Summary of Product Characteristics (SmPC) - Promethazine Hydrochloride 10 mg film-coated tablets
1 NAME OF THE MEDICINAL PRODUCT
Promethazine hydrochloride 10 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg of promethazine hydrochloride.
Excipients with known effect:
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.
For full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Film-coated tablet
White to off-white coloured round shaped, biconvex film coated tablet debossed with "P10" on one side and plain on other side, 6.00 mm (± 0.30 mm) in diameter.
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.
For short term use as a paediatric sedative.
4.2 Posology and method of administration
Paediatric population
Not for use in children under the age of 2 years (see section 4.3). The use of Promethazine liquid is recommended for children aged 2-5 years.
| As an antihistamine in allergy: |
| Children 5-10 years | Either 10 mg or 20 mg as a single dose*. Or 10 mg twice a day . Maximum daily dose 20 mg. |
| Children over 10 years and adults (including elderly) | Initially 10 mg twice a day. Increasing to a maximum of 20 mg three times a day as required. |
| *Single doses are best taken at night. | ||
| As an antiemetic: | ||
| 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 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
For oral administration.
4.3 Contraindications
Hypersensitivity to the active substance, other phenothiazines, 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 should not be used for longer than 7 days without seeking medical advice.
Caution should be used in patients with:
- Asthma, bronchitis or bronchiectasis. Promethazine 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
Hypersensitivity reactions including anaphylaxis, urticaria and angioedema have been reported with promethazine use. In case of allergic reaction, treatment with Promethazine must be discontinued and appropriate symptomatic treatment initiated (see Section 4.8).
Promethazine should be avoided in patients with liver or renal dysfunction, Parkinson’s disease, hypothyroidism, cardiac failure, pheochromocytoma, myasthenia gravis, or prostate hypertrophy, or in patients with a history of narrow angle glaucoma or agranulocytosis.
Caution must be exercised when using H1-antihistamines such as Promethazine due to the risk of sedation. Combined use with other sedative medicinal products is not recommended (see section 4.5).
Ototoxicity
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 interval
As phenothiazines can prolong the QT interval, caution is advised in treated patients with pronounced bradycardia, cardiovascular disease, with a hereditary form of prolongation of the QT interval and concomitant use with other products leading to QT prolongation.
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.
Alcohol and alcohol-containing medicines should be avoided while on this medicine (see section 4.5).
Phenothiazines may be additive with, or may potentiate the action of, other CNS depressants such as opiates or other analgesics, barbiturates or other sedatives, general anesthetics, or alcohol.
The occurrence of unexplained infections or fever may be evidence of blood dyscrasia (see section 4.8) and requires immediate hematological investigation.
All patients should be advised that, if they experience fever, sore throat or any other infection, they should inform their physician immediately and undergo a complete blood count. Treatment should be discontinued if any marked changes (hyperleucocytosis, granulocytopenia) are observed in the blood count.
Excipients with known effect
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free.’
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. Combination with alcohol enhances the sedative effects of H1 antihistamines.
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.
Special caution is required when promethazine is used concurrently with other products leading to QT prolongation, including medicinal products such as antipsychotics, i.e., some phenothiazines (chlorpromazine, levomepromazine), benzamides (sulpiride, amisulpride, tiapride), pimozide, haloperidol, droperidol, citalopram, halofantrin, methadone, pentamidine, and moxifloxacine.
Cytochrome P450 2D6 Metabolism: Some phenothiazines are moderate inhibitors of CYP2D6. There is a possible pharmacokinetic interaction between inhibitors of CYP2D6, such as phenothiazines, and CYP2D6 substrates. Co administration of promethazine with
amitriptyline/amitriptylinoxide, a CYP2D6 substrate, may lead to an increase in the plasma levels of amitriptyline/amitriptylinoxide. Monitor patients for dose-dependent adverse reactions associated with
amitriptyline/amitriptylinoxide.
Promethazine should be avoided in patients taking monamine oxidase inhibitors within the previous 14 days, and monamine oxidase inhibitors should be avoided while using promethazine.
