Package Leaflet: Information for the User

Rosuvastatina Aurovitas 20 mg Film-Coated Tablets

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

-Keep this leaflet, as you may need to read it again.

-If you have any questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not pass it on to others even if they have similar symptoms, as it may harm them.

-If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is Rosuvastatina Aurovitas and what it is used for

2.What you need to know before taking Rosuvastatina Aurovitas

3.How to take Rosuvastatina Aurovitas

4.Possible side effects

5.Storage of Rosuvastatina Aurovitas

6.Contents of the pack and additional information

Rosuvastatinbelongs to a group of medications called statins.

You have been prescribedrosuvastatinbecause:

-You have high cholesterol levels. This means you are at risk of having a heart attack or a cerebral infarction.

Rosuvastatin is used in adults, adolescents, and children aged 6 years or older to treat high cholesterol.

-You have been advised to take a statin because the changes made to your diet and the increase in physical exercise have not been sufficient to correct your cholesterol levels. You must maintain a diet that helps to reduce cholesterol and continue to perform physical exercise while undergoing treatment withrosuvastatin.

Or

-You have other factors that increase your risk of suffering a heart attack, cerebral infarction, or other health-related problems.

A heart attack, cerebral infarction, and other health-related problems may be caused by a disease called atherosclerosis. Atherosclerosis is caused by the formation of fatty deposits in your arteries.

Why it is important to continue taking rosuvastatin

Rosuvastatinis used to correct the levels of fatty substances in the blood called lipids, with cholesterol being the most well-known.

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

-Rosuvastatinreduces the amount of "bad" cholesterol and increases "good" cholesterol.

-It acts by blocking the production of "bad" cholesterol and improves the body's ability to eliminate it from the blood.

In most people, high cholesterol levels do not affect how they feel since they do not produce any symptoms. However, if left untreated, fatty deposits can form in the walls of blood vessels, causing them to narrow.

Sometimes, these narrowed vessels can become blocked and prevent blood supply to the heart or brain, causing a heart attack or cerebral infarction. By reducing your cholesterol levels, you can reduce the risk of having a heart attack or cerebral infarction.

Youmust continue taking rosuvastatin, even if you have already achieved the correct cholesterol levels, as itprevents cholesterol levels from increasing again and forming fatty deposits. However, you should stop treatment if your doctor advises you to or if you become pregnant.

Do not take Rosuvastatina Aurovitas

-If you are allergic to rosuvastatin or any of the other ingredients of this medicine (listed in section 6).

-If you are pregnantor breastfeeding. If you become pregnant while taking rosuvastatin, stop taking it immediately and inform your doctor.. Women should avoid becoming pregnant during treatment with rosuvastatin using an appropriate contraceptive method.

-If you have liver disease.

-If you have severe kidney problems.

-If you have repeated or unjustified muscle pain and cramps..

-If you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir medications(used to treat a liver virus infection called hepatitis C).

-If you are taking a medication called ciclosporina(used, for example, after an organ transplant).

If you find yourself in any of the situations mentioned above (or are unsure),talk to your doctor.

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

?If you have moderate kidney problems(if unsure, consult your doctor).

?If your thyroid glanddoes not function correctly.

?If you have repeated or unjustified muscle pain and cramps, personal or family history of muscle problemsor history of muscle problems during treatment with other cholesterol-lowering medications.

?If you regularly consume large amounts of alcohol..

?If you are of Asian origin(for example, Japanese, Chinese, Filipino, Vietnamese, Korean or Indian).

?If you are taking other medications called fibratesto lower cholesterol.

If you find yourself in any of the situations mentioned above (or are unsure),talk to your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rosuvastatina Aurovitas.

-If you have kidney problems.

-If you have liver problems.

-If you have repeated or unjustified muscle pain and cramps, personal or family history of muscle problems or history of muscle problems during treatment with other cholesterol-lowering medications. Inform your doctor immediately if you have unjustified muscle pain or cramps, especially if you have general discomfort or fever. Also inform your doctor or pharmacist if you have constant muscle weakness.

-If you have or have had myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing) or myasthenia gravis (a disease that causes weakness of the eye muscles), as statins may sometimes worsen the disease or cause myasthenia (see section 4).

-If you have ever developed a severe skin rash or skin peeling, blisters and/or mouth sores after taking rosuvastatin or other related medications.

-If you regularly consume large amounts of alcohol.

-If your thyroid glanddoes not function correctly.

-If you are taking other medications called fibratesto lower cholesterol. Read this leaflet carefully, even if you have taken cholesterol-lowering medications before.

-If you are taking medications to treat HIV (HIV virus) infection, such as ritonavir with lopinavir and/or atazanavir, see “Other medications andRosuvastatina Aurovitas”.

-If you are taking or have taken within the last 7 days a medication called fusidic acid (an antibiotic) by mouth or injection. The combination of fusidic acid and rosuvastatin may cause severe muscle problems (rhabdomyolysis), see“Other medications andRosuvastatina Aurovitas”.

