Rozesta

Leaflet accompanying the packaging: patient information

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

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

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

Rozesta, 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 Rozesta and what is it used for
• 2. Important information before taking Rozesta
• 3. How to take Rozesta
• 4. Possible side effects
• 5. How to store Rozesta
• 6. Contents of the packaging and other information

1. What is Rozesta and what is it used for

Rozesta contains two different active substances in one tablet. One of the active substances is rosuvastatin, which belongs to a group of medicines called statins, and the other active substance is ezetimibe. Rozesta is a medicine used to lower the level of cholesterol in the blood, "bad" cholesterol (LDL cholesterol) and fatty substances called triglycerides. Additionally, Rozesta increases the levels of "good" cholesterol (HDL cholesterol). Rozesta lowers cholesterol levels by acting in two ways. The medicine reduces the amount of cholesterol absorbed in the gut and the amount of cholesterol produced in the body. Cholesterol is one of several fatty substances found in the blood. Total cholesterol is mainly made up of LDL cholesterol and HDL cholesterol. LDL cholesterol is often called "bad" cholesterol because it can build up on the walls of arteries, forming plaques. Eventually, these plaques can cause the arteries to narrow, restricting or blocking the flow of blood to vital organs such as the heart and brain. Blocking the flow of blood can lead to a heart attack or stroke. HDL cholesterol is often called "good" cholesterol because it helps prevent the buildup of bad cholesterol in the arteries and prevents heart disease. Triglycerides are another type of fat found in the blood, which can increase the risk of developing heart disease. The medicine is used in patients for whom diet alone is not enough to control cholesterol levels. While taking this medicine, you should follow a cholesterol-lowering diet. Rozesta is used in addition to a cholesterol-lowering diet in the following cases:

• high cholesterol levels in the blood (primary hypercholesterolemia [heterozygous familial or non-familial])
• when the patient is taking a statin and ezetimibe in separate tablets,
• inherited disorder (homozygous familial hypercholesterolemia) that increases cholesterol levels in the blood. In this case, the patient may also be treated with other types of therapy. Rozesta does not affect weight loss.

In most people, high cholesterol does not affect how they feel, as it does not cause any symptoms. However, if left untreated, fatty deposits can build up in the walls of blood vessels, leading to their narrowing. Sometimes, these narrowed blood vessels can become blocked, cutting off the flow of blood to the heart or brain, leading to a heart attack or stroke. If cholesterol levels return to normal, the risk of heart attack, stroke, or other similar health problems will decrease. You should continue taking Rozesta, even if your cholesterol levels have returned to normal, as this will prevent the cholesterol levels from rising again and the buildup of fatty deposits. However, you should stop treatment if your doctor decides to do so or if you are pregnant.

2. Important information before taking Rozesta

When not to take Rozesta:

• if the patient is allergic to ezetimibe, rosuvastatin, or any of the other ingredients of this medicine (listed in section 6).
• if the patient currently has liver disease.
• if the patient is pregnant or breastfeeding. If the patient becomes pregnant while taking Rozesta, they should stop treatment immediately and consult a doctor. Women of childbearing age taking Rozesta should avoid becoming pregnant, using effective methods of contraception.
• if the patient has severe kidney disease.
• if the patient has recurring or unexplained muscle pain or weakness (myopathy).
• 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 cyclosporin (e.g., after organ transplantation). If any of the above applies to the patient (or if there is any doubt), they should consult a doctor.

Additionally, Rozesta 40 mg + 10 mg (the highest available dose) should not be used:

• if the patient has moderate kidney problems (if in doubt, consult a doctor).
• if the patient has thyroid problems (hypothyroidism).
• if the patient has recurring or unexplained muscle pain or weakness, has a muscle disease, or has had muscle problems while taking other cholesterol-lowering medicines.
• if the patient regularly consumes large amounts of alcohol.
• if the patient is of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
• if the patient is taking other cholesterol-lowering medicines called fibrates (see "Rozesta and other medicines"). If any of the above applies to the patient (or if there is any doubt), they should consult a doctor.

