FRISIUM 10 TABLET 10 mg

Страна: Сингапур

Язык: английский

Источник: HSA (Health Sciences Authority)

Активный ингредиент:

CLOBAZAM

Доступна с:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

код АТС:

N05BA09

дозировка:

10 mg

Фармацевтическая форма:

TABLET

состав:

CLOBAZAM 10 mg

Администрация маршрут:

ORAL

Тип рецепта:

Prescription Only

Производитель:

Opella Healthcare International SAS

Статус Авторизация:

ACTIVE

Дата Авторизация:

1988-06-01

тонкая брошюра

FRISIUM
® 10MG
_Clobazam _
[sanofi logo]
Tablets
COMPOSITION
Each tablet contains 10mg clobazam as active ingredient.
Excipients: Lactose, maize starch, colloidal anhydrous silica, talc,
magnesium stearate.
INDICATIONS
Acute
and
chronic
anxiety
states,
which
may
produce
the
following
symptoms
in
particular: Anxiety, tension, restlessness, excitement, irritability,
sleep disturbances from
emotional causes, psychovegetative and psychosomatic disorders (for
example, in the
cardiovascular or gastro-intestinal area), and emotional instability.
In cases of psychovegetative and psychosomatic disorders, the doctor
should investigate
the possibility of an organic cause.
Before treatment of anxiety states associated with emotional
instability, it must first be
determined whether the patient suffers from a depressive disorder
requiring adjuvant of
different treatment.
-
As adjunctive therapy in patients with epilepsy who are not adequately
stabilized with
their anticonvulsant mono-therapy.
CONTRAINDICATIONS
Frisium10 must not be used

In patients with hypersensitivity to clobazam or any of the
excipients, or with any
history of drug dependence.

In patients with myasthenia gravis (risk of aggrevation of muscle
weakness)

In patients with severe respiratory insufficiency (risk of
deterioration)

In patients with sleep apnoea syndrome (risk of deterioration)

In
patients
with
severe
impairment
of
liver
function
(risk
of
precipitating
encephalopathy)

In breast-feeding women

During the first trimester of pregnancy(for use during second and
third trimester, see
section Fertility, Pregnancy and Lactation)

Benzodiazepines must not be given to children without careful
assessment of the need
for their use.
Children between the ages of 6 months and 3 years should not normally
be given
Frisium10; however, in exceptional cases, where there are compelling
indications, it can
be used for anticonvulsant treatment.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
In patients with schizophrenia or other psychoses, benzod

Характеристики продукта

SG/FRI10/1022/CCDSv8.1
1. NAME OF THE MEDICINAL PRODUCTS
FRISIUM
® 10MG
_Clobazam _
Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg clobazam. Contains lactose (see section
4.4).
For the full list of excipients, see section 6.1.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Acute and chronic anxiety states, which may produce the following
symptoms in particular:
Anxiety, tension, restlessness, excitement, irritability, sleep
disturbances from emotional
causes, psychovegetative and psychosomatic disorders (for example, in
the cardiovascular
or gastro-intestinal area), and emotional instability.
In cases of psychovegetative and psychosomatic disorders, the doctor
should investigate
the possibility of an organic cause.
Before treatment of anxiety states associated with emotional
instability, it must first be
determined whether the patient suffers from a depressive disorder
requiring adjuvant of
different treatment.
-
As adjunctive therapy in patients with epilepsy who are not adequately
stabilized with
their anticonvulsant mono-therapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
DOSAGE
Pharmaceutical presentation, dosage, and duration of treatment must be
adjusted to the
individual clinical response, the indication, and the severity of the
condition. Due regard
must be paid to the possibility of interference with alertness and
reaction time. The
fundamental principle is to keep the dose as low as possible.
When treatment with Frisium10 is to be discontinued after prolonged
administration, the
dosage should normally be tapered off over a period of time.
_ _
_Treatment of anxiety states:_
Adults and adolescents over 15 years of age: The initial dose is
usually 20mg Frisium10
daily. If necessary, the daily dose may be increase to 30mg.
Generally, it is recommended
that a total daily dose of 30 mg is not exceeded.
Elderly: Increased responsiveness and higher susceptibility to adverse
effects may be
present in elderly patients and require low initial doses and gradual
dose increments u