ROSUVASTATIN VIATRIS 10 mg FILM-COATED TABLETS

2. What you need to know before you take Rosuvastatina Viatris

Do not take Rosuvastatina Viatris

• If you are allergic to rosuvastatina or any of the other ingredients of this medicine (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 have repeated or unexplained muscle weakness, pain, or cramps.
• If you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir (used to treat a viral liver infection called hepatitis C).
• If you are taking a medicine called ciclosporin (used, for example, after an organ transplant).

If you are in any of the above situations (or are unsure), please consult your doctor.

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

• If you have moderate kidney problems (if in doubt, consult your doctor).
• If your thyroid gland does not work 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 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 are taking other medicines called fibrates to lower cholesterol.

If you are 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 general muscle weakness, which can affect the muscles used for breathing) or ocular myasthenia (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 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 medicines.
• If you have ever developed a severe skin rash or peeling of the skin, blisters, and/or sores in the mouth after taking rosuvastatina or other related medicines.
• If you regularly drink large amounts of alcohol.
• If your thyroid gland does not work correctly.
• If you are taking other medicines called fibrates to lower cholesterol. Read this leaflet carefully, even if you have taken cholesterol-lowering medicines before.
• If you are taking medicines to treat HIV infection, such as lopinavir/ritonavir, and/or atazanavir, see "Other medicines and Rosuvastatina Viatris".
• If you are taking or have taken in the last 7 days a medicine called fusidic acid (used to treat bacterial infections) by mouth or by injection. The combination of fusidic acid and rosuvastatina can cause serious muscle problems (rhabdomyolysis). See section "Other medicines and Rosuvastatina Viatris".
• If you have severe respiratory problems.
• If you are of Asian origin (for example, Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor will determine the appropriate starting dose of Rosuvastatina Viatris for you.

If you are 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

Tell your doctor or pharmacist immediately if you have unexplained muscle pain, tenderness, or weakness, especially if you also feel unwell or have a fever. Consult your doctor or pharmacist if you have persistent muscle weakness. You may need to have tests and additional medicines to diagnose and treat this.

Tell your doctor or pharmacist if you develop a persistent cough, shortness of breath, or difficulty breathing. This medicine may cause scarring of the lungs and you may need to be reviewed by your doctor.

Be careful while taking 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 treatment. Stop taking 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 can be identified by a simple blood test, which looks for increased levels of liver enzymes in the blood. For this reason, your doctor will usually do this blood test (liver function test) before and during treatment with Rosuvastatina Viatris.

While you are taking this medicine, 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 levels of sugar and fat in your blood, are overweight, and have high blood pressure.

Children and adolescents

• If the patient is under 6 years old:rosuvastatina should not be given to children under 6 years old.
• If the patient is under 18 years old:rosuvastatina 40 mg should not be given to children and adolescents under 18 years old.

Elderly patients

• If you are over 70 years old (as your doctor will determine the appropriate starting dose of rosuvastatina for you).

Other medicines and Rosuvastatina Viatris

• Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including:
• Ciclosporin (used, for example, after an organ transplant).
• Warfarin, ticagrelor, or clopidogrel (or any other anticoagulant medicine).
• Fibrates (such as gemfibrozil, fenofibrate) or any other medicine used to lower cholesterol (such as ezetimibe).
• Medicines for indigestion (used to neutralize stomach acid).
• Erythromycin (an antibiotic).
• Fusidic acid (an antibiotic - see also "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).
• 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).

The effects of these medicines may be altered by rosuvastatina or may alter the effect of rosuvastatina.

If you have to take fusidic acid by mouth to treat a bacterial infection, you will have to stop taking this medicine. Your doctor will tell you when you can restart treatment with rosuvastatina. The use of rosuvastatina with fusidic acid can cause muscle weakness, tenderness, 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

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

Rosuvastatina Viatris contains lactose

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

The complete list of ingredients is in section 6 of this leaflet.

3. How to take Rosuvastatina Viatris

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

Usual dose in adults

If you are taking Rosuvastatina Viatris for high cholesterol:

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 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.
• If you have factors that make you more vulnerable to possible side effects.

Check with your doctor or pharmacist what the best starting dose of rosuvastatina is for you.

Your doctor may decide to start treatment with the lowest 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 are at risk of having muscle pain or cramps (myopathy).

Dose increase and maximum daily dose

Your doctor may decide to increase your dose. This is so that you are taking the dose of rosuvastatina that is right 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 an interval of four weeks between each dose adjustment.

