Largactil

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Chlorpromazine hydrochloride 25 mg/mL

Available from:

Clinect NZ Pty Limited

INN (International Name):

Chlorpromazine hydrochloride 25 mg/mL

Dosage:

25 mg/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Chlorpromazine hydrochloride 25 mg/mL Excipient: Sodium chloride Sodium citrate dihydrate Sodium metabisulfite Sodium sulfite Water for injection

Units in package:

Ampoule, 10 x 2 mL, 20 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Sanofi Chimie

Product summary:

Package - Contents - Shelf Life: Ampoule, 2 mL - 10 dose units - 60 months from date of manufacture stored at or below 25°C protect from light

Authorization date:

1969-12-31

Patient Information leaflet

LARGACTIL
®
1
LARGACTIL
®
_chlorpromazine hydrochloride_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Largactil.
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 or pharmacist
has weighed the risks of you taking
Largactil against the benefits they
expect it will have for you.
IF YO
U HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THIS
MEDICINE.
You may need to read it again.
WHAT LARGACTIL IS USED
FOR
The active ingredient of Largactil is
chlorpromazine hydrochloride, one
of a group of medicines called
phenothiazines.
Largactil is used to treat a number of
conditions and may be used either for
a short time or for a long time.
Largactil is used to treat various
problems such as severe depression
or behavioural disturbances.
Largactil can also be used to treat
nausea, vomiting, severe pain and
unstoppable hiccups. Your doctor
may have prescribed Largactil for
another reason.
ASK YO
UR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY LARGACTIL HAS
BEEN PRESCRIBED FOR YOU.
Largactil is available only with a
doctor's prescription.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE LARGACTIL IF YOU HAVE
AN ALLERGY OR ANY OTHER REACTION TO
LARGACTIL OR ANY OF THE INGREDIENTS
LISTED AT THE END OF THIS LEAFLET.
DO NOT TAKE LARGACTIL IF YOU HAVE
TAKEN ANY OTHER 'PHENOTHIAZINE'
MEDICINE BEFORE, WHICH CAUSED
YOUR FACE, LIPS, TONGUE, THROAT,
HANDS OR FEET TO SWELL UP, OR MADE
IT HARD FOR YOU TO BREATHE.
If you have had an all
ergic reaction
to a phenothiazine before, you may
be allergic to Largactil.
DO NOT TAKE LARGACTIL IF YOU HAVE
ANY OF THE FOLLOWING:
•
circulatory, blood or bone
marrow problems
•
high blood pressure
•
phaeochromocytoma - a rare
tumour of the adrenal gland
which sits near the kidneys
•
liver problems
•
CNS depression, e.g. coma or
drug intoxication
DO NOT TA

Summary of Product characteristics

1
NEW ZEALAND DATA SHEET
1.
LARGACTIL
Largactil 25 mg film coated tablets
Largactil 100 mg film coated tablets
Largactil 25 mg/mL solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tablets: Each tablet contains 25 mg or 100 mg of chlorpromazine
hydrochloride
Solution for injection contains 25 mg/mL of chlorpromazine
hydrochloride.
Excipients with known effect:
Tablets: Lactose monohydrate
Solution for injection: Sodium metabisulfite and sodium sulfite
For the full list of excipients, see Section 6.1 List of Excipients.
3.
PHARMACEUTICAL FORM
Tablets, Solution for injection
_TABLETS _
25 mg: white to off-white, circular biconvex, film-coated tablets one
face impressed LG25 with the reverse
side plain film coated
100 mg: white to off-white, circular biconvex, film-coated tablets one
face impressed LG100 with the reverse
side plain film coated
_INJECTION _
The injection solution is a clear, bright, very pale yellow liquid.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Chlorpromazine is indicated in the following conditions:
•
Schizophrenia and other psychoses (especially paranoid), mania and
hypomania.
•
In
anxiety
psychomotor
agitation
excitement,
violent
or
dangerously
impulsive
behaviour.
Chlorpromazine is used as an adjunct in the short-term management of
these conditions.
•
Intractable hiccup.
•
Nausea and vomiting of terminal illness (where other medicines have
failed or are not available).
•
Childhood schizophrenia and autism.
2
4.2 DOSE AND METHOD OF ADMINISTRATION
_METHOD OF ADMINISTRATION _
ORAL
Oral administration should be used whenever possible. Dosages should
be low to begin with and gradually
increase under close supervision until the optimum dosage within the
recommended range for the individual
is reached. Individuals vary considerably and the optimum dose may be
affected by the formulation used.
LARGACTIL tablets should not be crushed and solutions should be
handled with care because of the risk of
contact dermatitis.
The parenteral formulation may be used in emergen