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SANOFI

Citywest Business Campus, Dublin 24, Ireland
Telephone: +353 1 4035600
Fax: +353 1 4035687
Medical Information e-mail: iemedinfo@sanofi.com


Summary of Product Characteristics last updated on medicines.ie: 02/10/2012
SPC Phenergan 5mg/5ml Oral Solution



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1. NAME OF THE MEDICINAL PRODUCT

Phenergan 5mg/5ml Oral Solution.


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 5ml spoonful contains Promethazine Hydrochloride 5mg.

Excipients: Contains Sodium sulphite (E221) 5.0mg, Sodium Benzoate (E211) 5.0mg, Malitol Liquid 4.44g.

For a full list of excipients, see section 6.1.


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3. PHARMACEUTICAL FORM

Oral solution.

A clear bright golden syrup with an odour of oranges.


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

In the treatment of allergic conditions and reactions.

As an antiemetic.


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4.2 Posology and method of administration

Route of administration: Oral

Not for use in children under the age of 2.

Adults:

The usual daily dose is 25-75mg as a single daily dose or in 3 divided doses, starting with the lower dose.

Children:

Children 2-5 years:

 

1-3 x 5ml spoonfuls (5-15mg) once daily at bedtime.

 

Children 5-10 years:

 

2-5 x 5ml spoonfuls (10-25mg) once daily at bedtime.

 

When two doses are required in 24 hours, the lower dose should be used.


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4.3 Contraindications

Phenergan should not be used in patients in pre-coma states, in a coma or suffering from CNS depression of any cause.

It must not be given to neonates, or premature infants.

Phenergan should not be given to patients with a known hypersensitivity to promethazine or to any of the excipients.

Phenergan should be avoided in patients with blood dycrasias and in patients taking monoamine oxidase inhibitors up to 14 days previously.

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


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4.4 Special warnings and precautions for use

Caution should be used in patients with pre-existing coronary insufficiency. Adjustment of dosage may be necessary to avoid postural hypotension, especially in the elderly.

Since the drug is metabolized in the liver, promethazine should be used cautiously in patients with hepatic impairment.

Prolonged treatment with this product may result in jaundice or blood dyscrasia necessitating regular monitoring of liver function and haemopoietic state.

Particular attention should also be paid to potential for inducing eye changes and myocardial conduction defects, especially if other concurrently administered drugs also have potential effects on these systems.

Body temperature may fall during treatment with this product and special care should be exercised in this regard in the elderly.

Promethazine should only be used cautiously in epileptic patients, since central nervous stimulation may sometimes occur. Caution should also be exercised in patients with narrow angle glaucoma, renal insufficiency, bladder-neck or pyloro-duodenal obstruction.

Promethazine may thicken or dry lung secretions and impair expectoration. It should be used with caution in patients with asthma, bronchitis or bronchiectasis.

Promethazine may delay the elderly diagnosis of intestinal obstruction or increased intracanial pressure through the suppression of vomiting.

Promethazine may mask the warning signs of ototoxicity caused by ototoxic drugs e.g. salicylates.

Neuroleptic malignant syndrome: The syndrome may occur with the use of any neuroleptic agent. Symptoms include clouding of consciousness, rigidity and other extrapyramidal effects, and autonomic dysfunction, most importantly hyperpyrexia. Treatment involves the immediate cessation of neuroleptic therapy and symptomatic management as appropriate.

Phenothiazines should be used with caution in patients with cardiac disease or cardiac arrhythmias.

The use of promethazine should be avoided in children and in adolescents with signs and symptoms suggestive of Reye's Syndrome.

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


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4.5 Interaction with other medicinal products and other forms of interaction

The product may potentiate the effects of alcohol and other central nervous system depressants.

Attention is drawn to the fact that many psychotropic and anti-histamine drugs are of the phenothiazine group, and a combination of both may lead to toxicity. Potentiation of action may also occur with monoamine oxidase inhibitors and analgesics. Use of promethazine should be avoided in patients taking monoamine oxidase inhibitors up to 14 days previously.

Antihypertensive therapy used concurrently may need adjustment of dosage to avoid hypotension, particularly in the elderly.

Promethazine may interfere with immunological urine pregnancy tests.

Phenergan should be discontinued at least 72 hours before commencing skin tests using allergen extracts, as the cutaneous histamine response may be inhibited.

Promethazine may lower the convulsion threshold. Dosage adjustment of anticonvulsant medication may be necessary.

Concurrently use of promethazine with other hepatotoxic medications may increase the potential for hepatotoxicity.

Concurrent use with other photosensitizing medications, e.g. tetracyclines, may cause additive photosensitizing effects.


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4.6 Pregnancy and lactation

Phenergan 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.


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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.


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4.8 Undesirable effects

The following side effects have been observed: drowsiness or dizziness, restlessness, headaches, nightmares, tiredness or disorientation. Anti-cholinergic side effects such as blurred vision, dry mouth and urinary retention occur occasionally. Children may display paradoxical hyperexcitability. Anaphylaxis, jaundice and blood dyscrasias including haemolytic anaemia rarely occur.

Use of this product at high (relative or absolute) doses may induce extra pyramidal side effects e.g. dyskinesia, akathisia, dystonia, especially in the presence of pre-existing brain damage. These are likely to be particularly severe in children. Children may also display parodoxical hyperexcitability.

Prolonged administration of this product may result in persistent or tardive dyskinesias particularly in the elderly. Other side effects in the elderly include anorexia, gastric irritation, palpitations, hypotension, arrhythmias, extrapyramidal effects, muscle spasms, and tic-like movements of the head and face.

The effect of phenothiazines on the heart are dose related. ECG changes, with prolongation of QT interval and T-wave changes have been reported commonly in patients treated with moderate or high dose; they are reversible on reducing the dose. In a very small percentage of cases they have been reported to precede serious arrhythmias, including ventricular tachycardia and fibrillation, which have also occurred after overdosage. Sudden, unexpected and unexplained deaths have been reported in patients receiving phenothiazines.

Very rare cases of allergic reactions, including urticaria, rash, pruritus and anaphalyxis have been reported. Photosensitive skin reactions have been reported. Strong sunlight should be avoided during treatment.


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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 may precede their occurrence. Tachycardia may develop. Cardiorespiratory depression is not 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.


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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

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


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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.


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5.3 Preclinical safety data

No additional pre-clinical data of relevance to the prescriber.


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipient(s)

Malitol, liquid

Citric acid (E330)

Sodium citrate

Ascorbic acid

Sodium sulphite anhydrous (E221)

Sodium benzoate (E211)

Orange juice flavour 510844E

Caramel HT (E150)

Acesulfame potassium (E950)

Purified water

Sodium metabisulphite


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6.2 Incompatibilities

Not applicable.


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6.3 Shelf life

Unopened : 2 years.

Use within 1 month of opening bottle.


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6.4 Special precautions for storage

Do not store above 25°C. Store in the original container in order to protect from light.


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6.5 Nature and contents of container

100ml Amber glass type III bottle with a rolled on, pilfer proof aluminium cap and a PVDC emulsion coated wad or HDPE/polypropylene child resistant closure with a tamper evident band packed in a outer box.


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6.6 Special precautions for disposal and other handling

No special requirements.


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7. MARKETING AUTHORISATION HOLDER

sanofi-aventis Ireland Ltd. T/A SANOFI

Citywest Business Campus

Dublin 24


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8. MARKETING AUTHORISATION NUMBER(S)

PA 540/121/1


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

1st April 1979/1st April 2009


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10. DATE OF REVISION OF THE TEXT

25 April 2012



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Active Ingredients

 
   Promethazine hydrochloride