Rozesta

Package leaflet: Information for the patient

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
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. 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 them even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Rozesta is and what it is used for
2. What you need to know before taking Rozesta
3. How to take Rozesta
4. Possible side effects
5. How to store Rozesta
6. Contents of the pack and other information

1. What Rozesta is and what it is 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. The other active substance is ezetimibe.
Rozesta is a medicine used to lower blood levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides.
Additionally, Rozesta increases levels of "good" cholesterol (HDL cholesterol).
Rozesta 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.
Cholesterol is one of several fatty substances present in the blood. Total cholesterol consists mainly of LDL cholesterol and HDL cholesterol.
LDL cholesterol is often called "bad" cholesterol because it can deposit on the walls of arteries, forming atherosclerotic plaques. Eventually, these plaques can narrow the arteries, restricting or blocking blood flow to vital organs such as the heart and brain. Blocked blood flow may lead to heart attack or stroke.
HDL cholesterol is often called "good" cholesterol because it helps prevent the buildup of "bad" cholesterol in the arteries and protects against heart disease.
Triglycerides are another type of fat present in the blood that may contribute to an increased risk of heart disease.
The medicine is used in patients in whom diet alone is not sufficient to maintain normal cholesterol levels. While taking this medicine, you should follow a cholesterol-lowering diet.
Rozesta is used as an adjunct to diet in the following conditions:
elevated blood cholesterol levels (primary hypercholesterolemia [heterozygous familial or non-familial])

• when a patient is taking statin and ezetimibe as separate tablets,
• in an inherited disorder (homozygous familial hypercholesterolemia) that increases blood cholesterol levels. In such cases, other types of treatment may also be used. Rozesta is used as replacement therapy in adult patients with ischemic heart disease and a history of acute coronary syndrome.

Rozesta does not affect body weight.
In most people, high cholesterol levels do not affect how they feel, as they cause no symptoms. However, if left untreated, fatty deposits may build up in the walls of blood vessels, leading to narrowing.
Sometimes these narrowed vessels may become blocked, cutting off blood supply to the heart or brain, which may result in a heart attack or stroke. If cholesterol levels return to normal, the risk of heart attack, stroke, or other related health problems is reduced.
You should continue taking Rozesta even if your cholesterol levels have returned to normal, as this helps prevent cholesterol levels from rising again and further fatty deposits from forming.
However, you should stop treatment if your doctor decides so, or if you are pregnant.

2. Important information before using Rozesta

When not to use 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 pregnancy occurs while taking Rozesta, treatment must be stopped immediately and the doctor consulted. Women of childbearing potential taking Rozesta should avoid becoming pregnant by using effective contraceptive methods.
• if the patient has severe kidney disease.
• if the patient has recurrent or unexplained muscle pain or discomfort (myopathy).
• if the patient is taking the combination of sofosbuvir/velpatasvir/voxilaprevir (used to treat hepatitis C virus infection).
• 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 there is any doubt whether they do), medical advice must be sought.

Warnings and precautions
Before starting Rozesta, discuss with your doctor or pharmacist if:

• the patient has kidney disease.

• the patient regularly drinks large amounts of alcohol or has previously had liver disease. Rozesta may not be suitable.

• the patient has recurrent or unexplained muscle pain or discomfort, has a muscle disorder, has a family history of muscle disorders, or previously experienced muscle-related problems while taking other cholesterol-lowering medicines. The patient should contact their doctor immediately if unexplained muscle symptoms or pain occur, especially if accompanied by malaise or fever. The patient should also inform their doctor or pharmacist if persistent muscle weakness occurs.

• the patient has hypothyroidism (underactive thyroid).

• the patient has severe respiratory insufficiency.

• the patient is taking medicines used to treat HIV infection, such as lopinavir and/or atazanawir (see section “Rozesta with other medicines”).

• the patient is over 70 years of age (as the doctor should determine the appropriate starting dose of Rozesta).

• the patient is taking other cholesterol-lowering medicines called fibrates (see section “Rozesta with other medicines”).

• the patient has planned surgery. It may be necessary to temporarily stop treatment with Rozesta.

• the patient is of Asian descent (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). The doctor will determine the appropriate starting dose of Rozesta.

• the patient is currently taking or has taken within the last 7 days a medicine called fusidic acid (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and Rozesta may cause serious muscle problems (rhabdomyolysis).

