Hidroxicarbamid Eugia

Leaflet attached to the packaging: information for the user

Hydroxycarbamid Eugia, 500 mg, hard capsules

Hydroxycarbamidum

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. 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 those not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Hydroxycarbamid Eugia and what is it used for

Hydroxycarbamid Eugia contains the active substance hydroxycarbamide, which belongs to a group of medicines used in certain blood disorders, and which inhibits the growth of cancer cells. This medicine is used to treat adults and has been prescribed by a doctor to treat blood disorders: chronic myeloid leukemia, essential thrombocythemia, and true erythrocytosis.

2. Important information before taking Hydroxycarbamid Eugia

When not to take Hydroxycarbamid Eugia

• If you are allergic to hydroxycarbamide or any of the other ingredients of this medicine (listed in section 6).
• If you have a low blood cell count (bone marrow suppression, leukopenia, thrombocytopenia, severe anemia).
• If you are pregnant or breastfeeding.
• If you have severe liver function disorders (Child-Pugh class C).
• If you have severe kidney function disorders (creatinine clearance <30 ml min).< li>
• Concomitantly with antiretroviral drugs (inhibiting or destroying retroviruses, such as the human immunodeficiency virus, HIV), e.g. didanosine and stavudine (may cause a decrease in white blood cell count).
• Concomitantly with the yellow fever vaccine (see section "Hydroxycarbamid Eugia and other medicines").

Warnings and precautions:

Before starting treatment with Hydroxycarbamid Eugia, discuss it with your doctor or pharmacist. Hydroxycarbamide treatment requires close monitoring. Before starting treatment and during treatment, blood tests will be performed to check if you have a sufficient number of blood cells and platelets, as well as sufficient kidney and liver function to take this medicine. Blood tests are usually performed once a week. In case of reduced red blood cell count (anemia) before starting treatment or its occurrence during treatment, red blood cells may be supplemented if necessary. If hemolytic anemia (a disorder in which red blood cells are destroyed faster than they can be produced) is detected during a blood test, the doctor will discontinue treatment with Hydroxycarbamid Eugia. You should avoid taking this medicine concomitantly with live, attenuated microorganisms (in the case of the yellow fever vaccine, see section "When not to take Hydroxycarbamid Eugia"): against measles, rubella, mumps, poliomyelitis, tuberculosis, chickenpox, with phenytoin and fosphenytoin (medicines used to treat epilepsy). In patients infected with HIV who received hydroxycarbamide in combination with antiretroviral drugs, particularly didanosine and stavudine, potentially fatal hepatotoxicity and pancreatitis, as well as severe peripheral neuropathy (see section "Hydroxycarbamid Eugia and other medicines"), have been reported. During treatment, drink plenty of fluids. If you have kidney and/or liver disease, inform your doctor before starting treatment with this medicine. With long-term hydroxycarbamide treatment, secondary leukemia may develop. Currently, it is not known to what extent this is caused by the underlying disease or hydroxycarbamide treatment. In patients taking hydroxycarbamide for a long time, cases of skin cancer have been reported. You should protect your skin from the sun and regularly check the condition of your skin during and after treatment with hydroxycarbamide. Your doctor will also check your skin during routine check-ups. If you have diabetes and use a continuous glucose monitoring system (CGM) to test your blood sugar. Hydroxycarbamide (also known as hydroxyurea) may cause falsely high glucose readings from some sensors. This can lead to the use of a higher dose of insulin than necessary, leading to low blood sugar (hypoglycemia). You should discuss with your doctor who prescribed the CGM system whether it can be used safely while taking Hydroxycarbamid Eugia.

Children

The safety and efficacy of hydroxycarbamide in children have not been studied.

