Stelazine 1mg tablets

Valsts: Lielbritānija

Valoda: angļu

Klimata pārmaiņas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktīvā sastāvdaļa:

Trifluoperazine hydrochloride

Pieejams no:

Mercury Pharma Group Ltd

ATĶ kods:

N05AB06

SNN (starptautisko nepatentēto nosaukumu):

Trifluoperazine hydrochloride

Deva:

1mg

Zāļu forma:

Oral tablet

Ievadīšanas:

Oral

Klase:

No Controlled Drug Status

Receptes veids:

Valid as a prescribable product

Produktu pārskats:

BNF: 04020100; GTIN: 5021691200130

Lietošanas instrukcija

PATIENT INFORMATION LEAFLET
STELAZINE 1MG AND 5MG 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 medicines for
psyc

Produkta apraksts

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Stelazine 1mg Tablets or Trifluoperazine 1mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Trifluoperazine hydrochloride equivalent to 1mg
of
trifluoperazine
3
PHARMACEUTICAL FORM
Tablet
Blue aqueous film coated tablets marked ‘FW231’.
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 children