ZADITEN ELIXIR 1mg / 5ml

Ketotifen hydrogen fumarate 1.38mg/5ml

For excipients, see Section 6.1.

Clear, colourless, strawberry flavoured elixir.

Symptomatic treatment of allergic conditions including rhinitis and conjunctivitis.

Adults

1mg twice daily with food. If necessary the dose may be increased to 2mg twice daily.

Children

(From 3 years of age): 1 mg twice daily with food.

Use in the elderly

No evidence exists that elderly patients require different dosages or show different side-effects from younger patients.

Patients known to be easily sedated should be given 0.5 - 1 mg at night for the first few days.

Hypersensitivity to ketotifen or any of the excipients. A reversible fall in the thrombocyte count in patients receiving ZADITEN® concomitantly with oral anti-diabetic agents has been observed in a few cases. This combination of drugs should therefore be avoided until this phenomenon has been satisfactorily explained.

Zaditen Elixir contains maltitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.

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.

ZADITEN® may potentiate the effects of sedatives, hypnotics, antihistamines and alcohol. Patients should be warned not to take charge of vehicles or machinery until the effect of ZADITEN® treatment on the individual is known.

Although there is no evidence of any teratogenic effect, recommendation for ZADITEN® in pregnancy cannot be given. Ketotifen is excreted in breast milk, therefore mothers receiving ZADITEN® should not breast feed.

During the first few days of treatment with ZADITEN® reactions may be impaired. Patients should be warned not to take charge of vehicles or machinery until the effect of ZADITEN® treatment on the individual is known. Patients should be advised to avoid alcoholic drinks.

Adverse reactions (Table 1) are ranked under heading of frequency, the most frequent first, using the following convention: very common ( 1/10); common ( 1/100, < 1/10); uncommon ( 1/1,000, < 1/100); rare ( 1/10,000, < 1/1,000) very rare (< 1/10,000), including isolated reports. Within each frequency grouping, adverse reactions are ranked in order of decreasing seriousness.

Sedation, dry mouth and dizziness may occur at the beginning of treatment, but usually disappear spontaneously with continued medication. Symptoms of CNS stimulation, such as excitation, irritability, insomnia, and nervousness, have been observed particularly in children.

The reported features of overdose include confusion, drowsiness, nystagmus, headache, disorientation, tachycardia, hypotension, reversible coma; especially in children, hyperexcitability or convulsions. Bradycardia and respiratory depression should be watched for.

Treatment should be symptomatic. Treatment with activated charcoal should be considered if the overdose has been taken within approximately one hour. If necessary, symptomatic treatment and monitoring of the cardiovascular system are recommended; if excitation is present, short acting barbiturates or benzodiazepines may be given.

Pharmacotherapeutic group: Other antihistamines for systemic use, ATC code: R06AX17

ZADITEN® is a potent antiallergic drug which inhibits the effects of certain endogenous substances known to be inflammatory mediators. ZADITEN® exerts a non-competitive blocking effect on histamine (H₁) receptors.

After oral administration the absorption of ZADITEN® is nearly complete. Bioavailability amounts to approximately 50% due to a first pass effect of about 50% in the liver. Maximal plasma concentrations are reached within 2-4 hours. Protein binding is 75%. Ketotifen is eliminated biphasically with a short half-life of 3-5 hours and a longer one of 21 hours. In urine about 1% of the substance is excreted unchanged within 48 hours and 60-70% as metabolites. The main metabolite in the urine is the practically inactive ketotifen-N-glucuronide.

Not stated.

Strawberry flavour, propyl hydroxybenzoate, methyl hydroxybenzoate, citric acid anhydrous, disodium phosphate anhydrous, ethanol 96% v/v, maltitol liquid (grade 80/55) and purified water.

Not applicable.

36 months

Store below 25^oC

Amber glass bottle with a child resistant, tamper evident closure, composed of a polypropylene or polyethylene outer, a polypropylene or polyethylene inner, with a wad faced with PP, PVDC or PET lining. Bottle sizes of 150ml and 300ml.

None

Defiante Farmacêutica, S.A.Rua dos Ferreiros, 2609000-082 Funchal, Portugal

PL 24030/0002

Date Present Licence Granted: 18 April 1997

Date of Expiry: 18 April 2002

1 October 2009