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TREOSULFAN CAPSULES 250MG

Active substance(s): TREOSULFAN / TREOSULFAN / TREOSULFAN

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Treosulfan Capsules 250 mg · 80300-VPGB · CA · 03.16 · Pharma-Code: 528
Format: 444 x 150 mm · HKS 44 · Corrective action: KV01_osc_27.04.16 / KV02_osc_29.04.16 / KV03_osc_08.09.16

Package leaflet: Information for the user

Treosulfan Capsules 250 mg
Treosulfan
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 Treosulfan Capsules are and what they are
used for
2. What you need to know before you take Treosulfan
Capsules
3. How to take Treosulfan Capsules
4. Possible side effects
5. How to store Treosulfan Capsules
6. Contents of the pack and other 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 ovarian cancer.

2. What you need to know before you take
Treosulfan Capsules
Do not take Treosulfan Capsules
• if you are allergic to treosulfan or any of the other
ingredients of this medicine (listed in section 6).
• if you 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.
Warnings and precautions
Talk to your doctor or pharmacist before taking
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.
• if you 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 of the following:
• the risk of getting different types of infections is
increased.
• different types of blood cancer may occur after longterm treatment.
• as treosulfan is excreted via your kidney your blood
counts should be carefully monitored and your dosage
adjusted accordingly if you suffer from impaired kidney
function.
• treatment with anticancer medicines 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.

Pregnancy and breast-feeding
Do not take treosulfan if you are pregnant or planning to
become pregnant or breast-feeding unless your doctor
considers it as absolutely necessary. You must use
effective contraception during therapy, e.g. birth
control pill.

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

Your doctor decides on the exact dose for you and how
often you should take this medicine.

The effect of ibuprofen/chloroquine treatment may be
reduced when given in combination with treosulfan.
It is not advisable to use any medicines without telling
your doctor as there may be interactions between
treosulfan and other medicines.

If you are planning to become pregnant or thinking of
breast-feeding discuss it with your doctor first.
Driving and using machines
Your ability to drive or operate machines may be
influenced in case of nausea and vomiting. If you are
affected in this way do not drive or operate machines.

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

The dose of treosulfan you should get depends on your
height and weight, blood tests, general condition, how
you respond to treatment and whether you also receive
other medicines against cancer or radiotherapy. In
general, 400-600 mg/m² treosulfan (corresponds mostly
to 3-4 capsules) are taken per day orally on days 1-28
and break on days 29-56. Courses can be repeated every
8 weeks, depending on the tolerability and efficacy of
treatment.

Swallow the capsules whole. Do not let them dissolve in
your mouth.
It is important to complete the treatment course exactly as
prescribed by your doctor.
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.
Use in 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 doctor may give you a
blood transfusion and will undertake other measures if
necessary.
If you forget to take Treosulfan Capsules
Do not take a double dose to make up for a forgotten
dose. 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
medicine, ask your doctor or pharmacist.

Treosulfan Capsules 250 mg · 80300-VPGB · CA · 03.16 · Pharma-Code: 528
Format: 444 x 150 mm · HKS 44 · Corrective action: KV01_osc_27.04.16 / KV02_osc_29.04.16 / KV03_osc_08.09.16

4. Possible side effects
Like all medicines, this medicine 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 (may affect more than 1 in 10 people):
• 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.
Common (may affect up to 1 in 10 people):
• Infections caused by fungi, viruses or bacteria.

Uncommon (may affect up to1 in 100 people):
• Different types of blood cancer (after long-term treatment).
• Inflammation of the mouth (stomatitis) if you chew the
capsules.
Rare (may affect up to 1 in 1,000 people):
• 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 red blood cells, white blood cells and
platelets at the same time which can cause weakness,
bruising or make infections more likely (pancytopenia).
Very rare (may affect up to 1 in 10,000 people):
• Severe generalised infection (sepsis)
• 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).
• 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
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is
stated on the bottle 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 to
protect the environment.

6. Contents of the pack and other information
What Treosulfan Capsules contain
• The active substance is treosulfan.
• The other ingredients are maize starch, hydroxypropyl
methylcellulose and magnesium stearate.
The capsule consists of gelatine and the colour is called
titanium dioxide E 171.

What Treosulfan Capsules look like and contents of
the pack
White opaque capsules.
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 revised in 03/2016.
------------------------------------------------------------------Full information is available on request from
medac
Gesellschaft für klinische Spezialpräparate mbH
Scion House
Stirling University Innovation Park
Stirling FK9 4NF
Tel.: 01786/ 458 086
Fax: 01786/ 458 032

80300-VPGB
CA

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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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