ZYPREXA ZYDIS ORODISPERSIBLE TABLET 5 mg

Pajjiż: Singapor

Lingwa: Ingliż

Sors: HSA (Health Sciences Authority)

Ingredjent attiv:

OLANZAPINE Micronized

Disponibbli minn:

DKSH SINGAPORE PTE. LTD.

Kodiċi ATC:

N05AH03

Dożaġġ:

5 mg

Għamla farmaċewtika:

TABLET

Kompożizzjoni:

OLANZAPINE Micronized 5 mg

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

Prescription Only

Manifatturat minn:

CATALENT U.K. SWINDON ZYDIS LTD

L-istatus ta 'awtorizzazzjoni:

ACTIVE

Data ta 'l-awtorizzazzjoni:

2003-12-09

Fuljett ta 'informazzjoni

Zyprexa & Zyprexa Zydis SG PI updated as at Oct 2009 Acc
(Shelf Life and Storage Condn) 
1 
ZYPREXA/ZYPREXA ZYDIS 
OLANZAPINE 

1. 
NAME OF THE MEDICINAL PRODUCT 

ZYPREXA/ZYPREXA ZYDIS  

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each ZYPREXA 5 mg ,7.5mg, 10mg, 15mg & 20mg Tablet contains 5 mg, 7.5mg, 10mg, 15mg 
& 20mg olanzapine respectively.  
Each ZYPREXA ZYDIS 5mg & 10mg Orodispersible Tablet contains
5 mg and 10mg olanzapine 
respectively.  

For excipients, see 6.1.  

3. 
PHARMACEUTICAL FORM


COATED TABLETS 

ZYPREXA  5  mg,  7.5mg  &  10mg  Tablets  are  round,  white,  coated  tablets  imprinted  with 
"LILLY" and a numeric identicode. 
ZYPREXA  15  mg  Tablets  are  elliptical  blue  coated  tablets  debossed  with  “LILLY”  and  a 
numeric identicode “4415”. 
ZYPREXA  20  mg  Tablets  are  elliptical  pink  coated  tablets  debossed  with  “LILLY”  and  a 
numeric identicode “4420”.

ORODISPERSIBLE TABLET 

ZYPREXA  ZYDIS  5mg  and  10mg  Orodispersible  Tablet  is  a  freeze  dried,  rapid-dispersing 
preparation  to  be  placed  in  the  mouth  or  alternatively  to  be  dispersed  in  water  or  other  suitable 
beverage for administration. 



All formulation may not be available in all countries 

4. 
CLINICAL PARTICULARS 

4.1.1  THERAPEUTIC INDICATIONS 

Olanzapine  is  indicated  for  the  acute  and  maintenance  treatment  of  schizophrenia  and  other 
psychoses  where  positive  symptoms  (e.g.,  delusions,  hallucinations,  disordered  thinking, 
hostility,  and  suspiciousness)  and/or  negative  symptoms  (e.g.,  flattened  affect,  emotional  and 
social  withdrawal,  poverty  of  speech)  are  prominent.  Olanzapine  also  allev

Karatteristiċi tal-prodott

Page 1 of 27
1. NAME OF THE MEDICINAL PRODUCT
Zyprexa Tablet 5mg
Zyprexa Tablet 10mg
Zyprexa Zydis Orodispersible Tablet 5mg
Zyprexa Zydis Orodispersible Tablet 10mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Zyprexa Tablet 5mg
Each coated tablet contains 5mg olanzapine.
Excipient with known effect: Each coated tablet contains 156mg lactose
monohydrate.
Zyprexa Tablet 10mg
Each coated tablet contains 10mg olanzapine.
Excipient with known effect: Each coated tablet contains 312mg lactose
monohydrate.
Zyprexa Zydis Orodispersible Tablet 5mg
Each orodispersible tablet contains 5mg olanzapine.
Excipients with known effect: Each orodispersible tablet contains 0.60
mg aspartame
(E951),
0.1125 mg sodium methyl parahydroxybenzoate (E219), 0.0375
mg sodium propyl parahydroxybenzoate (E217).
Zyprexa Zydis Orodispersible Tablet 10mg
Each orodispersible tablet contains 10mg olanzapine.
Excipients with known effect: Each orodispersible tablet contains 0.80
mg aspartame
(E951),
0.15 mg sodium methyl parahydroxybenzoate (E219),
0.05 mg sodium propyl parahydroxybenzoate (E217).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Zyprexa Tablet
Zyprexa Tablet 5mg
Round, white, coated tablets imprinted with ‘LILLY’ and a numeric
identicode ‘4115’.
Page 2 of 27
Zyprexa Tablet 10mg
Round, white, coated tablets imprinted with ‘LILLY’ and a numeric
identicode ‘4117’.
Zyprexa Zydis Orodispersible Tablet
Yellow, round, freeze dried, rapid-dispersing preparation to be placed
in the mouth or
alternatively to be dispersed in water or other suitable beverage for
administration.
4. CLINICAL PARTICULARS
4.1
Therapeutic indications
Olanzapine is indicated for the acute and maintenance treatment of
schizophrenia and
other psychoses where positive symptoms (e.g. delusions,
hallucinations, disordered
thinking, hostility, suspiciousness) and/or negative symptoms (e.g.
flattened affect,
emotional and social withdrawal, poverty of speech) are prominent.
Olanzapine also
alleviates the secondary affective symptoms