Ezehron Duo

Leaflet attached to the packaging: patient information

Ezehron Duo, 5 mg + 10 mg, tablets

Ezehron Duo, 10 mg + 10 mg, tablets

Ezehron Duo, 20 mg + 10 mg, tablets

Rosuvastatine + Ezetimibe

It is essential to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept, so that it can be read again if necessary.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Ezehron Duo and what is it used for

Ezehron Duo contains two different active substances in one tablet. One of the active substances is rosuvastatine, which belongs to a group of medicines called statins, and the other active substance is ezetimibe. Ezehron Duo is 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 "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. Ezehron Duo is used in patients who do not have sufficient control over their cholesterol levels through diet alone. During treatment with this medicine, the patient should continue to follow a low-cholesterol diet and maintain physical activity. The doctor may prescribe Ezehron Duo if the patient is already taking rosuvastatine and ezetimibe in the same doses as in the combination medicine. The medicine is used in patients with:

• high levels of cholesterol in the blood (primary hypercholesterolemia)
• heart disease - Ezehron Duo 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.

Ezehron Duo does not help with weight loss.

2. Important information before taking Ezehron Duo

When not to take Ezehron Duo

• if the patient is allergic to rosuvastatine, 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 combination of sofosbuvir/velpatasvir/voxilaprevir (used to treat hepatitis C virus infection)
• if the patient is taking a medicine containing cyclosporine (used, for example, after organ transplantation)
• if the patient is pregnant or breastfeeding. If the patient becomes pregnant while taking Ezehron Duo, they should stop taking the medicine and inform their doctor. During treatment with Ezehron Duo, the patient should avoid becoming pregnant, using effective methods of contraception (see "Pregnancy and breastfeeding")
• if the patient has ever had a severe skin rash or skin peeling, blisters, and/or ulcers in the mouth after taking Ezehron Duo or other similar medicines.

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

Warnings and precautions

Before taking Ezehron Duo, the patient should discuss it with their doctor or pharmacist if:

the patient has kidney problems; the patient has liver problems; the patient has experienced recurring or unexplained muscle pain, or has had muscle problems in the past or has a family history of muscle problems, or has had previous muscle problems related to taking other cholesterol-lowering medicines. In case of unexplained muscle pain, especially if accompanied by malaise or fever, the patient should immediately consult their doctor. The patient should also inform their doctor or pharmacist about persistent muscle weakness; the patient is of Asian origin (Japan, China, Philippines, Vietnam, Korea, or India). The doctor will determine the appropriate dose of Ezehron Duo for the patient; the patient is taking antiviral medicines, including those used to treat HIV or hepatitis C, such as ritonavir with lopinavir and/or atazanavir or simeprevir (see "Ezehron Duo and other medicines"); the patient has severe respiratory failure; the patient is taking other cholesterol-lowering medicines (so-called fibrates) (see "Ezehron Duo and other medicines"); the patient regularly consumes large amounts of alcohol; the patient has been diagnosed with hypothyroidism (underactive thyroid); the patient is over 70 years old (as the doctor will need to choose a suitable dose of Ezehron Duo for the patient); the patient is taking or has taken within the last 7 days an oral or injectable medicine called fusidic acid (used to treat bacterial infections). Taking fusidic acid and Ezehron Duo at the same time may lead to serious muscle problems (rhabdomyolysis); the patient has or has had myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing) or myasthenic syndrome (a disease that causes muscle weakness in the eyes), as statins may sometimes exacerbate the symptoms of the disease or lead to the development of myasthenia (see section 4). If any of the above situations apply to the patient (or if the patient has any doubts), they should consult their doctor or pharmacist before starting treatment with Ezehron Duo. 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 during treatment with Ezehron Duo. It is essential for the patient to attend these tests as scheduled. During treatment with this medicine, the doctor will closely monitor the patient's condition, especially 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. Ezehron Duo has been associated with the development of severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS). If the patient experiences any of the symptoms described in section 4, they should stop taking Ezehron Duo and seek medical attention immediately.

Children and adolescents

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

Ezehron Duo and other medicines

The patient should inform 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 inform their doctor about taking any of the following medicines:

• cyclosporine (a medicine used, for example, after organ transplantation to prevent rejection of the transplanted organ. Cyclosporine increases the effect of rosuvastatine taken at the same time). During treatment with cyclosporine, the patient should not take Ezehron Duo.
• anticoagulant medicines, such as warfarin, acenocoumarol, or fluindione (taking Ezehron Duo at the same time may increase the anticoagulant effect, with a higher 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). When taken at the same time, the effect of rosuvastatine is increased.
• colestyramine (a medicine used to lower cholesterol levels), as it affects the way ezetimibe works.
• darolutamide, regorafenib (used to treat cancer)
• fosmetpantoinib (used to treat low platelet count)
• febuxostat (used to treat and prevent high levels of uric acid in the blood)
• teriflunomide (used to treat multiple sclerosis)
• camrelizumab (used to treat cancer)
• roxadustat (used to treat anemia in patients with chronic kidney disease)
• daptomycin (an antibiotic used to treat complicated skin and skin structure infections and bacteremia)
• tafamidis (used to treat cardiomyopathy - a disease that causes, among other things, enlargement and thickening of the heart muscle)
• 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, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.
• medicines used to treat indigestion, containing aluminum and magnesium (used to neutralize stomach acid). These medicines may reduce the level of rosuvastatine in the blood. This effect can be reduced by taking these medicines 2 hours after taking rosuvastatine.

