Coroswera

Patient Information Leaflet

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, 30 mg + 10 mg, film-coated tablets
Coroswera, 40 mg + 10 mg, film-coated tablets
Rosuvastatin + Ezetimibe
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet Contents

1. What Coroswera is and what it is used for
2. What you need to know 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 Coroswera is and what it is used for

Coroswera contains two different active substances. One of them is rosuvastatin, which belongs to a group of medicines called statins, and the other is ezetimibe.
Coroswera is a medicine used to lower blood levels of total cholesterol, so-called "bad" cholesterol (LDL cholesterol), and fat substances called triglycerides.
In addition, Coroswera increases the level of so-called "good" cholesterol (HDL cholesterol). HDL cholesterol is often called "good" because it helps prevent the buildup of "bad" cholesterol in the arteries and thus protects against heart disease.
Coroswera lowers cholesterol levels by acting in two ways: by reducing the amount of cholesterol absorbed in the gastrointestinal tract and by reducing the amount of cholesterol produced in the body.
Coroswera is used in patients whose cholesterol levels cannot be adequately controlled by diet alone. While taking this medicine, you must continue to follow a cholesterol-lowering diet.
Your doctor may prescribe Coroswera if you are already taking rosuvastatin and ezetimibe separately at the same doses as those contained in the combination product.
If you have heart disease, Coroswera reduces the risk of heart attack, stroke, the need for a surgical procedure 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 levels remain at an appropriate level, because this prevents cholesterol levels from rising again and from cholesterol deposits building up in the arteries. You should stop treatment if your doctor advises you to do so, or if you become pregnant.

2. Important information before using Coroswera

When not to use 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, she must immediately stop taking it and inform her doctor. Effective contraceptive methods must be used to avoid pregnancy while taking Coroswera;
• if the patient has liver disease;
• if the patient has severe kidney function impairment;
• if the patient experiences recurrent, unexplained muscle pain;
• if the patient is taking the combination sofosbuvir/velpatasvir/voxilaprevir (used to treat viral hepatitis C);
• if the patient is taking a medicine called cyclosporine (e.g. after organ transplantation).

If any of the above situations apply to the patient (or if the patient has any doubts),
consult a doctor.
Additionally, do not use Coroswera 30 mg + 10 mg or 40 mg + 10 mg (the highest dose) if:
- the patient has moderate kidney function impairment (in case of doubt, contact a doctor);
- the patient has abnormal thyroid function;
- the patient has experienced recurrent or unexplained muscle pain, or previously had muscle disorders, either personally or in family members, or prior muscle-related problems;
- the patient regularly consumes large amounts of alcohol;
- the patient is of Asian origin (Japan, China, Philippines, Vietnam, Korea, or India);
- the patient is taking other medicines called fibrates to lower cholesterol levels;
- if any of the above situations apply to the patient or if the patient has any doubts, consult a doctor.

Warnings and precautions

Before starting Coroswera, discuss with a doctor or pharmacist if:
- the patient has kidney function impairment;
- the patient has liver function impairment;
- the patient has experienced recurrent or unexplained muscle pain, or previously had muscle disorders personally or in family members, or prior muscle-related problems associated with taking other cholesterol-lowering medicines. In case of unexplained muscle pain, especially when accompanied by malaise or fever, contact a doctor immediately. Also inform the doctor or pharmacist about persistent muscle weakness;
- the patient regularly consumes large amounts of alcohol;
- the patient has abnormal thyroid function;
- the patient is taking other medicines called fibrates to lower cholesterol levels. Read this leaflet even if the patient has previously taken cholesterol-lowering medicines;
- the patient is receiving medicines used to treat HIV infection, e.g. ritonavir with lopinavir and (or) atazanavir – see section "Coroswera with other medicines";
- the patient is currently receiving or has received within the last 7 days oral or injectable fusidic acid (used to treat bacterial infections). Concomitant use of fusidic acid and Coroswera may lead to serious muscle disorders (rhabdomyolysis);
- the patient is over 70 years of age (as the doctor will need to select an appropriate starting dose of Coroswera);
- the patient has severe respiratory insufficiency;
- the patient is of Asian origin (Japan, China, Philippines, Vietnam, Korea, or India). The doctor will determine the appropriate starting dose of Coroswera for the patient;
- if the patient has ever experienced severe skin rash, skin peeling, blisters and (or) oral ulcers after taking rosuvastatin or other similar medicines;
- if the patient has or has had myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease causing weakness of eye muscles), as statins may sometimes worsen symptoms or trigger myasthenia (see section 4).

