Trifluoperazine 5mg tablets

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv bestanddel:

Trifluoperazine hydrochloride

Tilgængelig fra:

Dr Reddy's Laboratories (UK) Ltd

ATC-kode:

N05AB06

INN (International Name):

Trifluoperazine hydrochloride

Dosering:

5mg

Lægemiddelform:

Oral tablet

Indgivelsesvej:

Oral

Klasse:

No Controlled Drug Status

Recept type:

Valid as a prescribable product

Produkt oversigt:

BNF: 04020100

Indlægsseddel

PATIENT LEAFLET: INFORMATION FOR THE USER
TRIFLUOPERAZINE 1MG AND 5MG TABLETS
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 tablets are and what are they 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 ARE THEY USED FOR
These tablets contain the active ingredient trifluoperazine, they are
available in two strengths, 1 and 5
milligrammes (mg). Your doctor will have prescribed one strength of
tablet for you. The strength
will be shown on your tablet pack.
This medicine belongs to a class of drugs called phenothiazine
tranquillisers. You may also hear it
referred to as a neuroleptic drug. It influences the activity of
certain brain cells by decreasing the
effect of dopamine, a natural chemical in the brain.
At a low dosage ‘Trifluoperazine’ is used to manage anxiety,
depression caused by anxiety and
agitation. It is used in this way for short periods of time.
‘Trifluoperazine’ may also be used to treat
nausea (feeling sick) and vomiting (being sick).
At high doses ‘Trifluoperazine’ is used to treat schizophrenia and
related conditions. It can also be
used for short periods of time to treat very bad agitation or
dangerous behaviour.
2.WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRIFLUOPERAZINE TABLETS
DO NOT TAKE TRIFLUOPERAZINE TABLETS:
• If

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Trifluoperazine Tablets 5mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Trifluoperazine hydrochloride 6 mg BP (equivalent to trifluoperazine
5mg)
Excipient(s) with known effect – Sucrose and Lactose
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
Blue sugar coated tablet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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.
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:_ _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: 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.
When satisfactory control has been achieved, dosage should be reduced
gradually
until an effective maintenance level has been established.
As will all major tranquillisers clinical improvement may not be
evident for several
weeks after starting treatment and there may also be a delay before
recurrence of
symptoms after stopping treatment. Gradual withdrawal from high dosage
treatments
is advisable.
_ _
ELDERLY
Reduce starting dose in elderly or frail patie