PHENERGAN NIGHT TIME

Adults (including the elderly) and children over 16 years of age: 25 mg or 50 mg as a single night time dose.

Paediatric population:

Not to be used in children under 16 years of age. Method of administration For oral use.

The following CIOMS frequency rating is used:

Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10 00 to < 1/1000); very rare (< 1/10 000), not known (cannot be estimated from the available data). Immune system disorders Allergic reactions including urticaria, rash, pruritus and anaphylactic reactions have been reported, Skin and subcutaneous tissue disorders Photosensitive skin reactions have been reported.

Nervous system disorders Somnolence, dizziness, headaches, extrapyramidal effects, restless legs syndrome, muscle spasms and tic-like movements of the head and face. The elderly are particularly susceptible to the anticholinergic effects and confusion due to promethazine.

Psychiatric disorders Restlessness, nightmares and disorientation. Eye disorders Blurred vision Gastrointestinal disorders Epigastric irritation/discomfort, dry mouth Renal and urinary disorders Urinary retention Metabolism and nutrition disorders Anorexia Cardiac disorders Palpitations, arrhythmias, (including QT prolongation and torsade de pointes) Vascular disorders Hypotension Hepatobiliary disorders Jaundice Blood and lymphatic system disorders Blood dyscrasias including haemolytic anaemia rarely occur.

Agranulocytosis. General and administration site conditions Tiredness 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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Phenergan should not be used for longer than 7 days without seeking medical advice. Caution should be used in patients with: • Asthma, bronchitis or bronchiectasis. Phenergan Night Time may thicken or dry lung secretions and impair expectoration.

• Severe coronary artery disease • Narrow angle glaucoma • Epilepsy • Hepatic and renal insufficiency • Bladder neck or pyloro-duodenal obstruction. g. salicylates. It may also delay the early diagnosis of intestinal obstruction or raised intracranial pressure through the suppression of vomiting.

QT prolongation Phenothiazine derivatives may potentiate QT interval prolongation which increases the risk of onset of serious ventricular arrhythmias of the torsade de pointes type, which is potentially fatal (sudden death). e. drug induced) QT prolongation.

8). Photosensitivity reactions Due to the risk of photosensitivity, exposure to strong sunlight should be avoided during or shortly after treatment. Paediatric population The use of promethazine should be avoided in children and adolescents with signs and symptoms suggestive of Reye’s Syndrome.

Excipient(s) with known effect Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

1. Phenergan Night Time should not be used in patients in coma or suffering from CNS depression of any cause. Phenergan Night Time should be avoided in patients taking monoamine oxidase inhibitors up to 14 days previously.