EXELON PATCH 10

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

RIVASTIGMINE

Available from:

NOVARTIS ISRAEL LTD

ATC code:

N06DA03

Pharmaceutical form:

PATCHES

Composition:

RIVASTIGMINE 9.5 MG/DAY

Administration route:

TRANSDERMAL

Prescription type:

Required

Manufactured by:

LTS LOHMANN THERAPIE SYSTEME AG, GERMANY

Therapeutic area:

RIVASTIGMINE

Therapeutic indications:

Treatment of mild to moderate dementia of the Alzheimer's type.

Authorization date:

2023-11-30

Patient Information leaflet

.ةقصلل قصلالا بناجلا يطغت ةيقاو ةقبط
كلانه
●
سملت لاو ةيقاولا ةقبطلا نم دحاو بناج
عزنإ
.كعباصأب ةقصلل قصلالا مسقلا
وأ ايلعلا ةقطنملا ىلع ةقصلل قصلالا
مسقلا عض
●
عارذلا نم يولعلا مسقلا يف ،رهظلا نم
ىلفسلا
.ةيقاولا ةقبطلل يناثلا مسقلا عزنأو
ردصلا ىلع وأ ةيناث 30 ةدمل ةدشب ةقصللا ىلع طغضلا بجي
نلآا
●
نم دكأتلا لجأ نم ديلا ةحار ةدعاسمب
لقلأا ىلع
.يغبني امك فارطلأا قاصتلإ
ملق ةطساوب ةقصللا ىلع عوبسلأا نم مويلا
ةباتك
ً
لاثم كنكمي ،كدعاسي رملأا ناك اذإ
.قيقد ربح
نم .ةديدج ةقصلب اهليدبت دعوم نيح ىلإ
رارمتسإب ناكملا يف ةقصللا ءاقبإ بجي
نكاملأا داجيإ لجأ نم ةديدجلا ةقصللا
قصلل ةفلتخم نكامأ ةبرجت يف بغرت نأ
زئاجلا
.ةقصللاب بايثلا اهيف كتحت لا يتلا
نكاملأاو ةحار رثكلأا
؟ةقصل نوليسكإ عزن بجي فيك
.دلجلا نع اهعزن لجأ نم ةقصللا نم دحاو
فرط ءطببو فطلب بحسلا بجي
ءىفاد ءامب فطلب ةقطنملا بيطرتب مق
،دلجلا ىلع ةقصلا ةدام راثآ ءاقب لاح يف
لئاوس وأ لوحكلا لامعتسإ زوجي لا
.اهتلازلإ لافطلأا تيز لمعتسإ وأ فيطل
نوباصو
.)ىرخأ تابيذم وأ رفاظلأا ءلاط ليزم(
ةبيذم ىرخأ
وأ نينيعلا عم سامتلا ةلاح يف .ةقصللا
عزن دعب ءاملاو نوباصلاب نيديلا لسغ بجي
نم ريثكلاب
ً
اروف نينيعلا فطش بجي ،ةقصللاب جلاعلا
دعب نينيعلا يف رارمحإ رهظ اذإ
.ضارعلأا هذهل
ً
لاح دجت مل ا

Summary of Product characteristics

EXE APL JUL23 V11
Page 1 of 14
EU SmPC Apr.2023
1.
NAME OF THE MEDICINAL PRODUCT
Exelon patch 5
Exelon patch 10
Exelon patch 15
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Exelon patch 5
Each transdermal patch releases 4.6 mg of rivastigmine per 24 hours.
Each transdermal patch of 5 cm
2
contains 9 mg of rivastigmine.
Exelon patch 10
Each transdermal patch releases 9.5 mg of rivastigmine per 24 hours.
Each transdermal patch of 10 cm
2
contains 18 mg of rivastigmine.
Exelon patch 15
Each transdermal patch releases 13.3 mg of rivastigmine per 24 hours.
Each transdermal patch of 15 cm
2
contains 27 mg of rivastigmine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Transdermal patch.
Exelon patch 5
Each transdermal patch is a thin, matrix-type transdermal patch
consisting of three layers. The outside of
the backing layer is beige and labelled with “
Exelon patch 5
”, and “AMCX”.
Exelon patch 10
Each transdermal patch is a thin, matrix-type transdermal patch
consisting of three layers. The outside of
the backing layer is beige and labelled with “Exelon
patch 10
”, and “BHDI”.
Exelon patch 15
Each transdermal patch is a thin, matrix-type transdermal patch
consisting of three layers. The outside of
the backing layer is beige and labelled with “Exelon
patch 15
”, and “CNFU”.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Exelon patch 5, Exelon patch 10:
Treatment of mild to moderate dementia of the Alzheimer's type.
Exelon patch 15:
Exelon Patch is indicated for the treatment of dementia of the
Alzheimr’s type (AD).
Efficacy has been demonstrated in patients with mild, moderate and
sever
e Alzheimer’s disease
.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated and supervised by a physician
experienced in the diagnosis and treatment
of Alzheimer’s dementia. Diagnosis should be made according to
current guidelines. Similar to any
treatment initiated in patients with dementia, therapy with
rivastigmine should only be started if a
caregiver is