ORAP FORTE

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

PIMOZIDE

متاح من:

J-C HEALTH CARE LTD

ATC رمز:

N05AG02

الشكل الصيدلاني:

TABLETS

تركيب:

PIMOZIDE 4 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

LUSOMEDICAMENTA - SOCIEDADE TECNICA FARMACEUTICA, PORTUGAL

المجموعة العلاجية:

PIMOZIDE

المجال العلاجي:

PIMOZIDE

الخصائص العلاجية:

Neuroleptic.

تاريخ الترخيص:

2012-07-31

نشرة المعلومات

PATIENT PACKAGE INSERT IN ACCORDANCE WITH
THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986
The dispensing of this medicine requires a doctor's prescription
Read this package insert carefully in its entirety before using this
medicine
The format of this leaflet was determined by the Ministry of Health
and its content has been checked and approved
ORAP FORTE
Tablets
COMPOSITION:
Each tablet contains: Pimozide 4 mg
Inactive ingredients:
Calcium hydrogen phosphate dihydrate, Maize starch, Microcrystalline
cellulose, Talc, Polyvidone K30, Cottonseed oil hydrogenated, Yellow
ferric oxide (E172), Indigotindisulphonate (E132-Aluminium Lake).
THERAPEUTIC GROUP:
An antipsychotic drug of the diphenylbutylpiperidine class.
THERAPEUTIC ACTIVITY:
A neuroleptic preparation.
WHEN SHOULD THE PREPARATION NOT BE USED?
Do not breastfeed while using this medicine.
Do not take Orap Forte if you suffer from a very slow heart rate.
Do not use this medicine if there is a known sensitivity to any of its
ingredients.
Do not use this medicine if you suffer from depression.
Do not use this medicine if you are suffering from Parkinson’s
disease.
Do not use this medicine if you experience drowsiness or slowness
resulting from an illness, from taking medications or from drinking
alcohol.
Do not use this medicine if you have heart problems, particularly
heart
rate disorders, irregular electrical activity of the heart (sometimes
called
“QT segment prolongation”), if you have a family history of
electrical
activity disorders of the heart or if you are using medicines that can
change the electrical activity of the heart.
Do not use this medicine if you have lower than usual mineral
(electrolyte)
levels in your blood. Your doctor will advise you in this matter.
Do not take Orap Forte together with:
• certain azole antifungals (for instance: ketoconazole,
itraconazole,
miconazole or fluconazole) or with certain antibiotics from the
macrolide group, such as: erythromycin, azithromycin, clarithromycin
or troleandomycin. Use of medicines from

خصائص المنتج

ORAP FORTE PI JUL2012
ע עבקנ הז ןולע טמרופ
"
רשואו קדבנ ונכותו תואירבה דרשמ י
_ _
ינויב
2011
1.
TRADE NAME OF THE MEDICINAL PRODUCT
ORAP FORTE
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
4 mg pimozide per tablet.
For excipients, see Section 6.1
3.
PHARMACEUTICAL FORM
Tablets.
Tablet appearance:
Green, circular, biconvex tablet with the inscription “JANSSEN” on
one side and cross-scored on the other side.
4.
CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Orap is mainly indicated in chronic psychoses, responsive to the
specific
antipsychotic effects of neuroleptics and as basic medication for
long-term
antipsychotic maintenance therapy aimed at promoting, restoring, or
maintaining optimum social integration.
Orap is also indicated as an initial therapy in outpatients and in
newly or re-
admitted patients, provided psychomotor agitation, aggressiveness, or
severe
anxiety do not constitute the predominant symptoms.
Orap is, moreover, indicated in patients with borderline psychosis,
causing
unadapted social behavior and requiring improvement or stabilization
of their
social integration.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
A single morning dose is recommended for all patients.
Since individual response to anti-psychotic drugs is variable, dosage
should
be individually determined and is best initiated and titrated under
close clinical
supervision.
_ Adults _
ORAP FORTE PI JUL2012
The initial recommended dose in patients with chronic schizophrenia is
2 to 4
mg once daily, with weekly increments of 2 to 4 mg until a
satisfactory level
of therapeutic effect is attained or excessive adverse effects occur.
The
average maintenance dose is 6 mg daily with the usual range of 2 to 12
mg
per day. The maximum daily dose is 20 mg.
The patients should be reviewed regularly to ensure the minimum
effective
dose is being used.
_Elderly patients _
The maintenance dose is the same as in adults but it is recommended to
start
with half of the adult starting dose.
_Children _
The