Stelazine 5mg tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

trifluoperazine hydrochloride

Available from:

Amdipharm Mercury Australia Pty Ltd

Class:

Medicine Registered

Authorization status:

Registered

Patient Information leaflet

Stelazine (trifluoperazine hydrochloride)
Page 1 of 10
CONSUMER MEDICINE INFORMATION
STELAZINE
®
_TRIFLUOPERAZINE HYDROCHLORIDE _
_ _
Film-coated tablets 1 mg, 2 mg and 5 mg
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start taking Stelazine.
This leaflet answers some common questions about Stelazine. It does
not contain all the
available information.
Reading this leaflet 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
Stelazine against the benefits this medicine is expected to 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 want to read it again.
WHAT STELAZINE IS USED FOR
Stelazine contains trifluoperazine hydrochloride as the active
ingredient. It belongs to a
group
of
medicines
called
phenothiazine
neuroleptics.
It
helps
to
correct
chemical
imbalances in the brain, which may cause mental illness. These
chemicals may also affect
the parts of the brain which control nausea and vomiting.
Stelazine is used to treat mental illnesses with disturbances in
thinking, feelings and
behaviour. It may also be used to treat nausea and vomiting, or used
short term in patients
with severe anxiety, tension and agitation.
Your doctor may have prescribed this medicine for another reason.
ASK YOUR DOCTOR IF YOU HAVE QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED
FOR YOU.
Stelazine is available only with a doctor's prescription.
Stelazine is not addictive.
Stelazine (trifluoperazine hydrochloride)
Page 2 of 10
BEFORE YOU TAKE STELAZINE
Stelazine is not suitable for everyone.
_WHEN YOU MUST NOT TAKE IT _
STELAZINE MUST NOT BE GIVEN TO ANYONE WHO HAS REDUCED CONSCIOUSNESS
DUE TO
MEDICATION, IS UNCONSCIOUS OR IN A COMA.
DO NOT TAKE STELAZINE IF YOU HAVE AN ALLERGY TO IT OR TO:

any other medicine containing trifluoperazine

any of the ingredients listed at the end of this leaflet

other similar medicines kn

Summary of Product characteristics

1
PRODUCT INFORMATION
STELAZINE
®
(TRIFLUOPERAZINE)
NAME OF THE MEDICINE
Trifluoperazine hydrochloride
Molecular formula: C
21
H
24
F
3
N
3
S.2HCl
MW: 480.4
Chemical structure:
.2HCl
CAS Registry Number: 440-17-5
DESCRIPTION
Trifluoperazine is a white to pale yellow, crystalline powder,
hygroscopic, freely soluble in water,
soluble in alcohol, practically insoluble in ether, which melts at
approx. 242°C, with decomposition.
Trifluoperazine is a phenothiazine tranquilliser with potent
antipsychotic, anxiolytic and antiemetic
activity.
Stelazine tablets 1 mg, 2 mg and 5 mg contains excipients: calcium
sulfate, sucrose, maize starch,
gelatin, purified talc, stearic acid, purified water and Opadry
OY-S-4492.
Stelazine capsules contain excipients: gelatin, maize starch, purified
talc, kaolin, sucrose, titanium
dioxide, microcrystalline wax, glyceryl distearate, quinoline yellow,
indigo carmine, docusate
sodium, shellac and iron oxide black.
Stelazine Liquid Forte contains excipients: sodium benzoate, saccharin
sodium, sodium chloride,
sodium citrate, citric acid monohydrate, glycerol, sorbitol, purified
water, sunset yellow FCF, Natural
Soluble Orange Flavour, Sweet No 1 07-2241 and 65359 Quassia Q5
Soluble Essence.
PHARMACOLOGY
Antagonism of dopamine-mediated synaptic neurotransmission is an
important action of neuroleptic
drugs including trifluoperazine and is believed to contribute to their
antipsychotic action. The
2
antidopaminergic effects are also considered to be responsible for the
diverse extrapyramidal
manifestations.
INDICATIONS
CHRONIC THERAPY
In higher doses for the management of psychotic disorders, such as
acute and chronic schizophrenia,
psychosis due to organic brain damage, toxic psychosis, manic
depressive psychosis, senile psychosis
and psychosis associated with mental deficiency.
SHORT TERM THERAPY
For the relief of delusions, hallucinations and confusion, and for the
control of tremulousness and
aggressive behaviour in alcoholic patients.
In low doses to control excessive anxiety, tension and