Warnings and precautions

Before starting treatment with Rozesta, the patient should discuss the following with their doctor or pharmacist:

• if the patient has kidney disease.
• if the patient regularly consumes large amounts of alcohol or has had liver disease in the past. Rozesta may not be suitable.
• if the patient has recurring or unexplained muscle pain or weakness, has a muscle disease, or has had muscle problems while taking other cholesterol-lowering medicines. The patient should contact their doctor immediately if they experience unexplained muscle pain or weakness, especially if accompanied by general malaise or fever. The patient should also inform their doctor or pharmacist if they experience persistent muscle weakness.
• if the patient has hypothyroidism (underactive thyroid).
• if the patient has severe respiratory failure.
• if the patient is taking medicines used to treat HIV infection, such as lopinavir and/or atazanavir (see "Rozesta and other medicines").
• if the patient is over 70 years old (as the doctor should determine the appropriate initial dose of Rozesta for the patient).
• if the patient is taking other cholesterol-lowering medicines called fibrates (see "Rozesta and other medicines").
• if the patient is scheduled for surgery. It may be necessary to stop treatment with Rozesta for a short time.
• if the patient is of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). The doctor will determine the appropriate initial dose of Rozesta for the patient.
• if the patient is currently taking or has taken within 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 Rozesta may cause serious muscle problems (rhabdomyolysis). For more information on rhabdomyolysis, see section 4. Patients taking Rozesta should inform any doctor who prescribes them a new medicine about their treatment.
• if the patient has ever had a severe skin rash or peeling of the skin, blisters, or ulcers in the mouth, throat, nose, genitals, or eyes after taking Rozesta or other similar medicines.

Be careful when taking Rozesta. Serious skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with Rozesta. If the patient experiences any of the symptoms described in section 4, they should stop taking Rozesta. Patients with diabetes or those at risk of developing diabetes will be closely monitored by their doctor while taking this medicine. Patients with high blood sugar and fat levels, overweight, and high blood pressure may be at risk of developing diabetes. Although statins may affect liver function, a simple blood test can detect increased liver enzyme activity in the blood. Therefore, the doctor will regularly order this blood test (liver function test) during treatment with Rozesta. It is essential to visit the doctor, who will order the necessary laboratory tests.

Children and adolescents

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

Rozesta 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. In particular, the patient should inform their doctor if they are taking any of the following medicines:

• cyclosporin (often used in patients after organ transplantation). Rozesta should not be taken while taking cyclosporin.
• darolutamide (used to treat cancer).
• medicines containing a substance that prevents blood clotting, such as warfarin or clopidogrel, phenprocoumon, acenocoumarol, fluindione, or ticagrelor (anticoagulant medicines).
• colestyramine (also used to lower cholesterol levels), as it affects the way Rozesta works.
• fibrates, such as gemfibrozil, fenofibrate (medicines used to lower cholesterol levels), or other medicines used to lower cholesterol (such as ezetimibe). Rozesta 40 mg + 10 mg should not be taken with fibrates.
• antacids containing aluminum and magnesium (used to neutralize stomach acid).
• erythromycin (an antibiotic).
• oral contraceptives (the "pill").
• hormone replacement therapy.
• regorafenib (used to treat cancer).
• any of the following medicines used to treat viral infections, including HIV or hepatitis C, alone or in combination with other medicines (see "Warnings and precautions"): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.
• fusidic acid - if the patient needs to take fusidic acid to treat a bacterial infection, they should temporarily stop taking Rozesta. The doctor will indicate when it is safe to resume taking Rozesta. Taking Rozesta with fusidic acid can rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4. Patients taking Rozesta should inform any doctor who prescribes them a new medicine about their treatment.

Taking Rozesta with alcohol

Rozesta 40 mg + 10 mg (the highest available dose) should not be taken if the patient regularly consumes large amounts of alcohol.

