Rosuvastatin Viatris 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Rosuvastatin Viatris 5 mg film-coated tablets EFG

Read the entire 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, and you must not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Rosuvastatin Viatris is and what it is used for
2. What you need to know before taking Rosuvastatin Viatris
3. How to take Rosuvastatin Viatris
4. Possible side effects
5. How to store Rosuvastatin Viatris

Contents of the pack and other information

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

Rosuvastatina Viatris contains the active substance rosuvastatin, which belongs to a group of medicines known as statins.

Your doctor has prescribed this medicine because:

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

You have been advised to take a statin because changes to your diet and increased physical activity have not been sufficient to correct your cholesterol levels. You must continue to follow a cholesterol-lowering diet and maintain regular physical activity while taking rosuvastatin.

Or

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

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

Why it is important that you continue taking Rosuvastatina Viatris:

• Rosuvastatin is used to correct levels of fatty substances in the blood called lipids, the most well-known being cholesterol.
• There are different types of cholesterol in the blood: “bad” cholesterol (LDL-C) and “good” cholesterol (HDL-C).
• Rosuvastatin lowers the amount of “bad” cholesterol and increases “good” cholesterol.
• It works by blocking the production of “bad” cholesterol and improves the body’s ability to remove it from the blood.
• In most people, high cholesterol does not cause any symptoms and therefore does not affect how they feel. However, if left untreated, fatty deposits can build up in the walls of blood vessels, causing them to narrow.
• Sometimes, these narrowed vessels can become blocked, cutting off blood supply to the heart or brain, leading to a heart attack or stroke. By lowering your cholesterol levels, you can reduce the risk of heart attack, stroke, or other related health problems.
• You need to keep taking rosuvastatin even after your cholesterol levels have reached the desired level, as it prevents cholesterol levels from rising again and stops the formation of fatty deposits. However, you should stop treatment if your doctor advises you to do so, or if you become pregnant.

2. What you need to know before taking Rosuvastatin Viatris

Do not take Rosuvastatin Viatris

• If you are allergic to rosuvastatin or to any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant or 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 by 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 for a viral liver infection called hepatitis C).
• If you are taking a medicine called cyclosporine (used, for example, after organ transplantation).

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

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

• If you have moderate kidney problems (if in doubt, consult your doctor).
• If your thyroid gland is not functioning properly.
• 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 consume large amounts of alcohol.
• If you are of Asian origin (e.g., 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 Rosuvastatin Viatris:

• If you have or have had myasthenia (a disease characterized by generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).
• If you have kidney problems.
• If you have liver problems.
• If you have, or 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, skin peeling, blisters, and/or mouth sores after taking rosuvastatin or related medicines.
• If you regularly consume large amounts of alcohol.
• If your thyroid gland is not functioning properly.
• If you are taking other medicines called fibrates to lower cholesterol. Read this leaflet carefully, even if you have previously taken cholesterol-lowering medicines.
• If you are taking medicines to treat HIV infection, such as lopinavir/ritonavir, and/or atazanavir; see “Other medicines and Rosuvastatin Viatris”.
• If you are taking or have taken within the last 7 days a medicine called fusidic acid (used to treat bacterial infection) by mouth or injection. The combination of fusidic acid and rosuvastatin may cause serious muscle problems (rhabdomyolysis). See section “Other medicines and Rosuvastatin Viatris”.
• If you have severe respiratory insufficiency.
• If you are of Asian origin (e.g., Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor must determine the appropriate starting dose of Rosuvastatin Viatris for you.

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

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

During treatment

Inform your doctor or pharmacist immediately if you experience unexplained or repeated muscle pain or cramps, especially if you also feel generally unwell or have a fever. Consult your doctor or pharmacist if you have persistent muscle weakness. You may need additional tests and treatment to diagnose and manage this.

