ALIMEMAZINE TARTRATE

Posology Not recommended for children less than 2 years old. 9). Urticaria and pruritus Adults: 10 mg (5 ml) two or three times daily; up to 100 mg (50 ml) per day have been used in intractable cases.

Elderly:

Dose should be reduced to 10 mg (5 ml) once or twice daily. 5mg (approx. 25 ml) three or four times daily. 5 ml) three or four times daily. Children over 12 years of age: 10mg (5 ml) two or three times daily. As a sedative before anaesthesia For the indication of sedation prior to anaesthesia, which requires a once only, high dose of alimemazine, the higher strength 30mg/5ml oral solution should be prescribed in order to limit propylene glycol (excipient) exposure.

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 Hepatobillary 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.

Renal and urinary disorders: • Retention of urine Vascular disorders:

Hypotension or pallor may occur in children. 4). 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. Skin and subcutaneous tissue disorders: • Contact skin sensitisation is a serious but rare complication in those frequently handling preparations of phenothiazines: Care must be taken to avoid contact of the drug with the skin.

• Skin rashes of various kinds may also be seen in patients treated with the drug. 4). Ocular changes and the development of a metallic greyish-mauve colouration of exposed skin have been noted in some individuals, mainly females, who have received chlorpromazine continuously for long periods (four to eight years).

Endocrine disorders: • Hyperprolactinaemia which may result in galactorrhoea, gynaecomastia, amenorrhoea and impotence. 9).

General disorders and administration site conditions:

Paradoxical excitement has been noted. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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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 warnings Sodium bisulphite, sodium metabisulfite:

May rarely cause severe hypersensitivity reactions and bronchospasm. 0 mg sodium benzoate in 5 ml oral solution Sodium: This medicine contains less than 1 mmol sodium (23mg) per dosage, that is to say essentially ‘sodium-free’. 3 mg propylene glycol in 5 ml oral solution Ethanol: This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per 5 ml.

1. 4).