Label: Information for the User

Rosuvastatina Viatris 20 mg Film-Coated Tablets

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

• Keep this label, you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4

6. Contents of the pack and additional information

Rosuvastatina Viatriscontains the active ingredient rosuvastatina, which belongs to a group of medications called statins.

You have been prescribedthis medicationbecause:

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

You have been told to take a statin because changes made to your diet and increased physical exercise have not been enough to correct your cholesterol levels. You must maintain a diet that helps to lower cholesterol and continue exercising while on treatment with rosuvastatina.

Or

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

A heart attack, stroke, and other health 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 Rosuvastatina Viatris:

• Rosuvastatina 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).
• Rosuvastatina decreases the amount of bad cholesterol and increases 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 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, preventing blood supply to the heart or brain, causing a heart attack or stroke. By lowering your cholesterol levels, you can reduce the risk of having a heart attack, stroke, or other health problems.
• You need to continue taking rosuvastatina, even if you have achieved the correct cholesterol levels, as it prevents 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 Viatris

• If you are allergic to rosuvastatina or any of the other ingredients of this medication (listed in section 6).
• If you are pregnant or breastfeeding. If you become pregnant while taking rosuvastatina, stop taking it immediately and inform your doctor. Women should avoid becoming pregnant during treatment with rosuvastatina using an appropriate contraceptive method.
• If you have liver disease.
• If you have severe kidney problems.
• If you haverepeated or unexplained muscle weakness,muscle pain,or cramps.
• If you take a combination of sofosbuvir/velpatasvir/voxilaprevir (used for 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 above situations (or are unsure), please consult your doctor.

Additionally, do not take rosuvastatina 40mg (the highest dose):

• If you have moderate kidney problems (if in doubt, consult your doctor).
• If your thyroid gland does not function correctly.
• If you have repeated or unexplained 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 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 take other medications called fibrates to 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 Viatris:

• If you have or have had myasthenia (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (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 kidney problems.
• If you have liver problems.
• If you have a personal or family history of muscle problems or a previous history of muscle problems during treatment with other cholesterol-lowering medications.
• If you have ever developed a severe skin rash or skin peeling, blisters, and/or mouth sores after taking rosuvastatina or other related medications.
• If you regularly consume large amounts of alcohol.
• If your thyroid gland does not function correctly.
• If you take other medications called fibrates to lower cholesterol. Read this leaflet carefully, even if you have taken cholesterol-lowering medications previously.
• If you take medications to treat HIV infection, such as lopinavir/ritonavir,and/oratazanavir,see “Other medications and Rosuvastatina Viatris”.
• If you are takingor have takenin the last 7daysa medication calledacid fusidic(used for bacterial infection)treatment by mouthor by injection.Thecombination of acidfusidicand rosuvastatina may produce severe muscle problems(rhabdomyolysis).See section “Other medications and Rosuvastatina Viatris”.
• If you have severe respiratory failure.
• If you are of Asian origin (for example, Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor should establish the starting dose of Rosuvastatina Viatris suitable for you.

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

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

During treatment

Inform your doctor or pharmacist immediately if you have unexplained or repeated muscle pain or cramps, especially if you have general discomfort or fever. Consult your doctor or pharmacist if you have persistent muscle weakness. You may need additional tests and medications to diagnose and treat it.

Inform your doctor or pharmacist if you develop persistent cough, shortness of breath, or difficulty breathing. This medication may cause lung scarring and may need to be reviewed by your doctor.

Be especially careful with Rosuvastatina Viatris:

Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with Rosuvastatina Viatris treatment. Stop using Rosuvastatina Viatris 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 identified by a simple test that looks for an increase in liver enzymes in the blood. For this reason, your doctor usually performs this blood test (liver function test) before and during treatment with Rosuvastatina Viatris.

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

Children and adolescents

• If the patient is under 6years:rosuvastatina should not be administered to children under 6years.
• If the patient is under 18 years:rosuvastatina 40 mg should not beadministered to children andadolescentsunder 18 years.

