Prospecto:information for the patient

Rosuvastatina Sandoz 5 mg film-coated tablets

Rosuvastatina Sandoz 10 mg film-coated tablets

Rosuvastatina Sandoz 20 mg film-coated tablets

rosuvastatina calcium

Read this prospectus carefully before starting to take this medicine,because it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult yourdoctororpharmacist.

-This medicine has been prescribedonlyto you,and you must not give it to others even if they havethe same symptomsas you,as it may harm them.

• If you experience any adverse effects,consult your doctor, or pharmacist,evenifthey are not listed in this prospectus. See section 4.

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

2.What you need to knowbeforestarting totake Rosuvastatina Sandoz

3.How to take Rosuvastatina Sandoz

4.Possible adverse effects

5Storage of Rosuvastatina Sandoz

6. Contents of the package and additional information

Rosuvastatin belongs to a group of medications called statins.

You have been prescribed rosuvastatin because:

• 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 on treatment with rosuvastatin.

Or

• You present other factors that increase the 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 is it important to continue taking Rosuvastatin Sandoz?

Rosuvastatin is 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).

• Rosuvastatin decreases the amount of bad cholesterol and increases good cholesterol.
• It acts by blocking the production of bad cholesterol and improving 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, cerebral infarction, or other health-related problems.

You needto continue taking rosuvastatin, even if you have already achieved the correct cholesterol levels, as itprevents cholesterol levels from increasing againand forming fatty deposits. However, you should interrupt treatment if your doctor advises you to do so or if you become pregnant.

Do not take Rosuvastatina Sandoz:

• if you areallergic to rosuvastatinor to any of the other ingredients of this medicine (listed in section 6 and at the end of section 2),
• if you are pregnantor breastfeeding. If you become pregnant while takingrosuvastatinstop taking it immediately and inform your doctor. Women should avoid becoming pregnant during treatment withrosuvastatinusing an appropriate contraceptive method,
• if you have liver disease,
• if you have severe kidney problems,
• if you have repeated or unjustified muscle pain or cramps,
• if you are taking acombination of sofosbuvir/velpatasvir/voxilaprevirmedicines (used to treat a liver infection called hepatitis C),
• if you are taking a medicine called ciclosporin(used for example, after an organ transplant).

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

Please consult your doctor.

Do not take the highest dose (Rosuvastatina 40 mg):

• if you have moderate kidney problems(if in doubt, consult your doctor),
• if your thyroid glanddoes not function correctly,
• if you have repeated or unjustified muscle pain or cramps,a personal or family history of muscle problems or a previous history of muscle problems during treatment with other cholesterol-lowering medicines,
• 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 medicines called fibratesto lower cholesterol.

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

Please consult your doctor.

Warnings and precautions

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

• if you have kidney problems,
• if you have liver problems,
• if you have repeated or unjustified muscle pain or cramps,a personal or family history of muscle problems or a previous history of muscle problems during treatment with other cholesterol-lowering medicines. 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 persistent 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 can sometimes worsen the disease or cause myasthenia (see section 4),

• if you have ever developed a skin rash or skin peeling, blisters and/or mouth sores after taking rosuvastatin or other related medicines,

• if you regularly consume large amounts of alcohol,
• if your thyroid glanddoes not function correctly,
• if you are taking other medicines called fibratesto lower cholesterol. Read this leaflet carefully, even if you have taken cholesterol-lowering medicines previously,
• if you are taking medicines to treat HIV (AIDS virus) infection,such as ritonavir with lopinavir, atazanavir and/or tipranavir, see “Taking Rosuvastatina Sandoz and other medicines”,
• if you are taking or have taken in the last 7 days a medicine called fusidic acid(a medicine for bacterial infections) by mouth or injection. The combination of fusidic acid and rosuvastatin can cause serious muscle problems (rhabdomyolysis), please see “Other medicines and Rosuvastatina Sandoz”,
• if you are over 70 years old,(as your doctor must establish the starting dose of rosuvastatin suitable 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 starting dose of rosuvastatin suitable for you.

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

• Do not take the highest dose of 40 mg 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) associated with rosuvastatin treatment have been reported. 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 increased levels of liver enzymes (transaminases) in the blood. For this reason, your doctor will normally perform blood tests (liver function test) before and after treatment with rosuvastatina.

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

Children and adolescents

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

Other medicines and Rosuvastatina Sandoz

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

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

• ciclosporina (used for example, after an organ transplant),
• warfarina, ticagrelor or clopidogrel (or any other anticoagulant), fibrates and other medicines that lower lipid levels (such as gemfibrozilo, fenofibrato) or any other medicine used to lower cholesterol (such as ezetimiba),
• medicines for indigestion (used to neutralize stomach acid),
• erythromycin (an antibiotic), fusidic acid (an antibiotic, see more below and “Warnings and precautions”),
• oral contraceptives (the pill),
• hormone replacement therapy,
• regorafenib (used to treat cancer),
• darolutamida(used to treat cancer),
• capmatinib (used to treat cancer),
• fostabatinib (used to treat low platelet count),
• febuxostat (used to treat and prevent high uric acid levels in the blood),
• roxadustat (used to treat anemia in patients with chronic kidney disease),
• teriflunomida (used to treat multiple sclerosis),
• tafamidis (used to treat a disease called transtiretina amyloidosis),
• 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. The effects of these medicines may be modified by rosuvastatin or may change the effect of rosuvastatin.

If you need to take fusidic acid orally to treat a bacterial infection, you should stop taking this medicine temporarily. Your doctor will tell you when it is safe to start taking rosuvastatin again. Taking rosuvastatin with fusidic acid can rarely cause muscle weakness, sensitivity or pain (rhabdomyolysis). See more information about rhabdomyolysis in section 4.

Pregnancy and breastfeeding

Do not takerosuvastatinif you are pregnant or breastfeeding. If you become pregnant while takingrosuvastatinstop taking it immediatelyand inform your doctor. Women should avoid becoming pregnant during treatment with rosuvastatin using an appropriate contraceptive method.

Consult your doctor or pharmacist before using any medicine.

Driving and operating machines

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

Rosuvastatina Sandoz contains lactose and sodium.

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

The complete list of components can be found inContents of the pack and additional information.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.This medication should be taken exactly as directed by your doctor or pharmacist.In case of doubt, consult your doctor or pharmacist again.

Usual doses in adults

If you are taking rosuvastatina for high cholesterol levels:

Starting dose

Your treatment with rosuvastatina should start with a dose of 5 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,and if you have factors that make you more vulnerable to potential side effects.

• your cholesterol levels,
• the degree of risk you have of having a heart attack or stroke,
• and if you have factors that make you more vulnerable to potential side effects.

Check with your doctor or pharmacist to determine the best starting dose of rosuvastatina for you.

Your doctor may decide to start treatment with the lower dose (5 mg) if:

• you are ofAsian origin(for example, Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian),
• you are over70 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 of rosuvastatina for 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 then to 40 mg, if necessary. There will be a four-week interval between each dose adjustment.

The maximum daily dose of rosuvastatina is 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 rosuvastatina 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 to 17 years

The dose range for children and adolescents aged 6 to 17 years is 5 to 20 mg once a day.

The usual recommended starting dose for treatment is 5 mg per day, and your doctor may gradually increase your dose to reach the appropriate dose of rosuvastatina for your condition. The maximum recommended daily dose of rosuvastatina is 10 mg or 20 mg for children aged 6 to 17 years, depending on the underlying condition being treated. Take the dose indicated by your doctor once a day.Do not administer the 40 mg rosuvastatina tablets to children.

Swallowing the tablets

Swallow each tablet whole with a glass of water.

Take rosuvastatina 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 to visit your doctor regularly for cholesterol level checks to ensure your cholesterol levels have normalized and remain at suitable levels.

Your doctor may decide to increase your dose to ensure you are taking the right dose of rosuvastatina for you.

If you take more Rosuvastatina Sandoz 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 rosuvastatina.

If you have taken moreRosuvastatina Sandozthan you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you forget to take Rosuvastatina Sandoz

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 Sandoz

Consult your doctor if you want to stop taking rosuvastatina. Your cholesterol levels may increase again if you stop taking rosuvastatina.

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).
• Flat, red patches on the trunk, often with central blisters, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. 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:

• Unjustified muscle pain or 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 calledrabdomiolysis,
• Syndrome with symptoms similar to lupus (including urticaria, joint disorders, and effects on blood cells),
• Muscle rupture.

