Stelazine 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Trifluoperazine hydrochloride

Available from:

Mercury Pharma Group Ltd

ATC code:

N05AB06

INN (International Name):

Trifluoperazine hydrochloride

Dosage:

5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04020100; GTIN: 5021691200154

Patient Information leaflet

STELAZINE
® 5 MG 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.
The product is known by the name above but will be referred to as
Stelazine Tablets throughout the rest of this leaflet. This medicine
is also
available as 1 mg tablets.
WHAT IS IN THIS LEAFLET:
1. What Stelazine Tablets are and what they are used for
2. What you need to know before you take Stelazine Tablets
3. How to take Stelazine Tablets
4. Possible side effects
5. How to store Stelazine Tablets
6. Contents of the pack and other information
1. AND
1. WHAT STELAZINE TABLETS ARE AND WHAT THEY ARE USED
FOR 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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE STELAZINE
TABLETS
DO NOT TAKE STELAZINE TABLETS:
- if you are allergic to trifluoperazine hydrochloride or any of the
other
ingredients of this medicine (listed in section 6)
- if you are suffering from liver problems, blood disorders,

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Stelazine 5 mg Tablets or Trifluoperazine 5 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Trifluoperazine hydrochloride equivalent to 5mg
of
trifluoperazine
3
PHARMACEUTICAL FORM
Tablet
Blue aqueous film coated tablets marked ‘FW241’.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_ _
_Low dosage: _‘Stelazine’_ _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: _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
DOSAGE:
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 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:_ Low dosage: _For children aged 6-12 years, up to a maximum
of 4
mg a day given in divided doses.
_High dosage: _For child