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SOMINEX is a brand name for Promethazine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: As a night-time sleep aid, for the correction of temporary disturbances of sleep pattern where there is difficulty in going to sleep or staying asleep, caused for example by specific dislocation of normal routine.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology For bedtime use only. Adults One tablet at bedtime. May be taken up to one hour after going to bed when sleep is difficult to achieve. Paediatric population Not to be given to children under the age of 16 years except on medical advice.
Elderly The normal adult dose may be taken. 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).
Blood and lymphatic system disorders Frequency not known:
Blood dyscrasias including haemolytic anaemia, agranulocytosis, leukopenia, eosinophilia, thrombocytopenia (including thrombocytopenic purpura).
Immune system disorders Frequency not known:
Allergic reactions, including anaphylactic reaction, urticaria, angioedema.
Metabolism and nutrition disorders Frequency not known:
Decreased appetite.
Psychiatric disorders Frequency not known:
Agitation, confusional state, anxiety.
Frequency not known:
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, disorientation.
Frequency not known:
Children less than 6 years of age also experienced aggression and hallucination.
Nervous system disorders Very common:
Sedation or somnolence.
This product should be used with caution in patients with seizure disorders or in patients receiving medication which may affect the seizure threshold because of risk of convulsions. Hypersensitivity reactions including anaphylaxis, urticaria and angioedema have been reported with Sominex use.
8). Sominex 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 Sominex due to the risk of sedation. 5). Sominex should not to be used for longer than 7 days without seeking medical advice. Caution should be used in patients with: • Asthma, bronchitis or bronchiectasis.
Sominex may thicken or dry lung secretions and impair expectoration. • Severe coronary artery disease. • Epilepsy. • Bladder neck or pyloro-duodenal obstruction. g. salicylates. It may also delay the early diagnosis of intestinal obstruction or raised intracranial pressure through the suppression of vomiting.
5). As this syndrome is potentially fatal, promethazine must be discontinued immediately and intensive clinical monitoring and symptomatic treatment should be initiated. 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 Lactose Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
1. • Sominex should not be used in patients in coma or suffering from CNS depression of any cause. • Sominex should be avoided in patients taking monoamine oxidase inhibitors up to 14 days previously.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Promethazine in United Kingdom.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
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:
Neuroleptic malignant syndrome, psychomotor hyperactivity. Frequency not known: children less than 6 years of age also experienced psychomotor hyperactivity.
Eye disorders Frequency not known:
Blurred vision.
Cardiac disorders Frequency not known:
Palpitations, arrhythmias, QT prolongation, torsade de pointes.
Vascular disorders Frequency not known:
Hypotension. 4), nasal congestion.
Gastrointestinal disorders Frequency not known:
Epigastric irritation/discomfort, dry mouth.
Hepatobiliary disorders Frequency not known:
Jaundice cholestatic.
Skin and subcutaneous tissue disorders Frequency not known:
Rash, photosensitivity reaction.
Renal and urinary disorders Frequency not known:
Urinary retention.
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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Sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’. 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.