Rosuvastatin/ezetimib Zentiva

Leaflet attached to the packaging: patient information

Rosuvastatin/Ezetimib Zentiva, 5 mg + 10 mg, tablets

Rosuvastatin/Ezetimib Zentiva, 10 mg + 10 mg, tablets

Rosuvastatin/Ezetimib Zentiva, 20 mg + 10 mg, tablets

Rosuvastatinum + Ezetimibum

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 as yours.
• 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 Rosuvastatin/Ezetimib Zentiva and what is it used for
• 2. Important information before taking Rosuvastatin/Ezetimib Zentiva
• 3. How to take Rosuvastatin/Ezetimib Zentiva
• 4. Possible side effects
• 5. How to store Rosuvastatin/Ezetimib Zentiva
• 6. Contents of the pack and other information

1. What is Rosuvastatin/Ezetimib Zentiva and what is it used for

Rosuvastatin/Ezetimib Zentiva contains two different active substances in one tablet. One of the active substances is rosuvastatin, which belongs to a group of medicines known as statins, and the other active substance is ezetimibe.
Rosuvastatin/Ezetimib Zentiva is a medicine used to lower the level of cholesterol in the blood, so-called "bad" cholesterol (LDL cholesterol) and fatty substances called "triglycerides", and also to increase the level of so-called "good" cholesterol (HDL cholesterol).
The medicine works in two ways: it reduces the amount of cholesterol absorbed in the gut and the amount of cholesterol produced in the body.
In most people, high cholesterol does not affect their well-being, as it does not cause any symptoms. However, if left untreated, it can cause fatty deposits to build up in the walls of blood vessels, leading to their narrowing. As a result of the narrowing, it is possible for the blood vessel to become blocked, cutting off blood flow to the heart or brain, leading to a heart attack or stroke. By lowering cholesterol levels, the risk of heart attack, stroke, or other similar health problems can be reduced.
Rosuvastatin/Ezetimib Zentiva is used in patients for whom diet alone is not enough to maintain a healthy cholesterol level. While taking this medicine, you should continue to follow a low-cholesterol diet and maintain physical activity.
Your doctor may prescribe Rosuvastatin/Ezetimib Zentiva if you are already taking rosuvastatin and ezetimibe in the same doses as in the combination medicine.
The medicine is used in patients:

• with high cholesterol levels in the blood (primary hypercholesterolemia)
• with heart disease - Rosuvastatin/Ezetimib Zentiva 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.

Rosuvastatin/Ezetimib Zentiva does not help with weight loss.

2. Important information before taking Rosuvastatin/Ezetimib Zentiva

When not to take Rosuvastatin/Ezetimib Zentiva

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

If any of the above situations apply to the patient (or if the patient is in doubt), they should consult their doctor.

Warnings and precautions

Before taking Rosuvastatin/Ezetimib Zentiva, the patient should discuss it with their doctor or pharmacist if:
they have kidney problems;
they have liver problems;
they have experienced recurring or unexplained muscle pain, or have had muscle problems in the past or have a family history of muscle problems, or have had previous muscle problems related to taking other cholesterol-lowering medicines. If they experience unexplained muscle pain, especially if accompanied by malaise or fever, they should contact their doctor immediately. They should also tell their doctor or pharmacist about persistent muscle weakness;
they are of Asian origin (Japan, China, Philippines, Vietnam, Korea, or India). The doctor will determine the appropriate dose of Rosuvastatin/Ezetimib Zentiva for the patient;
they are taking antiviral medicines, including those used to treat HIV or hepatitis C, such as ritonavir with lopinavir and/or atazanavir (see "Rosuvastatin/Ezetimib Zentiva and other medicines");
they have severe respiratory failure;
they are taking other cholesterol-lowering medicines (so-called fibrates) (see "Rosuvastatin/Ezetimib Zentiva and other medicines");
they regularly consume large amounts of alcohol;
they have been diagnosed with hypothyroidism (underactive thyroid);
they are over 70 years old (as the doctor will need to choose an appropriate dose of Rosuvastatin/Ezetimib Zentiva for them);
they are taking or have taken fusidic acid (an antibiotic used to treat bacterial infections) orally or by injection in the last 7 days. Taking fusidic acid and Rosuvastatin/Ezetimib Zentiva at the same time may lead to serious muscle problems (rhabdomyolysis);
if the patient has ever had a severe skin rash or skin peeling, blisters, and/or ulcers in the mouth after taking Rosuvastatin/Ezetimib Zentiva or other similar medicines.
if the patient has or has 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 exacerbate the symptoms of the disease or lead to the development of myasthenia (see section 4).
Particular caution should be exercised when taking Rosuvastatin/Ezetimib Zentiva.
Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with Rosuvastatin/Ezetimib Zentiva. If any of the symptoms described in section 4 occur, the patient should stop taking Rosuvastatin/Ezetimib Zentiva.
If any of the above situations apply to the patient (or if they are in doubt), they should consult their doctor or pharmacist before starting to take Rosuvastatin/Ezetimib Zentiva.
In rare cases, statins may affect liver function. This can be detected by a simple blood test that checks for increased liver enzyme activity. Therefore, the doctor will recommend regular blood tests while taking Rosuvastatin/Ezetimib Zentiva. It is essential that the patient attends these tests as scheduled.
While taking this medicine, the doctor will closely monitor the patient's condition if they have diabetes or are at risk of developing it. There is a high risk of developing diabetes if the patient has high blood sugar and fat levels, is overweight, and has high blood pressure.
If the patient is hospitalized or treated for another condition, they should inform the medical staff that they are taking Rosuvastatin/Ezetimib Zentiva.

