number of patients, statins may affect liver function. To confirm such effects, a blood test to assess 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 lipid 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 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 the 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 the doctor or pharmacist about all medicines currently used, recently taken, or planned to be used.
Inform the doctor if the patient is taking:

• cyclosporine (used, for example, after organ transplantation),
• warfarin, clopidogrel, or ticagrelor (or any other anticoagulant medicine),
• a fibrate (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 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 uric acid levels),
• teriflunomide (used to treat multiple sclerosis),
• leflunomide (used to treat rheumatoid arthritis),
• 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),
• momelotinib (used to treat 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 to treat a bacterial infection,
Crestor should be temporarily discontinued. The doctor will inform the patient when it is safe to
resume taking 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 breastfeeding. If a woman becomes pregnant while taking
Crestor, treatment should be stopped immediately and the doctor should be contacted. While taking Crestor, pregnancy should 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 will not impair their abilities. However, some patients may experience dizziness during treatment with Crestor. If this symptom occurs, the patient should contact the 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)], this should be reported to the doctor before using 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 you have any doubts, consult your
doctor or pharmacist.
Crestor is available in the following strengths: 10 mg, 20 mg.
Adults
Taking 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 level of risk of heart attack or stroke in the patient,
• the presence of factors increasing susceptibility to adverse effects in the patient.

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 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 as appropriate for the patient's needs.
If treatment was 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 was 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 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 the dose if the patient has any of the factors described above.
Use in children and adolescents aged 6–17 years
The dosing 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 type of disease being treated. The medicine should be taken once daily. Crestor 40 mg should not be used in children.
Taking 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.
Monitoring cholesterol tests
To ensure that cholesterol levels have decreased and remain within normal limits, regular check-ups and blood tests should be performed.
Your doctor may decide to increase the dose of Crestor as appropriate for the patient.
Taking more Crestor than prescribed
If you take 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.
Missed 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
Inform 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 experiences them.
It is important for the patient to know which adverse reactions may occur. Usually they are
mild and resolve shortly after starting treatment.
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 itching of the skin (with lumps);
• Red, flat, disc-shaped or round spots on the trunk, often with blisters in the center, peeling skin, mouth ulcers, throat, nose, genital organs and eyes. These 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).

Stop taking Crestor and contact your 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 has led to potentially life-threatening muscle damage (rhabdomyolysis) in these patients.
• 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 if the patient has high blood sugar and fat 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 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 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 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 an allergic reaction, stop taking Crestor immediately and seek medical help.
• Muscle damage in adults – exercise caution, 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 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 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, 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). Talk to your doctor if the patient experiences weakness in hands or legs that worsens after periods of activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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 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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This helps 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 of the medicine 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 medicine, blisters in a cardboard box containing 30 tablets.
Pack contents: pink, round tablets marked with "ZD4522" and "10" on one side, the other side smooth.

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

Marketing Authorisation Holder in Romania, the country of export:
Grünenthal GmbH
Zieglerstraße 6, 52078 Aachen, Germany

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

Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Marketing Authorisation Number in Romania, the country of export: 5609/2013/01
Parallel Import Licence Number: 324/25

This medicine is authorised for sale 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, PL, NO, PT, SE)