Procarbazine 50mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Procarbazine hydrochloride

Available from:

Alliance Pharmaceuticals Ltd

ATC code:

L01XB01

INN (International Name):

Procarbazine hydrochloride

Dosage:

50mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08010500; GTIN: 5024403000042

Patient Information leaflet

ARTWORK INFORMATION
Product Title:
Procarbazine PIL
Date:
02-07 -14
Product Size:
148 x 210mm
Label Number:
14-139
Colours Used:
Black
Fonts Used:
Bosis Light, Medium and Semibold
Font size:
7pt
Artwork by:
Kevin Raddy
14-139 Procarbazine PIL 02-07-14_Layout 1 02/07/2014 10:49 Page 1
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 Procarbazine 50mg Capsules are and what they are used for
2.
What you need to know before you take Procarbazine 50mg
Capsules
3.
How to take Procarbazine 50mg Capsules
4.
Possible side effects
5.
How to store Procarbazine 50mg Capsules
6.
Contents of the pack and other information
1.
WHAT PROCARBAZINE 50MG CAPSULES ARE AND WHAT THEY
ARE USED FOR
Procarbazine is one of the group of medicines known as alkylating
agents, which interfere with the growth of certain types of cells in
the
body.
Procarbazine is used as one of the chemotherapy drugs in the
treatment of some cancers.
In adults, Procarbazine is used on its own or in combination with
other drugs in the treatment of cancers such as Hodgkin’s disease (a
cancer of the lymph glands).
In children (aged 2-18 years), Procarbazine is used in combination
with
other drugs in the treatment of Hodgkin’s disease.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PROCARBAZINE 50MG
CAPSULES
DO NOT TAKE PROCARBAZINE 50MG CAPSULES:
•
if you are allergic to procarbazine or any of the other ingredients
of this medicine (listed in section 6)
•
if you have anything wrong with your blood, in particular, too few
white cells or pl

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Procarbazine 50mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
capsule
contains
58.3mg
Procarbazine
hydrochloride
(equivalent
to
50mg of Procarbazine).
For a full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Capsules with white opaque cap and body. Marked ‘CL50’ on one
half.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The main indication is Hodgkin's disease (lymphadenoma).
Procarbazine may also be useful in other advanced lymphomata and a
variety
of solid tumours which have proved resistant to other forms of
therapy.
Children
Procarbazine is indicated in the treatment of Hodgkin’s lymphoma in
children
aged 2-18, when associated with other antineoplastic drugs in an
appropriate
protocol.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
In combination chemotherapeutic regimens:
Procarbazine is usually administered concomitantly with other
appropriate cytostatic
drugs in repeated four- to six-weekly cycles. In most such combination
chemotherapy
regimens currently in use (eg. the so-called MOPP schedule with
mustine, Vincristine
and Prednisone) Procarbazine is given daily on the first 10 - 14 days
of each cycle in
a dosage of 100mg per sq. metre of body surface (to nearest 50mg).
As sole therapeutic agent: Adults:
Treatment should begin with small doses which are increased gradually
up to a
maximum daily dose of 250 or 300mg divided as evenly as possible
throughout the
day.
Initial dosage scheme
1st day:
50mg
4th day:
200mg
2nd day:
100mg
5th day:
250mg
3rd day:
150mg
6th day et seq:
250-300mg
Further procedure:
Treatment should be continued with 250 or 300mg daily until the
greatest possible
remission has been obtained, after which a maintenance dose is given.
Maintenance dose:
50 -150mg daily. Treatment should be continued until a total dose of
at least 6g has
been given. Otherwise, a negative result is not significant.
Elderly:
Procarbazine should be used with caution in the elderly. Patients in
this group should
be