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

Rosuvastatin + Ezetimibe

You should carefully read the contents of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your 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 used to lower the level of cholesterol in the blood, "bad" cholesterol (LDL cholesterol) and fatty substances called triglycerides. Additionally, Rozesta increases the level of "good" cholesterol (HDL cholesterol). Rozesta works by reducing 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 blood flow to vital organs such as the heart and brain. Restricting blood flow 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 that 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 medication. 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 blood flow 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 return 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 or if you are pregnant.

2. Important information before taking Rozesta

When not to take Rozesta:

• if you are allergic to ezetimibe, rosuvastatin, or any of the other ingredients of this medicine (listed in section 6).
• if you currently have liver disease.
• if you are pregnant or breastfeeding. If you become pregnant while taking Rozesta, you should stop taking it immediately and consult your doctor. Women of childbearing age using Rozesta should avoid becoming pregnant, using effective methods of contraception.
• if you have severe kidney disease.
• if you have recurring or unexplained muscle pain or weakness (myopathy).
• if you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir (used to treat hepatitis C virus infection).
• if you are taking a medicine called cyclosporin (e.g., after organ transplantation). If any of the above applies to you (or if you are unsure), consult your doctor.

Warnings and precautions

Before taking Rozesta, discuss with your doctor or pharmacist:

• if you have kidney disease.
• if you regularly drink large amounts of alcohol or have previously had liver disease. Rozesta may not be suitable.
• if you have recurring or unexplained muscle pain or weakness, you have muscle disease, or it has occurred in your family, or if you have previously experienced muscle problems while taking other cholesterol-lowering medicines. You should contact your doctor immediately if you experience unexplained muscle pain or weakness, especially if accompanied by general malaise or fever. You should also inform your doctor or pharmacist if you experience persistent muscle weakness.
• if you have hypothyroidism (underactive thyroid).
• if you have severe respiratory failure.
• if you are taking medicines used to treat HIV infection, such as lopinavir and/or atazanavir (see "Rozesta and other medicines").
• if you are over 70 years old (as your doctor will need to determine the appropriate starting dose of Rozesta for you).
• if you are taking other cholesterol-lowering medicines called fibrates (see "Rozesta and other medicines").
• if you are scheduled for surgery. It may be necessary to stop treatment with Rozesta for a short time.
• if you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor will determine the appropriate starting dose of Rozesta for you.
• if you are currently taking or have taken fusidic acid (an antibiotic used to treat bacterial infections) orally or by injection within the last 7 days. If you need to take fusidic acid to treat a bacterial infection, you will need to temporarily stop taking Rozesta. Your doctor will tell you when it is safe to restart Rozesta. Taking Rozesta with fusidic acid can, in rare cases, cause serious muscle problems (rhabdomyolysis). For more information on rhabdomyolysis, see section 4. If you are taking Rozesta, you should inform any doctor who prescribes you a new medicine.
• if you have ever had a severe skin rash or skin peeling, blisters, and/or mouth sores after taking Rozesta or other similar medicines.
• if you have or have had myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease that causes muscle weakness in the eyes), as statins can sometimes worsen symptoms of the disease or cause myasthenia (see section 4).

Be particularly 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 you experience any of the symptoms described in section 4, you 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, being overweight, and having high blood pressure may be at risk of developing diabetes.
In rare cases, statins can affect liver function. A simple blood test can detect increased liver enzyme activity in the blood. For this reason, your doctor will regularly order this blood test (liver function test) during treatment with Rozesta. It is essential to visit your 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

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, especially:

• cyclosporin (often used in patients who have had an organ transplant). Do not take Rozesta while taking cyclosporin.
• darolutamide (used to treat cancer).
• medicines containing anticoagulants, such as warfarin or clopidogrel, fenprocoumon, acenocoumarol, fluindione, or ticagrelor (blood thinners).
• colestyramine (also used to lower cholesterol levels), as it affects the way Rozesta works.
• fibrates, such as gemfibrozil, fenofibrate (used to lower cholesterol levels), or other cholesterol-lowering medicines (such as ezetimibe).
• 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 virus infection, given 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 you need to take fusidic acid to treat a bacterial infection, you will need to temporarily stop taking Rozesta. Your doctor will tell you when it is safe to restart Rozesta. Taking Rozesta with fusidic acid can, in rare cases, cause serious muscle problems (rhabdomyolysis). For more information on rhabdomyolysis, see section 4. If you are taking Rozesta, you should inform any doctor who prescribes you a new medicine.

Pregnancy and breastfeeding

Do not take Rozesta if you are pregnant, planning to become pregnant, or think you may be pregnant. If you become pregnant while taking Rozesta, you must stop taking it immediately and inform your doctor. While taking Rozesta, women should use effective methods of contraception.
Do not take Rozesta while breastfeeding, as it is not known whether the medicine passes into breast milk.