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

Use special caution with Rosuvastatin Viatris:

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

In a small number of people, statins may affect the liver. This is detected by a simple blood test measuring increased levels of liver enzymes. For this reason, your doctor will usually perform this blood test (liver function test) before and during treatment with Rosuvastatin Viatris.

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

Children and adolescents

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

Elderly patients

• If you are over 70 years of age (as your doctor must determine the appropriate starting dose of rosuvastatin for you).

Other medicines and Rosuvastatin Viatris

• Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including the following:
• Cyclosporine (used, for example, after organ transplantation).
• Warfarin, ticagrelor, or clopidogrel (or any other anticoagulant).
• Fibrates (such as gemfibrozil, fenofibrate) or any other medicine used to lower cholesterol (such as ezetimibe).
• Treatments for indigestion (used to neutralize stomach acid).
• Erythromycin (an antibiotic).
• Fusidic acid (an antibiotic – please see below and under “Warnings and precautions”).
• 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 may be altered by rosuvastatin or may change the effect of rosuvastatin.

If you need to take oral fusidic acid to treat a bacterial infection, you must stop taking this medicine. Your doctor will advise you when you can restart treatment with rosuvastatin. Using rosuvastatin with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information about rhabdomyolysis, see section 4.

Pregnancy and breastfeeding

Do not take rosuvastatin if you are pregnant or 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 by using an appropriate contraceptive method.

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

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

Rosuvastatin Viatris contains lactose

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

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

3. How to take Rosuvastatin Viatris

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

Usual doses in adults

If you are taking Rosuvastatin Viatris for high cholesterol levels:

Starting dose

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

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

Check with your doctor or pharmacist to determine the best starting dose of rosuvastatin 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 muscle pain and muscle cramps (myopathy).

Dose increase and maximum daily dose

Your doctor may decide to increase your dose so that you are taking the appropriate dose of rosuvastatin for your condition. If you started with a 5 mg dose, your doctor may decide to double it to 10 mg, then to 20 mg, and later to 40 mg, if necessary. If you started with a 10 mg dose, your doctor may decide to double it 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 rosuvastatin is 40 mg. This dose is only for patients with high cholesterol and a high risk of heart attack or stroke whose cholesterol levels do not decrease sufficiently with 20 mg.

If you are taking rosuvastatin to reduce the risk of 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 for children and adolescents aged 6 to 17 years is 5 mg to 20 mg once daily. The usual recommended starting dose is 5 mg daily. Your doctor may gradually increase your dose until reaching the appropriate dose of rosuvastatin for treating your condition. The maximum recommended daily dose of rosuvastatin is 10 mg or 20 mg for children aged 6 to 17 years, depending on the underlying condition being treated. Take the dose prescribed by your doctor once daily. Doses of 40 mg of rosuvastatin must not be administered to children.

How to take the tablets

Swallow each tablet whole with water.

Take rosuvastatin once daily. You may 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 cholesterol level checks

It is important to visit 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 appropriate dose of rosuvastatin for you.

If you take more Rosuvastatin Viatris than you should

Contact your doctor or nearest hospital for advice.

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

If you are admitted to hospital or receive treatment for another condition, inform healthcare staff that you are taking rosuvastatin.

If you forget to take Rosuvastatin Viatris

Do not worry; simply take the next scheduled dose at the usual time. Do not take a double dose to make up for a missed dose.

If you stop taking Rosuvastatin Viatris

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

Consult your doctor or pharmacist if you have any questions about using this medicine.

4. Possible adverse effects

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

It is important that you are aware of what these adverse effects may be. They are usually mild and disappear within a short period of time; however, some may be serious and require immediate medical attention.

Stop taking rosuvastatin and seek immediate medical attention 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.
• Severe itching of the skin (with hives).
• Reddish, flat spots on the trunk, often circular or target-shaped, sometimes with central blisters, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• Widespread rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Also stop taking rosuvastatin and contact your doctor immediately if you experience unexplained or persistent muscle weakness lasting longer than expected. Muscle symptoms are more common in children and adolescents than in adults. As with other statins, a very small number of people have experienced unpleasant muscle effects, which very rarely have resulted in a potentially fatal muscle injury known as rhabdomyolysis.