Pregnancy and breastfeeding

Rozesta should not be taken if the patient is pregnant, plans to become pregnant, or suspects they may be pregnant. If the patient becomes pregnant while taking Rozesta, they should stop treatment immediately and inform their doctor. While taking Rozesta, women should use effective methods of contraception. Rozesta should not be taken during breastfeeding, as it is not known whether the medicine passes into breast milk.

Driving and using machines

Rozesta is unlikely to affect the patient's ability to drive or use machines. However, the patient should consider that some people may experience dizziness after taking Rozesta. If the patient experiences dizziness after taking this medicine, they should contact their doctor before driving or using machines.

Rozesta contains lactose monohydrate (a type of sugar) and sodium

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

3. How to take Rozesta

This medicine should always be taken as directed by the doctor. If the patient is unsure, they should consult their doctor or pharmacist.

• Before starting treatment with Rozesta, the patient should follow a cholesterol-lowering diet.
• While taking Rozesta, the patient should follow a cholesterol-lowering diet. The doctor will determine the appropriate dose for the patient, depending on their current treatment and individual risk factors. The recommended dose is 1 tablet of Rozesta, once a day.

Rozesta is not suitable for starting treatment. Treatment should be initiated or the dose adjusted, if necessary, by administering the active substances in separate tablets. Only after determining the appropriate doses can the combination medicine Rozesta be used at the appropriate dose. The maximum daily dose of rosuvastatin is 40 mg, which is only used in patients with high cholesterol levels and a high risk of heart attack or stroke, for whom the 20 mg dose was not sufficient to lower cholesterol levels. The patient should try to take the tablet at the same time every day, which will help them remember. The medicine can be taken with or without food. Each tablet should be swallowed whole, with a glass of water. If the doctor has prescribed Rozesta with another cholesterol-lowering medicine containing the active substance colestyramine or another bile acid sequestrant, the patient should take Rozesta at least 2 hours before or 4 hours after taking the bile acid sequestrant.

Regular cholesterol tests

To ensure that cholesterol levels have decreased and remain at a normal level, the patient should visit their doctor regularly and have blood tests. The doctor may decide to increase the dose to make it suitable for the patient.

Taking a higher dose of Rozesta than recommended

The patient should contact their doctor or go to the emergency room, as medical attention may be necessary.

Missing a dose of Rozesta

There is no need to worry; the patient should skip the missed dose and take the next scheduled dose at the usual time. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Rozesta

The patient should consult their doctor or pharmacist, as cholesterol levels 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, Rozesta can cause side effects, although not everybody gets them.

The patient should stop taking Rozesta and seek medical attention immediately if they experience any of the following symptoms:

• difficulty breathing with swelling of the face, lips, tongue, and/or throat, or without; swelling of the face, lips, tongue, and/or throat, which may cause difficulty swallowing; severe skin itching (with raised bumps). These may be symptoms of a severe allergic reaction.
• any unexplained muscle pain, tenderness, or weakness. This is because muscle problems, including muscle breakdown leading to kidney damage, can be serious and potentially life-threatening.
• 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, ulcers in the mouth, throat, nose, genitals, 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).

