ROSUVASTATIN OPKO 20 mg FILM-COATED TABLETS

Introduction

PATIENT INFORMATION LEAFLET

Rosuvastatin OPKO20 mg film-coated tablets EFG

Rosuvastatin

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.Keep this leaflet. You may need to read it again.

• Keep this leaflet, as you may need to read it again.
• 1. If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What Rosuvastatin OPKO is and what it is used for
2. What you need to know before you take Rosuvastatin OPKO
3. How to take Rosuvastatin OPKO
4. Possible side effects
   1. Storage of Rosuvastatin OPKO

Contents of the pack and other information

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

Rosuvastatin belongs to a group of medicines called statins.

You have been prescribed Rosuvastatin OPKO because:

• You have high levels of cholesterol. This means you are at risk of having a heart attack or stroke. Rosuvastatin is used in adults, adolescents, and children aged 6 years or older to treat high cholesterol.

• You have been told to take a statin because changes to your diet and increasing exercise have not been enough to correct your cholesterol levels. You should continue with your cholesterol-lowering diet and exercise while taking rosuvastatin.

Or

• You have other factors that increase your risk of having a heart attack, stroke, or other related health problems.

Heart attack, stroke, and other related health problems can be caused by a disease called atherosclerosis. Atherosclerosis is caused by the buildup of fatty deposits in your arteries.

Why it is important to keep taking Rosuvastatin OPKO

Rosuvastatin is used to correct the levels of fatty substances in the blood called lipids, the most well-known of which is cholesterol.

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

• Rosuvastatin lowers the amount of "bad" cholesterol and increases the "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 they feel because they do not produce any 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 the blood supply to the heart or brain, leading to a heart attack or stroke. By lowering your cholesterol levels, you can reduce your risk of having a heart attack, stroke, or related health problems.

You need to continue taking Rosuvastatin OPKO, even if you have already achieved the correct cholesterol levels, as it prevents your cholesterol levels from rising again and causing the buildup of fatty deposits.However, you should stop taking it if your doctor tells you to or if you become pregnant.

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

Do not take Rosuvastatin OPKO

• If you are allergic (hypersensitive) to the active substance or any of the other ingredients of Rosuvastatin OPKO (listed in section 6).
• If you are pregnantor 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.
• If you have liver disease.
• If you have severe kidney problems.
• If you have repeated or unexplained muscle pains or cramps.
• 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 ciclosporin(used, for example, after an organ transplant).

If you are 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 you are unsure, consult your doctor).
• If your thyroid glandis not working correctly.
• If you have repeated or unexplained muscle pains or cramps,a personal or family history of muscle problems, or a 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.

Warnings and precautions

Consult your doctor or pharmacist before starting to take rosuvastatin

• If you have kidney problems.
• If you have liver problems.
• If you have repeated or unexplained muscle pains or cramps,a personal or family history of muscle problems, or a history of muscle problems during treatment with other cholesterol-lowering medicines. Inform your doctor immediately if you have unexplained muscle pain, tenderness, or weakness, especially if you also have a fever. Also, inform your doctor or pharmacist if you have 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 myasthenia (see section 4).
• If you have ever developed a severe skin rash or peeling of the skin, blisters, and/or sores in the mouth after taking Rosuvastatin OPKO or other related medicines
• If you regularly drink large amounts of alcohol.
• If your thyroid glandis not working 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 (AIDS),such as ritonavir with lopinavir and/or atazanavir, see "Other medicines and Rosuvastatin OPKO".
• If you are taking or have taken in the last 7 days a medicine called fusidic acid,(an antibiotic), by mouth or by injection. The combination of fusidic acid and rosuvastatina can cause serious muscle problems (rhabdomyolysis), see "Other medicines and Rosuvastatin OPKO".
• If you are over 70 years old,as your doctor will need to choose the right starting dose of rosuvastatina 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 rosuvastatina for you.

If you are in any of the above situations (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 (including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms - DRESS) have been reported with rosuvastatina. These can be life-threatening or fatal. At the time of prescription, patients should be advised of the signs and symptoms of severe skin reactions and closely monitored. If signs and symptoms suggestive of these reactions appear, treatment with rosuvastatina should be discontinued immediately and an alternative treatment considered.

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 carry out blood tests (liver function tests) before and during treatment with rosuvastatina.

While you are on this medicine, your doctor will closely monitor you if you have diabetes or are at risk of developing diabetes. You are at risk of developing diabetes if you have high blood sugar levels, are overweight, or have high blood pressure.

