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TREOSULFAN CAPSULES 250MG

Active substance(s): TREOSULFAN

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Treosulfan Capsules 250 mg · 80300-VPGB · BA · 01.15 · Pharma-Code: 528
Format: 296 x 150 mm · HKS 44 · Corrective action: KV01_osc_22.12.14

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Treosulfan Capsules 250 mg
Treosulfan
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 Treosulfan Capsules are and what they are
used for
2. Before you take Treosulfan Capsules
3. How to take Treosulfan Capsules
4. Possible side effects
5. How to store Treosulfan Capsules
6. Further information
1. WHAT TREOSULFAN CAPSULES ARE AND
WHAT THEY ARE USED FOR
Treosulfan belongs to the group of anticancer
medicines called bifunctional alkylating agents.
These agents inhibit tumour growth.
Treosulfan Capsules have been prescribed by your
doctor for the treatment of all types of ovarian
cancer or certain types of cancer which do not
respond to usually given kind of therapy.

2. BEFORE YOU TAKE TREOSULFAN CAPSULES
Do not take Treosulfan Capsules, if you
• are allergic (hypersensitive) to treosulfan or any
of the other ingredients of Treosulfan Capsules.
• do not have enough blood cells (severe bone
marrow depression).
You will have regular blood tests to check that
you have enough blood cells to take Treosulfan
Capsules.
Take special care with Treosulfan Capsules,
if you
• experience reduction in blood cells as this may
become worse with ongoing treatment. Blood
tests will be performed at shorter intervals
starting with the third course of treatment. This
is especially important if combined with other
forms of therapy that suppress the bone marrow
function such as radiotherapy.
• develop inflammation of the lungs which
causes shortness of breath (allergic alveolitis or
pulmonary fibrosis); treatment with treosulfan
should then be stopped.
Be also aware that:
• the risk of getting different types of infections is
increased.
• treatment with cytostatics may increase the risk
of generalised infection after some vaccinations.
Therefore you should not receive vaccination
with live vaccines.
• because of the possible development of
bladder inflammation with pain, more frequent
or urgent urination with or without bloody urine
(haemorrhagic cystitis) you are advised to drink
more fluids than usual while taking Treosulfan
Capsules.
• inflammation of the mouth (stomatitis) may
occur if you chew the capsules. For this reason
swallow the capsules whole.

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.
It is not advisable to use any medical treatment,
without telling your doctor as there may be
interactions between treosulfan and other
medicines.
Pregnancy and breast-feeding
Do not take treosulfan if you are pregnant or
planning to become pregnant. You must use
effective contraception during therapy, e.g. birth
control pill.

Your doctor reduces the dose if other cytotoxic
medicines or radiotherapy have also been given.
The course of treosulfan therapy usually lasts
8 weeks. The following regimen may be indicated
for your treatment:
Regimen A: 4 capsules daily, given in four divided
doses for four weeks, followed by four weeks
without treosulfan.
Regimen B: 4 capsules daily, given in four divided
doses for two weeks, followed by two weeks
without treosulfan.

Do not breast-feed while taking treosulfan.

Regimen C: 6 capsules daily, given in three
divided doses for one week only, followed by three
weeks without treosulfan.

If you are thinking of becoming pregnant or breastfeeding discuss it with your doctor first.

Swallow the capsules whole. Do not let them
dissolve in your mouth.

Driving and using machines
Your ability to drive or operate machines may be
influenced because of nausea and vomiting. If you
are affected in this way do not drive or operate
machinery.

It is important to complete the treatment course
exactly as prescribed by your doctor.

3. HOW TO TAKE TREOSULFAN CAPSULES
Always take Treosulfan Capsules exactly as your
doctor has told you. You should check with your
doctor or pharmacist if you are not sure.
Your doctor decides on the exact dose for you and
how often you should take this medicine.
Your doctor will calculate your treosulfan dose
on the basis of your blood counts measured,
concurrent chemotherapy and your weight.

