Phenergan

Phenergan Elixir 5 mg/5 ml Oral Solution

Each 5ml of solution contains 5 mg of the active substance promethazine hydrochloride.

Excipient(s) with known effect:

Each 5 ml of solution contains 36.65 mg sodium, 1.457 mg potassium, and 5 mg sodium benzoate (see section 4.4).

Also contains maltitol, sodium sulphite anhydrous (E221) and sodium metabisulphite (E223).

For the full list of excipients see section 6.1.

Oral Solution

Clear, golden, syrupy liquid.

• As symptomatic treatment for allergic conditions of the upper respiratory tract and skin including allergic rhinitis, urticaria and anaphylactic reactions to drugs and foreign proteins.

• As an antiemetic.

For short term use:

• Treatment of insomnia in adults.

• As a paediatric sedative.

Paediatric population

Not for use in children under the age of 2 years (see section 4.3).

As an antihistamine in allergy:

As an antiemetic:

As a paediatric sedative for short term use and for short term treatment of insomnia in adults:

Method of administration

For oral administration.

• Phenergan should not be given to patients with a known hypersensitivity to promethazine or to any of the excipients listed in section 6.1.

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

• Promethazine is contraindicated for use in children less than two years of age because of the potential for fatal respiratory depression.

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

Phenergan Elixir 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 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

Otoxicity

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 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.Excipients with known effect

Sugar as hydrogenated glucose syrup (maltitol liquid): Patients with rare hereditary problems of fructose intolerance should not take this medicine. If you have diabetes, you should be aware that Phenergan Elixir contains carbohydrates, which the body will convert into small amounts of sugar. The maximum 25 ml single dose of Phenergan Elixir is equivalent to approximately 5 g of sugar, or one teaspoon of sugar/sugar lump. Taking this amount of Phenergan Elixir is unlikely to affect the control of your diabetes or require you to increase your diabetes medication.

Sodium: This medicinal product contains 36.65 mg sodium per 5 ml, equivalent to 1.83% of the WHO recommended daily intake of 2 g sodium for an adult. This should be taken into account if you are on a controlled sodium diet.

Sulphites: These are preservatives used in Phenergan Elixir, which may rarely cause severe hypersensitivity reaction , characterised by circulatory collapse with CNS depression and bronchospasm in certain susceptible individuals with allergic tendencies.

Benzoic acid

Phenergan Elixir contains 5mg sodium benzoate in each 5ml dose, which is equivalent to 1mg/ml. Sodium benzoate may increase bilirubinemia in newborn babies (up to 4 weeks old).

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

Phenergan 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 Elixir should not be used in pregnancy unless the physician considers it essential. The use of Phenergan 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.

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)

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.

No additional preclinical data of relevance to the prescriber.

Maltitol liquid

Citric acid monohydrate (E330)

Sodium citrate (E331)

Ascorbic acid (E300)

Sodium sulphite anhydrous (E221)

Sodium metabisulphite (E223)

Sodium benzoate (E211)

Orange juice flavour 510844E

Caramel (E150)

Acesulfame potassium (E950)

Purified water

None stated.

2 years when unopened.

1 month when opened.

Store below 25°C. Keep the bottle in the outer carton in order to protect from light.

Amber glass type III bottle containing 100 ml. Closed by a child-proof cap with a seal containing polyvinylidene chloride seal.

No special requirements.

Opella Healthcare UK Limited, trading as Sanofi

410 Thames Valley Park Drive,

Reading,

Berkshire,

RG6 1PT,

United Kingdom.

PL 53886/0057

Date of first authorisation: 28 February 1973

Date of latest renewal: 12 June 2003

16/06/2023

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