Ezehron Duo

Leaflet accompanying the packaging: patient information

Ezehron Duo, 15 mg + 10 mg, tablets

Ezehron Duo, 30 mg + 10 mg, tablets

Ezehron Duo, 40 mg + 10 mg, tablets

Rosuvastatinum + Ezetimibum

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

• The leaflet should be kept, so that it can be re-read if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• 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. Package contents 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 rosuvastatin, which belongs to a group of so-called statins, and the other active substance is ezetimibe. Ezehron Duo is used to reduce the level of total cholesterol, 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 by reducing the amount of cholesterol absorbed in the gut and the amount of cholesterol produced in the body. In most people, high cholesterol levels do not affect their well-being, as they do not cause any symptoms. However, if left untreated, it can cause fatty deposits to accumulate in the walls of blood vessels, leading to their narrowing. As a result of narrowing, it is possible to close the lumen of the blood vessel and cut 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 diet to maintain normal cholesterol levels. During treatment with this medicine, a low-cholesterol diet should be followed at all times. The doctor may prescribe Ezehron Duo if the patient is 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)
• 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 reduce body weight.

2. Important information before taking Ezehron Duo

When not to take Ezehron Duo

• 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 combination of sofosbuvir/velpatasvir/voxilaprevir (used to treat viral hepatitis C 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 immediately and inform their doctor. During treatment with Ezehron Duo, patients should avoid becoming pregnant by 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.

In addition, do not take Ezehron Duo, 40 mg + 10 mg (the highest dose):

• if the patient has moderately severe kidney disease (in case of doubt, the doctor should be consulted),
• if the patient has thyroid disease,
• if the patient experiences frequent or unexplained muscle pain or weakness, or if the patient or their family members have had muscle diseases or have had muscle problems while taking cholesterol-lowering medicines,
• if the patient regularly consumes large amounts of alcohol,
• if the patient is of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian),
• if the patient is taking other cholesterol-lowering medicines, such as fibrates (see "Ezehron Duo and other medicines").

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

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 diseases in the past or has had muscle problems while 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 (fibrates). The patient should read the leaflet carefully, even if they have taken other cholesterol-lowering medicines before; 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 the appropriate dose of Ezehron Duo for them); the patient is taking or has taken fusidic acid (an antibiotic) orally or by injection in the last 7 days. Taking fusidic acid and Ezehron Duo at the same time may lead to serious muscle problems (rhabdomyolysis); the patient has or has had myasthenia gravis (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 may sometimes exacerbate the symptoms of the disease or lead to the development of myasthenia (see section 4); the patient has ever had a severe skin rash or skin peeling after taking rosuvastatin or other similar medicines. If any of the above situations apply to the patient (or if the patient has any doubts), they should not take Ezehron Duo, 40 mg + 10 mg (the highest dose), and 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 while taking 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 condition of patients with diabetes or at risk of developing diabetes. 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. Rosuvastatin 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 is not recommended for use 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, which increases the effect of rosuvastatin taken at the same time). While taking cyclosporine, the patient should not take Ezehron Duo;anticoagulants, such as warfarin, acenocoumarol, fluindione, ticagrelor, or clopidogrel (taking Ezehron Duo at the same time may increase the anticoagulant effect, increasing the risk of bleeding); other cholesterol-lowering medicines, such as fibrates, which also regulate triglyceride levels in the blood (e.g., gemfibrozil and other medicines in this group). Taking Ezehron Duo at the same time increases the effect of rosuvastatin. The patient should not take Ezehron Duo 40 mg + 10 mg at the same time as fibrates; colestyramine (a medicine used to lower cholesterol levels), as it affects the way ezetimibe works; darolutamide, regorafenib, or capmatinib (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, 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 rosuvastatin in the blood. This effect can be reduced by taking these medicines 2 hours after taking rosuvastatin; erythromycin (an antibiotic). Taking Ezehron Duo 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 should 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). Taking Ezehron Duo at the same time increases the level of sex hormones released by the pill; hormone replacement therapy (increasing hormone levels in the blood); fostamatinib (used to treat low platelet count); febuxostat (used to treat and prevent high uric acid levels in the blood); teriflunomide (used to treat multiple sclerosis). If the patient is to be hospitalized or treated for another illness, they should inform the medical staff that they are taking Ezehron Duo.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, 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, patients should use effective methods of contraception to avoid becoming pregnant (see "Pregnancy and breastfeeding").

