PROMETHAZINE HYDROCHLORIDE

3). The use of Promethazine liquid is recommended for children aged 2-5 years.

As an antihistamine in allergy:

Children 5-10 years Either 10 mg or 20 mg as a single dose*. Or 10 mg twice a day . Maximum daily dose 20 mg. Children over 10 years and adults (including elderly) Initially 10 mg twice a day. Increasing to a maximum of 20 mg three times a day as required.

*Single doses are best taken at night.

As an antiemetic:

Children 5-10 years 10 mg to be taken the night before the journey. To be repeated after 6–8 hours as required. Children over 10 years and adults (including elderly) 20 mg to be taken the night before the journey. To be repeated after 6–8 hours as required.

As a paediatric sedative for short term use and for short term treatment of insomnia in adults: Children 5-10 years 20 mg as a single night time dose. Children over 10 years and adults (including elderly) 20 to 50 mg as a single night time dose.

Method of administration For oral administration.

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 Frequency not known:

Allergic reactions, including urticaria, rash, pruritus, angioedema and anaphylactic reactions have been reported.

Skin and subcutaneous tissue disorders Frequency not known:

Rash, photosensitivity reaction Nervous system disorders Very common: Somnolence, sedation Frequency not known: dizziness, headaches, extrapyramidal effects, restless legs syndrome, muscle spasms and tic-like movements of the head and face, neuroleptic malignant syndrome, psychomotor hyperactivity.

Frequency not known:

Dystonia, including oculogyric crisis, usually transitory are commoner in children and young adults, and usually occur within the first 4 days of treatment or after dosage increases.

Frequency not known:

Anticholinergic effects such as ileus paralytic, risk of urinary retention, constipation, accommodation disorder. The elderly are particularly susceptible to the anticholinergic effects and confusion due to promethazine.

Frequency not known:

Children less than 6 years of age also experienced psychomotor hyperactivity.

Psychiatric disorders Frequency not known:

Agitation, confusional state, anxiety, hallucinations, aggression.

Frequency not known:

Infants, newborns and premature are susceptible to the anticholinergic effects of promethazine, while other children may display paradoxical hyperexcitability, restlessness, nightmares, and disorientation. Frequency not known: children less than 6 years of age also experienced aggression and hallucination.

4), nasal congestion Hepatobiliary disorders Frequency not known: Jaundice cholestatic Blood and lymphatic system disorders Frequency not known: Blood dyscrasias including haemolytic anaemia. Agranulocytosis, leukopenia, eosinophilia, thrombocytopenia (including thrombocytopenia purpura).

General and administration site conditions Frequency not known:

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.

Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

Promethazine should not be used for longer than 7 days without seeking medical advice. Caution should be used in patients with: • Asthma, bronchitis or bronchiectasis. Promethazine 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 Hypersensitivity reactions including anaphylaxis, urticaria and angioedema have been reported with promethazine use.

8). Promethazine should be avoided in patients with liver or renal dysfunction, Parkinson’s disease, hypothyroidism, cardiac failure, pheochromocytoma, myasthenia gravis, or prostate hypertrophy, or in patients with a history of narrow angle glaucoma or agranulocytosis.

Caution must be exercised when using H1-antihistamines such as Promethazine due to the risk of sedation. 5). g. salicylates. It may also delay the early diagnosis of intestinal obstruction or raised intracranial pressure through the suppression of vomiting.

QT interval As phenothiazines can prolong the QT interval, caution is advised in treated patients with pronounced bradycardia, cardiovascular disease, with a hereditary form of prolongation of the QT interval and concomitant use with other products leading to QT prolongation.

Photosensitivity reactions Due to the risk of photosensitivity, exposure to strong sunlight or ultraviolet light 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.

5). Phenothiazines may be additive with, or may potentiate the action of, other CNS depressants such as opiates or other analgesics, barbiturates or other sedatives, general anesthetics, or alcohol. 8) and requires immediate hematological investigation.

All patients should be advised that, if they experience fever, sore throat or any other infection, they should inform their physician immediately and undergo a complete blood count. Treatment should be discontinued if any marked changes (hyperleucocytosis, granulocytopenia) are observed in the blood count.

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1. Promethazine should not be used in patients in coma or suffering from CNS depression of any cause. Promethazine is contraindicated for use in children less than two years of age because of the potential for fatal respiratory depression.

Promethazine should be avoided in patients taking monoamine oxidase inhibitors up to 14 days previously.