Hydroxycarbamid Eugia and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. If you have previously taken or are currently taking similar medicines or radiation therapy, side effects may occur more frequently and be more severe. These effects include primarily a decrease in blood cell count (bone marrow suppression), gastric mucositis, and skin rash. Previous or concomitant radiation may cause redness and irritation of the skin. This medicine should not be taken concomitantly with the yellow fever vaccine (see section "When not to take Hydroxycarbamid Eugia"). You should also avoid taking this medicine concomitantly with live, attenuated vaccines (except for the yellow fever vaccine, see section "When not to take Hydroxycarbamid Eugia"), against measles, rubella, mumps, poliomyelitis, tuberculosis, chickenpox. Administration of a vaccine containing live microorganisms may cause severe infection. You should also avoid taking Hydroxycarbamid Eugia in combination with phenytoin and fosphenytoin (medicines used to treat epilepsy), didanosine (with or without stavudine) and other antiretroviral drugs (medicines used to treat HIV infection) (see "Warnings and precautions").

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

There is a risk of harm to the unborn child. Therefore, this medicine should not be taken during pregnancy. You should use effective contraception before starting treatment, during treatment, and for six months after its completion. If you become pregnant during or after taking this medicine, you should contact your doctor.

Breastfeeding

Hydroxycarbamid Eugia should not be taken during breastfeeding. The active substance of Hydroxycarbamid Eugia passes into human milk. You should consult your doctor.

Fertility

During treatment and for at least three months after its completion, men are advised to use effective contraception. Before starting treatment for the first time, you should ask your doctor about the possibility of storing sperm.

Driving and using machines

During treatment with Hydroxycarbamid Eugia, your ability to react may be impaired. You should keep this in mind when increased attention is required, e.g. when driving vehicles and operating machines.

Hydroxycarbamid Eugia contains lactose

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

Hydroxycarbamid Eugia contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means that the medicine is considered "sodium-free".

3. How to take Hydroxycarbamid Eugia

This medicine should always be taken exactly as advised by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist. AdultsIn chronic myeloid leukemia, continuous treatment is recommended (20 to 30 mg/kg body weight in a single daily dose). The dose is then adjusted individually depending on the white blood cell count. In true erythrocytosis, the standard initial dose is 15-20 mg/kg body weight per day. The dose is then adjusted individually depending on the blood cell count. In essential thrombocythemia, the standard initial dose is 15 mg/kg body weight per day, with possible individual dose adjustment depending on the blood cell count. Elderly patientsElderly patients may be more sensitive to hydroxycarbamide and may require a lower dose. The capsules should be swallowed whole and not broken in the mouth. Handle the capsules with care. Wear gloves or wash your hands thoroughly after contact with them. Even if the risk to the fetus is minimal, pregnant women should avoid contact with the capsules. To remove a capsule from the blister:

• press only one end of the capsule to push it through the foil.
• do not press on the center of the capsule, as this may cause it to break.

Taking a higher dose of Hydroxycarbamid Eugia than recommended

If you have taken more of this medicine than recommended, you should always contact your doctor or go to the hospital. Symptoms may occur on the mucous membranes and skin.

Missing a dose of Hydroxycarbamid Eugia

It is important to follow the treatment schedule exactly as advised by your doctor. Do not take a double dose to make up for a missed dose. If you miss a single dose, continue treatment as advised. If you miss several doses, continue treatment as advised, but contact your doctor for further advice.

Stopping treatment with Hydroxycarbamid Eugia

Stopping hydroxycarbamide treatment may worsen your condition. Hydroxycarbamide treatment should only be stopped or discontinued on the advice of a doctor. If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. You should contact your doctor immediately if you experience symptoms such as:

• Fever, cough, or difficulty breathing, which may be symptoms of a severe lung disease (frequency not known)
• High fever (> 39°C) with symptoms such as stomach problems, lung problems, muscle problems, liver problems, skin problems, and heart problems within 6 weeks of taking Hydroxycarbamid Eugia (rare).