Older adults

• If you are over 70 years old (as your doctor should establish the starting dose of rosuvastatina suitable for you).

OthermedicationsandRosuvastatina Viatris

• Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including the following:
• Ciclosporina (used, for example, after an organ transplant).
• Warfarina, ticagreloror clopidogrel (or any other anticoagulant medication).
• Fibrates (such as gemfibrozilo, fenofibrato) or any other medication used to lower cholesterol (such as ezetimiba).
• Medications for indigestion (used to neutralize stomach acid).
• Eritromicina (an antibiotic).
• Acid fusidic (an antibiotic - please 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,, 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 transtiretina amyloidosis).

The effects of these medications may be modified by rosuvastatina or may change the effect of rosuvastatina.

If you have totake acidfusidicoral to treata bacterial infectionyou will have tostop usingthis medication.Your doctorwill indicatewhen you canreinitiatethe treatment withrosuvastatina.The use ofrosuvastatinawith acidfusidic may producemuscle weakness, sensitivity or pain (rhabdomyolysis).For more information on rhabdomyolysis, see section 4.

Pregnancy and breastfeeding

Do not take rosuvastatina if you are pregnant or breastfeeding. If you become pregnant while taking rosuvastatina, stop taking it immediately and inform your doctor. Women should avoid becoming pregnant during treatment with rosuvastatina using 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 taking this medication.

Driving and operating machinery

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

Rosuvastatina Viatris contains lactose

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.

The complete list of components can be found insection 6 of this leaflet.

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

Usual doses in adults

If you are taking Rosuvastatina Viatris 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.
• 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 of rosuvastatina for you.

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

• You are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
• You are over 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 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 6-17 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 is 5 mg per day. Your doctor may increase your dose gradually to reach the dose of rosuvastatina that is right for treating 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 disease being treated. Take the dose indicated by your doctor once a day.Do notadminister 40 mg doses of rosuvastatina to children.

Swallowing the tablets

Swallow each tablet whole with water.

Take rosuvastatina once a day. You can take it at any time of the daywithorwithoutfood.

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 visit your doctor regularly for cholesterol checks, to ensure that your cholesterol levels have normalized and remain at appropriate 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 Viatris than you should

Contact your doctor or nearest hospital for advice.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

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

If you forget to take Rosuvastatina Viatris

Do not worry, simply take the next scheduled dose at the scheduled time. Do not take a double dose to compensate for a missed dose.

If you interrupt treatment with Rosuvastatina Viatris

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

Consult your doctor or pharmacist if you have any doubts about the use of this medication.

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, however, some may be serious and require medical attention.

Stop taking rosuvastatin and seek medical attention immediately if you experience any of the following allergic or skin 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 target 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 experiencerepeated or unexplained muscle weakness that lasts 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.

Also, you may observe the following side effects that could be signs of a serious problem. Seek medical help immediately if you observe any of the following symptoms::

• Feeling extremely tired or thirsty, urinating more frequently than usual, especially at night – these may be symptoms of 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.
• Severe stomach pain that extends to the back (may be a possible sign of pancreatitis inflammation).
• Easy bruising or bleeding, which may be a sign of low platelet count in the blood (thrombocytopenia).
• Yellowing of the skin and eyes (jaundice), with fever, abdominal pain, pale stools, or dark urine (may be signs of liver problems).
• Numbness, tingling, or burning sensations in the legs and arms (may be signs of nerve damage).

• Respiratory problems, including persistent cough and/or shortness of breath or fever (may be signs of lung scarring, known as interstitial lung disease).
• Syndrome similar to lupus disease (which includes skin rash, joint disorders, and effects on blood cells
• Muscle rupture (muscles damaged due to muscle fiber rupture; symptoms may include pain, swelling, bruises, sensitivity, and loss of function).

