Trifluoperazine 1mg tablets

Land: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Trifluoperazine hydrochloride

Fáanlegur frá:

Kent Pharma (UK) Ltd

ATC númer:

N05AB06

INN (Alþjóðlegt nafn):

Trifluoperazine hydrochloride

Skammtar:

1mg

Lyfjaform:

Oral tablet

Stjórnsýsluleið:

Oral

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 04020100

Upplýsingar fylgiseðill

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TRIFLUOPERAZINE 1MG AND 5MG TABLETS
(Trifluoperazine Hydrochloride)
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 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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Trifluoperazine is and what it is used for
2.
What you need to know before you take Trifluoperazine
3.
How to take Trifluoperazine
4.
Possible side effects
5.
How to store Trifluoperazine
6.
Contents of the pack and other information
1 WHAT TRIFLUOPERAZINE IS AND WHAT IT IS USED FOR
Trifluoperazine belongs to a group of medicines called phenothiazines.
They act on the central
nervous system and produce a calming effect, relieving anxiety and
tension.
Trifluoperazine is used for the following:
Low dose
•
For short term treatment of anxiety and agitation
•
To treat feeling or being sick (nausea and vomiting)
High dose
•
To treat and prevent relapse of mental disorders such as schizophrenia
•
To treat severe agitation, or mental disorders where dangerous or
impulsive behaviour may be
likely
2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRIFLUOPERAZINE
DO NOT TAKE TRIFLUOPERAZINE IF:
•
You are allergic (hypersensitive) to Trifluoperazine, other
phenothiazines or any of the other
ingredients of this medicine (listed in Section 6)
•
You have loss of consciousness (comatose state)
•
You have slower breathing or heartbeat, loss of motor skills, unclear
speech, thinking or vision
(CNS depression)
•
You have an untreated growth on your adrenal gland (phaeochromocytoma)
•
You have blood problems
•
You have liver problems
•
Y

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Trifluoperazine Tablets BP 1mg.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains trifluoperazine hydrochloride BP 1.2mg equivalent
to trifluoperazine 1mg.
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:_ 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
from high-
dosage treatment is advisable.
ELDERLY: Reduce the starting dose in elderly or fr