ALIMEMAZINE TARTRATE

4). 9). Urticaria and pruritus Adults: 10 mg (approx. 5 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. 5 ml) once or twice daily. 5 – 5 mg (approx. 3 ml) three or four times daily. Sedative premedication before general anaesthesia (Children aged 3-7 years:) the maximum dosage recommended is 2mg (approx.

3ml) per kg bodyweight 1-2 hours before the operation.

Method of administration:

For oral administration.

The following adverse reactions are classified by system organ class and ranked under heading of frequency using the following convention: Not known (cannot be estimated from the available data). Blood and lymphatic system disorders: • A 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. Psychiatric disorders: • Insomnia • Agitation. Nervous system disorders: • Drowsiness.

• Dizziness • Headache • Convulsions have been reported in some patients. • 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. 4). Pre-existing cardiac disease, old age, hypokalaemia and concurrent tricyclic antidepressants may predispose.

Vascular disorders: • Hypotension, or pallor may occur in children. 4). Respiratory, thoracic and mediastinal disorders: • Nasal congestion • Respiratory depression is possible in susceptible patients.

Gastrointestinal disorders: • Dry mouth • Constipation 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. 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).

Renal and urinary disorders: • Urinary retention Endocrine disorders: • Hyperprolactinaemia which may result in galactorrhoea, gynaecomastia, amenorrhoea and impotence. 9). General disorders and administration site conditions: • Paradoxical excitement has been noted.

Investigations:

ECG changes, usually benign, including: • QT interval prolongation • ST segment depression • U-wave abnormality • T-wave abnormality 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

5). 8). 8).

Paediatric population:

Alimemazine is contraindicated for use in children less than 3 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.

Alimemazine Syrup contains:

Sucrose: Patients with rare hereditary problems of fructose intolerance, glucose galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. 5mg/ml (4% w/v). The amount in 2ml of this medicine is equivalent to less than 2ml beer and 1ml wine.

The small amount of alcohol in this medicine will not have any noticeable effects. Sodium sulphite (E221) and sodium metabisulphite (E223) these may rarely cause severe allergic hypersensitivity reactions and bronchospasm. 17% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

1. • Use in patients with hepatic or renal dysfunction, epilepsy, Parkinson's disease, hypothyroidism, phaeochromocytoma, myasthenia gravis, and prostatic hypertrophy. • Use in patients with history of narrow angle glaucoma and agranulocytosis.

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