Saphris Sublingual Tablet 10mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Asenapine maleate 14.06mg eqv asenapine

Available from:

MSD PHARMA (SINGAPORE) PTE. LTD.

ATC code:

N05AH05

Dosage:

10mg

Pharmaceutical form:

TABLET, ORALLY DISINTEGRATING

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Catalent UK Swindon Zydis Limited

Authorization date:

2011-11-18

Patient Information leaflet

__________________________________________________________________________ 
_Copyright © 2013
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., _
_Whitehouse Station, NJ, USA _
All rights reserved. 
RA 1040 CCDS 4 (REF 4) 
CCDS-MK8274-ASP-SB-102012 

1. 
NAME OF THE MEDICINAL PRODUCT 
Saphris 5 mg sublingual tablets 
Saphris 10 mg sublingual tablets 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each Saphris 5 mg sublingual tablet contains 5 mg asenapine (as
maleate) 
Each Saphris 10 mg sublingual tablet contains 10 mg asenapine
(as maleate) 
For a full list of excipients, see section 6.1. 

3. PHARMACEUTICAL 
FORM 
SAPHRIS 5 MG SUBLINGUAL TABLETS 
Round, white to off-white, fast dissolving, sublingual tablets
debossed with “5” 
on one side. 
SAPHRIS 10 MG SUBLINGUAL TABLETS 
Round, white to off-white, fast dissolving, sublingual tablets
debossed with 
“10” on one side. 

4. CLINICAL 
PARTICULARS 
4.1 THERAPEUTIC 
INDICATIONS 
Saphris is indicated for the treatment of moderate to severe manic
episodes 
associated with bipolar I disorder in adults. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
Manic episode: 

__________________________________________________________________________ 
_Copyright © 2013
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., _
_Whitehouse Station, NJ, USA _
All rights reserved. 
Monotherapy: 
The recommended starting dose of Saphris as monotherapy is 10 mg
twice 
daily. One dose should be taken in the morning and one dose should
be 
taken in the evening. The dose can be reduced to 5 mg twice daily,
according 
to clinical assessment.  
Combination Therapy: 
A starting dose of 5 mg twice daily is recommended. Depending on the 
clinical response and tolerability in the individual patient, the
dose can be 
increased to 10 mg twice daily.  

Additional information on special populations 
_Paediatr