Patient Leaflet Updated 16-Dec-2025 | medac Pharma LLP
Hydroxycarbamide medac 500 mg capsule, hard
Hydroxycarbamide medac 500 mg capsules
Hydroxycarbamide
1. What Hydroxycarbamide medac is and what it is used for
2. What you need to know before you take Hydroxycarbamide medac
3. How to take Hydroxycarbamide medac
4. Possible side effects
5. How to store Hydroxycarbamide medac
6. Contents of the pack and other information
This medicine contains the active substance hydroxycarbamide, which belongs to a group of medicines used in certain blood diseases, and which interferes with the growth of cancer cells.
This medicine has been prescribed by your doctor for the treatment of blood diseases (tumours of the bone marrow: chronic myeloid leukaemia, essential thrombocythaemia and polycythaemia vera).
Talk to your doctor or pharmacist before taking Hydroxycarbamide medac.
Treatment with hydroxycarbamide requires extensive supervision. You will have blood tests before and during treatment to check that you have enough blood cells as well as sufficient kidney and liver function to receive this medicine. The blood tests will normally be carried out once a week. You should inform your doctor if you have ever suffered from gout. You should inform your doctor if you have folic acid deficiency.
In case you have decreased red blood cell counts (anaemia) before or develop it during treatment red blood cells may be replaced when needed. If haemolytic anaemia (disorder in which red blood cells are destroyed faster than they can be made) is detected when the blood tests are checked, your doctor will stop treatment with Hydroxycarbamide medac.
You should drink plenty of fluids during treatment.
If you suffer from kidney and/or liver problems you should inform your doctor before treatment with this medicine is started.
If you receive long-term treatment with hydroxycarbamide secondary leukaemia may develop. To what extent this is due to your underlying disease or to the treatment with hydroxycarbamide is presently unknown.
Skin cancer has been reported in patients receiving long term hydroxycarbamide. You should protect your skin from the sun and regularly inspect your skin yourself during the treatment and after discontinuation of the therapy with hydroxycarbamide. Your doctor will also inspect your skin during routine follow-up visits.
You may get leg ulcers. In this case your doctor will decide if you should continue to take this medicine. The ulcers usually heal slowly over some weeks if you stop taking this medicine.
Talk to your doctor or pharmacist before taking Hydroxyurea medac if you have diabetes and are using a continuous glucose monitor (CGM) to test your blood glucose. Hydroxycarbamide (also known as hydroxyurea) may cause falsely high sensor glucose readings from certain sensors. This could result in using more insulin than needed, leading to low blood sugar (hypoglycaemia). Talk to the physician that prescribed your CGM about whether it is safe to use while you are taking Hydroxyurea medac.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If you have previously received or are still receiving any similar medicines or irradiation therapy side effects can occur more frequently and more severely. These effects primarily include decrease in the number of blood cells (suppressed bone marrow function), inflammation of the mucous membrane of the stomach and inflammation of the skin.
Previous or simultaneous irradiation can result in reddening and irritation of the skin.
Hydroxycarbamide may increase the activity of NRTI (nucleoside reverse transcriptase inhibitors) which are medicines used for the treatment of HIV (e.g. didanosine, stavudine). Hydroxycarbamide in combination with didanosine, stavudine, and indinavir has been shown to cause a drop in white cell count (CD4 lymphocytes decreased). The combination of hydroxycarbamide and NRTI may increase the risk of side effects of NRTI.
If you recently had a vaccination or are planning to have one, tell your doctor.
If you are pregnant or breast-feeding, 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 harmful effects on the developing baby. You should therefore not take this medicine during pregnancy unless it is specifically prescribed by your doctor.
You must use effective contraception before the start of, during and for six months after treatment with this medicine. If you become pregnant while taking or after having taken this medicine, you should contact your doctor.
Breast-feeding
Hydroxycarbamide medac must not be taken during breast-feeding. The active substance of Hydroxycarbamide medac passes into breastmilk. Consult the doctor for advice.
Fertility
During treatment and for three months after treatment has stopped men are advised to use effective contraception. Please ask your doctor about the possibility of sperm conservation before first starting treatment.
Genetic counselling is recommended for patients intending to have children after therapy.
Your ability to react may be impaired during treatment with Hydroxycarbamide medac. You should bear this in mind when heightened attention is required, e.g. when driving and using machines.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Adults
In chronic myeloid leukaemia the common initial dose is 40 mg/kg bodyweight daily. The dose is then adjusted individually depending on the white blood cell count.
In polycythaemia vera the common initial dose is 15 – 20 mg/kg bodyweight daily. The dose is then adjusted individually to 1 – 2 capsules (500 – 1000 mg) depending on the blood cell count.
In essential thrombocythaemia the common initial dose is 15 mg/kg bodyweight daily with individual dose adjustment depending on the blood cell count.
Elderly patients
Elderly patients may be more sensitive to hydroxycarbamide, and may require a lower dose.
The capsules should be swallowed whole and must not disintegrate in the mouth. The capsules should be handled with care. You should use gloves or wash your hands thoroughly after handling them. Even if the risks for the foetus are minimal, pregnant women should avoid handling the capsules.
If you have taken a larger dose of this medicine than you have been prescribed always contact a doctor or a hospital. You may experience symptoms affecting the mucous membranes and skin.
It is important to follow the course of medication exactly as prescribed by your doctor.
Do not take a double dose to make up for a forgotten dose. If you have missed one single dose, continue treatment as prescribed. If you have missed several doses, continue treatment as prescribed, but contact your doctor for further advice.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if you experience symptoms such as:
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)
Not known (frequency cannot be estimated from the available data)
Cases of low blood levels of sodium which can cause tiredness and confusion, muscle twitching, fits or coma have been observed in post-marketing surveillance.
If you receive long-term treatment with hydroxycarbamide secondary leukaemia (blood cancer) may develop. To what extent this is due to your underlying disease or to the treatment with hydroxycarbamide is presently unknown.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
Do not store above 25 °C.
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
White hard capsules (capsules).
Available pack sizes: 50 or 100 capsules.
Not all pack sizes may be marketed.
This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Austria, Denmark, Finland, Iceland, Netherlands, Norway, Portugal, Sweden: Hydroxyurea medac
Germany: Syrea
Slovak Republic: Hydroxykarbamid medac
Spain: Hidroxicarbamida medac
United Kingdom (Northern Ireland): Hydroxycarbamide medac
This leaflet was last revised in October 2024.
pal (UK) Hydroxycarbamide medac 500 mg capsules
National version: 10/2024
Scion House, Stirling University Innovation Park, Stirling, FK9 4NF, UK
+44 (0)1786 458 086
www.medacpharma.co.uk
