NATULAN procarbazine 50mg (as hydrochloride) capsule bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

procarbazine hydrochloride, Quantity: 58.3 mg (Equivalent: procarbazine, Qty 50 mg)

Available from:

Link Medical Products Pty Ltd T/A Link Pharmaceuticals

INN (International Name):

procarbazine hydrochloride

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: Gelatin; iron oxide yellow; magnesium stearate; titanium dioxide; purified talc; mannitol; maize starch

Administration route:

Oral

Units in package:

50 capsules

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS AS AT 23 AUGUST 1991: Treatment of Hodgkin's disease (multiple lymphadenoma); treatment of other malignant lymphomas including lymphosarcoma, reticulosarcoma, Brill-Symmers disease. Natulan is dissimilar to other cytostatic agents and may be effective in cases resistant to other drugs and X-rays.

Product summary:

Visual Identification: Capsule size no.2, body and cap ivory opaque.; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-08-23

Patient Information leaflet

NATULAN
®
ACTIVE INGREDIENT: _procarbazine (as hydrochloride) _
_ _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET?
This leaflet answers some
common questions about
NATULAN capsules.
It does not contain all the
available information.
It does not take the place of
talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you
taking NATULAN capsules
against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it
again.
WHAT NATULAN IS
USED FOR
The name of your medicine is
NATULAN. It contains the
active ingredient called
procarbazine hydrochloride.
NATULAN belongs to a group
of medicines called anticancer
drugs. Anticancer drugs are
used to treat cancer and work
by stopping the growth of
certain types of cells in the
body, including diseased cells.
NATULAN is prescribed for
several conditions including
Hodgkin's disease and some
types of blood disorders.
There are many different
types of medicines used to
treat cancer. NATULAN
belongs to a group of
medicines known as
methylhydrazine compounds.
Your doctor may have
prescribed NATULAN for
another purpose. ASK YOUR
DOCTOR IF YOU HAVE ANY
QUESTIONS WHY NATULAN
HAS BEEN PRESCRIBED FOR
YOU.
This medicine is available only
with a doctor's prescription.
BEFORE YOU TAKE
NATULAN
_DO NOT TAKE NATULAN IF: _
•
You have an abnormal
number of white blood cells
or platelets
•
You have severe kidney or
liver disease
•
You are pregnant, or are
planning to become
pregnant
•
You have had an allergic
reaction to NATULAN or
any ingredients listed in the
INGREDIENTS section of this
leaflet.
An allergic reaction may result
in a skin rash.
DO NOT TAKE NATULAN AFTER
THE EXPIRY DATE {EXP}
PRINTED ON THE PACK.
It may have no effect or,
worse, an entirely unexpected
effect if you take it after the
expiry date.
DO NOT TAKE NATULAN IF THE
PACKAGE IS TORN OR SHOWS
SIGNS OF TAMPERING.
IF

Summary of Product characteristics

_Page 1 of 5_
AUSTRALIAN PRODUCT INFORMATION-NATULAN
® (PROCARBAZINE
(AS HYDROCHLORIDE))
1
NAME OF THE MEDICINE
Procarbazine (as hydrochloride)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Natulan contains the active component procarbazine (as the
hydrochloride). Each capsule contains
50 mg procarbazine (as the hydrochloride).
For the full list of excipients, see
SECTION
6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
Hard capsules (opaque ivory coloured with a white to yellowish fine
granular powder).
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC
INDICATIONS
Treatment of Hodgkin's disease (multiple lymphadenoma); treatment of
other malignant lymphomas
including lymphosarcoma, reticulosarcoma, Brill-Symmers disease.
Natulan is dissimilar to other
cytostatic agents and may be effective in cases resistant to other
drugs and X- rays.
4.2
DOSE
AND
METHOD
OF
ADMINSTRATION
INITIAL DOSAGE
Natulan is given by mouth, initially in small doses which are
increased gradually to a maximum of 250
to 300 mg daily. Dosage is 50 mg on the first day, increasing by 50 mg
daily up to 250 to 300 mg daily
after 5 or 6 days. Dosage is maintained at this level until the
greatest possible remission has occurred.
If during this time, leucopenia of about 3, 000/mm
3
or thrombocytopenia of about 80, 000/mm
3
occurs,
treatment should be suspended until leucocyte and platelet levels
recover and then recommenced.
MAINTENANCE DOSAGE
50 to 150 mg daily until a total dose of 6 g has been given. Otherwise
a negative result is not significant.
4.3
CONTRAINDICATIONS
•
Pre-existing leucopenia or thrombocytopenia; severe hepatic or renal
damage; If allergic skin
reactions occur, treatment must be stopped.
•
Pregnancy (see section 4.6 FERTILITY, PREGNANCY AND LACTATION – Use
in
pregnancy).
4.4
SPECIAL
WARNINGS
AND
PRECAUTIONS
FOR
USE
Bone marrow depression may occur and frequent blood counts are
advisable. If allergic skin reactions
occur, treatment should be interrupted. Intolerance to alcohol may
develop and abstinence may be
advisable during therapy.
Pr