Trifluoperazine 5mg tablets

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Trifluoperazine hydrochloride

Dostupné z:

Ennogen Pharma Ltd

ATC kód:

N05AB06

INN (Medzinárodný Name):

Trifluoperazine hydrochloride

Dávkovanie:

5mg

Forma lieku:

Oral tablet

Spôsob podávania:

Oral

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 04020100

Príbalový leták

Artwork No.
Customer
Description
Market
Language
Size
Min. Font Size
Page No.
Version No.
Date
Software
080414/4
Ennogen
Trifluoperazine Leaflet
UK
English
160 x 420 mm
9 pt
1 of 1
14
11-11-20
Coreldraw 12
Packaging Development
Quality Assurance (QA)
Quality Control (QC)
Production
e-mail : [e-mail]
Ph : [phone]
Colours Used
Black
Keyline
Trifluoperazine Tablets 1mg and 5mg
PACKAGE LEAFLET: INFORMATION FOR THE USER
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, pharmacist or nurse.
!
This medicine has been prescribed for you
only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same
as yours.
!
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section
4.
WHAT IS IN THIS LEAFLET
1.
What Trifluoperazine Tablets are and what they
are used for
2.
What you need to know before you take
Trifluoperazine Tablets
3.
How to take Trifluoperazine Tablets
4.
Possible side effects
5.
How to store Trifluoperazine Tablets
6.
Contents of the pack and other information
1. WHAT TRIFLUOPERAZINE TABLETS ARE
AND WHAT THEY ARE USED FOR
Trifluoperazine Tablets contain the active
substance trifluoperazine as 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.
Trifluoperazine Tablets in low dosage are useful
for:
!
Short term treatment of anxiety states,
depression associated with anxiety and
agitation usually in combination with other
treatments
!
Treatment of nausea and vomiting.
Trifluoperazine Tablets in high dosage are useful
for:
!
Treatment and prevention of recurrence in
schizophrenia and other psychiatric illnesses
although not usually

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Trifluoperazine Tablets BP 5mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains trifluoperazine hydrochloride BP 6mg equivalent
to
trifluoperazine 5mg.
Excipients with known effect
Lactose
Sucrose
Sodium benzoate (E211)
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Coated tablets for oral administration.
4.1
THERAPEUTIC INDICATIONS
In low dosage, trifluoperazine is indicated as an adjunct in the
short-term
management of anxiety states, depressive symptoms secondary to
anxiety,
and agitation. It is also indicated in the symptomatic treatment of
nausea and
vomiting.
In high dosage, trifluoperazine is indicated for the treatment of
symptoms
and prevention of relapse in schizophrenia and in other psychoses,
especially of the paranoid type, but not in depressive psychoses. It
may
also be used as an adjunct in the short-term management of severe
psychomotor agitation and of dangerously impulsive behaviour in, for
example, mental subnormality.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ADULTS: _Low dosage:_ This tablet strength is not suitable for the
initiation of this
dosage regime which starts with 2mg to 4mg daily in divided doses
according to the
severity of the patient’s condition. If necessary, dosage may be
increased to 6mg
daily, but above this level extrapyramidal symptoms are more likely to
occur in
some patients.
_High dosage:_ The recommended starting dose for physically fit adults
is 5mg twice
daily; after a week this may be increased to 15mg daily. If necessary,
further
increases of 5mg may be made at 3-day intervals, but not more often.
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