YCOMWYA 40 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

Ycomwya 40 mg film-coated tablets EFG

rosuvastatin

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What is Ycomwya and what is it used for
2. What you need to know before taking Ycomwya
3. How to take Ycomwya
4. Possible side effects
5. Storing Ycomwya
6. Package contents and additional information

1. What is Ycomwya and what is it used for

Ycomwya contains the active substance rosuvastatin, which belongs to a group of medicines 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 stroke. This medicine 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 increased physical exercise have not been enough to correct your cholesterol levels. You should maintain a diet that helps lower cholesterol and continue to exercise while taking this medicine.

Or

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

A heart attack, stroke, and other related health problems can be caused by a disease called atherosclerosis.

Atherosclerosis is caused by the formation of deposits of fatty substances in your arteries.

Why is it important to keep taking rosuvastatin?

This medicine 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, "bad" cholesterol (LDL-C) and "good" cholesterol (HDL-C).

• Rosuvastatin reduces 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, as 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, preventing blood from reaching the heart or brain, causing a heart attack or stroke. By lowering your cholesterol levels, you can reduce the risk of having a heart attack, stroke, or related health problems.

You need to keep taking this medicine, even if your cholesterol levels have returned to normal, as it prevents your cholesterol levels from rising againand causing the formation of fatty deposits. However, you should stop treatment if your doctor tells you to or if you become pregnant.

2. What you need to know before taking Ycomwya

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 unexplained muscle pain or weakness.
• 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.

In addition, do not take rosuvastatina 40 mg (the highest dose):

• If you have moderate kidney problems (if in doubt, consult your doctor).
• If your thyroid gland is not working correctly.
• If you have repeated or unexplained muscle pain or weakness, 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 (e.g., Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
• If you are taking other medicines called fibrates to 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 Ycomwya

• If you have kidney problems.
• If you have liver problems.
• If you have repeated or unexplained muscle pain or weakness, 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 or weakness, especially if you have general discomfort or fever. Also, inform your doctor or pharmacist if you have persistent muscle weakness.
• If you regularly drink large amounts of alcohol.
• If your thyroid gland is not working 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 infection or hepatitis C, such as ritonavir with lopinavir and/or atazanavir or simeprevir, see "Other medicines and Ycomwya".
• If you are taking or have taken in the last 7 days a medicine called fusidic acid (an antibiotic used to treat bacterial infections) orally or by injection. The combination of fusidic acid and rosuvastatin can rarely cause serious muscle problems (rhabdomyolysis). See more information on rhabdomyolysis in section 4.
• If you are over 70 years old (as your doctor will need to determine the appropriate starting dose of rosuvastatin for you).
• If you have severe respiratory failure.
• If you are of Asian origin, e.g., Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian. Your doctor will need to determine the appropriate starting dose of rosuvastatin for you.
• If you have ever developed a severe skin rash or peeling, blisters, and/or sores in the mouth after taking rosuvastatin or other statins.

• If you have or have had myasthenia (a disease that causes generalized muscle weakness, which can affect the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes worsen the disease or cause myasthenia to appear (see section 4).

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 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 tests) 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 are likely to 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 with rosuvastatin treatment. Stop taking 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 given to children under 6 years of age.
• If the patient is under 18 years of age: The 40 mg tablets of rosuvastatin should not be given to children and adolescents under 18 years of age.

Other medicines and Ycomwya

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Tell 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 medicine, 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 "Warnings and precautions" and section 4),
• oral contraceptives (the pill),
• regorafenib (used to treat cancer),
• darolutamide (used to treat cancer),
• hormone replacement therapy,

• 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 changed by rosuvastatin, or these medicines may change the effects of rosuvastatin.

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

Ycomwya contains lactose

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

3. How to take Ycomwya

Follow the instructions for taking this medicine exactly 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:

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 degree of risk you have of having a heart attack or stroke.
• If you have any 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 treatment with the smallest dose (5 mg):

• If you are of Asian origin (e.g., 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 having muscle pain or weakness (myopathy).

Dose increase and maximum daily dose

Your doctor may decide to increase your dose so that you are taking the dose of rosuvastatin that is right 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 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 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 your dose once a day. The 40 mg tablets of rosuvastatin should not be given to children.

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 cholesterol level checks

It is important to visit your doctor regularly to have your cholesterol levels checked, to ensure that your cholesterol levels have returned to normal and remain at appropriate levels.

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

If you take more Ycomwya 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, phone 91 562 04 20, indicating the medicine and the amount taken.

If you are admitted to hospital or receive treatment for another condition, inform the healthcare staff that you are taking rosuvastatin.

If you forget to take Ycomwya

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

If you stop taking Ycomwya

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 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).

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 frequent in children and adolescents than in adults. As with other statins, a very small number of people have suffered unpleasant muscle effects, which have very rarely resulted in a potentially life-threatening muscle injury called rhabdomyolysis.
• Lupus-like disease syndrome (including skin rash, joint disorders, and effects on blood cells).
• Muscle rupture.
• Red, non-raised spots on the torso, target-shaped or circular, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes 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).

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 blood sugar and lipid levels, 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 Ycomwya tablets (only for the 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 usual due to a low platelet count in the blood.
• Lupus-like disease syndrome (including skin 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.
• Increased breast size in men (gynecomastia).

Adverse Effects of 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.
• Constant muscle weakness.
• Severe myasthenia (a disease that causes generalized muscle weakness, which 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 difficulty 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 leaflet. You can also report them directly through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Ycomwya

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Ycomwya

• The active ingredient is rosuvastatin.

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

• The other ingredients 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 and Packaging of the Product

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 mg is available in blister packs 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

Manufacturer:

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

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

You can request 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:

Date of the last revision of this leaflet: October 2023

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).