ROSUVASTATIN SUN 10 mg FILM-COATED TABLETS

2. What you need to know before taking Rosuvastatin SUN

Do not take Rosuvastatin SUN

If you are allergic (hypersensitive) to the active substanceor to any of the other components of this medication (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 have repeated or unexplained muscle pain or weakness.

• If you are taking a combination of medications sofosbuvir/velpatasvir/voxilaprevir(used to treat a viral liver infection called hepatitis C)

If you are taking a medication called cyclosporin(used, for example, after an organ transplant).

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

Additionally, 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 working correctly.

If you have repeated or unexplained muscle pain or weakness, a personal or family history of muscle problems, or a history of muscle problems during treatment with other cholesterol-lowering medications.

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 medications called fibratesto lower cholesterol.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rosuvastatin SUN.

If you have kidney problems.

If you have liver problems.

• If you have repeated or unexplained muscle pain or weakness, a personal or family history of muscle problems, or a history of muscle problems during treatment with other cholesterol-lowering medications. Inform your doctor immediately if you have unexplained muscle pain or weakness, especially if you have general discomfort or fever. Also, inform your doctor or pharmacist if you have constant muscle weakness.
• If you have 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 can sometimes worsen the disease or cause myasthenia (see section 4).

• If you have ever developed a severe skin rash or peeling of the skin, blisters, and/or sores in the mouthafter taking rosuvastatin or other related medications.

If you regularly drink large amounts of alcohol.

If your thyroid gland is not working correctly.

If you are taking other medications called fibratesto lower cholesterol. Read this package leaflet carefully, even if you have taken cholesterol-lowering medications before.

If you are taking medications to treat HIV infection(such as ritonavir with lopinavir and/or atazanavir), see Taking Rosuvastatina SUN and other medications.

If you are taking or have taken in the last 7 days a medication called fusidic acid(an antibiotic), orally or by injection. The combination of fusidic acid and rosuvastatin can rarely cause serious muscle problems (rhabdomyolysis), see section 4.

If you are over 70 years old, as your doctor will need to determine the appropriate starting dose of rosuvastatin 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 will need to determine the appropriate starting dose of rosuvastatin for you.

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

Do not take the highest dose of rosuvastatin 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), have been reported with rosuvastatin treatment. Stop using Rosuvastatina SUN 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 blood test that checks for increased levels of liver enzymes (transaminases) in the blood. For this reason, your doctor will normally perform this blood test (liver function test) before and after treatment with rosuvastatin.

While taking this medication, your doctor will closely monitor you if you have diabetes or are at risk of developing diabetes. You are likely to 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 old: Rosuvastatin should not be administered to children under 6 years old.
• If the patient is under 18 years old: The 40 mg rosuvastatin tablets should not be administered to children and adolescents under 18 years old.

Other medications and Rosuvastatina SUNInform your doctor or pharmacist if you are taking, have recently taken, or might take any other medications.

Tell your doctor if you are using any of the following medications:

• cyclosporin (used after an organ transplant)
• warfarin, ticagrelor, or clopidogrel (or any other anticoagulant medication, such as acenocoumarol)
• fibrates (such as gemfibrozil, fenofibrate), or any other medication used to lower cholesterol (such as ezetimibe)
• indigestion treatments (used to neutralize stomach acid)
• erythromycin (an antibiotic), fusidic acid (an antibiotic - see also 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 uric acid levels in the blood),
• teriflunomide (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.

The effects of these medications 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 will need to stop taking this medication temporarily. Your doctor will tell you when it is safe to restart rosuvastatin. The use of Rosuvastatina SUN with fusidic acid can rarely cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on 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 using an appropriate contraceptive method.

Consult your doctor or pharmacist before using any medication.

Driving and using machines

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

Rosuvastatina SUN contains lactose and sodium

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

This medication contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

The complete list of ingredients can be found in the Package contents and additional informationsection later.

3. How to take Rosuvastatina SUN

Follow the instructions for administration of this medication indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Usual doses in adults

If you are taking rosuvastatin for high cholesterol:

Starting dose

Your treatment with rosuvastatin 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 degree of risk you have of having a heart attack or stroke.

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

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

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

If you are of Asian origin (for example, 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 having muscle pain or weakness (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 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 rosuvastatin 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 sufficiently with 20 mg.

If you are taking rosuvastatin to reduce the risk of having a heart attack, 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 above factors.

Use in children and adolescents aged 6 to 17 years

The dose range in 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 the appropriate dose of rosuvastatin is reached for you. The maximum recommended daily dose of rosuvastatin 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 daily. Taking the tablets

Swallow each tablet whole with water.

Take rosuvastatin once a day.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 cholesterol level checks

It is essential to visit your doctor regularly for cholesterol checks to ensure that your cholesterol levels have normalized and are being maintained 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 Rosuvastatina SUN than you should

Contact your doctor or the nearest hospital for advice.

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

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 medication and the amount ingested.

If you forget to take Rosuvastatina SUN

Do not worry, simply take the next scheduled dose at the planned time. Do not take a double dose to make up for forgotten doses.

If you stop taking Rosuvastatina SUN

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

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

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 can be. They are usually mild and disappear in a short period.

Stop takingrosuvastatinaand seek immediate medical attentionif 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 can cause difficulty swallowing.

??Intense skin itching (with hives).

• Red spots on the torso, not raised, 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).
• Generalized rash, high body temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).

??Also, stop takingrosuvastatinaand consult your doctor immediately:

• if you experience unjustified muscle pain and cramps that last 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.

?If you experience muscle rupture.

? If you present with a syndromethat has symptoms similar to lupus(including rash, joint disorders, and effects on blood cells).

Frequent 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 reverses on its own without the need to interrupt treatment with rosuvastatina tablets (frequent adverse effect only with the daily dose of 40 mg of rosuvastatina).

??Diabetes. This occurs more frequently in patients with high levels of sugar and fat 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)

??Urticaria, itching, and other skin reactions.

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

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, intense skin itching (with hives). If you think you are having an allergic reaction, stop takingrosuvastatinaand seek immediate medical attention.

??Muscle injury in adults – as a precaution, stop takingrosuvastatinaand consult your doctor immediately if you have unjustified muscle pain or crampsthat last longer than expected.

??Severe stomach pain (possible sign of pancreatitis).

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

??Bleeding or bruising more easily than normal due to a decrease in the level of platelets in the blood.

? A syndrome that has 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,

• Damage to the nerves of the legs and arms (with numbness or tingling),

??Joint pain,

??Memory loss,

??Enlargement of the breasts in men (gynecomastia)

Unknown Frequency (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.

• 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 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 that is not listed in this prospectus. 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 SUN

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

??Do not use this medicine after the expiration date that appears on the packaging/blister after CAD. The expiration date is the last day of the month indicated.

??Do not store at a temperature above 30°C. Store in the original packaging.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Rosuvastatina SUN

The active ingredient of Rosuvastatina SUN is rosuvastatina. Rosuvastatina SUN 10 mgcontains rosuvastatina calcium equivalent to 10 mg of rosuvastatina.

The other components are: lactose monohydrate, microcrystalline cellulose (E460), crospovidone, magnesium stearate, sodium citrate, opadry pink (hypromellose, titanium dioxide (E171), macrogol 400, iron oxide red (E172)).

Appearance of the Product and Package Contents

Rosuvastatina SUN 10 mg are film-coated tablets of pink to light pink color, round, with the engraving “RT 2” on one face and smooth on the reverse face.

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

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132JH Hoofddorp, 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,

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 Last Revision of this Prospectus:December 2023

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