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HYDROXYCARBAMIDE 500MG CAPSULES HARD

Active substance(s): HYDROXYCARBAMIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

SZ00000LT000

Hydroxycarbamide 500 mg Capsules, hard
Hydroxycarbamide
Read all of this leaflet carefully before you start taking this medicine.
• 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. Do not pass it on to others. It may harm
them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Hydroxycarbamide is and what it
is used for
2. Before you take Hydroxycarbamide
3. How to take Hydroxycarbamide
4. Possible side effects
5. How to store Hydroxycarbamide
6. Further information

1

What Hydroxycarbamide is and
what it is used for

Hydroxycarbamide is used for the
treatment of patients:
• with an aggressive white blood cell
disease starting at the bone marrow
(chronic myeloid leukaemia) in a chronic
or accelerated phase of the disease
• with a surplus of blood platelets
(essential thrombocythaemia)
• with a surplus of certain blood cells
(polycythaemia vera) associated with a
high risk of vascular occlusion
(thrombosis)
Hydroxycarbamide is a medicine to treat
tumour diseases.

2

Before you take
Hydroxycarbamide

Do not take Hydroxycarbamide
• if you are hypersensitive (allergic) to
hydroxycarbamide or any of the other
ingredients of hydroxycarbamide. Therapy
should be discontinued if hypersensitivity
to hydroxycarbamide occurs.
• if the function of the bone marrow is
considerably reduced, such as
- reduced number of white blood cells
(less than 2.5 x 109 leukocytes/l)
- deficiency of blood platelets (less than
100 x 109 thrombocytes/l)
- severe anaemia (reduction in red blood
cells).
• if you are pregnant or think you might
be pregnant.
• if you are breast-feeding.
• if you are concomitantly treated with
yellow fever vaccine.

hydroxycarbamide alone. These side
effects include the reduction of blood
formation in the bone marrow, stomach
and bowel complaints and inflammation in
the mouth cavity. Increase in inflammatory
reddening of the skin caused by previous
or existing radiotherapy is possible.
Laboratory tests have shown that
hydroxycarbamide enhances the toxicity of
certain medicines against tumour diseases,
e.g.
• fluoropyrimidines (e.g. fluorouracil) and
• cytarabine
It is not clear whether these interactions are
additive in their toxicity during use in
humans and whether the dose must be
adjusted.
• Medicines against viral diseases
(nucleoside analogues - medicines used
to prevent viral multiplication in infected
cells and medicines for the treatment of a
HIV infection)
• Prior or concomitant interferon
therapy
• Yellow fever vaccine
• Live attenuated vaccines (except
yellow fever)
• Ciclosporine, Tacrolimus
Pregnancy and breast-feeding
Hydroxycarbamide may impair the
development of your unborn child. You must
therefore not use hydroxycarbamide
during pregnancy.
Women of childbearing potential should
take contraceptive measures (for example:
oral contraceptives - commonly known as
the ‘Pill’ and/or condoms) before starting
and during treatment with
hydroxycarbamide. If a patient intends to
become pregnant after a therapy with
hydroxycarbamide a specialized
consultation is recommended.

Take special care with
Hydroxycarbamide
• if you suffer from impaired liver and/or
kidney function.
Only little experience is available
regarding this. Special caution is therefore
required during treatment with hydroxy
carbamide, particularly at the beginning
of therapy. The blood values as well as
liver and kidney function are to be
monitored by a doctor during treatment
with hydroxycarbamide.
• if you suffer from anaemia or if it occurs.
• if you notice skin changes (for example:
purple coloured rash and thinninng of the
skin).
• if you notice painful ulcers on the lower
legs.
These are usually difficult to treat and can
require interruption of treatment.
Discontinuation of hydroxycarbamide
usually enables the ulcers to slowly heal
after some weeks.
• if you receive long-term treatment in
cases of excessive formation of blood
cells such as polycythaemia vera (a
blood disorder in which the bone marrow
makes too many red blood cells) and
thrombocythaemia (a disorder in which
excess platelets are produced).
• if you experience impaired blood
formation in the bone marrow.
• if you are given other anticancer drugs or
radiotherapy treatment.
• if you are concomitantly treated with live
attenuated vaccines (expected yellow
fever vaccines see “Do not take
hydroxycarbamide”).

If a doctor deems the use absolutely
necessary during pregnancy, he/she should
inform you about the possible risk for your
child. If you become pregnant during
treatment with hydroxycarbamide, inform
your doctor without delay, and make use of
the possibility of specialized counselling.

Even after the dose has been stabilised, the
following levels in the blood needs to be
observed during treatment with
hydroxycarbamide:
- content of red blood pigment
- different types of white blood cells
- number of blood platelets
The control interval must be adjusted to a
particular individual, but is normally once a
week.

