Corosvera

Leaflet accompanying the packaging: patient information

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

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should consult a 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.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 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. Contents of the pack 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 reduce the level of total cholesterol, so-called "bad" cholesterol (LDL cholesterol) and fatty substances called triglycerides in the blood. 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 accumulation of "bad" cholesterol in the arteries, thereby protecting against heart disease. Coroswera reduces cholesterol levels by acting in two ways: it reduces the amount of cholesterol absorbed in the gastrointestinal tract and the amount of cholesterol produced in the body. Coroswera is used in patients for whom diet alone is not enough to maintain a normal cholesterol level. During treatment with this medicine, a cholesterol-lowering diet should be followed at all times. The doctor may prescribe Coroswera if the patient is already taking rosuvastatin and ezetimibe in the same doses as in the combination medicine. If the patient has 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 reduce body weight. You should continue taking Coroswera, even if your blood cholesterol level is under control, because this prevents the cholesterol level from rising againand forming deposits in the arteries. Treatment should be discontinued if the doctor advises it or if the patient becomes pregnant.

2. Important information before taking Coroswera

When not to take Coroswera

• if the patient is allergic to rosuvastatin or ezetimibe, or any of the other ingredients of this medicine (listed in section 6);
• if the patient is pregnant or breastfeeding. If the patient becomes pregnant while taking Coroswera, they should stop taking it immediately and inform their doctor. While taking Coroswera, the patient should avoid becoming pregnant by using effective methods of contraception;
• if the patient has liver disease;
• if the patient has severe kidney problems;
• if the patient experiences recurring, unexplained muscle pain;
• if the patient is taking a combination of sofosbuvir/velpatasvir/voxilaprevir (used to treat hepatitis C virus infection);
• if the patient is taking a medicine called ciclosporin (used, for example, after organ transplants).

If any of the above situations apply to the patient (or the patient has any doubts), they should consult a doctor.

In addition, the 40 mg + 10 mg (highest dose) Coroswera should not be taken if:

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the patient has moderate kidney problems (in case of doubt, the patient should consult a doctor);
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the patient has abnormal thyroid function;
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the patient has experienced recurring or unexplained muscle pain, has a history of muscle disorders, or has had previous muscle problems;
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the patient regularly consumes large amounts of alcohol;
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the patient is of Asian origin (Japan, China, Philippines, Vietnam, Korea, or India);
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the patient is taking other medicines called fibrates to lower cholesterol levels;
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if any of the above situations apply to the patient or the patient has any doubts, they should consult a doctor.

Warnings and precautions

Before starting to take Coroswera, the patient should discuss it with their doctor or pharmacist if they have:
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kidney problems;
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liver problems;
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experienced recurring or unexplained muscle pain, have a history of muscle disorders, or have had previous muscle problems related to taking other cholesterol-lowering medicines. In case of unexplained muscle pain, especially if accompanied by malaise or fever, the patient should immediately consult a doctor. The patient should also tell their doctor or pharmacist about persistent muscle weakness;
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regularly consume large amounts of alcohol;
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have abnormal thyroid function;

• the patient is taking other medicines called fibrates to lower cholesterol levels. The patient should read this leaflet, even if they have taken cholesterol-lowering medicines before;
• the patient is taking medicines used to treat HIV infection, such as ritonavir with lopinavir and/or atazanavir, see "Coroswera and other medicines";
• the patient is taking or has taken oral or injectable fusidic acid within the last 7 days to treat a bacterial infection. Taking fusidic acid and Coroswera at the same time may lead to serious muscle problems (rhabdomyolysis);
• the patient is over 70 years old (as the doctor will need to choose an appropriate starting dose of Coroswera for them);
• the patient has severe respiratory failure;
• the patient is of Asian origin (Japan, China, Philippines, Vietnam, Korea, or India). The doctor will determine an appropriate starting dose of Coroswera for the patient;
• if the patient has ever had a severe skin rash or peeling of the skin, blisters, and/or ulcers in the mouth after taking rosuvastatin or other medicines containing rosuvastatin;
• if the patient has or has had myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing) or myasthenic syndrome (a disease that causes muscle weakness in the eyes), as statins may sometimes worsen the symptoms of the disease or lead to the development of myasthenia (see section 4).

During treatment with this medicine, the doctor will closely monitor patients with diabetes or at risk of developing diabetes. There is a high risk of developing diabetes if the patient has high levels of sugar and fat in the blood, is overweight, and has 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, the doctor will recommend regular blood tests (liver function test) before and during treatment with Coroswera. Serious skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with rosuvastatin. If any of the symptoms described in section 4 occur, the patient should stop taking Coroswera and consult their doctor immediately.

