Crestor

Patient Information Leaflet

Caution! Keep this leaflet. The packaging label is in a foreign language.
Crestor
10 mg, film-coated tablets
Rosuvastatinum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet for future reference.
• 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, tell your doctor, pharmacist or nurse. See section 4.

Table of contents:

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

• You have been diagnosed with high cholesterol levels. This means you are at 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 cholesterol levels in your blood. While taking Crestor, you should also follow a cholesterol-lowering diet and engage in regular physical exercise.

or

• Crestor may also be prescribed if you have other risk factors that increase your chance of heart attack (myocardial infarction), stroke or similar conditions.

Heart attack, stroke and related problems may be caused by atherosclerosis.
Atherosclerosis results from the build-up of fatty 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, 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 cause any noticeable symptoms or changes in how they feel. However, if left untreated, fatty deposits build up in the walls of blood vessels, causing them to narrow.
Sometimes, a narrowed blood vessel may become completely blocked, cutting off blood flow to the heart or brain, leading to a heart attack or stroke. Achieving normal cholesterol levels reduces the risk of heart attack, stroke or similar conditions.
Even if your 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 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 of childbearing potential who are 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 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 previously experienced 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.
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 problems 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 they experience persistent muscle weakness,
• 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 a thyroid disorder,
• if the patient is taking lipid-lowering medicines from the fibrate group. 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 currently taking or has taken within the last 7 days oral or injectable 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 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):

• the patient should contact their doctor or pharmacist.

In a small number of patients, statins may affect liver function. To confirm this effect, a blood test to assess liver enzyme activity is performed. Usually, the doctor will recommend checking liver enzyme activity 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, treatment with Crestor should be discontinued and the patient should contact their doctor immediately.
Children and adolescents
Crestor should not be used in children under 6 years of age.
Other medicines and Crestor
Tell your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient plans to take.
Tell 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 (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),

• 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 for a bacterial infection,
Crestor should be temporarily discontinued. The doctor will inform the patient when it is safe to
resume taking 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 while breastfeeding. If a woman becomes pregnant while taking Crestor, treatment should be stopped immediately and the doctor should be contacted. Effective contraception must be used to avoid pregnancy while taking Crestor.
Before taking any medicine, consult a doctor or pharmacist.
Driving and operating machinery
Most people can drive and operate machinery while taking Crestor – it does not impair these abilities. However, some patients may experience dizziness while being treated 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 monohydrate (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 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
Taking 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 the patient.
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 was initiated with 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 with 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 a high risk of heart attack or stroke, in whom a 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 it if any of the factors described above apply to the patient.
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, 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.
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 healthcare staff that you are 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 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 which adverse reactions 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 spots on the trunk, often with blisters in the center, peeling of the skin, 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
you experience:

• 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),
• 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.
• Diabetes. The risk of developing diabetes is higher if the patient has high blood sugar and fat levels, overweight and high blood pressure. Your doctor 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 the urine. This symptom usually resolves spontaneously and does not require discontinuation of Crestor.

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 you suspect an allergic reaction, stop taking Crestor immediately and seek medical help.
• Muscle damage in adults - caution is advised, i.e. discontinue Crestor and contact your doctor immediately if you experience muscle pain

or other muscle symptoms 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 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 eye muscles). You should talk to your doctor if you 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, you should inform your doctor, pharmacist or nurse. 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 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 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 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 10 mg of rosuvastatin (as
rosuvastatin calcium).
Other components of the medicine are: monohydrate lactose, microcrystalline cellulose, calcium
phosphate, crospovidone, magnesium stearate.
Coating: monohydrate lactose, hypromellose, triacetin, titanium dioxide (E 171), red iron oxide (E 172).
What Crestor looks like and contents of the pack
Aluminium/Aluminium blisters containing 28 coated tablets, packed in a cardboard box.
Pack contents: pink, round tablets marked “ZD4522” and “10” on one side, the other side smooth.
For further 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
Grünenthal GmbH, Zieglerstraße 6, 52078 Aachen, Germany
AstraZeneca AB, S-152 57, 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 Spain, country of export: 661872.1
Parallel Import Licence number: 16/21
This medicinal product is authorised for sale in the European Economic Area under the following names:
Crestor 10 mg (NL, AT, BE, DE, DK, GR, ES, FI, FR, IS, IE, IT, LU, PL, NO, PT, SE)
Translation of the weekday symbols located next to each tablet on the immediate packaging:
lun - Monday
mar - Tuesday
mié - Wednesday
jue - Thursday
vie - Friday
sáb - Saturday
dom - Sunday