Package Insert: Information for the User

Rosuvastatina SUN 5 mg Film-Coated Tablets

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

2. What you need to know before starting to take Rosuvastatina SUN

3. How to take Rosuvastatina SUN

4. Possible adverse effects

5. Storage of Rosuvastatina SUN

6. Contents of the package and additional information

Rosuvastatina SUN belongs to a group of medications called statins.

You have been prescribed Rosuvastatina because:

??You have high cholesterol levels. This means you are at risk of suffering a heart attack or a cerebral infarction.

Rosuvastatina SUN is used in adults, adolescents, and children aged 6 years or older to treat high cholesterol.

You have been instructed to take a statin because the changes made to your diet and the increase in physical exercise have not been sufficient to correct your cholesterol levels. You must maintain a diet that helps to reduce cholesterol and continue to perform physical exercise while undergoing treatment with Rosuvastatina SUN.

Or

??You present other factors that increase the risk of suffering a heart attack, cerebral infarction, or other health-related problems.

Heart attacks, cerebral infarctions, and other health-related problems may be caused by a disease called atherosclerosis. Atherosclerosis is caused by the formation of fatty deposits in your arteries.

Why is it important to continue taking Rosuvastatina SUN?

Rosuvastatina SUN is used to correct the levels of fatty substances in the blood called lipids, with cholesterol being the most well-known.

There are different types of cholesterol in the blood, bad cholesterol (LDL-C) and good cholesterol (HDL-C).

??Rosuvastatina SUN reduces the amount of bad cholesterol and increases good cholesterol.

??Rosuvastatina SUN acts by blocking the production of bad cholesterol and improving the body's ability to eliminate it from the blood.

In most people, high cholesterol levels do not affect how they feel since they do not produce any symptoms. However, if left untreated, fatty deposits can form in the walls of blood vessels, causing them to narrow.

Sometimes, these narrowed blood vessels can become blocked and prevent blood supply to the heart or brain, causing a heart attack or cerebral infarction. By reducing your cholesterol levels, you can reduce the risk of suffering a heart attack, cerebral infarction, or other health-related problems.

You need to continue taking Rosuvastatina SUN, even if you have already achieved the correct cholesterol levels, as it prevents cholesterol levels from increasing again and forming fatty deposits.

However, you should stop treatment if your doctor instructs you to do so or if you become pregnant.

Do not take Rosuvastatina SUN

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

??If you are pregnantor 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.

??If you have liver disease.

??If you have severe kidney problems.

??If you have repeated or unjustified muscle pain and cramps.

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

??If you are taking a medicine called ciclosporina(used for example, after an organ transplant).

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

Also, do not take the higher dose (40 mg)??If you have moderate kidney problems(if in doubt, consult your doctor).

??If your thyroid glanddoes not function correctly.

??If you have repeated or unjustified muscle pain and 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(for example, Japanese, Chinese, Filipino, Vietnamese, Korean or Indian).

??If you are taking other medicines called fibratesto lower cholesterol.

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

Warnings and precautions

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

??If you have kidney problems.

??If you have liver problems.

• If you have ever developed a severe skin rash or skin peeling, blisters and/or mouth sores after taking rosuvastatina or other related medicines.

??If you regularly consume large amounts of alcohol.

??If your thyroid glanddoes not function 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 combat HIV (HIV virus) infection,such as ritonavir with lopinavir and/or atazanavir, seeTaking Rosuvastatina SUN and other medicines.

??If you are taking or have takenin the last 7 days a medicine called fusidic acid, (a medicine for bacterial infection), orally or by injection. The combination of fusidic acid and rosuvastatina can cause severe muscle problems (rhabdomyolysis), please see “Taking Rosuvastatina SUN and other medicines”.

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

If you find yourself in any of these situations mentioned above (or are unsure):

??Do not take the higher dose of rosuvastatina 40 mg and consult your doctor or pharmacist before starting to take any dose ofrosuvastatina.

Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with rosuvastatina 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 measures elevated liver enzymes (transaminases). For this reason, your doctor will normally perform this blood test (liver function test) before and after treatment with rosuvastatina.

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, obesity and high blood pressure.

Children and adolescents

• If the patient is under 6 years of age: Rosuvastatina should not be administered to children under 6 years of age.

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

Other medicines and Rosuvastatina SUNInform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine.

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

• ciclosporina (used after an organ transplant)
• warfarina, 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 ezetimiba)
• medicines for indigestion (used to neutralize stomach acid)
• erythromycin (an antibiotic), fusidic acid (an antibiotic - please see below and in Warnings and precautions),
• oral contraceptives (the pill),
• regorafenib (used to treat cancer),
• darolutamida (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),
• teriflunomida (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 may be modified by rosuvastatina or may change the effect of rosuvastatina.

