Phenergan Elixir 5mg/5ml Oral Solution
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Phenergan Elixir 5mg/5ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml of solution contains 5mg of the active substance promethazine hydrochloride.
Also contains 37mg sodium and 1.457mg potassium per 5ml dose.
Contains Maltitol, sodium sulphite anhydrous (E221) and sodium metabisulphite (E223).
For full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Oral Solution
Clear, golden, syrupy liquid.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
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.
4.2 Posology and method of administration
Route of administration: Oral.
Not for use in children under the age of 2 years (see section 4.3) As an antihistamine in allergy:
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Children 2-5 years |
Either 5-15 mg as a single dose. Or 5 mg bd. Maximum daily dose 15 mg. |
|
Children 5-10 years |
Either 10-25 mg as a single dose. Or 5-10 mg bd. Maximum daily dose 25 mg. |
|
Children over 10 years and adults (including elderly) As an antiemetic: |
Initially 10 mg bd. Increasing to a maximum of 20 mg tds as required. |
|
Children 2-5 years |
5 mg to be taken the night before the journey. To be repeated after 6-8 hours as required. |
|
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) |
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 2-5 years |
15 or 20 mg as a single night time dose. |
|
Children 5-10 years |
20 or 25 mg as a single night time dose. |
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Children over 10 years and adults (including elderly) |
25 or 50 mg as a single night time dose. The use of Phenergan tablets to provide these doses is recommended. |
|
4.3 Contra-Indications |
Phenergan should not be used in patients in coma or suffering from CNS depression of any cause.
Phenergan should not be given to patients with a known hypersensitivity to promethazine or to any of the excipients.
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.
4.4 Special Warnings and Special Precautions for Use
Phenergan may thicken or dry lung secretions and impair expectoration. It should therefore be used with caution in patients with asthma, bronchitis or bronchiectasis.
Use with care in patients with severe coronary artery disease, narrow angle glaucoma, epilepsy or hepatic and renal insufficiency.
Caution should be exercised in patients with bladder neck or pyloro-duodenal obstruction.
The use of promethazine should be avoided in children and adolescents with signs and symptoms suggestive of Reye’s Syndrome.
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.
Phenergan Elixir should not be used for longer than 7 days without seeking medical advice.
Phenergan Elixir contains Maltitol. 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 25ml single dose of Phenergan Elixir is equivalent to approximately 5 grams 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.
Phenergan Elixir contains sodium. The maximum 25ml single dose is equivalent to approximately 185mg of sodium. This should be taken into account if you are on a controlled sodium diet.
Phenergan Elixir contains sodium sulphite anhydrous and sodium metabisulphite these may rarely cause severe hypersensitivity reaction and bronchospasm.
4.5 Interaction with other medicinal products and other forms of interaction
Phenergan will enhance the action of any anticholinergic agent, tricyclic antidepressant, sedative or hypnotic. Alcohol should be avoided during treatment. Phenergan may interfere with immunological urine pregnancy tests to produce falsepositive 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.
4.6 Fertility, pregnancy and lactation
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.
Available evidence suggests that the amount excreted in milk is insignificant. However, there are risks of neonatal irritability and excitement.
4.7 Effects on ability to drive and use machines
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.
4.8 Undesirable effects
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).
Side effects may be seen in a few patients: drowsiness, dizziness, restlessness, headaches, nightmares, tiredness, and disorientation. Anticholinergic side effects such as blurred vision, dry mouth and urinary retention occur occasionally. Infants are susceptible to the anticholinergic effects of promethazine, while other children may display paradoxical hyperexcitability. The elderly are particularly susceptible to the anticholinergic effects and confusion due to promethazine. Other side effects include urticaria, rash, pruritus, anorexia, gastric irritation, palpitations, hypotension, arrhythmias, extrapyramidal effects, muscle spasms and tic-like movements of the head and face. Anaphylaxis, jaundice and blood dyscrasias including haemolytic anaemia rarely occur. Photosensitive skin reactions have been reported.
Strong sunlight should be avoided during treatment.
The preservatives used in Phenergan Elixir have been reported to cause hypersensitivity reactions, characterised by circulatory collapse with CNS depression in certain susceptible individuals with allergic tendencies.
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.
4.9 Overdose
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. 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 other suitable anticonvulsant.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
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.
5.2 Pharmacokinetic 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.
5.3 Preclinical safety data
No additional preclinical data of relevance to the prescriber.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
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
6.2 Incompatibilities
None stated.
6.3 Shelf life
2 years when unopened. 1 month when opened.
6.4 Special precautions for storage
Store below 25oC. Keep the bottle in the outer carton in order to protect from light.
6.5 Nature and contents of container
Amber glass type III bottle containing 100 ml. Rolled on pilfer proof aluminium cap and PVDC emulsion coated wad, or HDPE/polypropylene child resistant cap with tamper evident band.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
Aventis Pharma Limited
One Onslow Street
Guildford
Surrey
GU1 4YS
UK
Or trading as:-
Sanofi-aventis or Sanofi One Onslow Street Guildford Surrey
GUI 4YS UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 04425/0630
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 03 October 2008
10 DATE OF REVISION OF THE TEXT
12/10/2015