Package Insert: Information for the Patient

Ycomwya 40 mg Film-Coated Tablets EFG

rosuvastatina

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Rosuvastatina contains the active ingredient rosuvastatin, which belongs to a group of medications called statins.

You have been prescribed rosuvastatin because:

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

You have been advised to take a statin because the changes you made to your diet and the increase in physical exercise were not enough to correct your cholesterol levels. You must maintain a diet that helps to lower cholesterol and continue exercising while on treatment with this medication.

Or

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

A heart attack, stroke, and other health problems can 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?

This medication 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 reduces the amount of bad cholesterol and increases 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 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, preventing blood supply to the heart or brain, causing a heart attack or stroke. By lowering your cholesterol levels, you can reduce your risk of having a heart attack, stroke, or other health problems.

You needto continue taking this medication, even if you have already achieved the correct cholesterol levels, as itprevents cholesterol levels from increasing againand forming fatty deposits. However, you should stop treatment if your doctor advises you to or if you become pregnant.

Do not take Ycomwya

• If you are allergic to rosuvastatin or any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant or breastfeeding. If you become pregnant while taking this medicine, 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 unjustified muscle pain and cramps.
• If you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir medicines (used to treat a liver viral infection called hepatitis C).
• If you are taking a medicine called ciclosporin (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 rosuvastatin 40 mg (the highest dose):

• If you have moderate kidney problems (if in doubt, consult your doctor).
• If your thyroid gland does 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 fibrates to 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 Ycomwya

• 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 medicines. Inform your doctor immediately if you have unjustified muscle pain or cramps, especially if you have general discomfort or fever. Also, inform your doctor or pharmacist if you have constant muscle weakness.
• If you regularly consume large amounts of alcohol.
• If your thyroid gland does not function correctly.
• If you are taking other medicines called fibrates to lower cholesterol. Read this leaflet carefully, even if you have taken cholesterol-lowering medicines before.
• If you are taking medicines to treat HIV (AIDS virus) or hepatitis C infection, such as ritonavir with lopinavir and/or atazanavir or simeprevir, see "Other medicines and Ycomwya".
• If you are taking or have taken within the last 7 days a medicine called fusidic acid (an antibiotic), orally or by injection. The combination of fusidic acid and rosuvastatin may cause severe muscle problems (rhabdomyolysis). See "Other medicines and Ycomwya".
• If you are over 70 years old (since your doctor must establish the appropriate starting dose of rosuvastatin for you).
• If you have severe respiratory insufficiency.
• If you are of Asian origin, for example, Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian. Your doctor must establish the appropriate starting dose of rosuvastatin for you.
• If you have ever developed a severe skin rash or skin peeling, blisters, and/or mouth sores after taking rosuvastatin or other statins.

• 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 weakness of the eye muscles), as statins may sometimes worsen the disease or cause myasthenia (see section 4).

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 rosuvastatin.

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 rosuvastatin.

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 levels, are overweight, and have high blood pressure.

Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with rosuvastatin treatment. Stop using this medicine and seek medical attention immediately if you notice any of the symptoms described in section 4.

Children and adolescents

• If the patient is under 6 years of age: Rosuvastatin should not be administered to children under 6 years of age.
• If the patient is under 18 years of age: Rosuvastatin 40 mg tablets should not be administered to children and adolescents under 18 years of age.

Other medicines and Ycomwya

Inform 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:

• ciclosporin (used after an organ transplant),
• warfarin, clopidogrel, or ticagrelor (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),
• hormone replacement therapy,

• any of the following medicines used to treat viral infections, including HIV or hepatitis C infection, 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 changed by rosuvastatin or these medicines may change the effects of rosuvastatin.

If you need to take fusidic acid orally to treat a bacterial infection, you should stop taking this medicine temporarily. Your doctor will tell you when it is safe to start taking Ycomwya again. Taking rosuvastatin with fusidic acid may rarely cause muscle weakness, sensitivity, or pain (rhabdomyolysis). See more information about rhabdomyolysis in section 4.

Taking Ycomwya with food and drinks

You can take rosuvastatin with or without food.

Pregnancy and breastfeeding

Do not take this medicineif you are pregnant or breastfeeding. If you become pregnant while taking rosuvastatin stop taking it immediatelyand 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 medicine.

Driving and operating 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.

Ycomwya contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

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 taking rosuvastatin for high cholesterol levels:

Initial 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 previously. The choice of initial dose will depend on:

•Your cholesterol levels.

•The degree of risk you have of having a heart attack or cerebral infarction.

•If you have any factor that makes you more vulnerable to possible adverse effects.

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

Your doctor may decide to start treatment with 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 renal 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 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 later 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 cerebral infarction, whose cholesterol levels do not decrease enough with 20 mg.

If you are taking rosuvastatinto reduce the risk of having 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 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 is 5 mg per day and your doctor may increase your dose gradually to reach the right dose of rosuvastatin 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 your dose once a day. Do not administer rosuvastatin 40 mg tablets 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 checks

It is essential that you visit your doctor regularly for cholesterol checks, to ensure that your cholesterol levels have normalized and remain at appropriate levels.

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

If you take more 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 illness, inform the healthcare staff that you are taking rosuvastatin.

If you forget to take rosuvastatin

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 rosuvastatin

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

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 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 skin itching (with rashes).

Also, stop taking rosuvastatin and consult your doctor immediately if you experience any of the following:

• 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 side effects, which, very rarely, have resulted in a potentially fatal muscle injury calledrabdomiolysis.
• Symptoms similar to lupus (including skin rash, joint disorders, and effects on blood cells).
• Muscle rupture.
• Flat, red spots on the trunk, often with blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin eruptions may be preceded by fever and symptoms similar to the flu (Stevens-Johnson syndrome).
• Generalized rash, high body temperature, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).

Frequent 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 stop treatment with rosuvastatin tablets (frequent side effect only with the daily dose of 40 mg of rosuvastatin).
• Diabetes. This is more likely if you have high blood sugar and lipid levels, overweight, and high blood pressure. Your doctor will closely monitor you while you are taking this medicine.

Rare 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 stop treatment with rosuvastatin tablets (only for doses of 5 mg, 10 mg, and 20 mg of rosuvastatin).

Very 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 taking rosuvastatinand seek medical attention immediately.
• Muscle injury in adults – as a precaution,stop taking rosuvastatin and consult your doctor immediately if you experience 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 low platelet count in the blood.
• Symptoms similar to lupus (including skin 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 the breasts in men (gynecomastia).

Side effects of unknown frequency (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.
• 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 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.

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 after CAD. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature. Store in the original packaging to protect it from moisture.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Ycomwya

-The active ingredient is rosuvastatin.

-Each film-coated tablet contains 40 mg of rosuvastatin (as rosuvastatin calcium).

-The other components are: lactose, microcrystalline cellulose, crospovidone (type A), magnesium stearate, and anhydrous colloidal silica in the tablet core and poly(vinyl alcohol), titanium dioxide (E171), macrogol 3350, talc, and yellow iron oxide (E172) in the tablet coating. See section 2 “Ycomwya contains lactose”.

Appearance of the product and contents of the pack

Ycomwya 40 mg film-coated tablets are yellow-brown, biconvex, capsule-shaped tablets marked with the number 40 on one face of the tablet (dimensions: 16 mm x 9 mm).

Ycomwya 40 mgis available in packs with a blister of 28 and 30 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

KRKA, d.d., Novo mesto,Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Responsible for manufacturing:

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

You can obtain more information about this medicine by contacting the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain.

This medicine is authorized in the member states of the European Economic Area under the following names:

Last review date of this leaflet: October 2023

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