ALIMEMAZINE TARTRATE

4). 9). Urticaria and pruritus Adults: 10 mg (approx. 6 ml) two or three times daily; up to 100 mg per day have been used in intractable cases.

Elderly:

Dose should be reduced to 10 mg (approx. 6 ml) once or twice daily. 5 mg/5 ml Oral Solution is recommended.

Sedative premedication before general anaesthesia Children aged 3-7 years:

The maximum dosage recommended is 2 mg (approx. 33 ml) per kg bodyweight 1-2 hours before the operation. 5 mg/5 ml Oral Solution is recommended. Method of administration For oral administration.

Gastrointestinal disorders • Constipation • Dry mouth Respiratory, thoracic and mediastinal disorders • Nasal congestion • Respiratory depression is possible in susceptible patients Psychiatric disorders • Insomnia • Agitation Nervous system disorders • Extrapyramidal effects, such as: - Acute dystonias or dyskinesias, usually transitory are commoner in children and young adults and usually occur within the first 4 days of treatment or after dosage increases - Akathisia characteristically occurs after large doses - Parkinsonism is commoner in adults and the elderly.

It usually develops after weeks or months of treatment. One or more of the following may be seen: tremor, rigidity, akinesia or other features of Parkinsonism (commonly just tremor) - Tardive dyskinesia: If this occurs it is usually, but not necessarily, after prolonged or high dosage.

It can even occur after treatment has been stopped. Dosage should therefore be kept low whenever possible • Convulsions have been reported in some patients • Dizziness • Headache • Drowsiness Hepatobiliary disorders Jaundice, usually transient, occurs in a very small percentage of patients.

A premonitory sign may be a sudden onset of fever after one to three weeks of treatment followed by the development of jaundice. Neuroleptic jaundice has the biochemical and other characteristics of obstructive jaundice and is associated with obstructions of the canaliculi by bile thrombi; the frequent presence of an accompanying eosinophilia indicates the allergic nature of this phenomenon.

Treatment should be withheld on the development of jaundice. 4). Pre-existing cardiac disease, old age, hypokalaemia and concurrent tricyclic antidepressants may predispose. Investigations Electrocardiogram changes, usually benign, including: • QT interval prolongation • U-wave abnormality • T-wave abnormality • ST segment depression Eye disorders • Accommodation disorders Blood and lymphatic system disorders • Mild leukopenia occurs in up to 30% of patients on prolonged high dosage • Agranulocytosis may occur rarely; it is not dose related The occurrence of unexplained infections or fever requires immediate haematological investigation.

5). 8). 8) Paediatric population Alimemazine is contraindicated for use in children less than 2 years of age due to the risk of marked sedation and respiratory depression. There is a risk of post-operative restlessness especially if the child is in pain.

Excipients Sodium benzoate (E211):

This medicine contains 5 mg of sodium benzoate. This may result in increase in bilirubinaemia following its displacement from albumin may increase neonatal jaundice which may develop into kernicterus (non-conjugated bilirubin deposits in the brain tissue).

5 mg sodium metabisulphite. These may rarely cause severe hypersensitivity reactions and bronchospasms. 2% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

4).