The maximum daily dose of rosuvastatina is 40 mg. This dose is only for patients with high cholesterol 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, stroke, or related health problems:

The recommended dose is 20 mg once 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 recommended starting dose is 5 mg once daily. Your doctor may gradually increase your dose to achieve the dose of rosuvastatina that is right to treat 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 prescribed by your doctor once daily. Do notgive rosuvastatina 40 mg to children.

Taking the tablets

Swallow each tablet whole with water.

Take rosuvastatina once daily. You can take it at any time of day, with or without food.

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

Regular checks of cholesterol levels

It is important that you visit your doctor regularly to have your cholesterol levels checked, to ensure that your cholesterol levels have returned to normal and are being maintained at appropriate levels.

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

If you take more Rosuvastatina Viatris 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, telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you are admitted to hospital or receive treatment for another condition, inform the medical staff that you are taking rosuvastatina.

If you forget to take Rosuvastatina Viatris

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

If you stop taking Rosuvastatina Viatris

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

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

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 may be. They are usually mild and disappear in a short period, however, some can be severe and require medical attention.

Stop taking rosuvastatina and seek medical attention immediately if you experience any of the following allergic reactions 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 can cause difficulty swallowing.
• Intense itching of the skin (with hives).
• Red patches on the trunk, not elevated, in a target or circular shape, 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 rosuvastatina and consult your doctor immediately if you experiencerepeated or unjustified muscle weaknessthat lasts 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.

You may also observe the following adverse effects that could be signs of a serious problem. Seek medical help immediately if you observe any of the following symptoms:

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

• Respiratory problems, including persistent cough and/or shortness of breath or fever (can be signs of scarring in the lungs, known as interstitial lung disease).
• Lupus-like syndrome (which includes skin rash, joint disorders, and effects on blood cells
• Muscle rupture (muscle damage due to muscle fiber rupture; symptoms can include pain, swelling, bruising, sensitivity, and loss of function).

Other possible adverse effects

Common (may affect up to 1 in 10 people):

• Headache.
• Stomach pain.
• Constipation.
• Feeling unwell.
• Muscle pain.
• Weakness.
• Dizziness.
• An increase in the amount of protein in the urine – this usually reverses on its own without the need to interrupt treatment with rosuvastatina (only with the 40 mg dose).

Uncommon (may affect up to 1 in 100 people):

• Hives, itching, skin rash with raised bumps (hives).
• An increase in the amount of protein in the urine – this usually reverses on its own without the need to interrupt treatment with rosuvastatina (only with the 5 mg, 10 mg, and 20 mg doses).

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

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

Very rare (may affect up to 1 in 10,000 people):

• Traces of blood in the urine.
• Joint pain.
• Memory loss.
• Enlargement of the breasts 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 ruptures or tears.
• 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 difficulty breathing.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed 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 Rosuvastatina Viatris

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiration date stated on the packaging/blister/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.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection 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 Rosuvastatina Viatris

The active ingredient is rosuvastatina.

Each tablet contains 10 mg of rosuvastatina (as rosuvastatina calcium).

The other ingredients 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 package contents

Film-coated tablets, biconvex, round, pink, marked with "M" on one side and "RS1" on the other.

Rosuvastatina 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 cap that contains a desiccant. Do not eat the desiccant.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

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

You can request more information about this medicine by contacting 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 10 mg filmomhulde tabletten

Bulgaria: Rosuvastatin Viatris 10 mg

Cyprus: Rosuvastatin Mylan 10 mg Film-coated Tablets

Croatia: Rosacol 10 mg filmom obložene tablete

Denmark: Rosuvastatin Viatris 10 mg

Spain: Rosuvastatina Viatris 10 mg comprimidos recubiertos con película EFG

France: Rosuvastatine Viatris 10 mg comprimé pelliculé

Greece: Rosuvastatin / Mylan

Ireland: Rosuvastatin Viatris 10 mg film-coated tablet

Italy: Rosuvastatina Mylan

Luxembourg: Rosuvastatine Viatris 10 mg comprimés pelliculés

Netherlands: Rosuvastatine Mylan 10 mg filmomhulde tabletten

Portugal: Rosuvastatina Mylan

United Kingdom (Northern Ireland): Rosuvastatin 10 mg film-coated tablets

Czech Republic: Rosuvastatin Viatris

Sweden: Rosuvastatin Viatris 10 mg

Date of the last revision of this leaflet:February 2025

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