LARGACTIL SYRUP chlorpromazine hydrochloride 5mg/ml oral liquid

Country: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Virkt innihaldsefni:

chlorpromazine hydrochloride, Quantity: 5 mg/mL

Fáanlegur frá:

Clinect Pty Ltd

INN (Alþjóðlegt nafn):

Chlorpromazine hydrochloride

Lyfjaform:

Oral Liquid

Samsetning:

Excipient Ingredients: sucrose; caramel; Peppermint Oil; Spearmint oil; polysorbate 20; purified water; citric acid; sodium citrate dihydrate; ascorbic acid; sodium sulfite; sodium metabisulfite; sodium benzoate; Flavour

Stjórnsýsluleið:

Oral

Einingar í pakka:

100ml bottle, 500ml bottle

Gerð lyfseðils:

(S4) Prescription Only Medicine

Ábendingar:

1. Treatment of acute functional psychosis (eg schizophrenia, mania or psychotic depression). 2. Long-term treatment of schizophrenia. 3. Short-term treatment of agitation and severe depression. 4. Severe behavioural disturbances, as can be found in some children with mental retardation or autism, including the treatment of self-injurious and aggressive behaviour or overactivity. Use of chlorpromazine should be in conjunction with an appropriate non-pharmacological management program and long-term use should only be carried out under the supervision of a physician experienced in the management of psychotic disorders in children. 5. In the management of terminal illness to enhance the effect of analgesics and to control nausea and vomiting. 6. Control of intractable hiccough.

Vörulýsing:

Visual Identification: A clear bright golden brown syrupy liquid; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Leyfisstaða:

Licence status A

Leyfisdagur:

2005-05-02

Upplýsingar fylgiseðill

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 YOU 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 YOUR 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 allergic 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 TAKE LARGACTIL AFTER

Vara einkenni

largactil-ccdsv4-piv13-17dec19
1
AUSTRALIAN PRODUCT INFORMATION – LARGACTIL
(CHLORPROMAZINE HYDROCHLORIDE)
1
NAME OF THE MEDICINE
Chlorpromazine hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tablets: Each tablet contains 10 mg, 25 mg or 100 mg of chlorpromazine
hydrochloride
Syrup: Each 1 mL of syrup contains 5 mg of chlorpromazine
hydrochloride
Injection: The injection solution contains 50 mg/2 mL of
chlorpromazine hydrochloride
Excipients with known effect:
Tablets: Lactose Monohydrate
Syrup: Sucrose, sodium sulfite, sodium metabisulfite, sodium benzoate
Injection: Sodium sulfite, sodium metabisulfite
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Tablets, Syrup, Injection Solution
TABLETS
10 mg: white to off-white, circular biconvex, film-coated tablets one
face impressed LG10
with the reverse side plain film coated tablet
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
SYRUP
The syrup is a clear bright, golden brown, syrupy liquid
INJECTION
The injection solution is a clear, bright, very pale yellow liquid.
largactil-ccdsv4-piv13-17dec19
2
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of acute functional psychosis (e.g. schizophrenia, mania or
psychotic depression).
Long-term treatment of schizophrenia.
Short-term treatment of agitation and severe depression.
Severe behavioural disturbances, as can be found in some children with
mental retardation or
autism, including the treatment of self-injurious and aggressive
behaviour or overactivity.
Use of chlorpromazine should be in conjunction with an appropriate
non-pharmacological
management program and long-term use should only be carried out under
the supervision of a
physician experienced in the management of psychotic disorders in
children.
In the management of terminal illness t