Children and adolescents

Rosuvastatin/Ezetimib Zentiva should not be used in children and adolescents under 18 years of age.

Rosuvastatin/Ezetimib Zentiva 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 tell their doctor about taking any of the following medicines:

• Cyclosporin (a medicine used, for example, after organ transplantation to prevent rejection. Cyclosporin increases the effect of rosuvastatin). Do not take Rosuvastatin/Ezetimib Zentiva while taking cyclosporin.
• Anticoagulant medicines, such as warfarin, acenocoumarol, or fluindione (taking Rosuvastatin/Ezetimib Zentiva at the same time may increase the anticoagulant effect, increasing the risk of bleeding) ticagrelor or clopidogrel.
• Other cholesterol-lowering medicines (so-called fibrates), which also regulate triglyceride levels in the blood (e.g., gemfibrozil and other medicines in this class). Taking these medicines at the same time increases the effect of rosuvastatin.
• Cholestyramine (a medicine used to lower cholesterol levels), as it affects the way ezetimibe works.
• Medicines used to treat indigestion, containing aluminum and magnesium (used to neutralize stomach acid). These medicines may reduce the level of rosuvastatin in the blood. This effect can be reduced by taking these medicines 2 hours after taking rosuvastatin.
• Erythromycin (an antibiotic). Taking erythromycin at the same time reduces the effect of rosuvastatin.
• Fusidic acid. If the patient needs to take fusidic acid orally to treat a bacterial infection, they will need to stop taking Rosuvastatin/Ezetimib Zentiva temporarily. The doctor will inform them when it is safe to restart taking the medicine. Taking Rosuvastatin/Ezetimib Zentiva and fusidic acid at the same time may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.
• Oral contraceptives (birth control pills). Taking these medicines at the same time increases the level of sex hormones released from the pill.

The patient should tell their doctor or pharmacist about taking any of the following medicines:

• Hormone replacement therapy (increasing hormone levels in the blood).
• Regorafenib (used to treat cancer).
• Any of the following medicines used to treat viral infections, including HIV or hepatitis C, taken alone or in combination with other medicines (see "Warnings and precautions"): ritonavir, lopinavir, atazanavir, sofosbuvir, velpatasvir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.

If the patient is to be hospitalized or treated for another condition, they should inform the medical staff that they are taking Rosuvastatin/Ezetimib Zentiva.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Pregnancy

Rosuvastatin/Ezetimib Zentiva should not be takenif the patient is pregnant, trying to become pregnant, or thinks they may be pregnant. If the patient becomes pregnant while taking Rosuvastatin/Ezetimib Zentiva, they should stop taking the medicine immediatelyand inform their doctor. While taking Rosuvastatin/Ezetimib Zentiva, the patient should use effective methods of contraception.

Breastfeeding

Rosuvastatin/Ezetimib Zentiva should not be takenduring breastfeeding, as it is not known whether the medicine passes into breast milk.

Driving and using machines

Rosuvastatin/Ezetimib Zentiva is unlikely to affect the patient's ability to drive or use machines. However, they should be aware that Rosuvastatin/Ezetimib Zentiva may cause dizziness. If this happens, the patient should contact their doctor before driving or using machines.

Rosuvastatin/Ezetimib Zentiva tablets contain lactose monohydrate

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Rosuvastatin/Ezetimib Zentiva

The patient should always take this medicine exactly as their doctor or pharmacist has told them. If they are unsure, they should consult their doctor or pharmacist.
While taking Rosuvastatin/Ezetimib Zentiva, the patient should continue to follow a low-cholesterol diet and maintain physical activity.
The recommended daily dose for adults is one tablet of the prescribed strength.

Rosuvastatin/Ezetimib Zentiva should be taken once a day.

The medicine can be taken at any time of day, with or without food. The tablets should be swallowed whole, with a glass of water.
The patient should take the medicine at the same time every day.
Rosuvastatin/Ezetimib Zentiva is not suitable for starting treatment. If treatment is started or the dose needs to be changed, the patient should take each active substance separately and only switch to Rosuvastatin/Ezetimib Zentiva once the doses have been established.

Regular cholesterol level checks

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

Taking a higher dose of Rosuvastatin/Ezetimib Zentiva than recommended

If the patient takes more than the recommended dose, they should contact their doctor or the emergency department of the nearest hospital, as medical attention may be necessary.

