Corosvera

Package Leaflet: Information for the Patient

Coroswera, 5 mg + 10 mg, film-coated tablets

Coroswera, 10 mg + 10 mg, film-coated tablets

Coroswera, 15 mg + 10 mg, film-coated tablets

Coroswera, 20 mg + 10 mg, film-coated tablets

Coroswera, 40 mg + 10 mg, film-coated tablets

Rosuvastatin + Ezetimibe

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this package leaflet, tell your doctor or pharmacist. See section 4.

Package Leaflet Contents

• 1. What is Coroswera and what is it used for
• 2. Important information before taking Coroswera
• 3. How to take Coroswera
• 4. Possible side effects
• 5. How to store Coroswera
• 6. Package contents and other information

1. What is Coroswera and what is it used for

Coroswera contains two different active substances. One of the active substances is rosuvastatin, which belongs to a group of medicines called statins, and the other active substance is ezetimibe. Coroswera is used to lower the level of cholesterol in the blood, so-called "bad" cholesterol (LDL cholesterol) and fatty substances called triglycerides. Additionally, Coroswera increases the level of so-called "good" cholesterol (HDL cholesterol). HDL cholesterol is often referred to as "good" because it helps prevent the buildup of "bad" cholesterol in the arteries, thereby protecting against heart disease. Coroswera lowers cholesterol levels by acting in two ways: reducing the amount of cholesterol absorbed in the gut and the amount of cholesterol produced in the body. Coroswera is used in patients for whom diet alone is not enough to maintain a healthy cholesterol level. During treatment with this medicine, you should continue to follow a cholesterol-lowering diet. Your doctor may prescribe Coroswera if you are already taking rosuvastatin and ezetimibe in the same doses as in the combination medicine. If you have heart disease, Coroswera reduces the risk of heart attack, stroke, the need for surgical procedures to improve blood flow to the heart, or hospitalization due to chest pain. Coroswera does not help with weight loss. You should continue taking Corosweraeven if your cholesterol level is under control, as this will prevent the level of cholesterol from rising again and forming deposits in the arteries. You should stop treatment if your doctor advises you to or if you become pregnant.

2. Important information before taking Coroswera

When not to take Coroswera

stop taking it immediately and inform your doctor. While taking Coroswera, you should avoid becoming pregnant by using effective methods of contraception;

If any of the above applies to you (or you are unsure), consult your doctor.

In addition, do not take Coroswera 40 mg + 10 mg (the highest dose), if:

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you have moderate kidney problems (if in doubt, consult your doctor);
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you have abnormal thyroid function;
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you have had recurring or unexplained muscle pains, or have had muscle problems in the past or have a family history of muscle problems;
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you regularly drink large amounts of alcohol;
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you are of Asian origin (Japan, China, Philippines, Vietnam, Korea, or India);
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you are taking other medicines called fibrates to lower cholesterol levels;
­consult your doctor.

Warnings and precautions

Before starting Coroswera, discuss with your doctor or pharmacist if you have:
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kidney problems;
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liver problems;
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had recurring or unexplained muscle pains, or have had muscle problems in the past or have a family history of muscle problems, or have had previous muscle problems related to taking other cholesterol-lowering medicines. If you experience unexplained muscle pain, especially if accompanied by feeling unwell or fever, seek medical advice immediately. You should also tell your doctor or pharmacist about persistent muscle weakness;
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regularly drink large amounts of alcohol;
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have abnormal thyroid function;

• you are taking other medicines called fibrates to lower cholesterol levels. You should read this package leaflet, even if you have taken cholesterol-lowering medicines before;
• you are taking medicines used to treat HIV infection, such as ritonavir with lopinavir and/or atazanavir, see "Coroswera and other medicines";
• you are taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (used to treat bacterial infections). Taking fusidic acid and Coroswera at the same time may lead to serious muscle problems (rhabdomyolysis);
• you are over 70 years old (as your doctor will need to choose a suitable starting dose of Coroswera for you);
• you have severe respiratory failure;
• you are of Asian origin (Japan, China, Philippines, Vietnam, Korea, or India). Your doctor will determine a suitable starting dose of Coroswera for you;

While taking this medicine, your doctor will closely monitor your condition if you have diabetes or are at risk of developing it. There is a high risk of developing diabetes if you have high levels of sugar and fat in your blood, are overweight, and have high blood pressure. In a small number of people, statins may affect liver function. This is detected by a simple blood test that checks for increased liver enzyme activity. Therefore, your doctor will recommend regular blood tests (liver function tests) before and during treatment with Coroswera. Serious skin reactions, including Stevens-Johnson syndrome and drug rash with eosinophilia and systemic symptoms (DRESS), have been reported with rosuvastatin. If you experience any of the symptoms described in section 4, stop taking Coroswera and seek medical advice immediately.

