CRESTOR 5 mg FILM-COATED TABLETS

Introduction

PATIENT INFORMATION LEAFLET

Crestor5 mg film-coated tablets

rosuvastatin

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• 1. If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Crestor and what is it used for
2. What you need to know before you take Crestor
3. How to take Crestor
4. Possible side effects
   1. Storing Crestor

1. Contents of the pack and further information

1. What is Crestor and what is it used for

Crestor belongs to a group of medicines called statins.

You have been prescribed Crestor because:

• You have high levels of cholesterol. This means you are at risk of having a heart attack or stroke. Crestor is used in adults, adolescents, and children over 6 years to treat high cholesterol.

• You have been told to take a statin because changes to your diet and increasing exercise have not been enough to correct your cholesterol levels. You should keep to a diet that helps lower your cholesterol and continue to exercise while you are taking Crestor.

Or

• You have other factors that increase your risk of having a heart attack, stroke, or other related health problems.

Heart attack, stroke, and other related health problems can be caused by a disease called atherosclerosis. Atherosclerosis is caused by the buildup of fatty deposits in your arteries.

Why it is important to keep taking Crestor

Crestor is used to correct the levels of fatty substances in the blood called lipids, the most well-known of which is cholesterol.

There are different types of cholesterol in the blood, the "bad" cholesterol (LDL-C) and the "good" cholesterol (HDL-C).

• Crestor lowers the "bad" cholesterol and raises the "good" cholesterol.
• It works by blocking the production of "bad" cholesterol and improving the body's ability to remove it from the blood.

In most people, high cholesterol does not affect how they feel because it does not produce any symptoms. However, if left untreated, fatty deposits can build up in the walls of blood vessels, causing them to narrow.

Sometimes these narrowed blood vessels can become blocked, cutting off the blood supply to the heart or brain, causing a heart attack or stroke. By lowering your cholesterol levels, you can reduce your risk of having a heart attack, stroke, or related health problems.

You need to keep taking Crestor, even if you have already lowered your cholesterol levels, because it prevents your cholesterol levels from rising again and causing fatty deposits to build up.However, you should stop taking it if your doctor tells you to, or if you become pregnant.

2. What you need to know before you take Crestor

Do not take Crestor

• If you are allergic (hypersensitive) to the active substance or any of the other ingredients of Crestor (listed in section 6).
• If you are pregnantor breast-feeding. If you become pregnant while taking Crestor, stop taking it immediatelyand tell your doctor. Women should avoid becoming pregnant while taking Crestor by using a suitable method of contraception.
• If you have liver disease.
• If you have severe kidney problems.
• If you have repeated or unexplained muscle pains.
• If you take a combination of sofosbuvir/velpatasvir/voxilaprevir(used to treat hepatitis C, a viral liver infection).
• If you are taking a medicine called ciclosporin(used, for example, after an organ transplant).

If you are in any of these situations (or if you are not sure), please go back to your doctor.

Also, do not take the highest dose (40 mg)

• If you have moderate kidney problems(if you are unsure, ask your doctor).
• If your thyroid gland does not work properly.
• If you have repeated or unexplained muscle pains,a personal or family history of muscle problems, or a previous history of muscle problems when taking other cholesterol-lowering medicines.

• If you regularly drink large amounts of alcohol.

• If you are of Asian origin(for example, Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
• If you take other medicines called fibratesto lower your cholesterol.

If you are in any of these situations (or if you are unsure), please go back to your doctor.

