Rosuvastatin Sun 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Rosuvastatin SUN 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 must not be given 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 adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Rosuvastatin SUN is and what it is used for
2. What you need to know before taking Rosuvastatin SUN
3. How to take Rosuvastatin SUN
4. Possible side effects
5. How to store Rosuvastatin SUN
6. Contents of the pack and other information

1. What Rosuvastatin film-coated tablets are and what they are used for

Rosuvastatin SUN belongs to a group of medicines 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 stroke.
• Rosuvastatin SUN is used in adults, adolescents, and children aged 6 years and older to treat high cholesterol.
• Your doctor has advised you to take a statin because changes to your diet and increased physical activity have not been sufficient to correct your cholesterol levels. You must maintain a cholesterol-lowering diet and continue exercising while taking Rosuvastatin SUN.

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 disease called atherosclerosis. Atherosclerosis is caused by the buildup of fatty deposits in your arteries.

Why is it important that you continue taking Rosuvastatin SUN?

Rosuvastatin SUN 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 SUN reduces 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 you feel, as they produce no symptoms. However, if left untreated, fatty deposits can build up in the walls of blood vessels, causing them to narrow.

Sometimes, these narrowed blood 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 having a heart attack, stroke, or related health problems.

You need to continue taking Rosuvastatin SUN, even after your cholesterol levels have returned to normal, because it prevents cholesterol levels from rising again and forming 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 SUN

Do not take Rosuvastatin SUN

• If you have ever had an allergic reaction to rosuvastatin 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 rosuvastatin, stop taking it immediately and inform your doctor. Women should avoid becoming pregnant during treatment with rosuvastatin.
• If you have liver disease.
• If you have severe kidney problems.
• If you experience repeated or unexplained muscle 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 situations listed above (or are unsure), please consult your doctor again.

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

• If you have moderate kidney problems (if in doubt, consult your doctor).
• If your thyroid gland is not functioning properly.
• If you experience repeated or unexplained muscle pain or cramps, 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 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 situations listed above (or are unsure), please consult your doctor again.

Warnings and precautions

Talk to your doctor or pharmacist before starting Rosuvastatin SUN.

• If you have kidney problems.
• If you have liver problems.
• If you experience repeated or unexplained muscle pain or cramps, have 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 experience unexplained muscle pain or cramps, especially if accompanied by general malaise or fever. Also inform your doctor or pharmacist if you experience persistent muscle weakness.
• If you have or have had myasthenia (a condition characterized by generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a condition 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 ever developed a severe skin rash, 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 gland is not functioning properly.
• 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 (AIDS virus), such as ritonavir with lopinavir and/or atazanavir; see Taking Rosuvastatin SUN with other medicines.
• If you are taking or have taken within the last 7 days a medicine called fusidic acid (a medicine for bacterial infection), taken orally or by injection. The combination of fusidic acid and rosuvastatin may cause serious muscle problems (rhabdomyolysis); please see “Taking Rosuvastatin SUN with other medicines”.
• If you are over 70 years old, as your doctor must determine the appropriate starting dose of rosuvastatin for you.
• If you have severe respiratory failure.
• 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 for you.

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

• Do not take the highest dose of rosuvastatin (40 mg) and consult your doctor or pharmacist before starting 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 SUN 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 showing increased levels of liver enzymes (transaminases). For this reason, your doctor will usually perform this blood test (liver function test) before and after starting treatment with rosuvastatin.

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

Other medicines and Rosuvastatin SUN

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

• cyclosporine (used after organ transplantation),
• warfarin, ticagrelor, or clopidogrel (or any other anticoagulant, such as acenocoumarol),
• 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 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 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 and vadadustat (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 they may alter the effect of rosuvastatin.

• If you need to take oral fusidic acid to treat a bacterial infection, you will need to temporarily stop taking this medicine. Your doctor will advise you when it is safe to restart rosuvastatin. Using Rosuvastatin SUN with fusidic acid may rarely 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.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Most patients can drive and operate machinery while being treated with 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 SUN contains lactose and sodium

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

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

For the full list of ingredients, see section Contents of the pack and other information below.

3. How to take Rosuvastatina SUN

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Usual doses in adults

If you are taking rosuvastatin 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 adverse effects.

Check with your doctor or pharmacist which starting dose of rosuvastatin is best for you.

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

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

??If you are over 70 years old.

??If you have moderate kidney problems.

??If you are at risk of muscle pain and cramps (myopathy).

Dose increase and maximum daily dose

Your doctor may decide to increase your dose so that you take the rosuvastatin dose appropriate for you. If you started with a 5 mg dose, 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 10 mg dose, 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 rosuvastatin is 40 mg. This dose is only for patients with high cholesterol levels 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 to 17 years

The dose range for children and adolescents aged 6 to 17 years is 5 mg to 20 mg once daily. The usual starting dose is 5 mg per day, and your doctor may gradually increase the dose until reaching the rosuvastatin dose appropriate for you. The recommended maximum 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.

