ZADITEN ELIXIR

Adults 1mg twice daily with food. In patients susceptible to sedation, a slow increase in dosage is recommended during the first week of treatment. If necessary the dose may be increased to 2mg twice daily. At the higher dose, an accelerated onset of efficacy may be expected.

Special populations Pediatrics (from 3 years of age and adolescents) 1 mg twice daily with food. Geriatrics (aged 65 years and above) No evidence exists that elderly patients require different dosages or show different side- effects from younger patients.

2). 2). 5 - 1 mg at night for the first few days. Efficacy guidance In the prevention of bronchial asthma it may take several weeks of treatment to achieve the full therapeutic effect. It is therefore recommended that treatment with Zaditen should be maintained for a minimum of two to three months, even in patients not adequately responding within a few weeks.

Concomitant bronchodilator therapy: if bronchodilators are used concomitantly with Zaditen, the frequency of bronchodilator use can be reduced. If it is necessary to stop treatment with Zaditen, this should be done gradually over a period of 2 to 4 weeks.

Symptoms of asthma may recur.

Adverse drug reactions from clinical trials, spontaneous reports and literature cases are listed by MedDRA system organ class. Adverse drug reactions are ranked under heading of Preferred Term (PT) frequency, with the most frequent first.

Since reactions from spontaneous reports and literature cases are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency which is therefore categorized as not known. The following convention is used: 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), not known (cannot be estimated from the available data), including isolated reports.

Within each frequency grouping, adverse reactions are ranked in order of decreasing seriousness.

Infections and infestations Uncommon:

Cystitis Immune system disorders Very rare: Erythema multiforme, Stevens-Johnson syndrome, severe cutaneous adverse reaction Metabolism and nutrition disorders Rare: Weight increased Psychiatric disorders** Common: Agitation, irritability, insomnia, nervousness Nervous system disorders Uncommon: Dizziness* Rare: Sedation* Very rare: Not known: Convulsions Somnolence, headache Gastrointestinal disorders Uncommon: Dry mouth* Not known: Vomiting, nausea, diarrhoea Hepatobiliary disorders Very rare: Hepatitis, hepatic enzymes increased Skin and subcutaneous tissue disorders Not known: Rash, urticaria *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 agitation, irritability, insomnia, and nervousness, have been observed particularly in children. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

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

Zaditen Elixir contains methyl and propyl hydroxybenzoate. They may cause allergic reactions (possibly delayed). This medicine contains 100 mg of alcohol (ethanol) per 5 ml of solution. The amount in 1 ml of this medicine is equivalent to less than 0,5 ml beer or 0,2 ml wine.

The small amount of alcohol in this medicine will not have any noticeable effects. This medicine contains less than 1 mmol sodium (23 mg) per 5 ml dose, that is to say essentially “sodium-free”. Symptomatic and prophylactic anti-asthmatic drugs already in use should never be stopped abruptly when long-term treatment with Zaditen is started.

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 (biguanides) has been observed in rare cases. 3). In case of reduced attention, possibly due to the sedating effect of Zaditen, the dose should be reduced.

Zaditen is not effective in preventing or treating acute asthma attacks.

1. Epilepsy. 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.

Breastfeeding.