Warnings and precautions

Ask your doctor or pharmacist before you start taking Crestor

• If you have kidney problems.
• If you have liver problems.
• If you have repeated or unexplained muscle pains,a personal or family history of muscle problems, or a previous history of muscle problems when taking other cholesterol-lowering medicines. Tell your doctor immediately if you have unexplained muscle pains, especially if you also feel unwell or have a fever. Also, tell your doctor or pharmacist if you have muscle weakness that persists.
• If you have or have had muscle weakness (myasthenia),because statins can sometimes make this condition worse or trigger the onset of myasthenia (see section 4).
• If you have ever developed severe skin rashes or skin blistering, peeling, and/or mouth sores after taking Crestor or other medicines.
• If you regularly drink large amounts of alcohol.
• If your thyroid gland does not work properly.
• If you take other medicines called fibratesto lower your cholesterol. Read this leaflet carefully, even if you have taken cholesterol-lowering medicines before.
• If you take medicines to treat HIV infection (such as ritonavir, lopinavir, and/or atazanavir),see "Other medicines and Crestor".
• If you are taking or have taken in the last 7 days a medicine called fusidic acid(a medicine for bacterial infection), by mouth or by injection. The combination of fusidic acid and Crestor can, in rare cases, lead to muscle weakness, tenderness, or pain (rhabdomyolysis), see more information in section 4.
• If you are over 70 years old,as your doctor needs to choose the right starting dose of Crestor for you.
• If you have severe respiratory problems.
• If you are of Asian origin(for example, Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor needs to choose the right starting dose of Crestor for you.

If you are in any of these situations (or if you are unsure):

• Do not take the highest dose of 40 mg and ask your doctor or pharmacist before you start taking any dose of Crestor.

Severe skin reactions (including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms - DRESS) have been reported with Crestor. Stop taking Crestor and seek medical help immediately if you notice any of the symptoms described in section 4.

In a small number of people, statins can affect the liver. This can be detected by a simple blood test that looks for increased levels of liver enzymes (transaminases) in the blood. For this reason, your doctor will normally do blood tests before and after starting treatment with Crestor.

While you are on this medicine, your doctor will closely monitor you if you have diabetes or are at risk of developing diabetes. You are likely to be at risk of developing diabetes if you have high levels of sugar in your blood, are overweight, or have high blood pressure.

Children and adolescents

• If the patient is under 6 years of age:Crestor should not be given to children under 6 years of age.

Other medicines and Crestor

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Tell your doctor if you are taking any of the following medicines:

• ciclosporin (used after an organ transplant),
• warfarin, clopidogrel, or ticagrelor (or any other anticoagulant, such as acenocoumarol),
• fibrates (such as gemfibrozil, fenofibrate) or any other medicine used to lower cholesterol (such as ezetimibe),
• indigestion treatments (used to neutralize stomach acid),
• erythromycin (an antibiotic),
• fusidic acid (an antibiotic - see also under "Warnings and precautions" and section 4),
• oral contraceptives (the pill),
• 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, alone or in combination (see "Warnings and precautions"): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir,
• roxadustat (used to treat anemia in patients with chronic kidney disease),
• tafamidis (used to treat a disease called transthyretin amyloidosis),
• momelotinib (used to treat myelofibrosis in adults with anemia.

The effects of these medicines can be altered by Crestor or they can alter the effect of Crestor.

If you need to take fusidic acid by mouth to treat a bacterial infection, you must stop taking Crestor temporarily.Your doctor will tell you when it is safe to start taking Crestor again. Taking Crestor with fusidic acid can, in rare cases, lead to muscle weakness, tenderness, or pain (rhabdomyolysis). See more information in section 4.

Pregnancy and breast-feeding

Do not take Crestorif you are pregnant or breast-feeding. If you become pregnant while taking Crestor, stop taking it immediatelyand tell your doctor. Women should avoid becoming pregnant while taking Crestor by using a suitable method of contraception.

Ask your doctor or pharmacist before using any medicine.

Driving and using machines

Most patients can drive and use machines while taking Crestor as it is unlikely to affect their ability to do so. However, some people may feel dizzy while taking Crestor. If you feel dizzy, consult your doctor before attempting to drive or use machines.

Crestor contains lactose.

If your doctor has told you that you have an intolerance to some sugars (lactose or milk sugar), ask your doctor before taking Crestor.

The complete list of ingredients is in Contents of the pack and further information.

3. How to take Crestor

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Adult dose

If you are taking Crestor for high cholesterol:

Starting dose

Your treatment with Crestor should start with 5 mg or 10 mg, even if you have taken a higher dose of another statin before. The choice of starting dose will depend on:

• Your cholesterol levels.
• The level of risk you have of having a heart attack or stroke.
• Whether you have factors that make you more sensitive to the possible side effects.

