COMPOSITION AND PHARMACEUTICAL FORM
Zaditen hard capsules contain 1 mg ketotifen (as
the hydrogen fumarate).
Zaditen tablets ( scored ) contain mg ketotifen
( as the hydrogen fumarate ).
Zaditen SRO ( slow release oral ) tablets ( film-coated ) contains 2 mg ketotifen ,as the
Zaditen syrup contains 1 mg ketotifen (as the
hydrogen fumarate) per 5 mL.
Zaditen oral solution contains I mg ketotifen (as
the hydrogen fumarate) per 1 mL ( = 20 drops ).
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
Certain dosage strengths and do age forms may
not be available in all countries
Zaditen 1 mg Tablet : White or yellow-tinged
white tablet with circular, flat. be haled edge with
one side scored and coded HI
Zaditen Syrup : Clear. colourless to faintly yellow
Preventative treatment of bronchial asthma
especially when associated with atopic
Zaditen is not effective in aborting established
attacks of asthma.
Prevention and treatment of multisystem allergic
• chronic urticaria
• atopic dermatitis
• allergic rhinitis and conjunctivitis
DOSAGE AND ADMINISTRATION
1 Zaditen SRO tablet (2 mg) in the evening, or 1
Zaditen capsule (1 mg), or 1 Zaditen tablet (1
mg) twice daily (with morning and evening
meals). In patients susceptible to sedation, a
slow increase in dose is recommended during
the first week of treatment, starting with
tablet twice daily or 1 capsule in the evening
only, and increasing to the full therapeutic dose.
If necessary, the daily dose may be increased up
to 4 mg. i.e. 2 Zaditen SRO tablets once a day in
the evening, or 2 Zaditen capsules or 2 Zaditen
tablets twice daily. At the higher dose, an
accelerated onset of efficacy may be expected.
Children aged 6 months to 3 years
0.05 mg ( = 1 drop of Zaditen oral solution) per
kilogram body weight twice daily ( morning
and evening ).
Example: an infant weighing 10 kg may receive
10 drops in the morning and 10 drops in the
0.05 mg ( = 0.25 mL syrup ) per kilogram body
weight twice daily ( morning and evening ).
Example an infant weighing 10 kg may receive
2.5 mL ( =
½ teaspoonful ) of Zaditen syrup in
the morning and evening.
Children over 3 years of age
5 mL (1 teaspoonful ) syrup or 1 capsule, or 1
tablet twice daily with morning and evening
meal, or 1 tablet SRO (2 mg) in the evening.
In the prevention of bronchial asthma it may
take several weeks of treatment to achieve the
full therapeutic effect. It is therefore
recommended that for patients not adequately
responding within a few weeks, treatment with Zaditen should be maintained for a minimum of
2 to 3 months.
Concomitant bronchodilator therapy : if bronchodilatos are used concomitantly with
Zaditen the frequency of bronchodilator usage
can be reduced.
It it is necessary to withdraw Zaditen, this should
be done progressively over a period of 2 to 4
weeks. Symptoms of asthma may recur
Zaditen SRO tablets should be swallowed whole.
Use in children
Clinical observations reflect pharmacokinetic
findings and indicate that children may require a
higher dose in mg/kg body weight than adults in
order to obtain optimal results. This higher dose
is as well tolerated as lower doses (see also
under section PHARMACOKINETIC PROPERTIES).
Use in the elderly
Experience with Zaditen has shown that there
are no special requirements in elderly patients.
Known hypersensitivity to ketotifen or any of the
excipients (see section EXCIPIENTS).
SPECIAL WARNINGS AND PRECAUTIONS FOR
Symptomatic and prophylactic anti-asthmatic
drugs already in use should never be withdrawn
abruptly when long-term treatment with Zaditen
is begun. This applies especially to systemic
corticosteroids. because of the possible
existence of adrenocortical insufficiency in
steroid-dependent patients; in such cases.
recovery of a normal pituitary-adrenal response
to stress may take up to 1 year.
A reversible fall in the thrombocyte count in
patients receiving Zaditen concomitantly with
oral antidiabetic agents has been observed in
rare cases. Thrombocyte counts should therefore
be carried out in patients taking antidiabetics
Convulsions have been reported very rarely
during Zaditen therapy. As Zaditen may lower
the seizure threshold it should be used with
caution in patients with a history of epilepsy.
In diabetic patients. the carbohydrate content of
the syrup ( 5 mL = 3g carbohydrate ) should be
taken into consideration.
The tablets and SRO film coated tablets n
lactose This medicine is not recommended for
patients with rare hereditary problems of galactose intolerance, of severe lactase
deficiency or of glucose-galactose
The syrup and oral solution contain maltitol
liquid. Patients with rare hereditary problems of
fructose intolerance should not take this