• the patient has ever had a severe skin rash, skin peeling, blisters, and/or oral ulcers after taking Rozesta or similar medicines.

• the patient has or has had myasthenia (a disease causing generalised muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen symptoms or trigger myasthenia (see section 4).

Take special care when using Rozesta
Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with Rozesta. If any of the symptoms described in section 4 occur, treatment with Rozesta must be stopped.
Patients with diabetes or those at risk of developing diabetes will be closely monitored during treatment with this medicine. Patients with high blood sugar and fat levels, overweight, and high blood pressure may be at increased risk of developing diabetes.
In a small number of patients, statins may affect liver function. To detect such effects, a simple blood test is performed to identify increased liver enzyme activity in the blood. Therefore, the doctor will regularly order such blood tests (liver function tests) during treatment with Rozesta. It is important to visit the doctor, who will arrange for the necessary laboratory tests.

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

Rozesta with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those not listed here. In particular, inform the doctor if the patient is taking any of the following medicines:

• Cyclosporine (often used in patients after organ transplantation). Do not take Rozesta while taking cyclosporine.
• Darolutamide (used to treat cancer).
• Medicines containing anticoagulant active substances such as warfarin or clopidogrel, phenprocoumon, acenocoumarol, fluindione, or ticagrelor (antiplatelet agents).
• Colestyramine (also used to lower cholesterol levels), as it affects the way Rozesta works.
• Fibrates such as gemfibrozil, fenofibrate (medicines used to lower cholesterol), or other cholesterol-lowering medicines (such as ezetimibe).
• Antacids containing aluminium and magnesium (used to neutralise 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, used alone or in combination with other medicines (see section “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, Rozesta should be temporarily discontinued. The doctor will advise when it is safe to restart Rozesta. Concomitant use of Rozesta with fusidic acid may rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). For further information on rhabdomyolysis, see section 4. The patient taking Rozesta should inform every doctor prescribing a new medicine about its use.

Pregnancy and breastfeeding
Do not use Rozesta if the patient is pregnant, planning to become pregnant, or suspects she may be pregnant. If pregnancy occurs during treatment with Rozesta, the patient must stop taking the medicine immediately and inform the doctor without delay. Women must use effective contraception during treatment with Rozesta.
Do not use Rozesta during breastfeeding, as it is not known whether the medicine passes into breast milk.

Driving and using machines
Rozesta is not expected to affect the ability to drive or operate machinery. However, dizziness may occur in some patients after taking Rozesta.
If dizziness occurs after taking this medicine, the patient should contact their doctor before driving or operating machinery.

Rozesta contains lactose monohydrate (a type of sugar) and sodium
If the patient has been previously diagnosed with an intolerance to certain sugars, they should consult their doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. the medicine is considered "sodium-free".

3. How to take Rozesta

This medicine should always be taken exactly as directed by the doctor. If in doubt, consult
your doctor or pharmacist.

• Before starting treatment with Rozesta, a cholesterol-lowering diet should be initiated.
• During treatment with Rozesta, a cholesterol-lowering diet should be maintained. Your doctor will determine the appropriate dose for you, depending on your current treatment and individual risk status.

The recommended dose is 1 Rozesta tablet once daily.
Rozesta is not suitable for initiating treatment.
Initiation of treatment or dose adjustments, if necessary, should be carried out using the active substances as separate medications. Only after the appropriate doses have been established may combination therapy with Rozesta at the appropriate dose be considered.
Try to take the tablet at the same time each day to help remember it.
The medicine may be taken with or without food. Swallow each tablet whole with water.
If your doctor has prescribed Rozesta together with another cholesterol-lowering medicine containing the active substance cholestyramine or another bile acid sequestrant, take Rozesta at least 2 hours before or 4 hours after taking the bile acid sequestrant.

Regular cholesterol monitoring
To ensure that cholesterol levels have decreased and remain at a proper level, regular check-ups with your doctor and blood tests are necessary. Your doctor may decide to increase the dose to suit your individual needs.

Taking more Rozesta than prescribed
Contact your doctor or go to the nearest hospital emergency department immediately, as medical assistance may be required.

If you miss a dose of Rozesta
Do not be concerned. Skip the missed dose and take the next scheduled dose at the usual time. Do not take a double dose to make up for a missed dose.