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, the patient should consult their doctor before driving or using machines.

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 exactly as prescribed 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 prescribed 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 patient should take the medicine 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 once the doses have been established. The maximum daily dose of rosuvastatin is 40 mg. It is used in patients with high cholesterol levels and a high risk of heart attack or stroke, for whom a dose of 30 mg was not sufficient to lower cholesterol levels.

Regular cholesterol level checks

It is essential for the patient to attend regular check-ups to monitor their cholesterol levels and ensure they have reached and maintained the desired level.

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 the patient misses a dose, they should take the next tablet 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 the medicine, 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 the medicine. The patient should stop taking Ezehron Duo and seek medical attention immediatelyif they experience any of the following:

• An allergic reaction: swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing and swallowing, severe itching of the skin (with lumps). These are rare possible side effects;
• Lupus-like syndrome (including rash, joint disorders, and effects on blood cells). This is a rare possible side effect;
• Muscle rupture. This is a rare possible side effect
• 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). The frequency of this side effect is not known;
• A widespread rash, high fever, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome). The frequency of this side effect is not known.

The patient should consult their doctor immediatelyif they experience any unusual, persistent muscle pain. This condition may 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 occur in more than 1 in 10 patients)
• common (may occur in up to 1 in 10 patients)
• uncommon (may occur in up to 1 in 100 patients)
• rare (may occur in up to 1 in 1,000 patients)
• very rare (may occur in up to 1 in 10,000 patients), including isolated cases

Common side effects

headache
constipation
nausea
muscle pain
muscle tenderness
feeling of weakness
dizziness
increased protein in the urine. This symptom usually resolves on its own and does not require stopping Ezehron Duo (only applies to a rosuvastatin dose of 40 mg).
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 during treatment with this medicine.
stomach pain
diarrhea
bloating (excess gas in the intestines)
feeling of fatigue
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 (applies to rosuvastatin doses of 15 mg and 30 mg)
increased results of some tests that assess muscle condition (creatine kinase activity, CK)
cough
indigestion
heartburn
nausea
joint pain
muscle cramps
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, which may radiate to the back
increased tendency to bleed or bruising due to low 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 arms and legs (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 lesions in a target shape (erythema multiforme);
muscle tenderness,
gallstones or cholecystitis (which may cause abdominal pain, nausea, vomiting)
myasthenia gravis (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 discuss with 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, 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. 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 requirements. The medicine should be stored out of sight and reach of children. The patient should not take this medicine after the expiry date stated on the carton and blister pack after EXP. The expiry date refers to the last day of the month. 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. Package contents and other information

What Ezehron Duo contains

The active substances of the medicine are rosuvastatin (in the form of rosuvastatin calcium) and ezetimibe. The tablets contain rosuvastatin calcium equivalent to 15 mg, 30 mg, or 40 mg of rosuvastatin. Each tablet contains 10 mg of ezetimibe. The other ingredients are lactose monohydrate, microcrystalline cellulose type 102, 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, 15 mg + 10 mg: white or almost white, hexagonal, biconvex, uncoated tablet, approximately 9 x 8 mm in size, with a double-sided embossing "E3". Ezehron Duo, 30 mg + 10 mg tablets: white or almost white, rectangular, biconvex, uncoated tablet, 12 x 6 mm in size, with a double-sided embossing "X". Ezehron Duo, 40 mg + 10 mg tablets: white or almost white, elliptical, biconvex, uncoated tablet, approximately 13 x 6 mm in size, with a double-sided embossing "E6". The packaging contains 28, 30, 56, 60, 90, or 100 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
phone: +48 22 732 77 00

Manufacturer:

Adamed Pharma S.A.
ul. Marszałka J. Piłsudskiego 5
95-200 Pabianice

Date of last revision of the leaflet: