Rosuvastatin/ezetimib Zentiva

Leaflet accompanying 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 necessary.
• In case of 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 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 packaging 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 called 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 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 reduce body weight.

2. Important information before taking Rosuvastatin/Ezetimib Zentiva

When not to take Rosuvastatin/Ezetimib Zentiva

If any of the above situations apply to you (or if you are in doubt whether such a situation exists), you should consult your doctor.

Warnings and precautions

Before taking Rosuvastatin/Ezetimib Zentiva, you should discuss it with your doctor or pharmacist if:
you have kidney problems;
you have liver problems;
you have experienced recurring or unexplained muscle pain, or if you or your family members have had muscle disorders, or if you have had previous muscle problems related to taking other cholesterol-lowering medicines. If you experience unexplained muscle pain, especially if accompanied by malaise or fever, you should contact your doctor immediately. You should also tell your doctor or pharmacist about persistent muscle weakness;
you are of Asian origin (Japan, China, Philippines, Vietnam, Korea, or India). Your doctor will determine the appropriate dose of Rosuvastatin/Ezetimib Zentiva for you;
you are taking antiviral medicines, including those used to treat HIV or hepatitis C virus infection, such as ritonavir with lopinavir and/or atazanavir (see "Rosuvastatin/Ezetimib Zentiva and other medicines");
you have severe respiratory failure;
you are taking other cholesterol-lowering medicines (so-called fibrates) (see "Rosuvastatin/Ezetimib Zentiva and other medicines");
you regularly consume large amounts of alcohol;
you have been diagnosed with hypothyroidism (underactive thyroid);
you are over 70 years old (as your doctor will need to choose a suitable dose of Rosuvastatin/Ezetimib Zentiva for you);
you are taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (used to treat bacterial infections). Taking fusidic acid and Rosuvastatin/Ezetimib Zentiva at the same time may lead to serious muscle problems (rhabdomyolysis);
if you have ever had a severe skin rash or skin peeling, blisters, and/or mouth sores after taking Rosuvastatin/Ezetimib Zentiva 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 exacerbate symptoms of the disease or lead to myasthenia (see section 4).
Be particularly cautious when taking Rosuvastatin/Ezetimib Zentiva.
Severe skin reactions have been reported with Rosuvastatin/Ezetimib Zentiva, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS). If you experience any of the symptoms described in section 4, you should stop taking Rosuvastatin/Ezetimib Zentiva.
If any of the above situations apply to you (or if you are in doubt whether such a situation exists), you should consult your doctor or pharmacist before starting Rosuvastatin/Ezetimib Zentiva.
A small number of people taking statins may have liver problems. This can be detected by a simple blood test that checks for increased liver enzyme activity. Therefore, your doctor will recommend regular blood tests while taking Rosuvastatin/Ezetimib Zentiva. It is essential that you attend these tests as scheduled by your doctor.
While taking this medicine, your doctor will closely monitor your condition if you have diabetes or are at risk of developing it. There is a high risk of developing diabetes if you have high blood sugar and fat levels, are overweight, and have high blood pressure.
If you are hospitalized or treated for another condition, you should inform the medical staff that you 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

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
You should tell your doctor about taking any of the following medicines:

• Cyclosporin (a medicine used, for example, after organ transplantation to prevent rejection of the transplanted organ. Cyclosporin increases the effect of rosuvastatin). Do not take Rosuvastatin/Ezetimib Zentiva while taking cyclosporin.
• Anticoagulants, 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 you need to take fusidic acid orally to treat a bacterial infection, you will need to stop taking Rosuvastatin/Ezetimib Zentiva temporarily. Your doctor will tell you when you can safely resume taking it. Taking Rosuvastatin/Ezetimib Zentiva and fusidic acid at the same time may rarely cause muscle weakness, muscle tenderness, or pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.
• Oral contraceptives (birth control pills). Taking Rosuvastatin/Ezetimib Zentiva at the same time increases the level of sex hormones released from the pill.

an increase in the level of sex hormones in the blood (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, 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 you are to be hospitalized or treated for another condition, you should inform the medical staff that you are taking Rosuvastatin/Ezetimib Zentiva.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.

Pregnancy

Rosuvastatin/Ezetimib Zentiva should not be takenif you are pregnant, trying to become pregnant, or think you may be pregnant. If you become pregnant while taking Rosuvastatin/Ezetimib Zentiva, you should stop taking the medicine immediatelyand inform your doctor. While taking Rosuvastatin/Ezetimib Zentiva, women should use effective methods of contraception (see "Pregnancy and breastfeeding").

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 your ability to drive or use machines. However, you should be aware that Rosuvastatin/Ezetimib Zentiva may cause dizziness. If this happens, you should contact your doctor before driving or using machines.

Rosuvastatin/Ezetimib Zentiva tablets contain lactose monohydrate

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take Rosuvastatin/Ezetimib Zentiva

You should always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, you should ask your doctor or pharmacist.
While taking Rosuvastatin/Ezetimib Zentiva, you should continue to follow a low-cholesterol diet and maintain physical activity.
The recommended daily dose for adults is one tablet of the given 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 medicine should be taken 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, you 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 you attend regular check-ups with your doctor to ensure that you have achieved and maintained a healthy cholesterol level.

Taking a higher dose of Rosuvastatin/Ezetimib Zentiva than recommended

In case of overdose, you should contact your doctor or the emergency department of the nearest hospital, as medical attention may be necessary.

Missing a dose of Rosuvastatin/Ezetimib Zentiva

If you miss a dose, you should take the next tablet at the right time. Do not take a double dose to make up for the missed dose.

Stopping Rosuvastatin/Ezetimib Zentiva treatment

You should tell your doctor if you want to stop taking Rosuvastatin/Ezetimib Zentiva. After stopping Rosuvastatin/Ezetimib Zentiva, your cholesterol level may increase again.
If you have any further doubts about taking this medicine, you should consult your 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 you know what side effects may be associated with taking Rosuvastatin/Ezetimib Zentiva.

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

• if you experience any of the following allergic reactions:
• swelling of the face, lips, tongue, and/or throat, which may make it difficult to breathe and 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, mouth sores, and/or genital ulcers. 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 syndrome or drug hypersensitivity reaction).

You should contact your doctor immediatelyif you experience any unusual, persistent muscle pain. This condition can rarely progress to life-threatening muscle damage (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 affect more than 1 in 10 people)
• common (may affect up to 1 in 10 people)
• uncommon (may affect up to 1 in 100 people)
• rare (may affect up to 1 in 1,000 people)
• very rare (may affect up to 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 in patients with high blood sugar and fat levels, who are overweight, and have high blood pressure. Your doctor will monitor your 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 certain tests that assess muscle condition (creatine kinase activity, CK)
cough
indigestion
heartburn
joint pain
muscle spasms
neck pain
decreased appetite
pain
chest pain
hot flashes
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)
liver inflammation
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, round, or oval patches on the torso, 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).
You should talk to your doctor if you experience muscle 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 any not listed in this leaflet, you should tell 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:
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 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. You should ask your 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 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 European Economic Area member states under the following names:

Italy: Quiloga Poland: Rosuvastatin/Ezetimib Zentiva

For more information, please contact your 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