How to take the tablets

Swallow each tablet whole with water.

Take rosuvastatin once a day. 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 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 so that you are taking the rosuvastatin dose appropriate for you.

If you take more Rosuvastatina SUN than you should

Contact your doctor or nearest hospital for advice.

If you go to a hospital or receive treatment for another illness, inform your medical team that you are taking Rosuvastatina SUN.

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 medicine and the amount ingested.

If you forget to take Rosuvastatina SUN

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

If you stop taking Rosuvastatina SUN

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

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

4. Possible adverse effects

Like all medicines, this medicine may 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.

Stop taking rosuvastatin and seek immediate medical attention if 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.
• Severe itching of the skin (with hives).
• Reddish, flat, non-elevated 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 consult your doctor immediately:

• If you experience unexplained muscle pain and cramps that last 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 called rhabdomyolysis.
• If you experience muscle breakdown.
• If you develop a syndrome with symptoms similar to lupus (including rash, joint disorders, and effects on blood cells).

Common adverse effects (may affect up to 1 in 10 people)

??Headache,

??Stomach pain,

??Constipation,

??Nausea,

??Muscle pain,

??Weakness,

??Dizziness,

??An increase in the amount of protein in the urine – this usually returns to normal on its own without the need to discontinue treatment with rosuvastatin tablets (common adverse effect only with the 40 mg daily dose of rosuvastatin).

??Diabetes. This occurs more frequently in patients with high levels of sugar and fats in the blood, in cases of overweight and high blood pressure. Your doctor will monitor you while you are taking this medicine.

Uncommon adverse effects (may affect up to 1 in 100 people)

??Hives, itching, and other skin reactions.

??An increase in the amount of protein in the urine – this usually returns to normal on its own without the need to discontinue treatment with rosuvastatin tablets (uncommon adverse effect with the 5 mg, 10 mg, and 20 mg daily doses of rosuvastatin).

Rare adverse 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, and intense itching of the skin (with hives). If you think you are having an allergic reaction, stop taking rosuvastatin and seek immediate medical attention.

??Muscle injury in adults – as a precaution, stop taking rosuvastatin and consult your doctor immediately if you have unexplained muscle pain or cramps that last longer than expected.

??Severe stomach pain (possible sign of pancreas inflammation).

??Increase in liver enzymes (transaminases) in blood.

??Bleeding or bruising more easily than normal due to decreased platelet levels in the blood.

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

Very rare adverse 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 arms and legs (with numbness or tingling),

??Joint pain,

??Memory loss,

??Breast enlargement in men (gynecomastia)

Adverse effects with unknown frequency (cannot be estimated from available data)

??Diarrhea (loose stools),?

??Cough,

??Shortness of breath,

??Edema (swelling),

??Sleep disturbances, including insomnia and nightmares,

??Sexual difficulties,

??Depression,

??Respiratory problems, including persistent cough and/or shortness of breath or fever, tendon injuries, and constant muscle weakness.

• Myasthenia gravis (a disease that causes generalized muscle weakness which, 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 the 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 not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rosuvastatin SUN

??Keep this medicine out of the sight and reach of children.

??Do not use this medicine after the expiry date which is stated on the packaging/blister after EXP. The expiry date refers to the last day of the month indicated.

??Do not store above 30°C. Keep in the original packaging.

Medicines should not be disposed of via wastewater or household waste. Unused containers and medicines should be taken to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and unwanted medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rosuvastatin SUN

The active substance in Rosuvastatin SUN is rosuvastatin. Rosuvastatin SUN 5 mg contains calcium rosuvastatin equivalent to 5 mg of rosuvastatin.

The other components are: lactose monohydrate, microcrystalline cellulose, crospovidone, magnesium stearate, sodium citrate, Opadry Yellow (hypromellose, titanium dioxide (E171), polyethylene glycol 400, iron oxide yellow (E172)).

Nature of the medicine and contents of the pack

Rosuvastatin SUN 5 mg are yellow to light yellow, film-coated, round tablets, engraved with "RT 1" on one side and smooth on the reverse side.

Rosuvastatin SUN is available in packs of 7, 14, 15, 20, 28, 30, 42, 50, 56, 60, 84, 90, 98 and 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132JH Hoofddorp, The Netherlands

Manufacturer:

Terapia SA

Str. Fabricii nr. 124, Cluj Napoca 400 632

Romania

Or

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH, Hoofddorp,

The Netherlands

Local representative

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya, 53-55

08007 Barcelona, Spain

Tel.: +34 93 342 78 90

Date of the most recent review of this leaflet: January 2026

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/