Check with your doctor or pharmacist which starting dose of Crestor is best for you.

Your doctor may decide to start you on the lowest dose (5 mg):

• If you are of Asian origin(for example, Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
• If you are over 70 years old.
• If you have moderate kidney problems.
• If you are at risk of muscle pains (myopathy).

Increasing the dose and maximum daily dose

Your doctor may decide to increase your dose. This is so you are taking the dose of Crestor that is right for you. If you started with 5 mg, your doctor may decide to double the dose to 10 mg, then to 20 mg, and finally to 40 mg, if necessary. If you started with 10 mg, your doctor may decide to double the dose to 20 mg, and then to 40 mg, if necessary. There will be a gap of at least 4 weeks between each dose increase.

The maximum daily dose of Crestor is 40 mg. This dose is only for patients with very high cholesterol levels and a high risk of heart attack or stroke, whose cholesterol levels do not come down enough with 20 mg.

If you are taking Crestor to reduce the risk of having a heart attack, stroke, or related health problems:

The recommended dose is 20 mg daily. However, your doctor may decide to use a lower dose if you have any of the factors mentioned above.

Use in children and adolescents aged 6-17 years

The dose range in children and adolescents aged 6 to 17 years is 5 mg to 20 mg once daily. The usual starting dose is 5 mg once daily, and your doctor may gradually increase your dose as needed, up to a maximum dose of 10 mg or 20 mg daily, depending on the condition being treated. Take your dose once a day.

Swallowing the tablets

Swallow each tablet whole with water.

Take Crestor once a day.You can take it at any time of the day, with or without food.

Try to take your tablets at the same time each day. This will help you to remember to take them.

Regular checks of your cholesterol levels

It is important that you have regular check-ups with your doctor to monitor your cholesterol levels and to make sure they are under control.

Your doctor may decide to increase your dose, so you are taking the dose of Crestor that is right for you.

If you take more Crestor than you should

Contact your doctor or the nearest hospital for advice.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service (91 562 04 20), stating the name of the medicine and the amount taken.

If you go into hospital or receive treatment for any other condition, tell the medical staff that you are taking Crestor.

If you forget to take Crestor

Do not worry, just take your next scheduled dose at the right time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Crestor

Consult your doctor if you want to stop taking Crestor. Your cholesterol levels may rise again if you stop taking Crestor.

If you have any other questions about taking this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

It is essential that you know what these adverse effects can be. They are usually mild and disappear in a short period.

Stop taking Crestor and seek immediate medical attentionif you experience any of the following allergic reactions:

• Difficulty breathing, with or without swelling of the face, lips, tongue, and/or throat.
• Swelling of the face, lips, tongue, and/or throat, which can cause difficulty swallowing.
• Intense itching of the skin (with hives).
• Reddish patches on the trunk, target-shaped or circular, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin eruptions can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• Widespread rash, high body temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).

Also, stop taking Crestor and consult your doctor immediately:

• If you experience unjustified muscle pain and crampsthat last longer than expected. Muscle symptoms are more frequent in children and adolescents than in adults. As with other statins, a very small number of people have suffered unpleasant muscle effects that, very rarely, have resulted in a potentially fatal muscle injury called rhabdomyolysis.

• If you experience muscle rupture.

• If you present with a syndrome that has symptoms similar to lupus(including hives, joint disorders, and effects on blood cells).

Common Adverse Effects (may affect up to 1 in 10 people)

• Headache, stomach pain, constipation, nausea, muscle pain, weakness, dizziness.
• An increase in the amount of protein in the urine – this usually reverses itself without the need to interrupt treatment with Crestor tablets (common adverse effect only with the daily dose of 40 mg of Crestor).
• Diabetes. This is more likely if you have high blood sugar and lipid levels, are overweight, and have high blood pressure. Your doctor will closely monitor you while you are taking this medicine.

