PRIDE 400

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

AMISULPRIDE

متاح من:

UNIPHARM LTD, ISRAEL

ATC رمز:

N05AL05

الشكل الصيدلاني:

FILM COATED TABLETS

تركيب:

AMISULPRIDE 400 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

UNIPHARM LTD, ISRAEL

المجال العلاجي:

AMISULPRIDE

الخصائص العلاجية:

Treatment of schizophrenia.

تاريخ الترخيص:

2021-02-28

نشرة المعلومات

119068010
07D22
PATIENT PACKAGE INSERT IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS
)PREPARATIONS( – 1986
The medicine is dispensed with
a doctor’s prescription only
PRIDE 100
PRIDE 400
FILM-COATED TABLETS
THE ACTIVE INGREDIENT AND ITS QUANTITY:
PRIDE 100: each film-coated tablet contains
Amisulpride 100 mg
PRIDE 400: each film-coated tablet contains
Amisulpride 400 mg
INACTIVE AND ALLERGENIC INGREDIENTS IN THE PREPARATION –
see section 6 ”Further information“. See also in section 2
under ”Important information about some of the ingredients
of the medicine“.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING
THE MEDICINE.
Keep this leaflet; you may need to read it again.
This leaflet contains concise information about the
medicine. If you have further questions, refer to the doctor
or pharmacist.
This medicine has been prescribed to treat you. Do not
pass it on to others. It may harm them even if it seems to
you that their medical condition is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
The medicine is intended to treat schizophrenia.
THERAPEUTIC GROUP: PRIDE belongs to the substituted
benzamide group of antipsychotics.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
• You are sensitive )allergic( to the active ingredient or
to any of the additional ingredients contained in the
medicine )see section 6 ”Further information“(. Signs
of an allergic reaction include: rash, swallowing or
breathing problems, swelling of the lips, face, throat or
tongue.
• You have breast cancer or a prolactin-dependent tumor.
• You have a tumor on the adrenal gland )called
pheochromocytoma(.
• You are taking levodopa, a medicine for treatment of
Parkinson’s disease, and dopaminergic agonists such
as bromocriptine, ropinirole )see section 2 under ”Drug
interactions“(.
• You have been diagnosed with a tumor in the pituitary
gland.
• The patient is under 18 years of age.
Do not take the medicine if any of the above conditions
apply to you. If you are not sure, consult with your doc

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Pride 100, 400.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100mg or 400mg of the active substance,
amisulpride.
Each 100mg tablet contains 22.7mg of lactose monohydrate.
Each 400mg tablet contains 90.8mg of lactose monohydrate.
For a full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Film-coated tablet.
Pride 100mg:
Round, biconvex, white film-coated tablet with a break-line on one
side.
Pride 400mg:
Oval, biconvex, white film-coated tablet with a break-line on one
side.
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
Treatment of schizophrenia.
4.2
Posology and method of administration
Usually, if the daily dose is ≤ 400 mg, it is to be administered as
a once-daily dose. If
the daily dose exceeds 400 mg, it is to be administered as two divided
doses.
Predominantly negative episodes:
Doses between 50 mg/day and 300 mg/day are recommended. Doses should
be adjusted
individually. The optimum dosage is about 100 mg/day.
For patients with mixed positive and negative symptoms, doses should
be adjusted to
obtain optimal control of positive symptoms.
Acute psychotic episodes:
_When initiating treatment _
• It is possible to start via the IM route for a few days, at a
maximum dose of 400
mg/day, switching thereafter to oral treatment,
• Oral doses between 400 mg/day and 800 mg/day are recommended. The
maximum
dose should never exceed 1200 mg. Given that there has been no
large-scale safety
assessment of doses higher than 1200 mg/day, these doses should not be
used.
_Thereafter _
• The dosage should then be maintained or adjusted according to the
patient's individual
response.
In all cases, the maintenance treatment should be established
individually with the
minimum effective dose.
Elderly:
The safety of Amisulpride has been examined in a limited number of
elderly patients.
Amisulpiride should be used with particular caution in this patients
population due to the
risk of hypotension or sedation (see section 4.4).