ZADITEN SRO TABLET 2 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

KETOTIFEN

Available from:

NOVARTIS (SINGAPORE) PTE LTD

ATC code:

R06AX17

Dosage:

2 mg

Pharmaceutical form:

TABLET, FILM COATED

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

NOVARTIS FARMA S P A

Authorization date:

1992-06-10

Patient Information leaflet

ZADITEN
 
/ ZADITEN

 SRO 
Antihistamines for systemic use. 
DESCRIPTION AND COMPOSITION 
PHARMACEUTICAL FORM(S) 
Tablets (scored);  
SRO (slow release oral) film coated tablets;  
Syrup 
ACTIVE SUBSTANCE 
Zaditen tablets (scored) contain
the equivalent of 1 mg ketotifen (as the hydrogen fumarate). 
Zaditen SRO (slow release oral) tablets (film-coated) contains the
equivalent of 2 mg 
ketotifen (as the hydrogen fumarate). 
Zaditen syrup contains the equivalent of 1 mg ketotifen (as
the hydrogen fumarate) per 5 mL. 
ACTIVE MOIETY 
Ketotifen 
EXCIPIENTS 
Tablets contain lactose as an excipient (see section
SPECIAL WARNINGS AND 
PRECAUTIONS FOR USE). 
Syrup and oral solution contain maltitol liquid (hydrogenated
glucose syrup) as an excipient 
(see section SPECIAL WARNINGS AND PRECAUTIONS FOR USE). 
For the full list of excipients, see section EXCIPIENTS. 
INDICATIONS 
Preventive treatment of bronchial asthma especially when
associated with atopic symptoms. 
Zaditen is not effective in aborting established attacks of
asthma. Zaditen is not a substitute 
for
corticosteroid treatment (inhaled or systemic) when corticosteroid is indicated in the 
treatment of asthma. 
Prevention and treatment of multisystem allergic disorders: 
  chronic urticaria  
  atopic dermatitis 
  allergic rhinitis and conjunctivitis 
Novartis   Page 
2 
Singapore Specific Package Leaflet  19 Sep 2011   
Zaditen/Zaditen SRO 

DOSAGE AND ADMINISTRATION 
USE IN ADULTS 
1 Zaditen SRO tablet (2 mg) in the evening, or
1 Zaditen tablet (1 mg) twice daily (with 
morning and evening meals). In patients susceptible to sedation,
slow increase in dose is 
recommended during the first week of treatment, starting with
½ tablet twice daily and 
increasing to the full therapeutic dose. If
necessary, the daily dose may be increased up to 4 
mg, i.e. 2 Zaditen SRO tab