Stopping Rozesta
Consult your doctor or pharmacist, as cholesterol levels may rise again.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
You should stop taking Rozesta and seek immediate medical help if any of the following symptoms occur:

• 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 lumps). These may be symptoms of a severe allergic reaction.
• Any unexplained muscle pain, tenderness or weakness. This is because, in rare cases, 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, disc-shaped or round spots on the trunk, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genital organs and around the eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• Widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Common (may occur in up to 1 in 10 people):
Diarrhea; flatulence; feeling of fatigue; increased blood laboratory test values assessing liver function (liver aminotransferases); headache; abdominal pain; constipation; nausea; muscle pain; feeling of weakness; dizziness; diabetes mellitus – 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 during treatment with this medicine.

Uncommon (may occur in up to 1 in 100 people):
Increased blood laboratory test values related to muscle function (CK, creatine kinase); cough; indigestion; heartburn; joint pain; muscle cramps; neck pain; decreased appetite; pain; chest pain; hot flush; high blood pressure; tingling sensation; dry mouth; gastritis; itching; rash; urticaria or other skin reactions; back pain; muscle weakness; pain in arms and legs; swelling, especially of hands and feet; increased protein in urine – usually returns to normal spontaneously without the need to discontinue Rozesta (only for rosuvastatin 10 mg and 20 mg).

Rare (may occur in up to 1 in 1,000 people):
Decreased number of blood cells, which may lead to bruising and (or) bleeding (thrombocytopenia); severe abdominal pain (pancreatitis).

Very rare (may occur in up to 1 in 10,000 people):
Jaundice (yellowing of the skin and eyes); hepatitis; presence of trace amounts of blood in urine; nerve damage in arms and legs (e.g. numbness); memory loss; gynecomastia (enlargement of breasts in men).

Frequency not known (cannot be estimated from available data):
Shortness of breath; swelling; sleep disorders, including insomnia and nightmares; sexual dysfunction; breathing problems, including persistent cough and (or) shortness of breath or fever; tendon injury; persistent muscle weakness; raised red rash, sometimes with lesions in the shape of a disc (erythema multiforme); muscle tenderness; gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting); myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing).
Ocular myasthenia (a disease causing weakness of eye muscles).

You should talk to your doctor if you experience weakness in arms or legs, worsening after periods of activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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
Adverse reactions can also be reported to the marketing authorization holder or its representative in Poland.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Rozesta

Keep the 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 marked "EXP". The expiry date refers to the last day of the stated month.
Keep the medicine in its original packaging to protect it from moisture and light.
There are no special requirements regarding storage temperature.
Medicines must 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 pack and other information

What Rozesta contains

• The active substances in this medicine are rosuvastatin and ezetimibe. Each tablet contains 5 mg, 10 mg, or 20 mg of rosuvastatin (as rosuvastatin calcium) and 10 mg of ezetimibe. The other ingredients are: microcrystalline cellulose (PH 102), anhydrous colloidal silicon dioxide, magnesium stearate, povidone K 30, sodium croscarmellose, sodium lauryl sulfate, monohydrate lactose, hypromellose.
  Rozesta 5 mg + 10 mg: Opadry yellow: hypromellose, titanium dioxide (E171), macrogol 4000, iron oxide yellow (E172), talc, iron oxide red (E172).
  Rozesta 10 mg + 10 mg: Opadry beige: hypromellose 2910, titanium dioxide (E171), macrogol 4000, iron oxide yellow (E172), talc.
  Rozesta 20 mg + 10 mg: Vivacoat Yellow: hypromellose, titanium dioxide (E171), talc, macrogol 4000, iron oxide yellow (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 approximately 10 mm, imprinted with "EL5" on one side.
Rozesta 10 mg + 10 mg are beige, round, biconvex film-coated tablets with a diameter of approximately 10 mm, imprinted with "EL4" on one side.
Rozesta 20 mg + 10 mg are yellow, round, biconvex film-coated tablets with a diameter of approximately 10 mm, imprinted with "EL3" on one side.
Rozesta 5 mg + 10 mg and 10 mg + 10 mg are 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 Authorisation 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 authorised in the countries of the European Economic Area under the following names:
Netherlands, Estonia, Latvia, Poland: Rozesta
France: Quiloga
Czech Republic, Portugal, Romania, Hungary, Slovakia: Rozetin
Bulgaria: Розетин

Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00