Driving and using machines

You should not expect Rozesta to affect your ability to drive or use machines. However, you should consider that some people may experience dizziness after taking Rozesta.
If you experience dizziness after taking this medicine, you should contact your doctor before driving or using machines.

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

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

3. How to take Rozesta

This medicine should always be taken exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

• Before starting treatment with Rozesta, you should be on a cholesterol-lowering diet.
• While taking Rozesta, you should continue to follow a cholesterol-lowering diet. Your doctor will determine the appropriate dose for you, depending on your current treatment and individual risk factors. The recommended dose is one Rozesta tablet per day.

Rozesta is not suitable for initiating treatment.
Initiation of treatment or dose adjustments, if necessary, should be done with the individual active substances. Only after determining the appropriate doses can the combination medicine Rozesta be used at the appropriate dose.
Try to take your tablet at the same time each day, as this will help you remember.
You can take the medicine with or without food. Swallow each tablet whole with water.
If your doctor has prescribed another cholesterol-lowering medicine containing the active substance cholestyramine or another bile acid sequestrant, you should take Rozesta at least 2 hours before or 4 hours after taking the bile acid sequestrant.

Regular cholesterol tests

To ensure that your cholesterol levels have decreased and are being maintained at the correct level, you should have regular check-ups with your doctor and have blood tests. Your doctor may decide to increase the dose to make it suitable for you.

Taking more Rozesta than prescribed

Contact your doctor or go to the emergency department of your nearest hospital, as medical attention may be necessary.

Missing a dose of Rozesta

Do not worry, just skip the missed dose and take the next scheduled dose at the usual time. Do not take a double dose to make up for the missed dose.

Stopping treatment with Rozesta

Consult your doctor or pharmacist, as your cholesterol levels may rise again.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Rozesta can cause side effects, although not everybody gets them.

Stop taking Rozesta and seek medical help immediately if you experience any of the following:

• difficulty breathing, swelling of the face, lips, tongue, and/or throat, with or without difficulty swallowing; swelling of the face, lips, tongue, and/or throat, which may cause difficulty swallowing; severe itching of the skin (with raised bumps). These may be signs of a severe allergic reaction.
• any unexplained muscle pain, tenderness, or weakness. This is because

rarely, muscle problems, including muscle breakdown, can be serious and potentially life-threatening.

• lupus-like syndrome (including rash, joint disorders, and effects on blood cells).
• muscle rupture.
• red, flat, or rounded skin patches on the trunk, often with blisters in the center, skin peeling, mouth sores, ulcers in the mouth, throat, nose, genitals, and eyes. The occurrence of this type of severe skin rash can 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 evaluating liver function (liver transaminases); headache; abdominal pain; constipation; nausea; muscle pain; feeling weak; dizziness; diabetes - is more likely if you have high blood sugar and fat levels, are overweight, and have high blood pressure. Your doctor will monitor your condition while taking this medicine.
Uncommon(may affect up to 1 in 100 people):
increased values of some laboratory blood tests evaluating muscle function (CK, creatine kinase); cough; indigestion; heartburn; joint pain; muscle spasms; neck pain; decreased appetite; pain; chest pain; hot flushes; high blood pressure; tingling sensation; dry mouth; gastritis; itching; rash; hives or other skin reactions; back pain; muscle weakness; pain in 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 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 skin rash, sometimes with changes in the shape of a target (erythema multiforme); muscle tenderness; gallstones or cholecystitis (which can cause abdominal pain, nausea, vomiting); myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing). Myasthenia gravis (a disease that causes muscle weakness in the eyes).
You should discuss with your doctor if you experience 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 those not listed in this leaflet, please inform your 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rozesta

Keep this medicine out of the 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.
Store in the original packaging to protect from moisture and light. There are no special storage temperature requirements.
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. 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 rosuvastatin (as rosuvastatin calcium) and 10 mg 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).

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 about 10 mm, with "EL5" engraved on one side.
Rozesta, 10 mg + 10 mg, are beige, round, biconvex, film-coated tablets with a diameter of about 10 mm with "EL4" engraved on one side.
Rozesta, 20 mg + 10 mg, are yellow, round, biconvex, film-coated tablets with a diameter of about 10 mm with "EL3" engraved on one side.
Rozesta, 5 mg + 10 mg, 10 mg + 10 mg, is available in packs containing 10, 15, 30, 60, 90, or 100 film-coated tablets.
Rozesta, 20 mg + 10 mg, is available in packs containing 30, 60, 90, 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
ELPEN Pharmaceutical Co. Inc.
Zapani, Block 1048,
Keratea, 19001
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

For further information on this medicine, please contact the representative of the marketing authorization holder in Poland:

Zentiva Polska Sp. z o.o.
Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00
Date of last revision of the leaflet:December 2024