PROMETHAZINE HYDROCHLORIDE

Route of administration:

Oral. 3). The use of Promethazine Hydrochloride liquid is recommended for children aged 2-5 years. Or 10 mg twice a day. Maximum daily dose 20 mg. Children over 10 years and adults (including elderly) Initially 10 mg bd. 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 insomniain 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.

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 theavailable 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. Frequency “not known”: neuroleptic malignant syndrome, psychomotor hyperactivity The elderly are particularly susceptible to the anticholinergic effects and confusion due to promethazine.

Psychiatric disorders Restlessness, nightmares, and disorientation. Frequency “not known”: hallucinations, aggression Infants are susceptible to the anticholinergic effects of promethazine, while other children may display paradoxical hyperexcitability.

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) Frequency “not known”: QT prolongation, Torsade de pointes Vascular disorders Hypotension Hepatobiliary disorders Jaundice Blood and lymphatic system disorders Blood dyscrasias including haemolytic anaemia rarely occur.

Agranulocytosis. Frequency “not known”: thrombocytopenia General and administration site conditions Tiredness Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinalproduct is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Cardin the Google Play or Apple App Store.

Promethazine Hydrochloride 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 hydrochloride 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. 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.

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 or ultraviolet light should be avoided during or shortly aftertreatment. Paediatric population The use of promethazine should be avoided in children and adolescents withsigns and symptoms suggestive of Reye’s Syndrome.

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

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

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