ZIZ

3) The use of Promethazine liquid is recommended for this age group.

As an antihistamine in allergy:

Children 5-10 years Either 10 or 20 mg as a single dose*. Or 10 mg twice a day(bd). Maximum daily dose 20 mg. Children over 10 years and adults (including elderly) Initially 10 mg twice a day (bd). Increasing to a maximum of 20 mg three times a day (tds) 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 dose at bedtime Children over 10 years and adults (including elderly) 20 mg to be taken at bedtime, which may be increased up to 50 mg if necessary.

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, rashes, pruritus pruritus and anaphylactic reactions have been reported.

Skin and subcutaneous tissue disorders Photosensitive skin reactions have been reported, strong sunlight should be avoided during treatment. Nervous system disorders Somnolence, drowsiness, dizziness, headaches, extrapyramidal effects including 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. Not known: neuroleptic malignant syndrome, psychomotor hyperactivity Psychiatric disorders Restlessness, nightmares, and disorientation.

Infants are susceptible to the anticholinergic effects of promethazine, while other children may display paradoxical hyperexcitability. Not known: hallucinations, aggression Eye disorders Blurred vision Gastrointestinal disorders Epigastric irritation /discomfort, dry mouth Renal and urinary disorder Urinary retention Metabolism and nutrition disorders anorexia Cardiac disorders Palpitations, arrhythmias 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. Not known: thrombocytopenia 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Promethazine should not be used for more 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.

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.

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 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 This medicine contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. This medicine contains sucrose.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

1. Ziz should not be used in patients: • in coma or; • suffering from CNS depression of any cause or, Ziz is contraindicated for use in children less than two years old because of the potential for fatal respiratory depression. ) Ziz should be avoided in patients taking monoamine oxidase inhibitors up to 14 days previously.