LARGACTIL chlorpromazine hydrochloride 10mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

chlorpromazine hydrochloride, Quantity: 10 mg

Available from:

Sanofi-Aventis Australia Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: lactose monohydrate; maize starch; colloidal anhydrous silica; hypromellose; macrogol 200; magnesium stearate; titanium dioxide; purified water; industrial methylated spirit

Administration route:

Oral

Units in package:

100 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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.

Product summary:

Visual Identification: White to off white circular biconvex, film- coated tablets one face impressed LG10 with the reverse side plain.; Container Type: Blister Pack; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1995-04-26

Patient Information leaflet

LARGACTIL
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING LARGACTIL?
Largactil contains the active ingredient chlorpromazine hydrochloride,
one of a group of medicines called phenothiazines. Largactil is
used to treat several conditions and may be used either for a short
time or for a long time.
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. For more information, see Section 1. Why am I using
Largactil? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE LARGACTIL?
Do not use if you have ever had an allergic reaction to Largactil or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Largactil? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Largactil and affect how it works. A
list of these medicines is in Section 3. What if I am taking
other medicines? in the full CMI.
4.
HOW DO I USE LARGACTIL?
•
Your doctor or pharmacist will tell you how many tablets or how much
syrup you will need to take each day. This depends on
your condition and whether or not you are taking any other medicines.
More instructions can be found in Section 4. How do I use Largactil?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING LARGACTIL?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Largactil.
•
If you become pregnant while taking Largactil, tell your doctor or
pharmacist.
•
You should avoid very cold or very hot environments.
•
You should avoid exposure to strong sunlight while you are taking
Largactil.
•
Call your doctor straight away if you notice

Summary of Product characteristics

largactil-ccdsv5-piv14-12may22
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-ccdsv5-piv14-12may22
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