Stemetil 12.5 mg/ml solution for injection - 1 ml Ampoule

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PROCHLORPERAZINE MESILATE

Available from:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC code:

N05AB; N05AB04

INN (International Name):

PROCHLORPERAZINE MESILATE

Dosage:

12.5 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Phenothiazines with piperazine structure; prochlorperazine

Authorization status:

Marketed

Authorization date:

1977-04-01

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
STEMETIL® 12.5 MG/ML SOLUTION FOR INJECTION -1 ML AMPOULE
_Prochlorperazine Mesilate _
_ _
IS THIS LEAFLET HARD TO SEE OR READ? PHONE [phone] FOR HELP
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START HAVING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again
•
If you have any further questions, ask your doctor or pharmacist
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if their symptoms are the same as yours
•
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist. This includes any possible side
effects not listed in this
leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Stemetil Injection is and what it is used for
2.
What you need to know before you take Stemetil Injection
3.
How Stemetil Injection is given
4.
Possible side effects
5.
How to store Stemetil Injection
6.
Contents of the pack and other information
1. WHAT STEMETIL INJECTION IS AND WHAT IT IS USED FOR
Stemetil Injection contains a medicine called prochlorperazine
mesilate. This belongs to a group of
medicines called ‘phenothiazine antipsychotics’. It works by
blocking the effects of a chemical in the
brain.
Stemetil Injection can be used to:
•
Treat balance problems or dizziness (vertigo). This includes problems
of the inner ear such as
‘Meniere’s Syndrome’
•
Stop you feeling sick (nausea) or being sick (vomiting). This can be
from any cause including
migraines
•
Treat schizophrenia
•
Treat over-active behaviour or thoughts (mania)
•
Treat anxiety in the short-term, when used in addition to other
medicines
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE STEMETIL INJECTION
DO NOT HAVE THIS MEDICINE AND TELL YOUR DOCTOR IF:
•
You are allergic (hypersensitive) to prochlorperazine mesilate, other
phenothiazine
medicines such as chlorpromazine or any of the other ingredients of

Summary of Product characteristics

Health Products Regulatory Authority
02 November 2023
CRN00CXNS
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Stemetil 12.5 mg/ml solution for injection - 1 ml Ampoule
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml of solution contains 12.5 mg of Prochlorperazine Mesilate.
Excipients: Also includes anhydrous sodium sulfite (E221) 1.0 mg per
1ml; sodium metabisulphite (E223) 0.75 mg per 1ml.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Injection.
A clear, bright solution, almost colourless or not more than very pale
yellow, contained in a printed ring coded ampoule.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Stemetil injections are recommended in the management of acute vertigo
such as is associated with Meniere’s syndrome,
nausea and vomiting, migraine and anxiety states. The course of
treatment should not normally exceed 2 weeks duration.
In the management of phobias, schizophrenia, acute mania, and similar
psychotic reactions.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Intramuscular
_Recommended Dosage:_
_ _
Adults:
For the management of migrane or nausea and vomiting: -
The usual total daily dosage is 12.5 mg followed by oral dosage 6
hours later if required.
In schizophrenia and other psychotic disorders:
The usual total daily dosage is 25-75mg in divided doses.
Elderly:
Stemetil should be used cautiously in the elderly owing to their
susceptibility to drugs acting centrally on the nervous system.
There is an increased risk of drug-induced Parkinsonism in the elderly
particularly after prolonged use therefore a lower initial
dosage is recommended. If required, dosage adjustment is recommended
in this population (see section 4.4). Care should also
be taken not to confuse the adverse effects of Stemetil, e.g.
orthostatic hypotension, with effects due to the underlying
disorder.
Children: Not recommended for use in children.
4.3 CONTRAINDICATIONS
Use in patients with a known hypersensitivity to prochlorperazine or
other Phenoth