Summary of medicine characteristics - PROMETHAZINE HYDROCHLORIDE 25 MG FILM-COATED TABLETS
1 NAME OF THE MEDICINAL PRODUCT
Promethazine hydrochloride 25mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25mg of Promethazine hydrochloride.
Excipient with known effect
Each tablet contains 179 mg of lactose monohydrate.
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated Tablet
Round, pale blue colored, biconvex, bevelled edge film coated tablets, debossed with ‘L11’ on one side and plain on other side.
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.
Promethazine 25 mg film-coated tablets are not recommended for use in children under 5 years.
Promethazine is contraindicated in children under the age of 2 years (see section 4.3).
As an antihistamine in allergy:
| Children 2–5 years | Promethazine 25 mg film-coated tablets are not suitable for this age group. Other strengths and pharmaceutical forms of promethazine may be available. (Promethazine Hydrochloride Liquid). |
| Children 5–10 years | 25 mg as a single dose*. Maximum daily dose 25 mg. |
| Children over 10 years and adults (including elderly) | 25 mg as a single dose*. Increasing to a maximum of 25 mg bd as required. |
*Single doses are best taken at night.
As an antiemetic:
| Children 2–5 years | The use of Promethazine Hydrochloride Liquid is recommended for this age group. Promethazine 25 mg film-coated tablets are not suitable for this age group. Other strengths and pharmaceutical forms of promethazine may be available. |
| Children 5–10 years | The use of Promethazine Hydrochloride Liquid or Promethazine Hydrochloride 10 mg Tablets is recommended. Promethazine 25 mg film-coated tablets are not suitable for this age group. Other strengths and pharmaceutical forms of promethazine may be available. |
| 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 | The use of Promethazine Hydrochloride Liquid is recommended for this age group. Promethazine 25 mg film-coated tablets are not suitable for this age group. Other strengths and pharmaceutical forms of promethazine may be available. |
| Children 5–10 years | 25 mg as a single night time dose. |
| Children over 10 years and adults (including elderly) | 25 or 50 mg as a single night time dose. |
4.3 Contraindications
Promethazine hydrochloride should not be used in patients in coma or suffering from
CNS depression of any cause
Promethazine hydrochloride 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 is contraindicated for use in children less than two years of age because of the potential for fatal respiratory depression.
Promethazine hydrochloride should be avoided in patients taking monoamine oxidase inhibitors up to 14 days previously
4.4 Special warnings and precautions for use
Promethazine Hydrochloride 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.
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.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Promethazine Hydrochloride should not be used for longer than 7 days without seeking medical advice.
Paediatric population
The use of promethazine should be avoided in children and adolescents with signs and symptoms suggestive of Reye’s Syndrome.
4.5 Interaction with other medicinal products and other forms of interaction Promethazine Hydrochloride will enhance the action of any anticholinergic agent, tricyclic anti- depressant, sedative or hypnotic. Alcohol should be avoided during treatment. Promethazine Hydrochloride may interfere with immunological urine pregnancy tests to produce false- positive or falsenegative results. Promethazine Hydrochloride 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 Hydrochloride should not be used in pregnancy unless the physician considers it essential. The use of Promethazine Hydrochloride 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.
Fertility
No data available
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.
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
4.9 OverdoseSymptoms 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. 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
5.3 Preclinical safety dataNo additional pre-clinical data of relevance to the prescriber.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Lactose monohydrate
Maize starch
Povidone K30
Magnesium stearate
Colourant: Opadry 03F505142 Blue
Titanium dioxide (E 171) Hypromellose (E464)
Macrogol/Polyethylene glycol (E1521)
Indigo carmine aluminium lake FD&C Blue no 2 (E132)
6.2 Incompatibilities
Not applicable
6.3 Shelf life
30 months
6.4 Special precautions for storage
Store below 30oC. Store in the original package in order to protect from light.
6.5 Nature and contents of container
White opaque PVC-PVDC 250 microns/20 microns Aluminium foil coated with VMCH in blister packs of 28, 56, 84 and 100 tablets. Not all pack sizes may be marketed.
6.6 Special precautions for disposal
6.6 Special precautions for disposalNo special requirements
7 MARKETING AUTHORISATION HOLDER
Noumed Life Sciences Limited
Noumed House, Shoppenhangers Road,
Maidenhead, Berkshire, SL6 2RB, UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 44041/0171
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
19/11/2020