Stemetil 5mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Prochlorperazine maleate

Available from:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC code:

N05AB; N05AB04

INN (International Name):

Prochlorperazine maleate

Dosage:

5 milligram(s)

Pharmaceutical form:

Tablet

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 5 MG TABLETS
_Prochlorperazine Maleate _
Is this leaflet hard to see or read? Phone [phone] for help
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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
WHAT IS IN THIS LEAFLET:
1.
What Stemetil Tablets are and what they are used for
2.
What you need to know before you take Stemetil Tablets
3.
How to take Stemetil Tablets
4.
Possible side effects
5.
How to store Stemetil Tablets
6.
Contents of the pack and other information
1.
WHAT STEMETIL TABLETS ARE AND WHAT THEY ARE USED FOR
Stemetil Tablets contain a medicine called prochlorperazine maleate.
This belongs to a group of
medicines called ‘phenothiazine antipsychotics’. It works by
blocking the effects of a chemical in the
brain.
Stemetil Tablets 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 TABLETS
DO NOT TAKE THIS MEDICINE AND TELL YOUR DOCTOR IF:
•
You are allergic (hypersensitive) to prochlorperazine maleate,
phenothiazine medicines such
as chlorpromazine or any of the other ingredients of Stemetil Tablets
(listed in Section 6
below). Signs of an allergic reaction include: a rash, swallowing or
breathing problems,
swelling of your

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 5mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg of Prochlorperazine Maleate.
Excipients: Also includes lactose monohydrate, 67 mg per tablet.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Off-white to pale cream coloured circular tablets approximately 6.4 mm
in diameter and 3.2 mm thick: not mottled or speckled.
Smooth almost biconvex surfaces, one face impressed ‘STEMETIL’
around a centrally impressed 5, reverse face plain.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Stemetil tablets 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
The route of administration is oral
_Recommended Dosage:_
_ _
Adults:
For the management of Meniere's syndrome, nausea and vomiting:
The usual total daily dosage is 10-40mg in divided doses
In schizophrenia and other psychotic disorders:
The usual total daily dosage is 75-100mg 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 the prochlorperazine
or other Phenothiaz