-If you are over 70 years old, as your doctor must establish the appropriate starting dose of rosuvastatin for you.

-If you have severe respiratory failure.

-If you are of Asian origin(for example, Japanese, Chinese, Filipino, Vietnamese, Korean or Indian). Your doctor must establish the appropriate starting dose of rosuvastatin for you.

If you find yourself in any of the situations mentioned above (or are unsure):

-Do not take the 40 mg dose of rosuvastatin (the highest dose) and consult your doctor or pharmacist before starting to take any dose of rosuvastatin.

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

In a small number of people, statins can affect the liver. This is detected by a simple test that detects elevated liver enzymes (transaminases) in the blood. For this reason, your doctor will normally perform blood tests (liver function test) before and after treatment with rosuvastatin.

If you have diabetes or are at risk of developing diabetes, your doctor will closely monitor you while taking this medication. You are likely to be at risk of developing diabetes if you have high blood sugar and fat levels, if you are overweight and if you have high blood pressure.

Children and adolescents

-Ifthe patient is under 6 years of age:Rosuvastatin should not be administered to children under 6 years of age.

-If the patient is under 18 years of age:The 40 mg rosuvastatin tablets should not be administered to children and adolescents under 18 years of age.

Other medications andRosuvastatina Aurovitas

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication.

Inform your doctor if you are using any of the following medications:

•ciclosporina (used after an organ transplant).

•warfarin, clopidogrel or ticagrelor (or any other anticoagulant medication).

•fibrates (such as gemfibrozil, fenofibrate) or any other medication used to lower cholesterol (such as ezetimiba).

•medications for indigestion (used to neutralize stomach acid).

•erythromycin (an antibiotic).

•fusidic acid (an antibiotic - see below and in Warnings and precautions).

•oral contraceptives (the pill).

•regorafenib (used to treat cancer).

•darolutamida (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 uric acid levels in the blood).

•teriflunomida (used to treat multiple sclerosis).

•any of the following medications used to treat viral infections, including HIV or hepatitis C, alone or in combination (see Warnings and precautions): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, simeprevir, 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 transtiretin amyloidosis).

The effects of these medications may be modified byrosuvastatinor may change the effect ofrosuvastatin.

If you need to take fusidic acid by mouth to treat a bacterial infection, you will need to temporarily stop taking this medication. Your doctor will tell you when it is safe to restart the treatment withrosuvastatin. Taking rosuvastatin with fusidic acid may cause, in rare cases, muscle weakness, sensitivity or pain (rhabdomyolysis). See more information about rhabdomyolysis in section 4.

Taking Rosuvastativa Aurovitas with food, drinks and alcohol

You can take rosuvastatin with food or without food.

Pregnancy, breastfeeding and fertility

Do not take rosuvastatinif you are pregnant or breastfeeding.

If you become pregnant while takingrosuvastatin, stop taking it immediatelyand inform your doctor.Women should avoid becoming pregnant during treatment withrosuvastatinusing an appropriate contraceptive method.

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machines

Most patients can drive vehicles and use machines during treatment withrosuvastatinas it will not affect their ability. However, some people may feel dizzy during treatment withrosuvastatin. If you feel dizzy, consult your doctor before attempting to drive or use machines.

Rosuvastatina Aurovitas contains lactose, red iron oxide and yellow iron oxide

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication may cause allergic reactions because it contains red iron oxide (E129) and yellow iron oxide (E110).

It may cause allergic-type reactions.

The complete list of components can be found inContainer contents and additional information.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Usual doses in adults:

If you are taking rosuvastatin for high cholesterol levels:

Starting dose:

Your treatment withrosuvastatinshould start witha dose of5 mg or 10 mg, even if you have taken a higher dose of another statin previously. The choice of starting dose will depend on:

-Your cholesterol levels.

-The degree of risk you have of having a heart attack or stroke.

-If you have factors that make you more vulnerable to potential side effects.

Check with your doctor or pharmacist which is the best starting dose ofrosuvastatinfor you.

Your doctor may decide to give you the lowest dose (5 mg) if:

-You are ofAsian origin(for example, Japanese, Chinese, Filipino, Vietnamese, Korean or Indian).

-You areover 70 years old.

-You have moderate kidney problems.

-You have a risk of developing muscle pain and cramps (myopathy).

Dose increase and maximum daily dose:

Your doctor may decide to increase your dose. This is to ensure you are taking the right dose ofrosuvastatinfor you. If you started with a dose of 5 mg, your doctor may decide to double the dose to 10 mg, then to 20 mg and later to 40 mg, if necessary. If you started with a dose of 10 mg, your doctor may decide to double the dose to 20 mg and later to 40 mg, if necessary. There will be a four-week interval between each dose adjustment.

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

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

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

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 a day. The usual recommended starting dose for treatment is 5 mg per day and your doctor may increase your dose gradually to reach the appropriate dose ofrosuvastatinfor your condition. The maximum recommended daily dose ofrosuvastatinis 10 mg or 20 mg for children aged 6 to 17 years, depending on the underlying disease being treated. Take the dose indicated by your doctor once a day.Do notadminister the 40 mg tablets ofrosuvastatinto children.