Missing a dose of Rosuvastatin/Ezetimib Zentiva

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

Stopping treatment with Rosuvastatin/Ezetimib Zentiva

The patient should tell their doctor if they want to stop taking Rosuvastatin/Ezetimib Zentiva. After stopping Rosuvastatin/Ezetimib Zentiva, the patient's cholesterol level may increase 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, Rosuvastatin/Ezetimib Zentiva can cause side effects, although not everybody gets them.
It is essential that the patient is aware of the possible side effects that may occur when taking this medicine.

The patient should stop taking Rosuvastatin/Ezetimib Zentiva and seek medical attention immediately

• if they experience any of the following allergic reactions:
• swelling of the face, lips, tongue, and/or throat, which may make it difficult to breathe or swallow;
• lupus-like syndrome (including rash, joint pain, and effects on blood cells);
• muscle rupture;
• red, flat, round, or oval patches on the torso, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and 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 hypersensitivity syndrome).

The patient should contact their doctor immediatelyif they experience any unusual, persistent muscle pain. This condition can rarely progress to a life-threatening muscle injury (known as rhabdomyolysis), causing malaise, fever, and kidney problems.
To determine the frequency of side effects, the following classification has been used:

• very common (may occur in more than 1 in 10 people)
• common (may occur in less than 1 in 10 people)
• uncommon (may occur in less than 1 in 100 people)
• rare (may occur in less than 1 in 1,000 people)
• very rare (may occur in less than 1 in 10,000 people), including isolated cases

Common side effects

headache
constipation
nausea
muscle pain
feeling of weakness
dizziness
diabetes - this is more likely to occur in patients with high blood sugar and fat levels, who are overweight, and have high blood pressure. The doctor will monitor the patient's condition while taking this medicine.
stomach pain
diarrhea
bloating (excess gas in the intestines)
feeling of tiredness
increased results of some blood tests that assess liver function (aminotransferase activity)

Uncommon side effects

rash, itching, hives
increased amount of protein in the urine, which usually resolves on its own without the need to stop taking Rosuvastatin/Ezetimib Zentiva tablets
increased results of some tests that assess muscle condition (creatine kinase activity, CK)
cough
indigestion
heartburn
joint pain
muscle spasms
neck pain
decreased appetite
pain
chest pain
hot flushes
high blood pressure
tingling
dry mouth
gastritis
back pain
muscle weakness
pain in the arms and legs
swelling, especially of the hands and feet

Rare side effects

pancreatitis, causing severe abdominal pain that may radiate to the back
decreased platelet count

Very rare side effects

jaundice (yellowing of the skin and eyes)
hepatitis
trace amounts of blood in the urine
nerve damage in the hands and feet (e.g., numbness)
memory loss
breast enlargement in men (gynecomastia)

Side effects with unknown frequency

shortness of breath
swelling
sleep disorders, including insomnia and nightmares
sexual disorders
depression
breathing difficulties, including persistent cough and/or shortness of breath or fever
tendon damage
persistent muscle weakness
red, raised rash, sometimes with changes in the shape of a target (erythema multiforme)
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).
ocular myasthenia (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 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:
Jerozolimskie Avenue 181C, 02-222 Warsaw
phone: +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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Rosuvastatin/Ezetimib Zentiva

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

6. Contents of the pack and other information

What Rosuvastatin/Ezetimib Zentiva contains

The active substances of the medicine are rosuvastatin (in the form of rosuvastatin calcium) and ezetimibe.
The tablets contain rosuvastatin calcium equivalent to 5 mg, 10 mg, or 20 mg of rosuvastatin and 10 mg of ezetimibe.
The other ingredients are lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, crospovidone type A, povidone K-30, sodium lauryl sulfate, and magnesium stearate.

What Rosuvastatin/Ezetimib Zentiva looks like and contents of the pack

Rosuvastatin/Ezetimib Zentiva, 5 mg + 10 mg
White or almost white, round, flat uncoated tablets with "E2" engraved on one side and "2" on the other side, with a diameter of 10 mm.
Rosuvastatin/Ezetimib Zentiva, 10 mg + 10 mg
White or almost white, oval, biconvex uncoated tablets with "E1" engraved on one side and "1" on the other side, measuring 15 mm x 7 mm.
Rosuvastatin/Ezetimib Zentiva, 20 mg + 10 mg
White or almost white, round, biconvex uncoated tablets with a diameter of 11 mm.
Blisters of PA/Aluminum/PVC/Aluminum foil in a cardboard box containing 30 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder
Zentiva, k.s.,
U kabelovny 130,
Dolní Měcholupy,
102 37 Prague 10,
Czech Republic
Manufacturer
Adamed Pharma S.A.
Marszałka Józefa Piłsudskiego 5
95-200 Pabianice
Poland

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

Italy: Quiloga Poland: Rosuvastatin/Ezetimib Zentiva

For more information, the patient should contact their local representative of the marketing authorization holder:

Zentiva Poland Sp. z.o.o.,
Bonifraterska 17
00-203 Warsaw, Poland
phone: +48 22 375 92 00
Date of last revision of the leaflet:June 2024