Frequent side effects (may affect up to 1 in 10 people and 1 in 100 people)

• Headache.
• Stomach pain.
• Constipation.
• Nausea.
• Muscle pain.
• Weakness.
• Dizziness.
• An increase in the amount of protein in urine. This usually reverts to normal on its own without the need to interrupt treatment with rosuvastatin tablets (frequent side effect only with a daily dose of 40 mg of rosuvastatin).
• Diabetes. This is more likely if you have high blood sugar and lipid levels, obesity, and high blood pressure. Your doctor will closely monitor you while you are taking this medicine.

Rare side effects (may affect up to 1 in 100 people and 1 in 1,000 people)

• Urticaria, itching, and other skin reactions.
• An increase in the amount of protein in urine. This usually reverts to normal on its own without the need to interrupt treatment with rosuvastatin tablets (rare side effect with daily doses of 5 mg, 10 mg, and 20 mg of rosuvastatin).

Very rare side effects (may affect up to 1 in 1,000 people and 1 in 10,000 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 unjustified muscle pain or crampsthat last longer than expected.
• Intense stomach pain (pancreatitis).
• Increased liver enzymes in the blood.
• Unusual bruising and bleeding due to low platelet count in the blood,
• Syndrome with symptoms similar to lupus (including urticaria, 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 (inflamed liver).
• Traces of blood in the urine.
• Nerve damage in the legs and arms (with numbness and tingling).
• Joint pain.
• Memory loss.
• Enlargement of the breasts in men (gynecomastia).

Side effects of unknown 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 injuries, sometimes resulting in rupture.
• Constant muscle weakness.
• Myasthenia gravis (a disease that causes generalized muscle weakness, which, in some cases, affects the muscles used for breathing).
• Myasthenia ocular (a disease that causes weakness of the eye muscles).

Consultyour doctor if you experience weakness in the 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 theSpanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe box and blister packafter CAD/EXP. The expiration date is the last day of the month indicated.

Shelf life after first opening:

Bottles: 100 days.

Store in the original packaging to protect it from moisture.

This medication does not require special storage temperature.

Medicines should not be disposed of through drains or in the trash. Dispose of containers and unused medicines at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medicines. By doing so, you will help protect the environment.

Composition of Rosuvastatina Sandoz

• The active ingredient is rosuvastatin.

Rosuvastatina Sandoz 5 mg: each tablet contains 5 mg of rosuvastatin (as rosuvastatin calcium).

Rosuvastatina Sandoz 10 mg: each tablet contains 10 mg of rosuvastatin (as rosuvastatin calcium).

Rosuvastatina Sandoz 20 mg: each tablet contains 20 mg of rosuvastatin (as rosuvastatin calcium).

• The other componentsare:

Core: lactose, anhydrous colloidal silica, microcrystalline cellulose, cornstarch, talc, stearate of fumaric acid and sodium.

Coating: hypromellose, mannitol (E 421), macrogol 6000, talc, titanium dioxide (E 171), yellow iron oxide (E 172) or red iron oxide (E 172).

Appearance of the product and contents of the package

Rosuvastatina Sandoz 5 mg

Brown, round, film-coated tablets, approximately 5 mm in diameter.

Rosuvastatina Sandoz 10 mg

Brown, round, film-coated tablets, approximately 6 mm in diameter, marked with “RSV 10” on one side.

Rosuvastatina Sandoz 20 mg

Brown, round, film-coated tablets, approximately 8 mm in diameter, marked with “RSV 20” on one side.

Film-coated tablets are packaged in OPA/Alu/PVC/Alu blisters or HDPE bottles with PP caps and silica gel desiccant, packaged in cardboard containers.

Package sizes

Blister: 7,10, 14, 20, 21, 28, 30, 40, 42, 50, 60, 70, 84, 90, 98 or 100 film-coated tablets.

Bottles: 28, 30, 50, 84, 90 or 100 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible manufacturer

Lek Pharmaceuticals d.d.

Verovškova ulica 57,

1526 Ljubljana

Slovenia

or

Lek S.A.

ul. Domaniewska 50 C,

02-672 Warszawa

Poland

or

S.C. Sandoz, S.R.L.

Str. Livezeni nr. 7A,

Târgu Mures, Mures,

540472 Romania

or

Lek Pharmaceuticals d.d.
Trimlini 2D
9220 Lendava
Slovenia

or

Lek S.A.

Ul. Podlipie 16

95 010 Strykow

Poland

Last review date of thisleaflet:February 2025

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