Your doctor determines the number of
capsules and the duration of treatment.

It is important to monitor uric acid levels
regularly. You should always drink sufficient
liquid during treatment with
hydroxycarbamide.
Appropriate contraceptive measures are to
be taken if one partner is treated with
hydroxycarbamide.
Men undergoing treatment with
hydroxycarbamide should not father a child
during treatment and up to 1 year
afterwards.
Seek advice on sperm conservation before
beginning therapy as hydroxycarbamide
therapy can cause transient infertility. If
pregnancy is desired, specialized
counselling is recommended even after
therapy.
Taking other medicines
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained
without a prescription.
• Other medicines against tumour
diseases or radiotherapy
Side effects can be more intense and
more common than after administration of

You must not use hydroxycarbamide while
breast-feeding. If treatment is
recommended by a doctor, you must stop
breast-feeding.
Driving and using machines
Reactivity can be impaired during treatment
with hydroxycarbamide. In this case, do not
drive a car, and do not operate hazardous
machines.

3

How to take
Hydroxycarbamide

Treatment should be conducted only by
experienced specialists.
Always take hydroxycarbamide exactly as
your doctor has told you. You should check
with your doctor or pharmacist if you are not
sure.
The capsules should be swallowed as a
whole and must not disintegrate within the
mouth.
The dosages stated in the following are
based on the patient’s actual or ideal
weight, whichever is the less.

• Aggressive white blood cell disease
(chronic myeloid leukaemia)
Depending on the number of white blood
cells, the initial dose is usually 40 mg
hydroxycarbamide per kg bodyweight
daily.
Your doctor will reduce the dose to 20 mg
per kg daily if the number of white blood
cells falls below 20 x 109/l. The dose is
then adjusted on an individual basis in
order to keep the number of white blood
cells at 5-10 x 109/l.
If the white blood cells are less than
5 x 109 per litre, the dosage should be
reduced, and it should be increased if
they are above 10 x 109/l.
If the white blood cells fall below
2.5 x 109/l or the blood platelets below
100 x 109/l, your doctor should interrupt
therapy until the values normalize.
An appropriate test time to determine the
efficacy of hydroxycarbamide is 6 weeks.
Your doctor will discontinue therapy if the
disease is progressing. If there is a
response, therapy can be continued
indefinitely.

Continued on the next page >>

• Surplus of blood platelets
(essential thrombocythaemia)
For this disease, the initial dose is
usually 15 mg hydroxycarbamide per
kg bodyweight daily. This should keep
the number of blood platelets below
600 x 109/l without reducing the number
of white blood cells below 4 x 109/l.
• Surplus of certain blood cells
(polycythaemia vera)
In this case, treatment should be started
with a dosage of 15-20 mg
hydroxycarbamide per kg bodyweight
daily. The dose is to be adjusted on an
individual basis in order to keep the ratio
between red blood cells and blood
plasma below 45% and the number of
blood platelets below 400 x 109/l.
This can be achieved in most patients
with a continuous administered dose
of 1 to 2 hard capsules daily on
average. If the ratio of red blood cells to
blood plasma and the number of blood
platelets remain stable, treatment should
be continued indefinitely.
Children
As these diseases only rarely occur in
children, no dosage schemes can be
established at present.
Elderly patients
Elderly patients can have a more
pronounced reaction to the effect of
hydroxycarbamide and possibly require a
lower dosage.
Patients with impaired liver or kidney
function
Recommendations cannot be given for
these patients as no data exists to date.
If you take more Hydroxycarbamide than
you should
If the dosage taken was several times more
than the recommended dosage, the
following acute skin and/or mucosal
changes may be signs of an overdose:
• soreness
• violet skin rash
• swellings on palms and soles, followed by
scaling of hands and feet
• sore feet
• excessive generalised pigmentation
• severe inflammation of tissue which lines
the mouth
Immediately inform a doctor if an overdose
occurs. Immediate treatment consists of
stomach irrigation, followed by supportive
measures and monitoring of the blood
formation.
If you forget to take Hydroxycarbamide
Do not take a double dose if you have
forgotten the previous intake. Go back to
your original directions for your next dose. If
you are unsure contact your doctor.
If you stop taking Hydroxycarbamide
Your disease might worsen if therapy is
discontinued.
Therapy with hydroxycarbamide may be
terminated or interrupted only on the orders
of the attending doctor.
If you have any further questions on the use
of this product, ask your doctor or
pharmacist.