Tablet intake:

Swallow each tablet whole with water.

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

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

Regular cholesterol level checks:

It is essential that you attend your doctor regularly for cholesterol checks, to ensure your cholesterol levels have normalized and remain at appropriate levels.

Your doctor may decide to increase your dose so that you are taking the right dose ofrosuvastatinfor you.

If you take more Rosuvastatin than you should:

Contact your doctor or nearest hospital for advice.

If you enter a hospital or receive treatment for another condition, inform the healthcare staff that you are taking rosuvastatin.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Rosuvastatina Aurovitas:

Do not worry, simply take the next scheduled dose at the scheduled time.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Rosuvastatina Aurovitas:

Consult your doctor if you want to stop treatment withrosuvastatin. Your cholesterol levels may increase again if you stop takingrosuvastatin.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

It is important that you know which side effects may occur. They are usually mild and disappear within a short period of time.

Stop taking rosuvastatin and seek medical attention immediatelyif 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 may cause difficulty swallowing.

-Intense itching of the skin (with rashes).

-Reddish patches on the trunk, in the shape of a bull's-eye or circles, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin eruptions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).

-Generalized rash, high body temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).

Also, stop taking rosuvastatin and consult your doctor immediately:

-If you experience unexplained muscle pain and crampsthat last longer than expected. Muscle symptoms are more common in children and adolescents than in adults. Like other statins, a very small number of people have experienced unpleasant muscle side effects, which, very rarely, have resulted in a potentially fatal muscle injury called rhabdomyolysis.

-If you experience muscle rupture.

-If you experience a syndrome with symptoms similar to lupus (including urticaria, joint disorders, and effects on blood cells).

Common side effects:may affect up to 1 in 10 people

-Headache.

-Stomach pain.

-Constipation.

-Nausea.

-Muscle pain.

-Weakness.

-Dizziness.

-Increased protein in urine – this usually returns to normal on its own without the need to stop taking rosuvastatin (common side effect only with a daily dose of 40 mg of rosuvastatin).

-Diabetes. This is more likely if you have high blood sugar and cholesterol levels, if you are overweight, and if you have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Uncommon side effects:may affect up to 1 in 100 people

-Rash, itching, and other skin reactions.

-Increased protein in urine – this usually returns to normal on its own without the need to stop taking rosuvastatin (uncommon side effect with daily doses of 5 mg, 10 mg, and 20 mg of rosuvastatin).

Rare side 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 rashes). If you think you are having an allergic reaction, stop taking rosuvastatinand seek medical attention immediately.

-Muscle injury in adults – as a precaution,stop taking rosuvastatin and consult your doctor immediately if you experience unexplained muscle pain and 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 low platelet count in the blood.

-Syndrome with symptoms similar to lupus (including rash, joint disorders, and effects on blood cells).

Very rare side effects:may affect up to 1 in 10,000 people

-Jaundice (yellowing of the skin and eyes).

-Hepatitis (inflammation of the liver).

-Traces of blood in the urine.

-Nerve damage in the legs and arms (with numbness or tingling).

-Joint pain.

-Memory loss.

-Enlargement of the breasts in men (gynecomastia).

Side effects of unknown frequency:the frequency cannot be estimated from available data

-Diarrhea (loose stools).

-Cough.

-Shortness of breath.

-Swelling.

-Sleep disturbances, including insomnia and nightmares.

-Sexual difficulties.

-Depression.

-Respiratory problems, including persistent cough and/or shortness of breath or fever.

-Tendon damage.

-Constant muscle weakness.

-Myasthenia gravis (a disease that causes generalized muscle weakness, which, in some cases, affects the muscles used for breathing).

Myasthenic eye disease (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, eyelid drooping, difficulty swallowing, or difficulty breathing.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

This medication does not require any special storage temperature. Store in the original packaging to protect it from light.

Do not use this medication after the expiration date that appears on the blister pack and on the box after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Rosuvastatina Aurovitas

-The active ingredient is rosuvastatina. Each film-coated tablet contains 20 mg of rosuvastatina (as rosuvastatina calcium).

-The other components are:

Core tablet:lactose monohydrate, calcium hydrogen phosphate, microcrystalline cellulose, crospovidone (type B), magnesium stearate.

Coating:hypromellose (15cP) (E464), lactose monohydrate, titanium dioxide (E171), yellow-orange S (E110), red allura AC (E129), indigo carmine (E132), triacetin.

Appearance of the product and contents of the package

Film-coated tablets of pink color, round, biconvex, with the mark “J” on one face and “55” on the other.

Rosuvastatina Aurovitas tabletsare available in blister packs of Poliamida/Al/PVC/Al.

Pack sizes: 28 and 30 film-coated tablets.

Only some pack sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

This medicine is authorized in the member states of theEuropean Economic Area withthe following names:

Last review date of this leaflet: October 2024

Further information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).