Uncommon Adverse Effects (may affect up to 1 in 100 people)

• Hives, itching, and other skin reactions.
• An increase in the amount of protein in the urine – this usually reverses itself without the need to interrupt treatment with Crestor tablets (uncommon adverse effect with daily doses of 5 mg, 10 mg, and 20 mg of Crestor).

Rare Adverse Effects (may affect up to 1 in 1,000 people)

• Severe allergic reaction – symptoms include swelling of the face, lips, tongue, and/or throat, difficulty swallowing and breathing, intense itching of the skin (with hives). If you think you are having an allergic reaction, stop taking Crestorand seek immediate medical attention.
• Muscle injury in adults – as a precaution, stop taking Crestor and consult your doctor immediately if you have unjustified muscle pain or crampsthat last longer than expected.
• Severe stomach pain (possible sign of pancreatitis).
• Increased liver enzymes (transaminases) in the blood.
• Bleeding or bruising more easily than normal due to a low platelet count in the blood.
• Syndrome that has symptoms similar to lupus (including hives, joint disorders, and effects on blood cells).

Very Rare Adverse Effects (may affect up to 1 in 10,000 people)

• Jaundice (yellowing of the skin and eyes), hepatitis (inflamed liver), traces of blood in the urine, nerve damage in the legs and arms (with numbness or tingling), joint pain, memory loss, and breast enlargement in men (gynecomastia).

Adverse Effects of Unknown Frequency (cannot be estimated from available data) that may include

• Diarrhea (loose stools), cough, shortness of breath, edema (swelling), sleep disturbances, including insomnia and nightmares, sexual difficulties, depression, respiratory problems, including persistent cough and/or shortness of breath or fever, tendon injuries, and constant muscle weakness.
• Severe myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing).
• Ocular myasthenia (a disease that causes weakness of the eye muscles).

Consult your doctor if you experience weakness in your arms or legs that worsens after periods of activity, double vision or drooping eyelids, difficulty swallowing or breathing.

Reporting Adverse Effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects that do not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Crestor

• Blisters: Do not store above 30°C. Store in the original package to protect from moisture.
• Bottles: Do not store above 30°C. Keep the bottle tightly closed to protect from moisture.
• Keep this medicine out of sight and reach of children.
• Do not use this medicine after the expiration date stated on the packaging/blister/label after CAD. The expiration date is the last day of the month indicated.
• Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Crestor

The active ingredient of Crestor is rosuvastatin. The film-coated Crestor tablets contain rosuvastatin calcium equivalent to 5 mg of rosuvastatin. The other ingredients of the tablets are: lactose monohydrate, microcrystalline cellulose (E460), calcium phosphate, crospovidone, magnesium stearate, hypromellose, glycerol triacetate, titanium dioxide (E171). Crestor 5 mg film-coated tablets also contain yellow iron oxide (E172).

Appearance of the Product and Package Contents

Crestor is available in packs with blisters of 7, 14, 15, 20, 28, 30, 42, 50, 56, 60, 84, 90, 98, and 100 tablets, and in plastic bottles of 30 and 100 tablets. (Not all pack sizes may be marketed in all countries).

Crestor 5 mg film-coated tablets are yellow, round, and have the engraving ‘ZD4522’ and ‘5’ on one side and are smooth on the other.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Grünenthal GmbH

Zieglerstraße 6

52078 Aachen

Germany

Manufacturer:

AstraZeneca AB, S-152 57, Södertälje, Sweden

Phone: +46 8 553 260 000

Grünenthal GmbH, Zieglerstraße 6, 52078 Aachen, Germany

Phone: +49 (0) 241 569 0

Farmaceutici Formenti S.p.A., Via Di Vittorio 2, 21040 Origgio (VA), Italy

Phone: +39 02 969581

Local Representative:

Almirall, S.A.

Ronda General Mitre, 151

08022 Barcelona

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Crestor 5 mg (NL, AT, BE, DE, DK, ES, FR, GR, FI, IS, IE, IT, LU, NO, PL, PT, SE).

Date of the Last Revision of this Leaflet: April 2025

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/