Rare, affects 1 to 10 users in 10,000
• allergic reactions
• hair loss
• development of an acute lung reaction
with accumulation of liquid in the lung,
fever, shortness of breath
• difficult or painful urination (dysuria)
• Potentially life-threatening metabolic
complications that can occur after
treatment of cancer leading to increased
uric acid level in the blood, which may
result in gout or acute renal failure
(tumour lysis syndrome)
Very rare, affects less than 1 user in 10,000
In isolated cases after maintenance therapy
for several years with daily intake of
hydroxycarbamide:
• excessive pigmentation on skin and nails
• thinning of skin and nails
• ulcers of the lower legs
• small, rough reddish patches on the skin,
which may become skin cancer if not
removed (actinic keratosis)
• skin cancer
• violet rash which is raised (small
aggregation of cells)
• skin scaling
• impaired kidney function
• skin ulcers (especially ulcers of the lower
legs)
Another white blood cell cancer can develop
in patients with excessive formation of blood
cells and continuously treated with
hydroxycarbamide. It is not known whether
this is attributable to the underlying disease
or to the treatment with hydroxycarbamide.
The risk of an inflammation of the blood
vessels of the skin, including blood vessel
ulcerations and deterioration, is increased.
Severe skin blood vessel ulcers have been
reported in patients with myeloproliferative
disease. Hydroxycarbamide should
therefore be discontinued if such ulcerations
develop. In addition, alternative medicines
should be used if necessary.
Severe stomach complaints such as
nausea, vomiting and loss of appetite,
which can occur in combination with
radiotherapy, can be controlled if
administration of hydroxycarbamide is
transiently stopped.
Hydroxycarbamide can enhance mucosal
inflammations caused by radiation.
Inflammatory reddening and excessive
pigmentation can occur in pretreated tissue.
Inflammation of the blood vessels of the
skin, including blood vessel ulcerations and
deterioration, have occurred in patients with
myeloproliferative disorders during therapy
with hydroxycarbamide. This was reported
most often in patients with a history of, or
currently receiving, interferon therapy (see
“Taking other medicines”).
High doses can cause moderate
sleepiness.
If any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or
pharmacist.

5

How to store
Hydroxycarbamide

Keep out of the reach and sight of children.

4

Possible side effects

Like all medicines, hydroxycarbamide can
cause side effects, although not everybody
gets them.
Some side effects could be serious:
If any of the following happens, stop taking
this medicine and tell your doctor
immediately or go to the casualty
department at your nearest hospital:
• a severe allergic (hypersensitive) reaction
Symptoms may include: allergic reaction
in lung, reddening and swelling of the
skin, itching
• rare disorders of nerve function including
headache, dizziness, disorientaion,
hallucinations and fits
• unusual bruising or bleeding caused by
low blood platelets.
The strength of suppressed blood formation
of the bone marrow determines the dosage
or whether therapy must be interrupted in
rare cases.
Side effects affecting the stomach or the
intestine only rarely require dose reduction
or cessation of treatment.
Side effects can occur with the following
frequencies:
Common, affects 1 to 10 users in 100
• suppressed blood formation in the bone
marrow
• reduced number of white blood cells (you
are more prone to catch infections)
• changes in the red blood count
(megaloblastosis - large immature red
blood cells).
Possible changes in the red blood count
which do not respond to treatment with
folic acid or vitamin B12 subside when
therapy is discontinued.
• diarrhoea
• constipation
Uncommon, affects 1 to 10 users in 1,000
• anaemia (reduction in red blood cells)
• nausea, vomiting, loss of appetite
• inflammation of tissue which lines the
mouth
• drug fever
• chills
• feeling unwell
• flaky, knotty inflamed skin (rash or swollen
patchy redness that changes the skin’s
texture), skin rash
• inflammatory reddening affecting face,
arms and legs
• elevated liver enzymes
• elevated bilirubin
• transient disorders of tubular kidney
function with increase in uric acid, urea
and creatinine in blood

Do not store above 30°C.
Do not use the medicine after the expiry
date which is stated on the pack. The expiry
date refers to the last day of that month.
The medicine should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help
to protect the environment.

6

Further information

What Hydroxycarbamide contains
• The active substance is
hydroxycarbamide
1 capsule, hard contains 500 mg
hydroxycarbamide.
• The other ingredients are:
Capsule contents
Citric acid anhydrous, disodium hydrogen
phosphate anhydrous, magnesium
stearate
Capsule shell
Gelatin, ferric oxide, yellow, titanium
dioxide
What Hydroxycarbamide looks like and
contents of the pack
Capsule, hard with white lower part and
yellow upper part
Hydroxycarbamide 500 mg capsules, hard
are available in PVC/PVDC/aluminiumblister packs of 20, 25, 50, 100 and 120
capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Sandoz Ltd, Woolmer Way, Bordon, Hants,
GU35 9QE, United Kingdom.
Manufacturer
AMAREG GmbH, Donaustaufer Str. 378,
93055 Regensburg, Germany
or
Salutas Pharma GmbH,
Otto-von-Guericke-Allee 1, 39179 Barleben,
Germany.
This leaflet was last approved in 02/2010

SZ00000LT000

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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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