Treosulfan 250mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Treosulfan

Available from:

Alliance Healthcare (Distribution) Ltd

ATC code:

L01AB02

INN (International Name):

Treosulfan

Dosage:

250mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08010100

Patient Information leaflet

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 tre

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Treosulfan Capsules 250 mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Capsules each containing 250 mg treosulfan as active substance.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule, hard.
White opaque capsules.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treosulfan is indicated for the palliative treatment of epithelial
ovarian cancer.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Treosulfan 400-600 mg/m²/day orally; day 1 - 28; four weeks rest,
repeat day 57.
_Duration of treatment _
Treatment should be continued until disease progression. In the case
of occurrence of
non-tolerable adverse events, the treatment must be stopped.
_Dose modification_
A treatment cycle should not be started if the white blood cell count
is less than
3,500/µl or the thrombocyte count less than 100,000/µl. A repeat
blood count should
be made after a week’s interval, when treatment may be restarted if
haematological
parameters are satisfactory.
If, following administration of treosulfan, the white cell count falls
below 1,000/µl
and/or the platelet count falls below 25,000/µl, the daily dose must
be reduced by one
capsule (250 mg).
If during treatment the white cell count does not fall below 3,500/µl
and/or the
platelet count does not fall below 100,000/µl, the daily dose in the
following course
of treatment may be increased by one capsule (250 mg).
_Elderly patients and patients with renal impairment _
Treosulfan is renally excreted. Blood counts should be carefully
monitored in elderly
and renally impaired patients and the dose adjusted accordingly.
_ _
_Paediatric population _
Treosulfan Capsules are not recommended for use in children.
Method of administration
The capsules should be swallowed whole and should not be allowed to
disintegrate
within the mouth.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in
section 6.1.
Severe and lasting bone marrow depression.
4