Hydroxycarbamide eugia

Patient Information Leaflet

Hydroxycarbamid Eugia, 500 mg, hard capsules
Hydroxycarbamidum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet Contents

1. What Hydroxycarbamid Eugia is and what it is 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 Hydroxycarbamid Eugia is and what it is 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 in the treatment of adults and has been prescribed by a doctor for the treatment of blood disorders: chronic myeloid leukaemia, essential thrombocythaemia, and polycythaemia vera.

2. Important information before using Hydroxycarbamid Eugia

When not to use Hydroxycarbamid Eugia

• If the patient is allergic to hydroxycarbamide or any of the other ingredients of this medicine (listed in section 6).
• If the patient has too low a number of blood cells (bone marrow suppression, leukopenia, thrombocytopenia, severe anemia).
• If the patient is pregnant or breastfeeding.
• If the patient has severe liver function impairment (Child-Pugh class C).
• If the patient has severe kidney function impairment (creatinine clearance < 30 mL/min).
• Concurrently with antiretroviral medicines [medicines that inhibit or destroy retroviruses, such as Human Immunodeficiency Virus (HIV)], e.g. didanosine and stavudine (a decrease in white blood cell count may occur).
• Concurrently with the yellow fever vaccine (see section "Hydroxycarbamid Eugia with other medicines").

Warnings and precautions:
Before starting treatment with Hydroxycarbamid Eugia, discuss this with your doctor or pharmacist.
Treatment with hydroxycarbamide requires close monitoring. Before starting and during treatment, blood tests will be performed to check whether the patient has an adequate number of blood cells and platelets, and whether kidney and liver function are sufficient for taking this medicine.
Blood tests will usually be carried out once a week.
If a reduction in red blood cells (anemia) is present before starting treatment or develops during treatment, red blood cells may be transfused if necessary. If hemolytic anemia (a condition in which red blood cells are destroyed faster than they can be produced) is detected during blood testing, the doctor will discontinue treatment with Hydroxycarbamid Eugia.
Avoid using this medicine concurrently with live attenuated microorganisms (in the case of the yellow fever vaccine, see section "When not to use Hydroxycarbamid Eugia"): vaccines against measles, rubella, mumps, poliomyelitis, tuberculosis, varicella. Also avoid concurrent use with phenytoin and fosphenytoin (medicines used in the treatment of epilepsy). In patients infected with HIV who received hydroxycarbamide in combination with antiretroviral medicines, particularly didanosine and stavudine, potentially fatal hepatotoxicity and pancreatitis, as well as severe peripheral neuropathy, have been reported (see section "Hydroxycarbamid Eugia with other medicines").
During treatment, drink plenty of fluids.
If the patient has kidney and/or liver disease, inform the doctor before starting treatment with this medicine.
With long-term treatment with hydroxycarbamide, secondary leukemia may develop. It is currently unknown to what extent this is caused by the underlying disease or by hydroxycarbamide treatment.
Cases of skin cancer have been reported in patients receiving long-term hydroxycarbamide treatment. Protect the skin from sunlight and regularly monitor skin condition during and after treatment with hydroxycarbamide. The doctor will also examine the skin during routine follow-up visits.
If the patient has diabetes and uses a Continuous Glucose Monitoring (CGM) system to measure blood glucose, hydroxycarbamide (also known as hydroxyurea) may cause falsely high glucose readings from certain sensors. This may lead to administration of more insulin than needed, resulting in low blood sugar (hypoglycemia). Talk to the doctor who prescribed the CGM system about whether it is safe to use it during treatment with Hydroxycarbamid Eugia.

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

Hydroxycarbamid Eugia with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
If the patient has previously received or is currently receiving similar medicines or radiation therapy, adverse reactions may occur more frequently and be more severe. These include mainly a reduced number of blood cells (bone marrow suppression), gastric mucositis, and skin inflammation.
Previous or concurrent radiation may cause redness and irritation of the skin.
This medicine must not be used concurrently with the yellow fever vaccine (see section "When not to use Hydroxycarbamid Eugia").
Avoid concurrent use of this medicine with live attenuated vaccines (except for the yellow fever vaccine; see section "When not to use Hydroxycarbamid Eugia"), such as vaccines against measles, rubella, mumps, poliomyelitis, tuberculosis, and varicella. Administration of a vaccine containing live microorganisms may cause severe infection.
Also avoid using Hydroxycarbamid Eugia in combination with phenytoin and fosphenytoin (medicines used in the treatment of epilepsy), with didanosine (with or without stavudine), and other antiretroviral medicines (medicines used in the treatment of Human Immunodeficiency Virus (HIV) infection) (see "Warnings and precautions").

