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HYDROXYCARBAMIDE MEDAC 500MG CAPSULE HARD

Active substance(s): HYDROXYCARBAMIDE

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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

medicines used in certain blood diseases, and which
interferes with the growth of cancer cells.

hydroxycarbamide and NRTI may increase the risk
of side effects of NRTI.

2. What you need to know before you take
Hydroxycarbamide

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.

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.

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.

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).

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.

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.

3. How to take Hydroxycarbamide

Warnings and precautions
Talk to your doctor or pharmacist before taking
Hydroxycarbamide.

Other medicines and Hydroxycarbamide
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.

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.

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.

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.

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.

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).

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.

1. What Hydroxycarbamide is and what it is used for
This medicine contains the active substance
hydroxycarbamide, which belongs to a group of

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.

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.

If you suffer from kidney and/or liver problems you
should inform your doctor before treatment with this
medicine is started.

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

If you recently had a vaccination or are planning to
have one, tell 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.

Always take this medicine exactly as your doctor
has told you. Check with your doctor or pharmacist
if you are not sure.

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.
40023722-06/16

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.

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 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.

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.

80250-VPGB-EXT
EC
40023722-06/16

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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