Children and adolescents

Coroswera should not be used in children and adolescents under 18 years of age.

Coroswera and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take. Inform your doctor about taking any of the following medicines:

• ciclosporin (used, for example, after organ transplants);
• warfarin, clopidogrel, or ticagrelor (or any other medicine used to thin the blood, such as phenprocoumon, acenocoumarol, or fluindione);
• fibrates (such as gemfibrozil, fenofibrate) or other medicines used to lower cholesterol levels (such as ezetimibe);
• antacids (used to neutralize stomach acid);
• erythromycin (an antibiotic);
• oral contraceptives (birth control pills);
• hormone replacement therapy;
• regorafenib (used to treat cancer);
• darolutamide (used to treat cancer);
• any of the following medicines used to treat viral infections, including HIV or hepatitis C virus infection, alone or in combination with other medicines (see "Warnings and precautions"): ritonavir, lopinavir, atazanavir, sofosbuvir, velpatasvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir;
• colestyramine (a cholesterol-lowering medicine), as it affects how ezetimibe works;

The effect of these medicines may be altered by Coroswera or they may alter the effect of Coroswera.

Taking Coroswera with food and drink

Coroswera can be taken with or without food.

Pregnancy and breastfeeding

Do not take Corosweraif you are pregnant or breastfeeding. If you become pregnant while taking Coroswera, you should stop taking it immediatelyand inform your doctor. While taking Coroswera, you should avoid becoming pregnant by using effective methods of contraception. Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines

Most people can drive and use machines while taking Coroswera, as it does not affect the ability to drive or use machines. However, some patients may experience dizziness while taking Coroswera. If this happens, consult your doctor before driving or using machines.

Coroswera contains lactose and sodium

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine. The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially "sodium-free".

3. How to take Coroswera

Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.

• Before starting treatment with Coroswera, you should be on a cholesterol-lowering diet and taking rosuvastatin and ezetimibe in the same doses as in the combination medicine. This medicine is not suitable for starting treatment.
• You should continue to follow a cholesterol-lowering diet while taking Coroswera.

The recommended dose is one Coroswera tablet once a day, taken orally. You can take the medicine at any time of day, with or without food. Swallow the tablet whole with water. Take the medicine at the same time every day.

Use in children and adolescents

Coroswera should not be used in children and adolescents.

Regular cholesterol level checks

It is important to visit your doctor regularly to ensure that your cholesterol level is under control and to maintain a healthy cholesterol level.

Overdose

If you take more Coroswera than you should, contact your doctor or the nearest hospital emergency department immediately, as medical attention may be necessary. If you are hospitalized or need to take other medicines to treat another condition, inform the medical staff that you are taking Coroswera.

Missed dose

If you miss a dose, take the next tablet at the usual time. Do not take a double dose to make up for a missed dose.

Stopping Coroswera

Tell your doctor if you want to stop taking Coroswera. After stopping Coroswera, your cholesterol level may rise again. If you have any further questions about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Coroswera can cause side effects, although not everybody gets them. It is important that you know what side effects may occur with Coroswera. They are usually mild and disappear after a short time.

Stop taking Coroswera and seek medical help immediately:

if 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.
• severe skin itching (hives).
• or if you experience any of the following side effects: ­ lupus-like syndrome (including rash, joint disorders, and effects on blood cells). ­ muscle rupture. ­ red, flat, round, or oval patches on the torso, often with blisters in the center, peeling of the skin, mouth sores, and/or genital or eye lesions. The occurrence of this type of severe skin rash may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome). ­ widespread rash, high fever, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).

In addition, stop taking Coroswera and contact your doctor immediately if you experience:

any unusual muscle pains that persist, which may be a sign of a rare but serious side effect called rhabdomyolysis. As with other statins, very rare cases of unpleasant muscle effects have been reported, which in rare cases can lead to rhabdomyolysis.

Common side effects (may affect up to 1 in 10 people):

• headache
• abdominal pain
• constipation
• nausea
• muscle pain
• feeling weak
• dizziness
• increased protein in the urine - usually resolves on its own without stopping Coroswera (applies to tablets containing 40 mg of rosuvastatin)
• diabetes - more likely in patients with high sugar and fat levels in the blood, overweight, and high blood pressure. Your doctor will monitor your condition while taking this medicine.
• increased results of some blood tests that check liver function (aminotransferase activity)
• muscle tenderness or weakness
• diarrhea
• bloating
• feeling tired

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

• rash, itching, or other skin reactions
• increased protein in the urine - usually resolves on its own, without stopping Coroswera (applies to tablets containing 5-20 mg of rosuvastatin)
• tingling sensation
• dry mouth
• hives
• back pain
• muscle weakness, pain in arms and legs
• swelling, especially of hands and feet
• increased results of some blood tests that check muscle function (creatine kinase activity)
• cough
• indigestion
• heartburn
• joint pain
• muscle spasms
• neck pain
• loss of appetite
• pain
• chest pain
• hot flushes
• high blood pressure

Rare side effects (may affect up to 1 in 1,000 people):

• severe allergic reactions - symptoms include swelling of the face, lips, tongue, and/or throat, difficulty swallowing and breathing, severe skin itching (hives). If you suspect an allergic reaction, stop taking Coroswera and seek medical help immediately.
• muscle damage in adults - as a precaution, stop taking Coroswera and contact your doctor immediatelyif you experience any unusual, persistent muscle pains.