You may also experience the following adverse effects, which could be signs of a serious problem. Seek immediate medical help if you notice any of the following symptoms:

• Feeling very tired or thirsty, urinating more often than usual, especially at night – these may be symptoms of diabetes. This is more likely if you have high blood sugar and lipid levels, are overweight, or have high blood pressure. Your doctor will monitor you closely while you are taking this medicine.
• Severe stomach pain spreading to your back (may be a possible sign of pancreas inflammation).
• Bruising or bleeding more often or more easily than usual, which may indicate a low platelet count in the blood (thrombocytopenia).
• Yellowing of the skin and eyes (jaundice), accompanied by fever, abdominal pain, pale stools, or dark urine (may be signs of liver problems).
• Numbness, tingling, or burning sensation in arms and legs (may be signs of nerve damage).
• Breathing problems, including persistent cough and/or shortness of breath or fever (may be signs of lung scarring, known as interstitial lung disease).
• Lupus-like disease syndrome (including skin rash, joint disorders, and effects on blood cells).
• Muscle rupture (damaged muscles due to torn muscle fibers; symptoms may include pain, swelling, bruising, tenderness, 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.
• Increase in the amount of protein in urine – this usually returns to normal on its own without needing to stop treatment with rosuvastatin (only at the 40 mg dose).

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

• Hives, itching, skin rash with raised bumps (urticaria).
• Increase in the amount of protein in urine – this usually returns to normal on its own without needing to stop treatment with rosuvastatin (only at doses of 5 mg, 10 mg, and 20 mg).

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

• Increased liver enzymes in blood, detected in blood tests.

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

• Traces of blood in urine.
• Joint pain.
• Memory loss.
• Enlargement of 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 worsened by ruptures or tears.
• Myasthenia gravis (a disease causing generalized muscle weakness, which in some cases affects the muscles used for breathing).
• Ocular myasthenia (a disease causing weakness of the eye muscles).

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

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rosuvastatin Viatris

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the pack/blister/label after CAD or EXP. The expiry date refers to the last day of the month indicated.
• Store below 25°C. Keep in the original container to protect it from moisture.
• Rosuvastatin Viatris supplied in bottles must not be used more than 3 months after first opening the bottle.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rosuvastatin Viatris

The active substance is rosuvastatin.

Each tablet contains 5 mg of rosuvastatin (as rosuvastatin calcium).

The other components are:

Tablet core:

Microcrystalline cellulose, lactose monohydrate, silica (colloidal anhydrous), 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).

Appearance of the product and contents of the container

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

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

The bottles have screw caps containing 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

Mylan Hungary Ltd.

Mylan utca 1.

Komárom, 2900

Hungary

Further information on this medicinal product is available from the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

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

Belgium: Rosuvastatine Viatris 5 mg filmomhulde tabletten

Cyprus: Rosuvastatin Mylan 5 mg Film-coated Tablets

Croatia: Rosacol 5 mg filmom obložene tablete

Denmark: Rosuvastatin Viatris 5 mg

Spain: Rosuvastatina Viatris 5 mg comprimidos recubiertos con película EFG

France: Rosuvastatine Viatris 5 mg comprimé pelliculé

Greece: Rosuvastatin / Mylan

Ireland: Rosuvastatin Viatris 5 mg film-coated tablet

Italy: Rosuvastatina Mylan

Luxembourg: Rosuvastatine Viatris 5 mg comprimés pelliculés

Netherlands: Rosuvastatine Viatris 5 mg filmomhulde tabletten

Portugal: Rosuvastatina Mylan

United Kingdom (Northern Ireland): Rosuvastatin 5 mg film-coated tablets

Sweden: Rosuvastatin Viatris 5 mg

Date of the most recent revision of this leaflet: April 2026

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