While taking this medicine, the doctor will closely monitor patients with diabetes or risk factors for developing diabetes. The risk of developing diabetes is higher if the patient has high blood sugar and fat levels, overweight, and high blood pressure.
In a small number of people, statins may affect liver function. This is detected by a simple blood test measuring increased liver enzyme activity. Therefore, the doctor will recommend regular blood tests (liver function tests) 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 use. If any of the symptoms described in section 4 occur, stop taking Coroswera and contact a doctor immediately.

Children and adolescents

Coroswera is not recommended for use in children and adolescents under 18 years of age.

Coroswera with other medicines

Inform the doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines the patient plans to take.

Inform the doctor if taking any of the following medicines:

• cyclosporine (a medicine used, for example, after organ transplantation);
• 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 (such as ezetimibe);
• medicines for indigestion (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);
• capmatinib (used to treat cancer);
• fostamatinib (used to treat low platelet count);
• febuxostat (used to treat and prevent high blood uric acid levels);
• teriflunomide (used to treat multiple sclerosis);
• leflunomide (used to treat rheumatoid arthritis);
• any of the following medicines used to treat viral infections, including HIV or hepatitis C virus infection, used alone or in combination with another medicine (see section "Warnings and precautions"): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir;
• roxadustat (used to treat anemia in patients with chronic kidney disease);
• tafamidis (used to treat a disease called transthyretin amyloidosis);
• cholestyramine (a cholesterol-lowering medicine), as it affects the way ezetimibe works;
• momelotinib (used to treat myelofibrosis in adults with anemia);
• if oral fusidic acid is required to treat a bacterial infection, temporary discontinuation of Coroswera is necessary. The doctor will advise when it is safe to restart Coroswera. Taking Coroswera with fusidic acid may rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). For more information about rhabdomyolysis, see section 4.

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 use Coroswera if the patient is pregnant or breastfeeding. If the patient becomes pregnant while taking Coroswera, she must immediately stop taking it and inform her doctor. Effective contraceptive methods must be used to avoid pregnancy while taking Coroswera.

Before taking any medicine, consult a doctor or pharmacist.

Driving and using machines

Most people can drive and operate machinery while taking Coroswera, as this medicine does not affect the ability to drive or operate machinery. However, some patients may experience dizziness while taking Coroswera. If dizziness occurs, consult a doctor before attempting to drive or operate machinery.

Coroswera contains lactose and sodium

If the patient has previously been diagnosed with intolerance to certain sugars, consult a doctor before taking this medicine.

The medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to take Coroswera

This medicine should always be taken exactly as directed by the physician or pharmacist. In case of doubts,
consult the physician or pharmacist.

• Before starting treatment with Coroswera, the patient should be on a cholesterol-lowering diet and should already be taking rosuvastatin and ezetimibe at the same doses as contained in the fixed-dose combination. This medicine is not suitable for initiating therapy.
• The patient should continue the cholesterol-lowering diet during treatment with Coroswera.

