STEMETIL prochlorperazine mesilate 12.5mg/1mL injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

prochlorperazine mesilate, Quantity: 12.5 mg/mL

Available from:

Sanofi-Aventis Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: water for injections; sodium metabisulfite; sodium chloride; monoethanolamine; sodium sulfite

Administration route:

Intramuscular

Units in package:

10 x 1mL

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Nausea and vomiting due to various causes including migraine; vertigo due to Meniere's Syndrome, labyrinthitis and other causes.

Product summary:

Visual Identification: Clean, bright, not more than very pale yellow solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-10-21

Patient Information leaflet

STEMETIL
®
S
t
e
m
e
t
i
l
®
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 STEMETIL?
Stemetil contains the active ingredient prochlorperazine. Stemetil is
used to treat nausea, vomiting and dizziness due to various
causes, including migraine (severe headache). For more information,
see Section 1. Why am I using Stemetil? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE STEMETIL?
Do not use if you have ever had an allergic reaction to
prochlorperazine 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 Stemetil? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Stemetil 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 STEMETIL?
•
For adults, the usual recommended dose for nausea and vomiting is 1 or
2 tablets two to three times daily. The usual
recommended dose for dizziness is 1 or 2 tablets three to four times
daily. If you are not able to take a tablet a 1mL (12.5mg)
injection is the recommended dose.
More instructions can be found in Section 4. How do I use Stemetil? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING STEMETIL?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Stemetil.
•
Call your doctor straight away if you notice any uncontrolled
movements of the tongue, face, mouth or
jaw, such as puffing of the cheeks, puckering of the mouth or chewing
movements.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine suddenly or reduce the dosage, even if
you are feeling better, without
checking with your doctor first.
•
Do not take any medicines that c

Summary of Product characteristics

ste-ccsiv5-piv20-24jan22
Page 1 of 18
AUSTRALIAN PRODUCT INFORMATION– STEMETIL
®
(PROCHLORPERAZINE MALEATE) TABLETS AND STEMETIL
®
(PROCHLORPERAZINE MESILATE) INJECTION
1
NAME OF THE MEDICINE
Stemetil Tablets – prochlorperazine maleate
Stemetil Solution for injection – prochlorperazine mesilate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Stemetil tablets: each tablet contains 5 mg prochlorperazine maleate.
Excipients of known effect: gluten.
Stemetil injection ampoules: each 1 mL ampoule contains 12.5 mg
prochlorperazine mesilate.
Excipients of known effect: sulfites.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Stemetil 5 mg tablets are off-white to pale cream coloured circular
tablets, not more than
slightly mottled or specked, one side impressed with 'S' and reverse
face plain.
Stemetil 12.5 mg/mL solution for injection is clean, bright and not
more than very pale
yellow.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nausea and vomiting due to various causes including migraine; vertigo
due to Meniere's
syndrome, labyrinthitis and other causes.
ste-ccsiv5-piv20-24jan22
Page 2 of 18
4.2
DOSE AND METHOD OF ADMINISTRATION
NAUSEA AND VOMITING
_ADULTS _
If oral administration is not practical, a deep intramuscular
injection of 1 mL (12.5 mg)
should be used, followed if required, by normal oral medication six
hours later.
Do not use a darkened solution for injection (more than pale yellow).
Dosage should be adjusted to suit the response of the individual,
beginning with lowest
recommended dosage.
Oral:
5 or 10 mg two or three times daily.
Acute:
20 mg at once, followed, if necessary by 10 mg two hours later.
_CHILDREN _
(See Section 4.4 Special warnings and precautions for use, Paediatric
Use).
If it is considered unavoidable to use prochlorperazine for a child,
the dosage is 250
micrograms/kg bodyweight two or three times a day.
Prochlorperazine has been associated with dystonic reactions
particularly after a cumulative
dosage of 500 micrograms/kg. It should