SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

ZADITEN ELIXIR 1mg/5ml

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Ketotifen hydrogen fumarate 1.38mg/5ml For excipients, see Section 6.1.

3    PHARMACEUTICAL FORM

Clear, colourless, strawberry flavoured elixir.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Symptomatic treatment of allergic conditions including rhinitis and conjunctivitis.

4.2    Posology and method of administration

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.

4.3 Contraindications

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

4.4 Special warnings and precautions for use

Zaditen Tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, of severe lactase deficiency or of glucose-galactose malabsorption 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.

4.5 Interaction with other medicinal products and other forms of interaction

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.

4.6 Fertility, Pregnancy and lactation

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.

Effects on ability to drive and use machines

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.

4.8 Undesirable effects

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.

Overdose

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.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

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 (Hj) receptors.

5.2 Pharmacokinetic properties

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.

5.3 Preclinical safety data

Not stated.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

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

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

36 months

6.4 Special precautions for storage

Store below 25^oC

6.5 Nature and contents of container

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.

6.6 Special precautions for disposal

None

MARKETING AUTHORISATION HOLDER

Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. Viale Shakespeare, 47 00144 Rome Italy

8    MARKETING AUTHORISATION NUMBER(S)

PL 08381/0011

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

01/10/2009

10    DATE OF REVISION OF THE TEXT

25/04/2014