Stelazine 1mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Trifluoperazine

Available from:

Mercury Pharmaceuticals Ltd

ATC code:

N05AB; N05AB06

INN (International Name):

Trifluoperazine

Dosage:

1 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Phenothiazines with piperazine structure; trifluoperazine

Authorization status:

Not marketed

Authorization date:

1977-04-01

Patient Information leaflet

PATIENT INFORMATION LEAFLET
STELAZINE
® 1MG AND 5MG FILM-COATED TABLETS
TRIFLUOPERAZINE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
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 become serious, or if you notice
any side effects not listed in this leaflet, please tell your doctor
or pharmacist.
The product is known by the name above but will be referred to as
Stelazine Tablets throughout the rest
of this leaflet.
IN THIS LEAFLET:
1. What Stelazine Tablets are and what they are used for
2. Before you take Stelazine Tablets
3. How to take Stelazine Tablets
4. Possible side effects
5. How to store Stelazine Tablets
6. Further information
1. WHAT STELAZINE TABLETS ARE AND WHAT THEY ARE USED FOR
Stelazine Tablets contain the active ingredient trifluoperazine
hydrochloride, which belongs to a class of
drugs called phenothiazine tranquilisers. It influences the activity
of certain brain cells by decreasing the
effect of dopamine, a natural chemical in the brain.
• At a low dose, Stelazine Tablets are used to manage anxiety and
depression. It is used in this way for
short periods of time
• Stelazine tablets may also be used to treat nausea (feeling sick)
and vomiting (being sick)
• At high doses, Stelazine Tablets are used to treat and prevent
relapses of schizophrenia (a serious mental
illness) and related conditions.
2. BEFORE YOU TAKE STELAZINE TABLETS
DO NOT TAKE STELAZINE TABLETS IF:
• You know that you are allergic to trifluoperazine hydrochloride or
any of the other ingredients of
Stelazine Tablets (see section 6 of this leaflet)
• You are suffering from liver problems, blood disorders, inability
of the heart to maintain adequate
circulation causing breathlessness and swelling of the ankles
• You have previously had to stop taking other medicin

Summary of Product characteristics

Health Products Regulatory Authority
27 February 2019
CRN008X3J
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Stelazine 1mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains trifluoperazine hydrochloride equivalent to 1 mg
of trifluoperazine.
Excipients: Each tablet contains 8mg sucrose
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Blue aqueous coated tablets having "FW231" embossed on one face.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Low dosage: ‘Stelazine’ is indicated as an adjunct in the
short-term management of anxiety states. It is also indicated in the
symptomatic treatment of nausea and vomiting.
High dosage: Treatment of symptoms and prevention of relapse in
schizophrenia and in other psychoses, especially of the
paranoid type, but not in depressive psychoses.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Oral Administration:
Adults:
Low Dosage Requirements
2-4 mg a day, given in divided doses, according to the severity of the
patient’s condition. If necessary, dosage may be
increased to 6 mg a day, but above this level extrapyramidal symptoms
are more likely to occur in some patients.
High Dosage Requirements
The recommended starting dose for physically fit adults is 5 mg twice
a day; after a week this may be increased to 15 mg a
day. If necessary, further increases of 5 mg may be made at three-day
intervals, but not more often to a maximum of 30 mg a
day. When satisfactory control has been achieved, dosage should be
reduced gradually until an effective maintenance level
has been established.
As with all major tranquillisers clinical improvement may not be
evident for several weeks after starting treatment, and there
may also be delay before recurrence of symptoms after stopping
treatment. Gradual withdrawal from high-dosage treatment
is advisable.
Children: Aged 6 to 12 years:
Low Dosage Requirements
The usual total daily dosage is 1 to 4 mg in divided doses
Health Products Regulat