Children and adolescents

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

Coroswera and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The patient should inform their doctor about taking any of the following medicines:

• ciclosporin (a medicine 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, alone or in combination with another medicine (see "Warnings and precautions"): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir;
• colestyramine (a cholesterol-lowering medicine), as it affects the way ezetimibe works;
• if it is necessary to take fusidic acid orally to treat a bacterial infection, the patient should temporarily stop taking Coroswera. The doctor will inform the patient when they can restart taking Coroswera. Taking Coroswera with fusidic acid can rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

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

Taking Coroswera with food and drink

Coroswera can be taken with or without food.

Pregnancy and breastfeeding

Coroswera should not be takenif the patient is pregnant or breastfeeding. If the patient becomes pregnant while taking Coroswera, they should stop taking it immediatelyand inform their doctor. While taking Coroswera, the patient should avoid becoming pregnant by using effective methods of contraception. Before taking any medicine, the patient should consult their doctor or pharmacist.

Driving and using machines

Most people can drive and use machines while taking Coroswera, as it does not affect their ability to drive or use machines. However, some patients may experience dizziness while taking Coroswera. If this occurs, the patient should consult their doctor before attempting to drive or use machines.

Coroswera contains lactose and sodium

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking Coroswera. The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Coroswera

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.

• Before starting treatment with Coroswera, the patient 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.
• The patient should continue to follow a cholesterol-lowering diet while taking Coroswera.

The recommended dose is one Coroswera tablet per day, taken orally. The medicine can be taken at any time of day, with or without food. The tablet should be swallowed whole with water. The patient should take the medicine at the same time every day.

Use in children and adolescents

Coroswera should not be used in children and adolescents.

Regular monitoring of cholesterol levels

It is essential to attend regular check-ups with the doctor to ensure that the cholesterol level is under control.

Taking a higher dose of Coroswera than recommended

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

Missing a dose of Coroswera

If the patient misses a dose, they should take the next tablet at the usual time. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Coroswera

The patient should tell their doctor if they want to stop taking Coroswera. After stopping Coroswera, the cholesterol level may rise again. If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Coroswera can cause side effects, although not everybody gets them. It is essential for the patient to know what side effects may be associated with taking Coroswera. They are usually mild and disappear after a short time.

The patient should stop taking Coroswera and seek medical attention immediately:

if they 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 (papular rash).
• or if they experience any of the following side effects:­ systemic lupus erythematosus (including rash, joint disorders, and effects on blood cells). ­ muscle rupture. ­ red, flat, round patches on the torso, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, and/or eyes. 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, the patient should stop taking Coroswera and consult their doctor immediately if they experience:

any unusual muscle pain that lasts longer than expected. As with other statins, unpleasant muscle symptoms have been reported in a very small number of people, which rarely worsen and lead to potentially life-threatening muscle damage called rhabdomyolysis.

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

• headache
• stomach pain
• constipation
• nausea
• muscle pain
• feeling weak
• dizziness
• increased protein in the urine - usually resolves on its own without the need to stop taking Coroswera tablets (applies to tablets containing 40 mg of rosuvastatin)
• diabetes - is more likely in patients with high levels of sugar and fat in the blood, overweight, and high blood pressure. The doctor will monitor the patient's condition while taking this medicine.
• increased results of some blood tests that assess 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 the need to stop taking Coroswera tablets (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 the hands and feet
• increased results of some blood tests that assess muscle function (creatine kinase activity)
• cough
• indigestion
• heartburn
• joint pain
• muscle cramps
• neck pain
• loss of appetite
• pain
• chest pain
• hot flashes (flushing)
• 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 (papular rash). If the patient suspects they have had an allergic reaction, they should stop taking Corosweraand consult their doctor immediately.
• muscle damage in adults - as a precaution, the patient should stop taking Coroswera

Coroswera and consult their doctor immediately if they experience any unusual, persistent muscle pain

• severe stomach pain (pancreatitis)
• decreased number of blood cells, which can 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 the arms and legs (e.g., numbness)
• memory loss
• breast enlargement in men (gynecomastia)

Frequency not known (frequency 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 can cause stomach 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)
The patient should talk to their doctor if they experience weakness in their arms or legs, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocides, 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, more information can be collected on the safety of the medicine.

5. How to store Coroswera

The medicine should be stored out of sight and reach of children. Do not take this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month stated. Store in the original packaging to protect from light and moisture. There are no special storage temperature requirements. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Coroswera contains

• The active substances of Coroswera 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, colloidal anhydrous 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 film-coated tablets, red iron oxide (E 172) - only for 15 mg + 10 mg, 20 mg + 10 mg, and 40 mg + 10 mg film-coated tablets, black iron oxide (E 172) - only for 40 mg + 10 mg film-coated 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 the inscription "R1" 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 the inscription "R2" 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 the inscription "R3" 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 the inscription "R4" 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 the inscription "R5" on one side of the tablet. Tablet diameter: approximately 10 mm. Coroswera is available in cardboard boxes 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 For more information about this medicine, the patient should 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 leaflet:28.02.2025