The recommended dose is one tablet of Coroswera once daily, 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 medicine should be taken at the same time each day.
Use in children and adolescents
Coroswera must not be used in children and adolescents.
Regular monitoring of cholesterol levels
It is important to attend regular check-ups with the physician to ensure that the desired cholesterol levels have been achieved and are being maintained.
Taking more Coroswera than recommended
If more than the recommended dose has been taken, contact the physician or the emergency department of the nearest hospital immediately, as medical assistance may be required.
If hospitalization or other medications are required for the treatment of another condition, inform the medical staff about the use of Coroswera.
Missing a dose of Coroswera
If a dose is missed, take the next tablet at the usual time. Do not take a double dose to make up for the missed dose.
Stopping Coroswera
Inform the physician if the patient intends to discontinue treatment with Coroswera. After stopping Coroswera, cholesterol levels may rise again.
If there are any further doubts about the use of this medicine, consult the physician or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, although not everyone will experience them.
It is important for the patient to be aware of the adverse effects that may be associated with the use of this medicine.
They are usually mild and resolve after a short period of time.
The patient must stop taking Coroswera and seek immediate medical help if any of the following allergic reactions occur:

• Difficulty in 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 in swallowing.
• Severe skin itching (urticarial rash).

Or if any of the following adverse effects occur:
­ Lupus-like syndrome (including rash, joint disorders and effects on blood cells).
­ Muscle rupture.
­ Red, flat, disc-shaped or circular lesions on the trunk, often with blisters in the center, skin peeling, mucosal ulcers in the mouth, throat, nose, genital organs and eyes. The occurrence of such serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
­ Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

In addition, the patient must stop taking Coroswera and contact a doctor immediately if experiencing any unusual muscle pain that lasts longer than expected. As with other statins, unpleasant muscle symptoms have occurred in a very small number of people, which rarely worsened and progressed to potentially life-threatening muscle damage called rhabdomyolysis.

Common adverse effects (may occur in up to 1 in 10 patients):

• Headache
• Abdominal pain
• Constipation
• Nausea
• Muscle pain
• Feeling of weakness
• Dizziness
• Increased protein in urine – usually resolves spontaneously without the need to discontinue Coroswera tablets (applies to tablets containing 40 mg of rosuvastatin)
• Diabetes – more likely in patients with high blood levels of sugar and fats, overweight and high blood pressure. The treating physician will monitor the patient’s condition during treatment with this medicine.
• Increased results of certain blood tests assessing liver function (aminotransferase activity)
• Muscle tenderness or weakness
• Diarrhea
• Flatulence
• Feeling of fatigue

Uncommon adverse effects (may occur in up to 1 in 100 patients):

• Rash, itching or other skin reactions
• Increased protein in urine – usually resolves spontaneously without the need to discontinue Coroswera tablets (applies to tablets containing 5–20 mg of rosuvastatin)
• Tingling sensation
• Dry mouth
• Urticaria
• Back pain
• Muscle weakness, pain in arms and legs
• Swelling, especially of hands and feet
• Increased results of certain blood tests assessing muscle function (creatine kinase activity, CK)
• Cough
• Indigestion
• Heartburn
• Joint pain
• Muscle cramps
• Neck pain
• Decreased appetite
• Pain
• Chest pain
• Hot flushes (flushing)
• High blood pressure

Rare adverse effects (may occur in up to 1 in 1,000 patients):

• Severe allergic reactions – symptoms include swelling of the face, lips, tongue and (or) throat, difficulty in swallowing and breathing, severe skin itching (urticarial rash). If the patient suspects an allergic reaction, they must stop taking Coroswera and seek immediate medical attention.

• Muscle damage in adults – as a precaution, the patient must stop taking Coroswera and contact a doctor immediately if experiencing any unusual, persistent muscle pain

• Severe abdominal pain (inflammation of the pancreas)

• Decreased number of blood cells, which may lead to bruising/bleeding (thrombocytopenia)

Very rare adverse effects (may occur in up to 1 in 10,000 patients):

• Jaundice (yellowing of the skin and eyes)
• Hepatitis (liver inflammation)
• Blood in urine
• Nerve damage in arms and legs (e.g. numbness)
• Memory loss
• Breast enlargement in men (gynaecomastia)

