Crestor: detailed information

Package leaflet: Information for the user

Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
Crestor
5 mg, film-coated tablets
Rosuvastatin
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

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 someone else, even if their symptoms are the same.
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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 recommended for use 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 for the treatment of high cholesterol.
Your doctor has recommended taking a statin because dietary changes 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.

Crestor is also recommended if the patient has other risk factors that increase the likelihood of heart attack (myocardial infarction), stroke, or similar cardiovascular diseases.

Heart attack, stroke, and other related problems may be caused by atherosclerosis. Atherosclerosis
results from the buildup of atherosclerotic plaques in blood vessels.
Why is it 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 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 cholesterol levels return to 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 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 must 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 of sofosbuvir/velpatasvir/voxilaprevir (used to treat 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.
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 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 or fever. The patient should also inform their 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 the 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 lipid-lowering fibrates. 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, 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 the section "Other medicines and Crestor",
if the patient is over 70 years of age (as the doctor must determine the 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). 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 consult a doctor or pharmacist before taking Crestor.

In a small number of patients, statins may affect liver function. To confirm this effect, a blood test to check 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.
Severe 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 must stop taking Crestor and contact their doctor immediately.
Children and adolescents
Crestor must not be used in children under 6 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 (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 levels of uric acid in the

blood),

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, taken 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 effects of these medicines, or these medicines may alter the effects 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
restart taking Crestor. Concomitant use of Crestor and 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 must be stopped immediately and the doctor must be contacted. Pregnancy must be avoided and effective contraception used during treatment with Crestor.
Always consult a doctor or pharmacist before taking any medicine.
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 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 your doctor has instructed. If you are unsure, 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 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 to severe kidney disease,
the patient is at risk of developing muscle diseases or muscle pain (myopathy).

Dose escalation and maximum daily dose
Your doctor may decide to increase the dose according to the patient's individual 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 given dose between each 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.
Taking 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 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 according to the patient's needs. 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. The 40 mg dose of Crestor 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 are within the normal range, regular check-ups and blood tests are necessary.
Your doctor may decide to increase the dose of Crestor according to your individual needs.
Taking more than the recommended dose of Crestor
If you take more than the recommended dose of Crestor, contact your doctor or go to the nearest hospital immediately.
If you are in hospital or being treated for another medical condition, inform your doctor or healthcare 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 which adverse reactions may occur. Usually, they are
mild and resolve shortly after starting treatment.
The use of Crestor must be stopped immediately and medical help must be sought 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 in swallowing,
Severe itching of the skin (with lumps),
Reddish, flat, disc-shaped or round spots on the trunk, often with blisters in the center, peeling of the skin, mucosal ulcers 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 fever and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

The use of Crestor must be discontinued and immediate contact with a doctor must be made 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, a small number of patients have experienced adverse effects on muscles. Rarely, these patients developed potentially life-threatening muscle damage (rhabdomyolysis),
Muscle rupture,
Symptoms of lupus-like syndrome (such as rash, joint disorders and hematological changes).

Frequently occurring adverse reactions (in more than 1 in 100 but less than 1 in 10 patients)

Headache, abdominal pain, constipation, nausea, muscle pain, fatigue, dizziness.
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.

Uncommon adverse reactions (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.

Rare adverse reactions (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, use of Crestor must be stopped immediately and medical help must be sought.
Muscle damage in adults – caution is required, i.e. discontinue use of Crestor and contact a doctor immediately if muscle pain or other muscle symptoms occur
that persist longer than expected.
Severe abdominal pain (pancreatitis).
Increased levels of liver enzymes 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 (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, 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 talk to their doctor if they experience weakness in hands or legs worsening 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 any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring 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 collect further 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 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 in use. 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 5 mg of rosuvastatin (as rosuvastatin calcium).
Other ingredients are: monohydrate lactose, microcrystalline cellulose, calcium phosphate, crospovidone, magnesium stearate.
Coating: monohydrate lactose, hypromellose, triacetin, titanium dioxide (E 171), yellow iron oxide (E 172).

What Crestor looks like and contents of the pack
Aluminium/Aluminium blisters in a cardboard box containing 28 coated tablets.
Pack contents: yellow, round, film-coated tablets marked with "ZD4522" and the number "5" on one side and smooth on the other side.

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

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

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

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 Spain, the country of export: 661858.5
Parallel Import Licence number: 8/21

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