For short term use in the treatment of insomnia in adults and as a sedative in children over 16 years of age.

Adults (including the elderly) and children over 16 years of age: 25 mg or 50 mg as a single night time dose.

Paediatric population: Not to be used in children under 16 years of age.

Method of administration

For oral use.

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

• Phenergan Night Time should not be used in patients in coma or suffering from CNS depression of any cause.

• Phenergan Night Time should be avoided in patients taking monoamine oxidase inhibitors up to 14 days previously.

Phenergan should not be used for longer than 7 days without seeking medical advice.

Caution should be used in patients with:

• Asthma, bronchitis or bronchiectasis. Phenergan Night Time 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.

Ototoxicity

Promethazine may mask the warning signs of ototoxicity caused by ototoxic drugs e.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). QT prolongation is exacerbated, in particular, in the presence of bradycardia, hypokalaemia, and acquired (i.e. drug induced) QT prolongation. If the clinical situation permits, medical and laboratory evaluations should be performed to rule out possible risk factors before initiating treatment with a phenothiazine derivative and as deemed necessary during treatment (see section 4.8).

Photosensitivity reactions

Due to the risk of photosensitivity, exposure to strong sunlight 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

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

Phenergan Night Time will enhance the action of any anticholinergic agent, tricyclic antidepressant, sedative or hypnotic.

Alcohol should be avoided during treatment. Combination with alcohol enhances the sedative effects of H1 antihistamines.

Phenergan Night Time may interfere with immunological urine pregnancy tests to produce false-positive or false-negative results.

Phenergan Night Time should be discontinued at least 72 hours before the start of skin tests as it may inhibit the cutaneous histamine response thus producing false-negative results.

Special caution is required when promethazine is used concurrently with drugs known to cause QT prolongation (such as antiarrhythmics, antimicrobials, antidepressants, antipsychotics) to avoid exacerbation of risk of QT prolongation.

Pregnancy

Phenergan Night Time should not be used in pregnancy unless the physician considers it essential. The use of Phenergan Night Time is not recommended in the 2 weeks prior to delivery in view of the risk of irritability and excitement in the neonate.

Breast-feeding

Phenergan is excreted in breast milk (see section 5.2). There are risks of neonatal irritability and excitement. Phenergan is not recommended for use in breast-feeding.

Because the duration of action may be up to 12 hours, patients should be advised that if they feel drowsy, they should not drive or operate heavy machinery.

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, 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.

The elderly are particularly susceptible to the anticholinergic effects and confusion due to promethazine.

Psychiatric disorders

Restlessness, nightmares and disorientation.

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)

Vascular disorders

Hypotension

Hepatobiliary disorders

Jaundice

Blood and lymphatic system disorders

Blood dyscrasias including haemolytic anaemia rarely occur. Agranulocytosis.

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

Symptoms

Symptoms of severe overdosage are variable. They are characterised in children by various combinations of excitation, ataxia, incoordination, athetosis and hallucinations, while adults may become drowsy and lapse into coma. Convulsions may occur in both adults and children; coma or excitement may precede their occurrence. Tachycardia may develop. Cardiorespiratory depression is uncommon. High doses (supratherapeutic doses) can cause ventricular arrhythmias including QT prolongation and torsade de pointes (see section 4.8).

Management

If the patient is seen soon enough after ingestion, it should be possible to induce vomiting with ipecacuanha despite the antiemetic effect of promethazine; alternatively, gastric lavage may be used.

Treatment is otherwise supportive with attention to maintenance of adequate respiratory and circulatory status. Convulsions should be treated with diazepam or another suitable anticonvulsant.

Pharmacotherapeutic group: Antihistamines for systemic use; Phenothiazine derivatives, ATC code: R06AD02

Potent, long acting, antihistamine with additional anti-emetic central sedative and anti-cholinergic properties.

Promethazine is distributed widely in the body. It enters the brain and crosses the placenta. Promethazine is slowly excreted via urine and bile. Phenothiazines pass into the milk at low concentrations.

There are no preclinical data of relevance to the prescriber, which are additional to any already included in other sections of the SmPC.

Lactose monohydrate

Maize starch

Povidone K30

Magnesium stearate

Polyethylene glycol 200

Hypromellose (Pharmacoat 606)

Colouring agent

Opaspray M-1-4210A:

Titanium dioxide (E171)

Hypromellose (E464)

Indigo carmine aluminium lake FD&C Blue no 2 (E132)

Not applicable

3 years.

Store below 30° C. Store in the original carton in order to protect from light.

Opaque white 250 µ m uPVC coated with 40 gsm PVdC. 20 µ m hard temper aluminium foil (coated with vinyl heat seal lacquer).

Pack size: 14 tablets

Not all pack sizes may be marketed.

No special requirements