Frequency not known (frequency cannot be estimated from available data):
­ Sleep disorders, including insomnia and nightmares
­ Sexual dysfunction
­ Depression
­ Breathing problems, including persistent cough and (or) shortness of breath or fever
­ Tendon damage
­ Persistent muscle weakness
­ Liver problems
­ Red, raised rash, sometimes with lesions in a target-like shape (erythema multiforme)
­ Rhabdomyolysis (breakdown of skeletal muscle)
­ Gallstones or cholecystitis (which may cause abdominal pain, nausea, vomiting)
­ Myasthenia gravis (a disease causing general muscle weakness, including in some cases muscles involved in breathing)
­ Ocular myasthenia (a disease causing weakness of eye muscles)

The patient should talk to a doctor if they experience weakness in arms or legs that worsens with activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, the patient should inform their doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store the medicine Coroswera

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer packaging following the abbreviation
EXP. The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from light and moisture.
No special temperature storage requirements for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures will help protect the environment.

6. Contents of the pack and other information

What the medicine Coroswera contains

• The active substances are rosuvastatin and ezetimibe.
  5 mg + 10 mg: Each coated tablet contains 5 mg rosuvastatin (as rosuvastatin calcium) and 10 mg ezetimibe.
  10 mg + 10 mg: Each coated tablet contains 10 mg rosuvastatin (as rosuvastatin calcium) and 10 mg ezetimibe.
  15 mg + 10 mg: Each coated tablet contains 15 mg rosuvastatin (as rosuvastatin calcium) and 10 mg ezetimibe.
  20 mg + 10 mg: Each coated tablet contains 20 mg rosuvastatin (as rosuvastatin calcium) and 10 mg ezetimibe.
  30 mg + 10 mg: Each coated tablet contains 30 mg rosuvastatin (as rosuvastatin calcium) and 10 mg ezetimibe.
  40 mg + 10 mg: Each coated tablet contains 40 mg rosuvastatin (as rosuvastatin calcium) and 10 mg ezetimibe.

• Other ingredients are:
  In the tablet core – microcrystalline cellulose, lactose, mannitol, crospovidone type A, sodium carmellose, 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, 15 mg + 10 mg and 30 mg + 10 mg coated tablets, red iron oxide (E 172) – only for 15 mg + 10 mg, 20 mg + 10 mg, 30 mg + 10 mg and 40 mg + 10 mg coated tablets, black iron oxide (E 172) – only for 30 mg + 10 mg and 40 mg + 10 mg 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, biconvex coated tablet (tablet) with bevelled edges, embossed with the code “R1” on one side of the tablet. Tablet diameter: approximately 10 mm.
10 mg + 10 mg: Light brownish-yellow to light brown-yellow, round, biconvex coated tablet (tablet) with bevelled edges, embossed with the code “R2” on one side of the tablet. Tablet diameter: approximately 10 mm.
15 mg + 10 mg: Light reddish-orange, round, biconvex coated tablet (tablet) with bevelled edges, embossed with the code “R3” on one side of the tablet. Tablet diameter: approximately 10 mm.
20 mg + 10 mg: Light pink, round, biconvex coated tablet (tablet) with bevelled edges, embossed with the code “R4” on one side of the tablet. Tablet diameter: approximately 10 mm.
30 mg + 10 mg: Light brown, round, biconvex coated tablet (tablet) with bevelled edges, embossed with the code “30” on one side of the tablet. Tablet diameter: approximately 10 mm.
40 mg + 10 mg: Light greyish-violet to light grey-violet, round, biconvex coated tablet (tablet) with bevelled edges, embossed with the code “R5” on one side of the tablet. Tablet diameter: approximately 10 mm.

Coroswera is available in cardboard packs containing 14, 15, 28, 30, 56, 60, 84, 90 or 98 coated tablets in blisters.
Not all pack sizes may be marketed.

Marketing Authorisation 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 {does not apply to 30 mg+10 mg strength}

This medicinal product is authorised in the European Economic Area under the following names:

For more detailed information about this medicinal product, please contact the local representative of the marketing authorisation holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5 Street
02-235 Warsaw
telephone: +48 22 573 75 00