Patient leaflet - Hydroxycarbamide Medac 500 mg capsule hard

1. What Hydroxycarbamide is and what it is used for

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).

2. What you need to know before you take Hydroxycarbamide

Do not take Hydroxycarbamide:

if you are allergic to hydroxycarbamide or any of the other ingredients of this medicine (listed in section 6).
if your blood cell count is too low.

Warnings and precautions

Talk to your doctor or pharmacist before taking Hydroxycarbamide.

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.

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.

If you experience persistent eye problems such as redness and pain of the eyes, sensitivity to light, and/or worsening vision while taking hydroxycarbamide, please consult a doctor promptly because these can be indicative of a rare but serious ocular disease called limbal stem cell deficiency. See also section 4.

Talk to your doctor or pharmacist before taking Hydroxyurea 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.

Other medicines and Hydroxycarbamide

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.

Pregnancy, breast-feeding and fertility

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 must not be taken during breast-feeding. The active substance of

Hydroxycarbamide 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.

Driving and using machines

Your ability to react may be impaired during treatment with Hydroxycarbamide. You should bear this in mind when heightened attention is required, e.g. when driving and using machines.

Hydroxycarbamide contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Hydroxycarbamide contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.

3. How to take Hydroxycarbamide

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 take more Hydroxycarbamide than you should

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.

Hydroxycarbamide 500 mg capsules ·

Format: 420 x 180 mm ·

If you forget to take Hydroxycarbamide

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.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Contact your doctor immediately if you experience symptoms such as:

Fever, cough or breathing problems, this could be a sign of serious lung disease (frequency not known)
High fever (>39°C) with stomach, lung, muscle, liver, skin and heart problems within 6 weeks of taking Hydroxycarbamide (frequency rare)

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

Absence or low amount of sperm in semen (azoospermia or oligospermia)
Decrease in the number of blood cells (suppressed bone marrow function), especially white blood cells (leukocytopenia), including type of white blood cell which help the body to fight disease (CD4 lymphocytes decreased), red blood cells (anaemia) and platelets (thrombocytopenia)
Feeling sick (nausea), vomiting, loss of appetite, mouth sores (stomatitis), diarrhoea, constipation, abdominal pain, inflammation of the lining (mucositis), digestion troubles (dyspepsia)
Black tarry stools or blood in the stools
In combination with certain HIV treatments: inflammation of the pancreas (pancreatitis) with stomach or abdominal pain.
Fever caused by the medicine, chills, feeling of discomfort (malaise), weakness, loss of energy
- Skin ulcers, especially leg ulcers
- Skin eruptions in form of spots and blisters (maculopapular rash), redness of the face, redness of hands and feet (hand-foot syndrome)
- Skin changes such as purple-coloured rash and thinning of the skin; darkening and wasting of nails and skin, itching, small, violet skin bumps; scaling of the skin, blackening and death of skin
- Loss of hair (alopecia)
- Temporary kidney problems with elevation of certain blood parameters like uric acid, urea and creatinine
- Difficulties in passing urine

Common (may affect up to 1 in 10 people)

Enlarged immature red blood cells (megaloblastosis)
Skin cancer
Increase in liver enzymes
Inflammation of the liver (hepatitis) which cause flu-like symptoms, including tiredness, loss of appetite, fever, aching, and feeling sick/being sick, pressure or pain below the right ribs and might also include yellowing of the skin or eyes
Problems with the flow of the bile (cholestasis). The bile which is made by the liver to aid in digestion of food may not flow properly. A build-up of bile can cause itchiness, yellow skin, very dark urine and very pale stools
Neurological disturbances including headache, dizziness, drowsiness, disorientation, hallucinations and fits
Acute and chronic lung reactions with changes in lung tissue seen in x-ray and shortness of breath, as well as fever in acute reactions and dry cough in chronic reactions
In combination with certain HIV treatments: numbness and tingling or pain in arms and legs (peripheral neuropathy) and abdominal pain, nausea or vomiting or yellow skin (hepatotoxicity)

Uncommon (may affect up to 1 in 100 people)

Thick and scaly patches of skin (actinic keratosis)
High levels of break down product of red blood cells (bilirubin) in blood
Rare (may affect up to 1 in 1,000 people)
- Allergic reactions
- Metabolic complications due to break-down products of cancer cells (tumour lysis syndrome)
- Skin ulceration with severe infection

Very rare (may affect up to 1 in 10,000 people)

Inflammation of the skin causing red scaly patches and possibly occurring together with pain in the joints
Reduced kidney function

Not known (frequency cannot be estimated from the available data)

High blood levels of potassium which can cause abnormal heart rhythm
Fever, cough or breathing problems, this could be a sign of serious lung disease; allergic inflammation of air sacs
Haemolytic anaemia
Dry skin
Deep sores in the tissue of the digestive tract
Persistent eye problems such as redness and pain of the eyes, sensitivity to light, and/or worsening vision (limbal stem cell deficiency). See also section 2

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.

Reporting of side effects

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.

5. How to store Hydroxycarbamide

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.

6. Contents of the pack and other information

What Hydroxycarbamide contains

The active substance is hydroxycarbamide. Each capsule contains 500 mg hydroxycarbamide.
The other ingredients are lactose monohydrate, calcium citrate, disodium citrate, magnesium stearate, gelatin and titanium dioxide (colorant E171).

What Hydroxycarbamide looks like and contents of the pack

White hard capsules (capsules).

Available pack sizes: 50 or 100 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer medac

Gesellschaft für klinische Spezialpräparate mbH Theaterstr. 6

22880 Wedel

Germany

Phone: +49 4103 8006-0

Fax: +49 4103 8006-100

This leaflet was last revised in September 2026.

Hydroxycarbamide 500 mg capsules