ALFRESED

4). 9). Urticaria and pruritus Adults: 10mg (approx. 7ml) two or three times daily; up to 100mg per day have been used in intractable cases. Elderly: dosage should be reduced to 10mg (approx. 7ml) once or twice daily. 5mg/5ml) for the indication of urticaria and pruritus.

As a sedative before anaesthesia Children aged 3 -7 years: the maximum dosage recommended is 2mg (approx. 33ml) per kg bodyweight 1-2 hours before the operation. 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 Hepatobilliary 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). Cardiac disorders Cardiac arrhythmias, including atrial arrhythmia. A-V block, ventricular tachycardia and ventricular fibrillation have been reported during therapy, possibly related to dosage.

Pre- existing cardiac disease, old age, hypokalaemia and concurrent tricyclic antidepressants may predispose.

Investigation:

ECG changes, usually benign, include widened QT interval, ST depression, U-waves and T- wave changes.

Eye disorders: • Accommodation disorders Blood and lymphatic system disorders:

A mild leukopaenia 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.

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 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). 8).

Paediatric population:

Alfresed 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. Excipient Warnings This product contains sucrose.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. This should be taken into account in patients with diabetes mellitus.

g. for two weeks or more. This product also contains methyl parahydroxybenzoate (E218), which may cause allergic reactions (possibly delayed). This product also contains sodium sulfite anhydrous (E221) and sodium metabisulfite (E223), which may rarely cause severe hypersensitivity reactions and bronchospasm.

This medicine contains less than 1mmol sodium (23mg) per 5ml, that is to say essentially ‘sodium-free’.

Alfresed should be avoided in patients with hepatic or renal dysfunction, epilepsy, Parkinson’s disease, hypothyroidism, phaeochromocytoma, myasthenia gravis, prostatic hypertrophy. 1 or with history of narrow angle glaucoma, history of agranulocytosis.

4).