Coroswera and seek medical help immediately if you experience any unusual, persistent muscle pains

• severe abdominal pain (pancreatitis)
• reduced number of blood cells, which may cause bruising/bleeding (thrombocytopenia)

Very rare side effects (may affect up to 1 in 10,000 people):

• jaundice (yellowing of the skin and eyes)
• liver inflammation
• blood in the urine
• nerve damage in arms and legs (e.g., numbness)
• memory loss
• breast enlargement in men (gynecomastia)

Frequency not known (cannot be estimated from the available data):

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sleep disorders, including insomnia and nightmares
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sexual disorders
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depression
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breathing problems, including persistent cough and/or shortness of breath or fever
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tendon damage
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persistent muscle weakness
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liver problems
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red, raised rash, sometimes with target-shaped lesions (erythema multiforme)
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breakdown of striated muscle
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gallstones or gallbladder inflammation (which may cause abdominal pain, nausea, vomiting)
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myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing)
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myasthenic syndrome (a disease that causes muscle weakness in the eyes)
Talk to your doctor if you experience muscle weakness in your arms or legs, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.

Reporting side effects

If you experience any side effects, including any not listed in this package leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Coroswera

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of that month. Store in the original package to protect from light and moisture. There are no special storage instructions for this medicine. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Coroswera contains

• The active substances are rosuvastatin and ezetimibe. 5 mg + 10 mg: each film-coated tablet contains 5 mg of rosuvastatin (as rosuvastatin calcium) and 10 mg of ezetimibe. 10 mg + 10 mg: each film-coated tablet contains 10 mg of rosuvastatin (as rosuvastatin calcium) and 10 mg of ezetimibe. 15 mg + 10 mg: each film-coated tablet contains 15 mg of rosuvastatin (as rosuvastatin calcium) and 10 mg of ezetimibe. 20 mg + 10 mg: each film-coated tablet contains 20 mg of rosuvastatin (as rosuvastatin calcium) and 10 mg of ezetimibe. 40 mg + 10 mg: each film-coated tablet contains 40 mg of rosuvastatin (as rosuvastatin calcium) and 10 mg of ezetimibe.
• Other ingredients are: in the tablet core- microcrystalline cellulose, lactose, mannitol, crospovidone type A, sodium croscarmellose, magnesium stearate, povidone K30, sodium lauryl sulfate, anhydrous colloidal silica; in the tablet coating- lactose monohydrate, hypromellose, titanium dioxide (E 171), triacetin, yellow iron oxide (E 172) - only for 10 mg + 10 mg and 15 mg + 10 mg tablets, red iron oxide (E 172) - only for 15 mg + 10 mg, 20 mg + 10 mg, and 40 mg + 10 mg tablets, black iron oxide (E 172) - only for 40 mg + 10 mg tablets. See section 2 "Coroswera contains lactose and sodium".

What Coroswera looks like and contents of the pack

5 mg + 10 mg: white or almost white, round, slightly convex, film-coated tablets with beveled edges, with "R1" engraved on one side of the tablet. Tablet diameter: approximately 10 mm.
10 mg + 10 mg: light brown-yellow to brown-yellow, round, slightly convex, film-coated tablets with beveled edges, with "R2" engraved on one side of the tablet. Tablet diameter: approximately 10 mm.
15 mg + 10 mg: light pink-orange, round, slightly convex, film-coated tablets with beveled edges, with "R3" engraved on one side of the tablet. Tablet diameter: approximately 10 mm.
20 mg + 10 mg: light pink, round, slightly convex, film-coated tablets with beveled edges, with "R4" engraved on one side of the tablet. Tablet diameter: approximately 10 mm.
40 mg + 10 mg: light gray-violet to gray-violet, round, slightly convex, film-coated tablets with beveled edges, with "R5" engraved on one side of the tablet. Tablet diameter: approximately 10 mm.
Coroswera is available in cartons containing 14, 15, 28, 30, 56, 60, 84, 90, or 98 film-coated tablets in blisters.
Not all pack sizes may be marketed.

Marketing authorization holder

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

Manufacturer/Importer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
To obtain more detailed information on this medicine, contact the local representative of the marketing authorization holder:
Krka Polska Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
phone: +48 22 573 75 00
Date of last revision of the package leaflet:28.02.2025