ROSUVASTATIN SUN 5 mg FILM-COATED TABLETS

2. What you need to know before you take Rosuvastatin SUN

Do not take Rosuvastatin SUN

If you are allergic (hypersensitive) to the active substanceor any of the other ingredients of this medicine (listed in section 6).

If you are pregnant or breast-feeding. If you become pregnant while taking rosuvastatin, stop taking it immediately and inform your doctor. Women must 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 pains.

• 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 cyclosporin(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 does not work correctly.

If you have repeated or unexplained muscle pains, 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 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 pains, 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 have unexplained muscle pain, especially if you feel unwell or have a fever. Also, inform your doctor or pharmacist if you experience persistent muscle weakness.
• If you have or have had myasthenia(a disease that causes general 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 condition or trigger the onset of 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 medicines.

If you regularly drink large amounts of alcohol.

If your thyroid gland does not work correctly.

If you are taking other medicines called fibratesto 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 ritonavir with lopinavir and/or atazanavir), see Taking Rosuvastatin SUN with other medicines.

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

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

If you have severe respiratory problems.

If you are of Asian origin(for example, Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor will need to choose the right 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. Stop taking Rosuvastatin 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 can be 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 do this blood test (liver function test) before and after starting treatment with rosuvastatin.

While you are taking this medicine, 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 given to children under 6 years old.
• If the patient is under 18 years old: The 40 mg rosuvastatin tablets should not be given to children and adolescents under 18 years old.

Other medicines and Rosuvastatin SUNTell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

• cyclosporin (used after an organ transplant)
• 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)
• indigestion treatments (used to neutralize stomach acid)
• erythromycin (an antibiotic), fusidic acid (an antibiotic - see also section above 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 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.

The effects of these medicines can be altered by rosuvastatin or can change the effect of rosuvastatin.

• If you need to take fusidic acid by mouth to treat a bacterial infection, you will have to stop taking this medicine temporarily. Your doctor will tell you when it is safe to start taking rosuvastatin again. The use of Rosuvastatin SUN with fusidic acid can rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Pregnancy and breast-feeding

Do not take rosuvastatin if you are pregnant or breast-feeding. If you become pregnant while taking rosuvastatin, stop taking it immediately and inform your doctor. Women must avoid becoming pregnant during treatment with rosuvastatin using an appropriate contraceptive method.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Most patients can drive and use machines while taking 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.

Rosuvastatin SUN contains lactose and sodium

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

This medicine 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 section Contents of the pack and other informationlater.

3. How to take Rosuvastatin SUN

Follow the instructions for administration of this medicine exactly as told by your doctor. If in doubt, consult your doctor or pharmacist again.

Usual dose 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 level 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 you on the lowest 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 muscle pain (myopathy).

Dose increase and maximum daily dose

Your doctor may decide to increase your dose. This is so that you are taking the right 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 enough 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 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 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 to the dose of rosuvastatin that is right 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 prescribed 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 checks of your cholesterol levels

It is important that you see your doctor regularly for cholesterol checks to ensure that your cholesterol levels have returned to normal and are being kept at the right levels.

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

If you take more Rosuvastatin SUN than you should

Contact your doctor or the nearest hospital for advice.

If you go to a hospital or receive treatment for another condition, tell your medical team that you are taking Rosuvastatin 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, stating the medicine and the amount taken.

If you forget to take Rosuvastatin SUN

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

If you stop taking Rosuvastatin SUN

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

If you have any other questions about the use of this medicine, 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 itching of the skin (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).
• Widespread 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 sugar and fat levels 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 itching of the skin (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.

? 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,

• Nerve damage in 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 Adverse Effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects that do not appear 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 SUN

??Keep this medicine out of 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 away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in 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 5 mg contains rosuvastatina calcium equivalent to 5 mg of rosuvastatina.

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

Appearance of the Product and Package Contents

Rosuvastatina SUN 5 mg are film-coated tablets of yellow to light yellow color, round, with the engraving “RT 1” 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 Laboratories, S.L.

Rambla de Catalunya, 53-55

08007 Barcelona.

Spain

Tel.: +34 93 342 78 90

Date of the Last Revision of this Leaflet: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/