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
There is a risk of harm to the developing baby. Therefore, this medicine should not be used during pregnancy.
Effective contraception must be used before starting treatment, during treatment, and for six months after treatment ends. If the patient becomes pregnant during or after treatment with this medicine, she should contact her doctor immediately.

Breastfeeding
Hydroxycarbamid Eugia must not be used during breastfeeding. The active substance of Hydroxycarbamid Eugia passes into human milk. Consult your doctor.

Fertility
Men are advised to use effective contraception during treatment and for at least three months after treatment ends. Before starting treatment for the first time, ask the doctor about the possibility of sperm banking.

Driving and operating machinery
During treatment with Hydroxycarbamid Eugia, the ability to react may be impaired. This should be kept in mind when increased attention is required, such as when driving vehicles or operating machinery.

Hydroxycarbamid Eugia contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before using this medicine.

Hydroxycarbamid Eugia contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicine is considered "sodium-free".

3. How to use Hydroxycarbamid Eugia

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Adults
For chronic myeloid leukemia, continuous treatment is recommended (20 to 30 mg/kg body weight as a
single daily dose). The dose is then individually adjusted depending on the white blood cell count.
For polycythemia vera, the standard starting dose is 15–20 mg/kg body weight per day. The dose is then
individually adjusted depending on blood cell counts.
For essential thrombocythemia, the standard starting dose is 15 mg/kg body weight per day, with the
possibility of individual dose adjustment based on blood cell counts.
Elderly patients
Elderly patients may be more sensitive to hydroxycarbamide and may require a lower dose.
Capsules should be swallowed whole and must not break apart in the mouth. Handle capsules with care.
Wear gloves or wash hands thoroughly after handling them. Even though the risk to the fetus is minimal,
pregnant women should avoid contact with the capsules.
To remove a capsule from the blister pack:

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

Taking more Hydroxycarbamid Eugia than recommended
If you take more of this medicine than recommended, contact your doctor immediately or go to hospital.
Symptoms affecting the mucous membranes and skin may occur.
Missing a dose of Hydroxycarbamid Eugia
It is important to follow the treatment regimen exactly as directed 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
recommended. If you miss several doses, continue treatment as recommended but contact your doctor
for further advice.
Stopping Hydroxycarbamid Eugia
Stopping treatment with hydroxycarbamide may lead to worsening of the patient's condition.
Treatment with hydroxycarbamide should only be interrupted or discontinued on the advice of a doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
You should contact a doctor immediately if the patient experiences symptoms such as:

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

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

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

Common (may affect up to 1 in 10 people)

• Skin cancer.
• Increased liver enzyme activity.
• Hepatitis, causing flu-like symptoms including fatigue, loss of appetite, fever, pain and nausea/vomiting, pressure or pain under the right ribs, and possibly including yellowing of the skin or eyes.
• Biliary flow problems (cholestasis). Bile produced by the liver to aid digestion may not flow properly. Accumulation of bile may 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, 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 products of tumour cell breakdown (tumour lysis syndrome).
• Tissue breakdown and necrosis (gangrene).

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

• Fever, cough or difficulty breathing may be symptoms of a severe lung disease; allergic alveolitis.
• Excessive breakdown of red blood cells (haemolytic anaemia).
• Nail pigmentation.
• Cutaneous 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 of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to 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 pack following: EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Hydroxycarbamid Eugia contains

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

The other ingredients are: monohydrate lactose, citric acid, disodium phosphate, magnesium stearate.
Cap: 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, gelatin hard capsules
size “0” printed with “H500” on the body, filled with white to yellowish-white crystalline
powder.
Hydroxycarbamid Eugia hard capsules are available in blister packs containing 20 or 100 capsules,
in a cardboard carton.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer/Importer

Marketing Authorisation Holder:
Eugia Pharma (Malta) Limited
Vault 14, level 2
Valletta Waterfront
Floriana, FRN 1914
Malta
e-mail: [email protected]

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 medicinal product is authorised in the European Economic Area countries 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