• If you need to take fusidic acid orally to treat a bacterial infection you will need to stop taking this medicine temporarily. Your doctor will tell you when it is safe to start taking rosuvastatina again. The use of Rosuvastatina SUN with fusidic acid can cause muscle weakness, sensitivity or pain (rhabdomyolysis) in rare cases. For more information on rhabdomyolysis see section 4.

Pregnancy and breastfeeding

Do not takerosuvastatina if you are pregnant or breastfeeding. If you become pregnant while taking rosuvastatina, stop taking it immediatelye inform your doctor. Women should avoid becoming pregnant during treatment with rosuvastatina using an appropriate contraceptive method.

Consult your doctor or pharmacist before using any medicine.

Driving and operating machines

Most patients can drive vehicles and use machines during rosuvastatina treatment as it will not affect their ability. However, some people may feel dizzy during rosuvastatina treatment. 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 medicine.

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

The complete list of components see the sectionContents of the pack and additional informationlater.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Usual doses in adults

If you are takingrosuvastatinafor high cholesterol levels:

Starting dose

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

??Cholesterol levels.

??The degree of risk you have of suffering a heart attack or cerebral infarction.

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

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

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

??If you are ofAsian origin(for example, Japanese, Chinese, Filipino, Vietnamese, Korean or Indian).

??If you areover 70 years old.

??If you have moderate renal problems.

??If you have a risk of suffering muscle pain and cramps (myopathy).

Dose increase and maximum daily dose

Your doctor may decide to increase your dose. This is so that you are taking the appropriate dose of rosuvastatina 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 a four-week interval between each dose adjustment.

The maximum daily dose of rosuvastatina is 40 mg. This dose is only for patients with high cholesterol levels and a high risk of suffering a heart attack or cerebral infarction, whose cholesterol levels do not decrease enough with 20 mg.

If you are takingrosuvastatinato reduce the risk of suffering a heart attack, a cerebral infarction 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 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 a day. The usual starting dose is 5 mg per day and your doctor may increase your dose gradually to reach the appropriate dose of rosuvastatina for you. 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 indicated by your doctor once a day.Swallowing the tablets

Swallow each tablet whole with water.

Takerosuvastatinaonce a day.You can take it at any time of the day with or without food. Try to take the tablets at the same time every day. This will help you remember to take them.

Regular cholesterol level checks

It is essential that you attend your doctor regularly for cholesterol level checks, in order to check that your cholesterol levels have normalized and are maintained at appropriate levels.

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

If you take more Rosuvastatina SUN than you should

Contact your doctor or nearest hospital for advice.

If you visit 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, consult your doctor or pharmacist immediately or call the Toxicological 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 scheduled time. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Rosuvastatina SUN

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them. It is important that you know which side effects may occur. They are usually mild and disappear within a short period of time.

Stop takingrosuvastatinaand seek medical attention immediatelyif 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.

??Intense skin itching (with rashes).

• Reddish patches on the trunk, not elevated, in the shape of a target or circles, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin eruptions may 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 unexplained muscle pain and cramps that last longer than expected. Muscle symptoms are more common in children and adolescents than in adults. Like other statins, a very small number of people have experienced unpleasant muscle effects, which, very rarely, have resulted in a potentially fatal muscle injury calledrabdomiólisis.

?If you experience muscle rupture.

?If you experience a syndromecharacterized by symptoms similar to lupus(including rash, joint disorders, and effects on blood cells).

Common side 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 urine – this usually returns to normal on its own without the need to interrupt treatment with rosuvastatina tablets (a common side effect only with a daily dose of 40 mg of rosuvastatina).

??Diabetes. It occurs more frequently in patients with high blood sugar and fat levels, obesity, and high blood pressure. Your doctor will monitor you while you are taking this medicine.

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

??Urticaria, itching, and other skin reactions.

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

Rare side 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 rashes).If you think you are having an allergic reaction, stop takingrosuvastatinaand seek medical attention immediately.

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

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

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

??Bleeding or bruising more easily than normal due to a decrease in platelet count in the blood.

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

Very rare side 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 breasts in men (gynecomastia)

Unknown (frequency cannot be estimated from available data)

??Diarrhea (loose stools),?

??Cough,

??Shortness of breath,

??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 persistent muscle weakness.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

??Do not use this medication 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 30º C. Store in the original packaging.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Rosuvastatina SUN

The active ingredient of Rosuvastatina SUN isrosuvastatina. 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 content of the container

Rosuvastatina SUN 5 mg are film-coated tablets of yellow to light yellow color, round,with the imprint “RT1”on one face and smooth on the reverse face.

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

Not all container sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132JH Hoofddorp, Netherlands

Responsible for manufacturing:

Terapia SA

Str. Fabricii nr. 124, Cluj Napoca 400 632

Romania

Ó

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

Last review date of this leaflet:December 2023

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/