Other possible side effects

Frequent (may affect1 in 10 people):

• Headache.
• Stomach pain.
• Constipation.
• Uncomfortable feeling.
• 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 stop taking rosuvastatin (only with the 40 mg dose).

Rare (may affect1 in 100 people):

• Urticaria, itching, skin rash with raised bumps (urticaria).
• An increase in the amount of protein in urine – this usually reverts to normal on its own without the need to stop taking rosuvastatin (only with the 5 mg, 10 mg, and 20 mg doses).

Very rare (may affect1 in 1,000 people):

• Increased liver enzymes in the blood, observed in blood tests.

Very rare (may affect1 in 10,000 people):

• Traces of blood in urine.
• Joint pain.
• Memory loss.
• Enlargement of breast tissue in men (gynecomastia).

Frequency not known(cannot be estimated from available data):

• Diarrhea (loose stools).
• Cough.
• Shortness of breath.
• Swelling (edema).
• Sleep disturbances, including insomnia and nightmares.
• Sexual difficulties.
• Depression.
• Tendon injuries, sometimes exacerbated by tears or ruptures.
• 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).

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 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 use this medication after the expiration date that appears on the packaging/container/label after CAD or EXP. The expiration date is the last day of the month indicated.
• Store below 25°C. Store in the original packaging to protect it from moisture.
• Rosuvastatina Viatris supplied in bottles should not be used after 3 months from the first opening of the bottle.

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. If in doubt, 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 RosuvastatinViatris

The active ingredient is rosuvastatin.

Each tablet contains 20 mg of rosuvastatin (as rosuvastatin calcium).

The other components are:

Core of the tablet:

Microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silica, crospovidone, magnesium oxide, magnesium stearate, red iron oxide (E-172).

Coating:

Lactose monohydrate, hypromellose (E-464), titanium dioxide (E-171), triacetin, yellow iron oxide (E-172), red iron oxide (E-172), black iron oxide (E-172).

Appearance of the product and contents of the package

Film-coated, biconvex, round, pink tablets, marked with “M” on one face and “RS2” on the other.

Rosuvastatin Viatris is available in blister packs of 14, 15, 28, 30, 56, 60, 84, 90, and 98 tablets or in plastic bottles of 28, 30, 56, 60, 84, and 90 tablets.

The bottles have a screw-top cap containing a desiccant. Do not eat the desiccant.

Not all package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible manufacturer

McDermott Laboratories Ltd. T/A Gerard Laboratories,

35/36 Baldoyle Industrial Estate, Grange Road,

Dublin 13, Ireland

or

Generics (UK) Limited,

Station Close, Potters Bar,

EN6 1TL, United Kingdom

or

Mylan Hungary Ltd.

Mylan utca 1.

Komárom, 2900

Hungary

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicine is authorized in the EEA member states and in the United Kingdom (Northern Ireland) under the following names:

Belgium:Rosuvastatine Viatris 20 mg filmomhulde tabletten

Bulgaria:Rosuvastatin Viatris 20 mg

Cyprus:Rosuvastatin Mylan 20 mg Film-coated Tablets

Croatia:Rosacol 20 mg filmom obložene tablete

Denmark:Rosuvastatin Viatris 20 mg

Spain:Rosuvastatina Viatris 20 mg comprimidos recubiertos con película EFG

France:Rosuvastatine Viatris 20 mg comprimé pelliculé

Greece:Rosuvastatin / Mylan

Ireland:Rosuvastatin Viatris 20 mg film-coated tablet

Italy:Rosuvastatina Mylan

Luxembourg:Rosuvastatine Viatris 20 mg comprimés pelliculés

Netherlands:Rosuvastatine Mylan 20 mg filmomhulde tabletten

Portugal:Rosuvastatina Mylan

United Kingdom (Northern Ireland): Rosuvastatin 20 mg film-coated tablets

Czech Republic:Rosuvastatin Viatris

Sweden:Rosuvastatin Viatris 20 mg

Last review date of this leaflet:February 2025

For detailed information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)https://www.aemps.gob.es/