PHENERGAN Solution for injection Ref.[7736] Active ingredients: Promethazine

Phenergan may thicken or dry lung secretions and impair expectoration. It should therefore be used with caution in patients with asthma, bronchitis or bronchiectasis.

Use with care in patients with severe coronary artery disease, narrow angle glaucoma, epilepsy or hepatic and renal insufficiency.

Caution should be exercised in patients with bladder neck or pyloro-duodenal obstruction.

The use of promethazine should be avoided in children and adolescents with signs and symptoms suggestive of Reye’s Syndrome.

Promethazine may mask the warning signs of ototoxicity caused by ototoxic drugs e.g. salicylates. It may also delay the early diagnosis of intestinal obstruction or raised intracranial pressure through the suppression of vomiting.

Intravenous injection should be performed with extreme care to avoid extravasation or inadvertent intra-arterial injection, which could lead to necrosis and peripheral gangrene. If a patient complains of pain during intravenous injection, stop the injection immediately, as this may be a sign of extravasation or inadvertent intra-arterial injection. Intramuscular injection must also be performed carefully to avoid inadvertent subcutaneous injection, which could lead to local necrosis.

Phenergan contains Sodium Sulphite and may rarely cause severe hypersensitivity reactions and bronchospasm.

Phenergan will enhance the action of any anticholinergic agent, tricyclic antidepressant, sedative or hypnotic. Alcohol should be avoided during treatment. Phenergan may cause hypotension, and dosage adjustment of antihypertensive therapy may therefore be required. Phenergan may lower the convulsive threshold, and dosage adjustment of anticonvulsant medication may therefore be required. Phenergan may interfere with immunological urine pregnancy tests to produce false-positive or false-negative results. Phenergan should be discontinued at least 72 hours before the start of skin tests as it may inhibit the cutaneous histamine response thus producing false-negative results. Phenergan injection may increase glucose tolerance.

Phenergan Injection should not be used in pregnancy unless the physician considers it essential. The use of Phenergan is not recommended in the 2 weeks prior to delivery in view of the risk of irritability and excitement in the neonate.

Available evidence suggests that the amount excreted in milk is insignificant. However, there are risks of neonatal irritability and excitement.

Ambulant patients receiving Phenergan for the first time should not be in control of vehicles or machinery for the first few days until it is established that they are not hypersensitive to the central nervous effects of the drug and do not suffer from disorientation, confusion or dizziness.

The following CIOMS frequency rating is used: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10,000 to ≥1/1000); very rare (<1/10 000), not known (cannot be estimated from the available data).

Side effects may be seen in a few patients: drowsiness, dizziness, restlessness, headaches, nightmares, tiredness, and disorientation. Anticholinergic side effects such as blurred vision, dry mouth and urinary retention occur occasionally. Newborn and premature infants are susceptible to the anticholinergic effects of promethazine, while other children may display paradoxical hyperexcitability. The elderly are particularly susceptible to the anticholinergic effects and confusion due to promethazine. Other side-effects include anorexia, gastric irritation, palpitations, hypotension, arrhythmias, extrapyramidal effects, muscle spasms and tic-like movements of the head and face. Jaundice and blood dyscrasias including haemolytic anaemia rarely occur. Very rare cases of allergic reactions, including urticaria, rash, pruritus and anaphylaxis, have been reported.

Photosensitive skin reactions have been reported; strong sunlight should be avoided during treatment.

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. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Not applicable.