PROMETHAZINE HYDROCHLORIDE

3).

As an antihistamine in allergy:

Children 6-10 years 25 mg as a single dose*. Maximum daily dose 25 mg. Children over 10 years and adults (including elderly) 25 mg as a single dose*. Increasing to a maximum of 25 mg twice a day as required. *Single doses are best taken at night.

As an antiemetic:

Children 6-10 years The use of promethazine hydrochloride liquid or Promethazine Hydrochloride 10 mg Film-coated Tablets is recommended. Children over 10 years and adults (including elderly) 25 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 6-10 years 25 mg as a single night time dose. Children over 10 years and adults (including elderly) 25 mg or 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 anaphylactic reaction, urticaria, angioedema.

Skin and subcutaneous tissue disorders Frequency not known:

Rash, photosensitivity reaction.

Nervous system disorders Very common:

Sedation or somnolence.

Frequency not known:

Dizziness, headaches, extrapyramidal effects including restless legs syndrome, muscle spasms and tic-like movements of the head and face.

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, dry mouth, 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.

Frequency not known:

Neuroleptic malignant syndrome, psychomotor hyperactivity.

Psychiatric disorders Frequency not known:

Agitation, confusional state, anxiety.

Frequency not known:

Infants, newborns and premature are susceptible to the anticholinergic effects of promethazine, while other children may display paradoxical hyperexcitability, restlessness, nightmares, disorientation.

Frequency not known:

Children less than 6 years of age also experienced aggression and hallucination.

Frequency not known:

Hallucinations, aggression. 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 thrombocytopenic purpura).

General disorders 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.

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Hypersensitivity reactions including anaphylaxis, urticaria and angioedema have been reported with Promethazine hydrochloride use. 8). Promethazine hydrochloride 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 hydrochloride due to the risk of sedation. 5). 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.

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). 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.

8). 8). 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 monohydrate. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

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 anaesthetics, or alcohol. 8) and requires immediate haematological 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 (hyperleukocytosis, granulocytopenia) are observed in the blood count.

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