PROSPECTO: INFORMATION FOR THE USER

Rosuvastatina OPKO20 mg film-coated tablets EFG

Rosuvastatina

Read this prospectus carefully before starting to take this medicine,because it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• 1. If you have any doubts, consult yourdoctor or pharmacist.

-This medicine has been prescribedonlyto you, and you must not give it to other people even iftheyhave the same symptomsas you,as it may harm them.

• If you experience any adverse effects,consult your doctor or pharmacist,evenifthey are not listed in this prospectus. See section 4.

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

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

3.How to take Rosuvastatina OPKO

4.Adverse effects

1. Storage of Rosuvastatina OPKO

Contents of the package and additional information

Rosuvastatinbelongs to a group of medications called statins.

They have prescribed Rosuvastatin OPKO because:

• Youhave high levels of cholesterol.This means you have a risk of suffering a heart attack or a cerebral infarction. Rosuvastatin is used in adults, adolescents, and children aged 6 years or older to treat high cholesterol.

• They have indicated that you should 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 rosuvastatin.

Or

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

A heart attack, cerebral infarction, 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 it is important to continue taking Rosuvastatin OPKO

Rosuvastatin 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).

• Rosuvastatin decreases the amount of bad cholesterol and increases good cholesterol.
• It acts by blocking the production of bad cholesterol and improving the body's ability to eliminate it from the blood.

In most people, high levels of cholesterol 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 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.

Youmust continue taking Rosuvastatin OPKO, even if you have already achieved the correct cholesterol levels, as itprevents cholesterol levels from increasing again and forming fatty deposits.However, you should interrupt treatment if your doctor advises you to do so or if you become pregnant.

Do not take Rosuvastatina OPKO

• If you are allergic (hypersensitive) to the active ingredient or to any of the other components of Rosuvastatina OPKO (listed in section 6).
• If you are pregnantor breastfeeding. If you become pregnant while taking rosuvastatinastop taking it immediately and inform your doctor. Women should avoid becoming pregnant during treatment with rosuvastatina using an appropriate contraceptive method.
• 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 medications(used to treat a liver infection called hepatitis C).
• If you are taking a medication called ciclosporina(used, for example, after an organ transplant).

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

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

• 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 medications.

• 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 medications called fibratesto lower cholesterol.

If you find yourself 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 rosuvastatina

• If you have kidney problems.
• If you have liver problems.
• 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 medications. Inform your doctor immediately if you have unjustified muscle pain or cramps, especially if you experience general discomfort or fever. Also, inform your doctor or pharmacist if you experience persistent muscle weakness.
• If you have or have had myasthenia(a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing) or myasthenia gravis (a disease that causes eye muscle weakness), as statins may sometimes worsen the disease or cause myasthenia (see section 4).
• If you have ever developed a severe skin rash or skin peeling, blisters and/or mouth sores after taking Rosuvastatina OPKO or other related medications.
• If you regularly consume large amounts of alcohol.
• If your thyroid glanddoes not function correctly.
• If you are taking other medications called fibratesto lower cholesterol. Read this leaflet carefully, even if you have taken cholesterol-lowering medications previously.
• If you are taking medications to treat HIV (AIDS virus),such as ritonavir with lopinavir and/or atazanavir, see “Other medications and Rosuvastatina OPKO ”.
• If you have taken or are taking a medication called fusidic acid(an antibiotic) orally or by injection in the last 7days. The combination of fusidic acid and rosuvastatina may cause severe muscle problems (rhabdomyolysis),please see“Other medications and Rosuvastatina OPKO ”.
• If you are over 70 years old,as your doctor must 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 must 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 highest dose of 40 mg and consult your doctor or pharmacist before starting to take any dose of rosuvastatina.

Severe skin reactions have been reported with rosuvastatina, including Stevens-Johnson syndrome (SSJ) and drug reaction with eosinophilia and systemic symptoms (DRESS), reactions that can be potentially fatal or fatal. At the time of prescription, patients should be warned of the signs and symptoms of severe skin reactions and should be closely monitored. If signs and symptoms suggest this reaction, treatment should be stopped immediately and an alternative considered.

In a small number of people, statins can affect the liver. This is detected by a simple test that detects increased levels of liver enzymes (transaminases) in the blood. For this reason, your doctor will normally perform blood tests (liver function test) before and after treatment with rosuvastatina.

While taking this medication, 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 levels, are overweight and have 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.

Other medications and Rosuvastatina OPKO

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication.

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

• ciclosporina (used after an organ transplant),
• warfarina, 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 ezetimiba),
• medications 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 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 modified by rosuvastatina or may change the effect of rosuvastatina.

If you need to take fusidic acid orally to treat a bacterial infection, you should stop taking this medication temporarily. Your doctor will tell you when it is safe to start taking rosuvastatina again. Taking rosuvastatina with fusidic acid may rarely cause muscle weakness, sensitivity or pain (rhabdomyolysis). See more information about rhabdomyolysis in section4.