Children and adolescents

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

Other medicines and Rosuvastatin OPKO

Tell 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:

• ciclosporin (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),
• medicines for indigestion (used to neutralize stomach acid),
• erythromycin (an antibiotic),
• fusidic acid (an antibiotic - see also "Warnings and precautions" and below),
• 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 rosuvastatina or can change the effect of rosuvastatina.

If you need to take fusidic acid by mouth to treat a bacterial infection, you must stop taking this medicine temporarily. Your doctor will tell you when it is safe to start taking rosuvastatina again. Taking rosuvastatina with fusidic acid can rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). See more information about rhabdomyolysis in section 4.

Pregnancy and breastfeeding

Do not take Rosuvastatin OPKOif you are pregnant or breastfeeding. If you become pregnant while taking rosuvastatina, stop 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 taking any medicine.

Driving and using machines

Most patients can drive and use machines while taking 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.

Rosuvastatin OPKO contains lactose.

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

The complete list of ingredients is found in Contents of the pack and other information.

3. How to take Rosuvastatin OPKO

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

Usual dose in adults

If you are taking rosuvastatina for high cholesterol:

Starting dose

Your treatment with rosuvastatina 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.
• If you have factors that make you more vulnerable to possible side effects.

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

Your doctor may decide to start you on 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 muscle pains or cramps (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 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 an interval of four weeks between each dose adjustment.

The maximum daily dose of rosuvastatina 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 rosuvastatina 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 factors mentioned above.

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 daily. The usual starting dose is 5 mg per day, and your doctor may gradually increase your dose to the dose of rosuvastatina that is right 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 your dose once daily. Do notgive children a dose of 40 mgper day.

Swallowing the tablets

Swallow each tablet whole with water.

Take rosuvastatina once daily.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 to have your cholesterol levels checked, to make sure that your cholesterol levels have returned to normal and are staying at the right levels.

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

If you take more Rosuvastatin OPKO than you should

Contact your doctor or the nearest hospital for advice.

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 are admitted to hospital or receive treatment for another condition, inform the medical staff that you are taking rosuvastatina.

If you forget to take Rosuvastatin OPKO

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

If you stop taking Rosuvastatin OPKO

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

If you have any further questions on 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 taking rosuvastatin and 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 patches on the torso, not elevated, 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 taking rosuvastatin and consult your doctor immediately

• If you experience unjustified muscle pain and crampsthat 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 Lupus-like disease syndrome (including rash, joint disorders, and effects on blood cells
• If you experience muscle rupture

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 reverses on its own without the need to interrupt treatment with rosuvastatin tablets (common adverse effect only with the daily dose of 40 mg of rosuvastatin).
• Diabetes. This is more likely if you have high sugar and lipid levels in your blood, are overweight, and have high blood pressure. Your doctor will closely 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 reverses on its own without the need to interrupt treatment with rosuvastatin tablets (uncommon adverse effect with daily doses of 5 mg, 10 mg, and 20 mg 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, intense itching of the skin (with hives). If you think you are having an allergic reaction, stop taking rosuvastatinand seek immediate medical attention.
• 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.
• Severe stomach pain (possible sign of pancreatitis).
• Increased liver enzymes (transaminases) in the blood.
• Bleeding or bruising more easily than normal due to a low platelet count in the blood.
• Syndrome with symptoms similar to lupus (including hives, 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), blood traces in the urine, nerve damage in the legs and arms (with numbness or tingling), joint pain, memory loss, and breast enlargement in men (gynecomastia).

Adverse Effects of Unknown Frequency (cannot be estimated from available data) that may include

• 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 your arms or legs that worsens after periods of activity, double vision or drooping eyelids, difficulty swallowing or breathing.

Reporting 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. Conservation of Rosuvastatina OPKO

• It does not require special storage conditions.
• 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.

Medicines should not be thrown away through drains or into the trash. 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 OPKO

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

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

Appearance of the Product and Package Contents

Rosuvastatina OPKO 20 mg is presented in aluminum-aluminum blister packs with 28 tablets.

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

Marketing Authorization Holder and Manufacturer

OPKO HEALTH SPAIN, S.L.U.

Pl. Europa 13-15, 08908

L'Hospitalet de Llobregat (Barcelona)

Spain

Manufacturer:

LABORATORI FUNDACIÓ DAU

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

08040 Barcelona,

Spain

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/