Summary of medicine characteristics - PROMETHAZINE HYDROCHLORIDE 10 MG TABLETS
1 NAME OF THE MEDICINAL PRODUCT
Promethazine Hydrochloride 10 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg of the active substance Promethazine Hydrochloride BP Excipients with known effect
Also contains 23.6 mg of lactose and 33.7 mg of Sucrose
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Sugar-coated tablet
Blue sugar coated tablets
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
Posology
Not for use in children under the age of 2 years (see section 4.3).
As an antihistamine in allergy:
| Children 2–5 years | The use of Promethazine liquid is recommended for this age group. |
| Children 5–10 years | Either 10 or 20 mg as a single dose*. Or 10 mg bd. Maximum daily dose 20 mg. |
| Children over 10 years and adults (including elderly) | Initially 10 mg bd. Increasing to a maximum of 20 mg tds as required. |
*Single doses are best taken at night.
As an antiemetic:
| Children 2–5 years | The use of Promethazine liquid is recommended for this age group. |
| 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) | 20 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 | The use of Promethazine liquid is recommended for this age group. |
| Children 5–10 years | 20 mg as a single night time dose. |
| Children over 10 years and adults (including elderly) | 20 to 50 mg as a single night time dose |
Method of administration Oral
4.3 Contraindications
Promethazine should not be given to patients with a known hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Promethazine 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.
Promethazine should be avoided in patients taking monoamine oxidase inhibitors up to 14 days previously.
4.4 Special warnings and precautions for use
Promethazine 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 and hepatic or 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.
Promethazine should not be used for longer than 7 days without seeking medical advice.
This medicine contains Lactose. Patients with a rare hereditary problem of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
This medicine contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
4.5 Interaction with other medicinal products and other forms of interaction Promethazine will enhance the action of any anticholinergic agent, tricyclic antidepressant, sedative or hypnotic.
Alcohol should be avoided during treatment.
Promethazine may interfere with immunological urine pregnancy tests to produce false-positive or false-negative results. Promethazine 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
Pregnancy
Promethazine should not be used in pregnancy unless the physician considers it essential. The use of promethazine is not recommended in the 2 weeks prior to delivery in view of the risk of irritability and excitement in the neonate.
Breast-feeding
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 (>1/1,000 to <1/100); rare (>1/10,000 to <1/1,000); 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, restless leg syndrome, 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.
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 the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
4.9 OverdoseSymptoms
Symptoms of severe overdosage are variable. They are characterised in children by various combinations of excitation, ataxia, inco-ordination, 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.
Cardiorespiratory depression is uncommon.
Management
If the patient is seen soon enough after ingestion, it should be possible to induce vomiting with ipecacuanha despite the anti-emetic 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.
5.1 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
5.3 Preclinical safety dataNo additional preclinical data of relevance to the prescriber.
6.1
Lactose
Maize Starch
Pregelatinised Maize Starch
Magnesium Stearate
Bleached Shellac
Talc
Titanium Dioxide
Polyvinylpyrrolidone K25 Opalux Blue AS-F-4321G Sucrose
Beeswax
Carnauba Wax
6.2 Incompatibilities
Promethazine Hydrochloride is incompatible with alkaline substances which precipitate Promethazine Base.
6.3 Shelf life
36 Months
6.4 Special precautions for storage
Store below 25°C
6.5 Nature and contents of container
Blister of 250 micron PVC and 20 micron aluminium foil, with 5/6 gsm heatseal lacquer on the dull side and printed on the bright side. Pack sizes: 16 and 56.
6.6 Special precautions for disposal
6.6 Special precautions for disposalNot applicable