EXELON CAPSULE 1.5 mg

البلد: سنغافورة

اللغة: الإنجليزية

المصدر: HSA (Health Sciences Authority)

العنصر النشط:

RIVASTIGMINE HYDROGEN TARTRATE EQV RIVASTIGMINE

متاح من:

NOVARTIS (SINGAPORE) PTE LTD

ATC رمز:

N06DA03

جرعة:

1.5 mg

الشكل الصيدلاني:

CAPSULE

تركيب:

RIVASTIGMINE HYDROGEN TARTRATE EQV RIVASTIGMINE 1.5 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

Prescription Only

المصنعة من قبل:

Siegfried Barbera S.L.

الوضع إذن:

ACTIVE

تاريخ الترخيص:

1998-09-24

نشرة المعلومات

EXELON


Hard capsules. 
Brain-selective cholinesterase inhibitor. 
DESCRIPTION AND COMPOSITION  
PHARMACEUTICAL FORM 
Hard capsules  
ACTIVE SUBSTANCE 
Exelon  hard  capsules  contain  1.5,  3.0,  4.5  or  6.0  mg  rivastigmine  (as  the  hydrogen  tartrate 
salt).  
Certain dosage strengths may not be available
in all countries. 
EXCIPIENTS 
1.5 MG CAPSULES 
Gelatin;  iron  oxide,  yellow  (E  172);  magnesium  stearate;  methylhydroxypropylcellulose; 
microcrystalline  cellulose;  printing  ink,  based  on  iron  oxide,  red  (E  172);  silica,  colloidal 
anhydrous; titanium dioxide (E 171). 
3.0 AND 6.0 MG CAPSULES 
Gelatin;  iron  oxide,  red  (E  172);  iron  oxide,  yellow  (E  172);  magnesium  stearate; 
methylhydroxypropylcellulose;  microcrystalline  cellulose;  printing  ink,  based  on  iron  oxide, 
red (E 172); silica, colloidal
anhydrous; titanium dioxide (E 171). 
4.5 MG CAPSULES 
Gelatin;  iron  oxide,  red  (E  172);  iron  oxide,  yellow  (E  172);  magnesium  stearate; 
methylhydroxypropylcellulose;  microcrystalline  cellulose;  printing  ink,  based  on  titanium 
dioxide (E 171); silica, colloidal anhydrous; titanium dioxide (E
171). 
Pharmaceutical formulations may vary between countries. 
INDICATIONS 
Treatment  of  patients  with  mild  to  moderately  severe  dementia  of  the  Alzheimer  type,  also 
termed probable Alzheimer’s Disease or Alzheimer’s Disease. 
Treatment  of patients  with mild to moderately severe dementia associated with Parkinson’s 
disease. 
Novartis 

Page 2 
Country Specific Package Leaflet 
27 May 2014 
Exelon hard capsules 

DOSAGE AND ADMINISTRATION 
ADMINISTRATION 
Exelon hard capsules should be administered twice a day,
with morning and evening meals. 

خصائص المنتج

Exelon Capsule Dec 2022.SIN
Page 1 of 18
EXELON

Hard capsules.
Brain-selective cholinesterase inhibitor.
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM
Hard capsules
ACTIVE SUBSTANCE
Each Exelon hard gelatin capsule contains rivastigmine hydrogen
tartrate corresponding to
1.5, 3.0, 4.5 or 6.0 mg rivastigmine base.
Certain dosage strengths may not be available in all countries.
EXCIPIENTS
CAPSULES
CAPSULE
CONTENT:
microcrystalline
cellulose;
magnesium
stearate;
hypromellose;
silica,
colloidal anhydrous.
CAPSULES SHELL:
gelatin; titanium dioxide (E 171); iron oxide, yellow (E 172);
printing ink,
based on iron oxide, red (E 172) and shellac.
Pharmaceutical formulations may vary between countries.
INDICATIONS
Treatment of patients with mild to moderately severe dementia of the
Alzheimer type, also
termed probable Alzheimer’s Disease or Alzheimer’s Disease.
Treatment of patients with mild to moderately severe dementia
associated with Parkinson’s
disease.
DOSAGE REGIMEN AND ADMINISTRATION
ADMINISTRATION
Exelon Capsule Dec 2022.SIN
Page 2 of 18
DOSAGE REGIMEN
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 of two
weeks of treatment, the dose may be increased to 3 mg twice a day.
Subsequent increases to
4.5 mg and then 6 mg twice a day should also be based on good
tolerability of the current
dose and may be considered after a minimum of two weeks’ treatment
at that dose level.
If adverse effects (e.g., nausea, vomiting, abdominal pain, or loss of
appetite) or weight
decrease are observed during treatment, these may respond to omitting
one or more doses. If
adverse effects persist, the daily dose should be reduced to the
previous well-tolerated dose.
MAINTENANCE DOSE
1.5 mg to 6 mg twice a day; to achieve maximum therapeutic benefit
patients should be
maintained on their highest well-tolerated dose.
RECOMMENDED MAXIMUM DAILY DOSE
6 mg twice a day.
RE-INITIATION OF THERAPY
The incidence and severity of adverse events are ge