Stemetil

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Prochlorperazine maleate 25mg

Available from:

sanofi-aventis new zealand limited

INN (International Name):

Prochlorperazine maleate 25 mg

Dosage:

25 mg

Pharmaceutical form:

Suppository

Composition:

Active: Prochlorperazine maleate 25mg Excipient: Suppository base E75 Suppository Base W35

Units in package:

Blister pack, PVC/PVDC white opaque torpedo, 5 suppositories

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Industria Chimica Milanese SpA

Therapeutic indications:

Prochlorperazine is used for nausea and vomiting from whatever cause. It may also be used for migraine, schizophrenia (particularly in the chronic stage) and acute mania.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC white opaque torpedo - 5 suppositories - 48 months from date of manufacture stored at or below 25°C

Authorization date:

1999-05-31

Patient Information leaflet

Stemetil®
1
STEMETIL
®
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?
•
The usual recommended dose for nausea and vomiting is a 1 mL (12.5mg)
injection
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 cause drowsiness while you are taking
Stemetil.
DRIVING OR USING
MACHINES
•
Be careful before you drive or use any machines or tools until you
know how Stemetil affects you.
•
Stemetil may cause drowsine

Summary of Product characteristics

ste-ccdsv6-dsv14-23nov22
Page 1
NEW ZEALAND DATA SHEET
1
STEMETIL
Stemetil 12.5mg/mL solution for injection.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Stemetil solution for injection contains 12.5 mg/mL prochlorperazine
mesilate. Each ampoule
contains 1 mL.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Stemetil solution for injection is clean, bright and not more than
very pale yellow.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prochlorperazine is used for nausea and vomiting from whatever cause.
It may also be used for
migraine, schizophrenia (particularly in the chronic stage) and acute
mania.
4.2
DOSE AND METHOD OF ADMINISTRATION
NAUSEA AND VOMITING
Adults
_Intramuscular _
_Treatment of nausea and vomiting _
12.5 mg by deep intramuscular injection, followed by oral
prochlorperazine six hours later, if
necessary.
ste-ccdsv6-dsv14-23nov22
Page 2
SCHIZOPHRENIA AND OTHER PSYCHOTIC DISORDERS
Adults
_Intramuscular _
12.5 mg to 25 mg two or three times a day by deep intramuscular
injection until oral treatment
becomes possible.
Children
Intramuscular prochlorperazine should not be given to children.
Elderly
Prochlorperazine should be used cautiously in this group in psychotic
disorders. Elderly patients
susceptible to centrally-acting medicines hence lower initial dosage
is recommended. There is an
increased risk of drug-induced Parkinsonism in the elderly,
particularly after prolonged use.
Correct initial diagnosis of the disorder is important. Care should
also be taken not to confuse
adverse effects of prochlorperazine, e.g. orthostatic hypotension with
effects due to the primary
disorder.
4.3
CONTRAINDICATION
Circulatory collapse, central nervous system depression (coma or drug
intoxication), previous
history of a hypersensitivity reaction (e.g. jaundice or blood
dyscrasia) to phenothiazines
especially to prochlorperazine, bone marrow depression.
Hypersensitivity to prochlorperazine, other phenothiazines, or to any
of the other ingredients of
Stemetil.
The use of prochlorperazine