Your doctor may change the dose and frequency
of dosing depending on your blood tests, your
general condition, further therapies and your
response to treosulfan. If you have any questions
about your treatment, ask your doctor, nurse or
pharmacist.
Children
This medicine is not recommended for use in
children.
If you take more Treosulfan Capsules than you
should
If you have taken too many capsules tell your
doctor or contact the nearest hospital accident
and emergency department immediately. Your

Treosulfan Capsules 250 mg · 80300-VPGB · BA · 01.15 · Pharma-Code: 528
Format: 296 x 150 mm · HKS 44 · Corrective action: KV01_osc_22.12.14

doctor may give you a blood transfusion and will
undertake other measures if necessary.
If you forget to take Treosulfan Capsules
If you have missed one or several doses please
ask your doctor or pharmacist immediately for
advice. It is important to complete the treatment
course exactly as prescribed by your doctor.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, treosulfan can cause side
effects, although not everybody gets them.
Contact your doctor straight away if you notice
any of the following:
• Allergic reactions: if you develop itching, rash,
swelling of the face, lips, tongue and/or throat,
which may cause difficulties in swallowing or
breathing, drop of blood pressure.
• Fever or infection: if you have a body
temperature of 38 °C or higher, sweating or other
signs of infection (since you might have fewer
white blood cells than normal).
• Weakness, becoming easily breathless or if you
look pale (since you might have fewer red blood
cells than normal).
• Bleedings from gums, mouth or nose,
unexpected bruising (since you might have fewer
platelets than normal).
• Difficulty in breathing (since you might have an
allergic reaction, inflammation or infection of the
lung).
Very common (affect more than 1 in 10 patients):
• Reduction in white blood cells (which make
infections more likely), platelets (which can

cause bruising and bleeding from gums, mouth
and nose) and red blood cells (which can
make the skin pale and cause weakness or
breathlessness) – hence the need for regular
blood tests.
• Stomach upsets including nausea (feeling sick)
with or without vomiting (being sick).
• Mild loss of hair. After your treatment, normal
hair growth should return.
• Bronze discolouration of the skin.
Uncommon (affect 1 to 10 in 1,000 patients):
• Different types of blood cancer (after long-term
treatment).
Not known (frequency cannot be estimated
from the available data):
• Allergic reactions (e.g. itching, rash, swelling
of the face, lips, tongue and/or throat with
difficulties in swallowing or breathing, drop of
blood pressure).
• Severe reduction of different blood cells at the
same time which can cause weakness, bruising
or make infections more likely (pancytopenia).
The following side effects have also been
reported:
• Addison‘s disease, a condition where the
adrenal glands do not work properly, leading
to bronzed skin, stomach upset, low blood
pressure (feeling faint) and a general feeling of
weakness.
• Sweating, trembling and hunger as a result of
the decreased amount of glucose in your blood
(hypoglycaemia).
• Pins and needles and a feeling of numbness
(paraesthesia).
• Inflammation of the mouth (stomatitis) if you
chew the capsules.
• Weakening of the heart muscle caused by a
structural change (cardiomyopathy).

• Difficulty in breathing (inflammation and scarring
of the lungs and infection of the lungs).
• Urticaria or hives, an itchy rash; inflammation
of the skin with or without scale formation
(scleroderma and psoriasis).
• Inflammation of the bladder with pain, more
frequent and urgent urination and with or without
bloody urine (haemorrhagic cystitis).
• Feeling of getting ill (flu-like complaints).
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.
By reporting side effects you can help provide
more information on the safety of this medicine.
5. HOW TO STORE TREOSULFAN CAPSULES

The capsule consists of gelatine and the colour
is called titanium dioxide E 171.
What Treosulfan Capsules look like and
contents of the pack
Treosulfan Capsules are packed in bottles, each
containing 100 capsules.
Each capsule contains 250 mg of treosulfan.
Marketing Authorisation Holder and
Manufacturer
medac
Gesellschaft für klinische Spezialpräparate mbH
Theaterstr. 6
22880 Wedel
Germany
This leaflet was last approved in 01/2015.

Keep out of the reach and sight of children.

_____________________________________________

Do not use Treosulfan Capsules after the expiry
date which is stated on the bottle after EXP.
The expiry date refers to the last day of that month.

Full information is available on request from

Medicines 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.

medac
Gesellschaft für klinische Spezialpräparate mbH
Scion House
Stirling University Innovation Park
Stirling FK9 4NF
Tel.: 01786/ 458 086
Fax: 01786/ 458 032

6. FURTHER INFORMATION
What Treosulfan Capsules contain
• The active substance is treosulfan.
• The other ingredients are maize starch,
hydroxypropyl methylcellulose and magnesium
stearate.

80300-VPGB
BA

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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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