Zaditen

Antihistamines for systemic use.

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 hydrogen fumarate). 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 EXCIPIENTS. Certain dosage strengths and do age forms may not be available in all countries

DESCRIPTION

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 solution.

INDICATIONS

Preventative treatment of bronchial asthma especially when associated with atopic symptoms.

Zaditen is not effective in aborting established attacks of asthma.

Prevention and treatment of multisystem allergic disorders:

• chronic urticaria

• atopic dermatitis

• allergic rhinitis and conjunctivitis

DOSAGE AND ADMINISTRATION

Adults 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

Children aged 6 months to 3 years

Oral solution

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 evening

Syrup

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 ( = 1/2 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.

Note

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.

CONTRAINDICATIONS

Known hypersensitivity to ketotifen or any of the excipients (see section EXCIPIENTS).

SPECIAL WARNINGS AND PRECAUTIONS FOR USE

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 concomitantly.

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 malabsorption.

The syrup and oral solution contain maltitol liquid. Patients with rare hereditary problems of fructose intolerance should not take this medicine.

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