RIVASTIGMINE DEXCEL 3 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

RIVASTIGMINE AS HYDROGEN TARTRATE

متاح من:

DEXCEL LTD, ISRAEL

ATC رمز:

N06DA03

الشكل الصيدلاني:

HARD CAPSULE

تركيب:

RIVASTIGMINE AS HYDROGEN TARTRATE 3 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

GENEPHARM S.A., GREECE

المجال العلاجي:

RIVASTIGMINE

الخصائص العلاجية:

Treatment of patients with mild to moderately severe dementia of the Alzheimer type, also termed probable alzheimer's disease or alzheimer's disease.Symptomatic treatment of mild to moderately severe alzheimer's dementia.Symptomatic treatment of mild to moderately severe dementiaassociated with Parkinson's disease.

تاريخ الترخيص:

2019-09-30

نشرة المعلومات

PATIENT PACKAGE INSERT ACCORDING TO PHARMACISTS' REGULATIONS
(PREPARATIONS) – 1986
This medicine can be sold with a physician’s prescription only
RIVASTIGMINE DEXCEL 1.5, 3, 4.5, 6 MG, CAPSULES
Each capsule contains Rivastigmine (as hydrogen tartrate) 1.5, 3, 4.5
or 6 mg respectively.
Inactive ingredients and allergens in the medicine - see section 6
"Additional information".
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This
leaflet contains concise
information about the medicine. If you have any further questions, ask
the doctor or
pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may
harm them, even if you think that their illness is similar.
1.
WHAT IS THE MEDICINE INTENDED FOR?
For the treatment of patients with mild to moderately severe dementia
of the
Alzheimer’s
type, also called Alzheimer’s
disease.
For the symptomatic treatment of mild to moderately severe
Alzheimer’s dementia.
For the symptomatic treatment of mild to moderately severe dementia
associated with
Parkinson’s disease.
Rivastigmine belongs to a group of substances called cholinesterase
inhibitors. In patients
with dementia of Alzheimer’s disease or Parkinson’s disease,
certain nerve cells die in the
brain, resulting in low levels of the neurotransmitter acetylcholine
(a substance that allows
nerve cells to communicate with each other). Rivastigmine works by
blocking the enzymes
that break down acetylcholine: acetylcholinesterase and
butyrylcholinesterase. By blocking
these enzymes, RIVASTIGMINE DEXCEL allows levels of acetylcholine to
be increased in the
brain, and helps to
reduce the symptoms of Alzheimer’s disease and dementia
associated
with Parkinson’s disease.
RIVASTIGMINE DEXCEL is intended for the treatment of adult patients
with mild to moderately
severe Alzheimer’s dementia
, a progressive brain disorder that gradually affects memory,
intellectual ability and behavior. The capsules can also be used to
treat dementia in adult
patients with
Parkin

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Rivastigmine Dexcel 1.5 mg, hard capsules
Rivastigmine Dexcel 3 mg, hard capsules
Rivastigmine Dexcel 4.5 mg, hard capsules
Rivastigmine Dexcel 6 mg, hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Rivastigmine Dexcel 1.5 mg
Each capsule contains rivastigmine (as hydrogen tartrate) 1.5 mg.
Rivastigmine Dexcel 3 mg
Each capsule contains rivastigmine (as hydrogen tartrate) 3 mg.
Rivastigmine Dexcel 4.5 mg
Each capsule contains rivastigmine (as hydrogen tartrate) 4.5 mg.
Rivastigmine Dexcel 6 mg
Each capsule contains rivastigmine (as hydrogen tartrate) 6 mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsules
Rivastigmine Dexcel 1.5 mg
Yellow hard gelatin capsules imprinted with "RIVA 1.5mg" in black on
the body, containing
white to off white granular powder.
Rivastigmine Dexcel 3 mg
Light orange hard gelatin capsules imprinted with "RIVA 3mg" in black
on the body,
containing white to off white granular powder.
Rivastigmine Dexcel 4.5 mg
Caramel hard gelatin capsules imprinted with "RIVA 4.5mg" in black on
the body, containing
white to off white granular powder.
Rivastigmine Dexcel 6 mg
Light orange/caramel hard gelatin capsules imprinted with "RIVA 6mg"
in black on the body,
containing white to off white granular powder
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Treatment of patients with mild to moderately severe dementia of the
Alzheimer type, also
termed probable Alzheimer's disease or Alzheimer's disease.
Symptomatic treatment of mild to moderately severe Alzheimer's
dementia.
Symptomatic treatment of mild to moderately severe dementia associated
with Parkinson's
disease.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Rivastigmine should be administered twice a day, with morning and
evening meals. The
capsules should be swallowed whole.
_ _
_Initial dose _
1.5 mg twice a day.
_ _
_Dose titration _
The starting dose is 1.5 mg twice a day. If this dose is well
tolerated after a minimum o