Stelazine 5mg Tablets/Trifluoperazine 5mg Tablets

Страна: Мальта

Язык: английский

Источник: Medicines Authority

Активный ингредиент:

TRIFLUOPERAZINE HYDROCHLORIDE

Доступна с:

Mercury Pharmaceuticals Limited Capital House, 85 King William Street, London EC4N 7BL, United Kingdom

код АТС:

N05AB06

ИНН (Международная Имя):

TRIFLUOPERAZINE HYDROCHLORIDE 5 mg

Фармацевтическая форма:

TABLET

состав:

TRIFLUOPERAZINE HYDROCHLORIDE 5 mg

Тип рецепта:

POM

Терапевтические области:

PSYCHOLEPTICS

Статус Авторизация:

Withdrawn

Дата Авторизация:

2006-03-27

тонкая брошюра

PATIENT INFORMATION LEAFLET
STELAZINE® 1MG AND 5MG TABLETS
TRIFLUOPERAZINE
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.
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. 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.
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,
inability

Характеристики продукта

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
Excipient with known effect: Sucrose
For the full list of excipients, see section 6.1.
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
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 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.
_Paediatric population _
_ _
_Low dosa