Common(may affect up to 1 in 10 people):
diarrhea; bloating; feeling tired; increased values of some laboratory blood tests that assess liver function (liver transaminases); headache; abdominal pain; constipation; nausea; muscle pain; feeling weak; dizziness; increased protein in the urine - usually returns to normal without the need to stop taking Rozesta (this effect occurred only with the 40 mg rosuvastatin dose); diabetes - is more likely if the patient has high blood sugar and fat levels, is overweight, and has high blood pressure. The doctor will monitor the patient's condition while taking this medicine.
Uncommon(may affect up to 1 in 100 people):
increased values of some laboratory blood tests that assess muscle function (CK, creatine kinase); cough; indigestion; heartburn; joint pain; muscle spasms; neck pain; decreased appetite; pain; chest pain; flushing; high blood pressure; feeling of tingling; dry mouth; gastritis; itching; rash; hives or other skin reactions; back pain; muscle weakness; pain in the arms and legs; swelling, especially of the hands and feet; increased protein in the urine - usually returns to normal without the need to stop taking Rozesta (only rosuvastatin 10 mg and 20 mg).
Rare(may affect up to 1 in 1,000 people):
decreased number of blood cells, which can cause bruising and/or bleeding (thrombocytopenia); severe abdominal pain (pancreatitis).
Very rare(may affect up to 1 in 10,000 people):
jaundice (yellowing of the skin and eyes); liver inflammation; presence of trace amounts of blood in the urine; nerve damage in the arms and legs (e.g., numbness); memory loss; gynecomastia (breast enlargement in men).
Frequency not known(cannot be estimated from the available data):
shortness of breath; swelling; sleep disorders, including insomnia and nightmares; sexual disorders; depression; breathing problems, including persistent cough and/or shortness of breath or fever; tendon injury; persistent muscle weakness; raised, red rash, sometimes with changes in the shape of a target (erythema multiforme); muscle tenderness; gallstones or cholecystitis (which can cause abdominal pain, nausea, vomiting).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products Al. Jerozolimskie 181 C 02 222 Warsaw tel.: +48 22 49 21 301 fax: +48 22 49 21 309 website: https://smz.ezdrowie.gov.pl Side effects can be reported to the marketing authorization holder or its representative in Poland. Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Rozesta

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the outer packaging and blister after "EXP". The expiry date refers to the last day of the month. The medicine should be stored in its original packaging to protect it from moisture and light. 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 packaging and other information

What Rozesta contains

• The active substances of Rozesta are rosuvastatin and ezetimibe. Each tablet contains 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin (as rosuvastatin calcium) and 10 mg of ezetimibe. The other ingredients are: microcrystalline cellulose (PH 102), anhydrous colloidal silica, magnesium stearate, povidone K 30, sodium croscarmellose, sodium lauryl sulfate, lactose monohydrate, hypromellose. Rozesta, 5 mg + 10 mg: Opadry yellow: hypromellose, titanium dioxide (E171), macrogol 4000, yellow iron oxide (E172), talc, red iron oxide (E172).

Rozesta, 10 mg + 10 mg: Opadry beige: hypromellose 2910, titanium dioxide (E171), macrogol 4000, yellow iron oxide (E172), talc. Rozesta, 20 mg + 10 mg: Vivacoat Yellow: hypromellose, titanium dioxide (E171), talc, macrogol 4000, yellow iron oxide (E172). Rozesta, 40 mg + 10 mg: Opadry white: lactose monohydrate, hypromellose, titanium dioxide (E171), macrogol 4000.

What Rozesta looks like and contents of the pack

Rozesta, 5 mg + 10 mg, are light yellow, round, biconvex, film-coated tablets with a diameter of approximately 10 mm, with the inscription "EL5" embossed on one side. Rozesta, 10 mg + 10 mg, are beige, round, biconvex, film-coated tablets with a diameter of approximately 10 mm, with the inscription "EL4" embossed on one side. Rozesta, 20 mg + 10 mg, are yellow, round, biconvex, film-coated tablets with a diameter of approximately 10 mm, with the inscription "EL3" embossed on one side. Rozesta, 40 mg + 10 mg, are white, round, biconvex, film-coated tablets with a diameter of approximately 10 mm, with the inscription "EL2" embossed on one side. Rozesta, 5 mg + 10 mg, 10 mg + 10 mg, is available in packs containing 10, 15, 30, 60, or 100 film-coated tablets. Rozesta, 20 mg + 10 mg, 40 mg + 10 mg, is available in packs containing 30, 60, or 100 film-coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder

Zentiva, k.s., U kabelovny 130 Dolní Měcholupy 102 37 Prague 10 Czech Republic

Manufacturer

ELPEN Pharmaceutical Industry Co. Inc. 95 Marathonos Avenue 19009, Pikermi, Attiki Greece

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Netherlands, Estonia, Latvia, Poland: Rozesta Czech Republic, Portugal, Romania: Rozetin Bulgaria: Розетин Zentiva Polska Sp. z o.o. ul. Bonifraterska 17 00-203 Warsaw tel.: +48 22 375 92 00 Date of last revision of the leaflet:April 2022