Very common (may affect more than 1 in 10 people)

• Absence or low sperm count in the semen (azoospermia or oligospermia), usually reversible.
• Decreased blood cell count (bone marrow suppression), particularly white blood cells (leukopenia), including a type of white blood cell that helps the body fight infections (reduced CD4 lymphocyte count), red blood cells (anemia), and platelets (thrombocytopenia).
• Nausea (nausea), vomiting, loss of appetite (anorexia), mouth ulcers (stomatitis), diarrhea, constipation, mucositis, and digestive problems (dyspepsia).
• In combination with certain HIV treatments: pancreatitis with abdominal or stomach pain.
• Drug-induced fever, chills, discomfort (malaise), weakness, loss of energy.
• Skin ulcers.
• Skin rashes in the form of spots and blisters (maculopapular rash), facial redness, redness of the hands and feet (palmar-plantar erythrodysesthesia syndrome).
• Skin changes, such as thinning of the skin, darkening, and wrinkling of the nails and skin, blackening, and necrosis of the skin.
• Hair loss (alopecia).
• Transient kidney function disorders with increased blood parameters, such as uric acid, urea, and creatinine.
• Painful urination.
• Vasculitis of the skin (cutaneous vasculitis).
• Dermatomyositis.
• Rash.

Common (may affect up to 1 in 10 people)

• Skin cancer.
• Increased liver enzyme activity.
• Hepatitis, which causes flu-like symptoms, including fatigue, loss of appetite, fever, pain, and nausea/vomiting, pressure or pain under the right ribs, and may include yellowing of the skin or eyes.
• Bile flow problems (cholestasis). Bile produced by the liver to aid digestion may not flow properly. Bile buildup can cause itching, yellowing of the skin, very dark urine, and very pale stools.
• Neurological disorders, including headache, dizziness, drowsiness, disorientation, hallucinations, and seizures, as well as peripheral neuropathy.
• In combination with certain HIV treatments: numbness and tingling or pain in the hands and feet (peripheral neuropathy) and yellowing of the skin (hepatotoxicity).

Rare (may affect up to 1 in 1,000 people)

• Metabolic complications caused by the breakdown of cancer cells (tumor lysis syndrome).
• Tissue breakdown and necrosis (gangrene).

Frequency not known (frequency cannot be estimated from the available data)

• Fever, cough, or difficulty breathing may be symptoms of a severe lung disease; allergic alveolitis.
• Excessive breakdown of red blood cells (hemolytic anemia).
• Nail pigmentation.
• Discoid lupus erythematosus, systemic lupus erythematosus (a condition in which the body's immune system attacks healthy tissues, causing symptoms such as joint swelling, fatigue, and rashes).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, 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, you can help provide more information on the safety of this medicine.

5. How to store Hydroxycarbamid Eugia

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton or blister after EXP. The expiry date refers to the last day of the month. There are no special precautions for storage. Medicines should 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 Hydroxycarbamid Eugia contains

• The active substance is hydroxycarbamide. Each hard capsule contains 500 mg of hydroxycarbamide.

Other ingredients are: lactose monohydrate, citric acid, disodium phosphate, magnesium stearate. Capsule shell:yellow iron oxide (E 172), indigo carmine (E 132), titanium dioxide (E 171), gelatin. Body:red iron oxide (E 172), titanium dioxide (E 171), gelatin. Printing ink (black):shellac, black iron oxide (E172), potassium hydroxide.

What Hydroxycarbamid Eugia looks like and contents of the pack

Hard capsule. Hydroxycarbamid Eugia, 500 mg, hard capsule:Green, opaque cap and pinkish-orange body OP, size "0" gelatin hard capsules with "H500" printed on the body, filled with white to yellowish-white crystalline powder. Hydroxycarbamid Eugia hard capsules are available in blisters containing 20 or 100 capsules, in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer/importer

Marketing authorization holder:

Eugia Pharma (Malta) Limited Vault 14, level 2 Valletta Waterfront Floriana, FRN 1914 Malta e-mail: medicalinformation@aurovitas.pl

Manufacturer/Importer:

APL Swift Services (Malta) Ltd. HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta Generis Farmacêutica, S.A. Rua João de Deus n.º 19, Venda Nova 2700-487 Amadora Portugal Arrow Génériques 26 Avenue Tony Garnier 69007 Lyon France

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

France:

HYDROXYCARBAMIDE ARROW 500 mg, gélule.

Italy:

Idrossicarbamide Aurobindo

Netherlands:

Hydroxycarbamide Eugia 500 mg, harde capsules

Poland:

Hydroxycarbamid Eugia

Portugal:

Hidroxicarbamida Generis

Date of last revision of the leaflet: 11/2024