The patient should also inform their doctor or pharmacist about taking:

• erythromycin (an antibiotic). When taken at the same time, the effect of rosuvastatine is reduced.
• fusidic acid. If the patient needs to take fusidic acid orally to treat a bacterial infection, they will need to temporarily stop taking Ezehron Duo. The doctor will inform them when it is safe to resume taking the medicine. Taking Ezehron Duo 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). When taken at the same time, the level of sex hormones released from the pill is increased.
• hormone replacement therapy (increased hormone levels in the blood).

If the patient is to be hospitalized or treated for another illness, they should inform the medical staff about taking Ezehron Duo.

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

Ezehron Duo 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 Ezehron Duo, they should stop taking the medicine immediatelyand inform their doctor. During treatment with Ezehron Duo, women should use effective methods of contraception.

Breastfeeding

Ezehron Duo should not be takenduring breastfeeding, as it is not known whether the medicine passes into breast milk.

Driving and using machines

Ezehron Duo is unlikely to affect the patient's ability to drive or use machines. However, the patient should be aware that Ezehron Duo may cause dizziness. In this case, before driving or using machines, the patient should consult their doctor.

Ezehron Duo tablets contain lactose monohydrate

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

Ezehron Duo tablets contain sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Ezehron Duo

This medicine should always be taken as directed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist. During treatment with Ezehron Duo, 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 given strength. Ezehron Duo 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. Ezehron Duo 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 Ezehron Duo after the doses have been established.

Regular cholesterol level checks

It is essential for the patient to attend regular check-ups with their doctor to monitor their cholesterol levels and ensure that the desired level has been achieved and maintained.

Taking a higher dose of Ezehron Duo than recommended

In case of overdose, the patient should consult their doctor or the emergency department of the nearest hospital, as medical attention may be necessary.

Missing a dose of Ezehron Duo

If a dose is missed, the next tablet should be taken at the scheduled time. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Ezehron Duo

The patient should inform their doctor if they want to stop taking Ezehron Duo. After stopping Ezehron Duo, 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, Ezehron Duo can cause side effects, although not everybody gets them. It is essential for the patient to know what side effects may be associated with taking Ezehron Duo. The patient should stop taking Ezehron Duo and seek medical attention immediatelyif they experience any of the following:

• allergic reaction: swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing and swallowing
• 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, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. The development 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 syndrome)

The patient should consult their doctor immediatelyif they 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 single 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, overweight, and high blood pressure. The doctor will monitor the patient's condition during treatment with 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 protein in the urine, which usually resolves on its own without the need to stop taking Ezehron Duo tablets
increased results of some tests that assess muscle condition (creatine kinase activity, CK)
cough
indigestion
heartburn
joint pain
muscle cramps
neck pain
decreased appetite
pain
chest pain
hot flashes
high blood pressure
tingling
dry mouth
stomach inflammation
back pain
muscle weakness
pain in the arms and legs
swelling, especially of the hands and feet

Rare side effects

pancreatitis causing severe stomach 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 legs and arms (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
gallstones or cholecystitis (which may cause stomach pain, nausea, vomiting)
myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing)
myasthenic syndrome (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 this leaflet, they should inform 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 181C, 02-222 Warsaw, tel.: +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. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Ezehron Duo

The medicine should be stored in its original packaging to protect it from light. There are no special storage temperature recommendations. The medicine should be stored out of sight and reach of children. The medicine should not be taken after the expiration date stated on the carton and blister pack after EXP. The expiration date refers to the last day of the specified month. 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 Ezehron Duo contains

The active substances of the medicine are rosuvastatine (in the form of rosuvastatine calcium) and ezetimibe. The tablets contain rosuvastatine calcium equivalent to 5 mg, 10 mg, or 20 mg of rosuvastatine. Each tablet contains 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 Ezehron Duo looks like and contents of the pack

Ezehron Duo 5 mg/10 mg tablets: white or almost white, round, flat, uncoated tablets with the inscription E2 on one side and 2 on the other. The diameter of the tablet is 10 mm. Ezehron Duo 10 mg/10 mg tablets: white or almost white, oval, biconvex, uncoated tablets with the inscription E1 on one side and 1 on the other. The tablet measures 15 mm x 7 mm. Ezehron Duo 20 mg/10 mg tablets: white or almost white, round, biconvex, uncoated tablets. The diameter of the tablet is 11 mm. The packaging contains 28, 56, or 84 tablets in a blister pack of PA/Aluminum/PVC/Aluminum foil, placed in a cardboard box with a patient information leaflet. Not all pack sizes may be marketed.

Marketing authorization holder

Adamed Pharma S.A., Pieńków, ul. M. Adamkiewicza 6A, 05-152 Czosnów, tel.: +48 22 732 77 00

Manufacturer

Adamed Pharma S.A., Pieńków, ul. M. Adamkiewicza 6A, 05-152 Czosnów

Date of last revision of the leaflet