Pregnancy and breastfeeding

Do not take Rosuvastatinaif you are pregnant or breastfeeding. If you become pregnant while taking rosuvastatinastop taking it immediatelyand 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 medication.

Driving and using machines

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

Rosuvastatina OPKO contains lactose.

If your doctor has told you that you have an intolerance to certain sugars (lactose or milk sugar), consult with him before taking Rosuvastatina OPKO.

The complete list of components can be found inContents of the package and additional information.

Follow exactly the administration instructions of this medication as 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 levels:

Starting dose

Your treatment with rosuvastatin 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:

• Your cholesterol levels.
• The degree of risk you have of having a heart attack or stroke.
• If you have factors that make you more vulnerable to potential side effects.

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

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

• If you are ofAsian 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 have a risk of developing muscle pain and cramps (myopathy).

Dose increase and maximum daily dose

Your doctor may decide to increase your dose. This is to ensure 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 a four-week interval 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 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, a 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 factors mentioned earlier.

Use in children and adolescents aged 6-17 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 for treatment is 5 mg per day and your doctor may increase your dose gradually to reach the right dose of rosuvastatin 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 disease being treated. Take your dose once a day.Do not administer a dose of40 mg per day to children.

Swallowing the tablets

Swallow each tablet whole with water.

Take rosuvastatin once 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, 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 right dose of rosuvastatin for you.

If you take more rosuvastatin than you should

Contact your doctor or nearest hospital for advice.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you enter a hospital or receive treatment for another condition, inform the healthcare staff that you are taking rosuvastatina.

If you forget to take Rosuvastatina OPKO

Do not worry, simply take the next scheduled dose at the planned time. Do not take a double dose to compensate for a missed dose.

If you interrupt treatment with Rosuvastatina OPKO

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.

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 taking rosuvastatin and 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 itching of the skin (with rashes).
• Reddish patches on the trunk, flat or circular, 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 taking rosuvastatin and consult your doctor immediately

• If you experience unjustified muscle pain and crampsthat 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 calledrabdomyolysis.

• If you experience lupus-like syndrome (including rash, joint disorders, and effects on blood cells)
• If you experience muscle rupture

Side effects that are common (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 stop taking rosuvastatin (common side effect only with a daily dose of 40 mg of rosuvastatin).
• Diabetes.This is more likely if you have high levels of sugar and lipids in your blood, being overweight, and high blood pressure. Your doctor will closely monitor you while you are taking this medicine.

Side effects that are infrequent (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 stop taking rosuvastatin (infrequent side effect with daily doses of 5 mg, 10 mg, and 20 mg of rosuvastatin).

Side effects that are rare (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 rashes). If you think you are having an allergic reaction, stop taking rosuvastatinand seek medical attention immediately.
• Muscle injury in adults – as a precaution,stop taking rosuvastatin and consult your doctor immediately if you have unjustified muscle pain or crampsthat last longer than expected.
• Intense stomach pain (possible sign of pancreatitis).
• Increased liver enzymes (transaminases) in the blood.
• Bleeding or bruising more easily than normal due to low platelet count in the blood.
• Syndrome with symptoms similar to lupus (including urticaria, joint disorders, and effects on blood cells).

Side effects that are very rare (may affect up to 1 in 10,000 people)

• Jaundice (yellowing of the skin and eyes), hepatitis (inflamed liver), blood in the urine, nerve damage in the legs and arms (with numbness or tingling), joint pain, memory loss, and increased breast size in men (gynecomastia).

Side effects of unknown frequency (cannot be estimated from available data) that may include

• Diarrhea (loose stools, cough, shortness of breath, edema, 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).
• Myasthenia ocular (a disease that causes weakness of the eye muscles).

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

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 Pharmacovigilance 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.

• No special storage conditions are required..
• 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/container after CAD. The expiration date is the last day of the month indicated.

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

Composition of Rosuvastatina OPKO

The active ingredient is rosuvastatina. The film-coated tablets of Rosuvastatina OPKO contain rosuvastatina calcium equivalent to 20 mg of rosuvastatina.

The other components of the tablets are: lactose monohydrate, microcrystalline cellulose, crospovidone, magnesium stearate, hypromellose, triacetin, titanium dioxide (E171) and iron oxide red (E172).

Appearance of the product and content of the packaging

Rosuvastatina OPKO 20 mg is presented in packaging with aluminum-aluminum blisters containing 28 tablets.

Rosuvastatina OPKO 20 mg film-coated tablets are pale pink, round, biconvex tablets with a fracture line on both faces that separates the engravings “11” and “37” on one face and ‘20’ on the other face.

Holder of the marketing authorization and responsible for manufacturing

OPKO HEALTH SPAIN, S.L.U.

Pl. Europa 13-15, 08908

L’Hospitalet de Llobregat (Barcelona)

Spain

Responsible for manufacturing:

LABORATORI FUNDACIÓ DAU

C/ C, 12-14 Pol. Ind. Zona Franca,

08040 Barcelona,

Spain

Date of the last review of this leaflet:December 2023

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