ZADITEN SYRUP 1 mg5 ml (sugar-free)

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

KETOTIFEN HYDROGEN FUMARATE EQV KETOTIFEN

Available from:

NOVARTIS (SINGAPORE) PTE LTD

ATC code:

R06AX17

Dosage:

1 mg/5 ml

Pharmaceutical form:

SYRUP

Composition:

KETOTIFEN HYDROGEN FUMARATE EQV KETOTIFEN 1 mg/5 ml

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

DELPHARM HUNINGUE SAS

Authorization status:

ACTIVE

Authorization date:

1993-12-15

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

Summary of Product characteristics

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) containing the equivalent of 1 mg ketotifen
(as hydrogen fumarate).
Zaditen SRO (slow release oral) tablets (film-coated) containing the
equivalent of 2 mg
ketotifen (as hydrogen fumarate).
Zaditen syrup containing the equivalent of 1 mg ketotifen (as hydrogen
fumarate) per 5 mL.
ACTIVE MOIETY
Ketotifen
EXCIPIENTS
Zaditen
tablets:
magnesium
stearate;
maize
starch;
maize
starch
preswollen;
lactose
monohydrate*.
Zaditen
SRO
tablets:
magnesium
stearate;
silica
(colloidal
anhydrous);
ethyl
cellulose;
polyvinylpyrrolidone;
maize
starch;
glyceryl
palmitostearate;
lactose
monohydrate*;
polyethylene glycol 6000; talc; methylhydroxy-propylcellulose; iron
oxide yellow; titanium
dioxide.
Zaditen syrup: strawberry flavoring agent; sodium propyl
p-hydroxybenzoate; sodium methyl
p-hydroxybenzoate; citric acid (anhydrous); disodium hydrogen
phosphate; maltitol liquid**;
purified water, demineralized.
* Tablets contain lactose as an excipient (see section WARNINGS AND
PRECAUTIONS).
** Syrup contains maltitol liquid (hydrogenated glucose syrup) as an
excipient (see section
WARNINGS AND PRECAUTIONS).
INDICATIONS
Preventive treatment of bronchial asthma especially when associated
with atopic symptoms.
Novartis
Page 2
Singapore Specific Package Leaflet 5 Jan 2015
Zaditen/Zaditen SRO
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
DOSAGE AND ADMINISTRATION
DOSAGE
GENERAL TARGET POPULATION
One Zaditen SRO tablet (2 mg) in the evening, or one Zaditen tablet (1
mg) twice daily (with
morning and evening meals). In pat