Package leaflet: Information for the user

Hydroxycarbamide 500 mg capsules

Hydroxycarbamide

Read all of this leaflet carefully before you start

taking this medicine because it contains important

information for you.

•    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 signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.    What Hydroxycarbamide is and what it is used for

2.    What you need to know before you take Hydroxycarbamide

3.    How to take Hydroxycarbamide

4.    Possible side effects

5.    How to store Hydroxycarbamide

6.    Contents of the pack and other information

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 your blood cell count is too low.

•    if you are allergic to hydroxycarbamide or any of the other ingredients of this medicine (listed in section 6).

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.

In case you have decreased red blood cell counts (anaemia) before or develop it during treatment red blood cells may be replaced when needed.

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 also been reported in patients receiving long term hydroxycarbamide. You should protect your skin from the sun, regularly inspect your skin yourself and be screened by your doctor for secondary malignancies 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.

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). 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 and during 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. Therefore you have to stop breast-feeding before taking this medicine for the first time.

Fertility

During treatment and for at least 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.

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.

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.

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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.

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.

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

• Absence or low amount of sperm in semen (azoospermia or oligospermia)

Common (may affect up to 1 in 10 people)

•    Decrease in the number of blood cells (suppressed bone marrow function), especially white blood cells (leukopenia), enlarged immature red blood cells (megaloblastosis)

•    Diarrhoea, constipation

•    Skin ulcers, especially leg ulcers

Uncommon (may affect up to 1 in 100 people)

•    Decreased red blood cell counts (anaemia) and platelets (thrombocytopenia)

•    Feeling sick (nausea), vomiting,

loss of appetite, mouth sores (stomatitis)

•    Fever caused by the medicine, chills, feeling of discomfort (malaise)

•    Skin eruptions in form of spots and blisters (maculopapular rash), redness of the face, redness of hands and feet (hand-foot syndrome)

•    Thick and scaly patches of skin (actinic keratosis), skin cancer

•    Increase in liver enzymes and bilirubin (break-down product of the red blood pigment)

•    Temporary kidney problems with elevation of certain blood parameters like uric acid, urea and creatinine

•    In combination with certain HIV treatments: inflammation of the pancreas (pancreatitis) with stomach or abdominal pain; abdominal pain, nausea or vomiting, or yellow skin (hepatotoxicity); numbness and tingling or pain in arms and legs (peripheral neuropathy)

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

•    Allergic reactions

•    Loss of hair (alopecia)

•    Acute lung reactions with changes in lung tissue seen in x-ray, fever and shortness of breath; allergic inflammation of air sacs

•    Difficulties in passing urine

•    Neurological disturbances including headache, dizziness, disorientation, hallucinations and fits

•    Metabolic complications due to break-down products of cancer cells (tumour lysis syndrome)

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

•    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

•    Reduced kidney function

•    Chronic lung reactions with changes in lung tissue seen in x-ray, shortness of breath and dry cough

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

•    High blood levels of potassium which can cause abnormal heart rhythm

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.

High doses may cause moderate drowsiness.

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 or pharmacist. 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 By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Hydroxycarbamide

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.

Marketing Authorisation Holder and Manufacturer

medac

Gesellschaft fur klinische Spezialpraparate mbH Theaterstr. 6 22880 Wedel Germany

Phone: +49 4103 8006-0 Fax:    +49 4103 8006-100

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria, Denmark, Finland, Greece, Iceland, Netherlands, Norway, Portugal, Sweden:

Hydroxyurea medac

Germany: Syrea

United Kingdom: Hydroxycarbamide This leaflet was last revised in June 2016.

80250-VPGB-EXT

EC

40023722-06/16