Seizure threshold-lowering drugs: Concomitant use of seizure-inducing drugs or seizure threshold-lowering drugs should be carefully considered due to the severity of the risk for the patient (see section 4.4).
Gastro-intestinal agents that are not absorbed (magnesium, aluminium and calcium salts, oxides and hydroxides): Reduced gastro-intestinal absorption of phenothiazines may occur. Such gastro-intestinal agents should not be taken at the same time as phenothiazines (at least 2 hours apart, if possible).
Drugs with anticholinergic properties: Concomitant use of Promethazine with drugs with anticholinergic properties enhances the anticholinergic effect
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. When promethazine has been given in high doses during late pregnancy, promethazine has caused prolonged neurological disturbances in the infant.
Advise patients to inform their healthcare provider of a known or suspected pregnancy. Advise patients to avoid becoming pregnant while receiving this medicine. Advise female patients of reproductive potential to use effective contraception.
There are no available animal studies regarding reproductive toxicity.
Breast-feeding
Promethazine is excreted in breast milk (see section 5.2). There are risks of neonatal irritability and excitement. Promethazine is not recommended for use in breast- feeding.
Fertility
There are no relevant fertility data in animals.
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, dizzy and have blurred vision, 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).
Immune system disorders
Frequency not known: Allergic reactions, including urticaria, rash, pruritus, angioedema and anaphylactic reactions have been reported.
Skin and subcutaneous tissue disorders
Frequency not known: Rash, photosensitivity reaction
Nervous system disorders
Very common: Somnolence, sedation
Frequency not known: dizziness, headaches, extrapyramidal effects, restless legs syndrome, muscle spasms and tic-like movements of the head and face, neuroleptic malignant syndrome, psychomotor hyperactivity.
Frequency not known: Dystonia, including oculogyric crisis, usually transitory are commoner in children and young adults, and usually occur within the first 4 days of treatment or after dosage increases.
Frequency not known: Anticholinergic effects such as ileus paralytic, risk of urinary retention, constipation, accommodation disorder.
The elderly are particularly susceptible to the anticholinergic effects and confusion due to promethazine.
Frequency not known: Children less than 6 years of age also experienced psychomotor hyperactivity.
Psychiatric disorders
Frequency not known: Agitation, confusional state, anxiety, hallucinations, aggression.
Frequency not known: Infants, newborns and premature are susceptible to the anticholinergic effects of promethazine, while other children may display paradoxical hyperexcitability, restlessness, nightmares, and disorientation.
Frequency not known: children less than 6 years of age also experienced aggression and hallucination.
Eye disorders
Frequency not known: Blurred vision
Gastrointestinal disorders
Frequency not known: Epigastric irritation/discomfort, dry mouth
Renal and urinary disorders
Frequency not known: Urinary retention
Metabolism and nutrition disorders
Frequency not known: decreased appetite
Cardiac disorders
Frequency not known: Palpitations, arrhythmias, QT prolongation, Torsade de pointes
Vascular disorders
Frequency not known: Hypotension
Respiratory, thoracic and mediastinal disorders
Frequency not known: Respiratory depression (see Section 4.4), nasal congestion
Hepatobiliary disorders
Frequency not known: Jaundice cholestatic
Blood and lymphatic system disorders
Frequency not known: Blood dyscrasias including haemolytic anaemia. Agranulocytosis, leukopenia, eosinophilia, thrombocytopenia (including thrombocytopenia purpura).
General and administration site conditions
Frequency not known: 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.
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
4.9 Overdose
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. Prolonged QT interval and cases of severe arrhythmias with fatal outcome have been described in overdose of phenothiazines.
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.
In the event of overdose of promethazine, take all appropriate measures immediately.
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 PROPERTIES
6.1 List of excipients
Tablet core
Calcium hydrogen phosphate dihydrate Cellulose microcrystalline type 101 Sodium starch glycolate (Type A) Stearic Acid
Magnesium stearate
Tablet coating
Opadry White 03A28437 containing: Hypromellose, type 2910 (E464) Titanium dioxide (E171)
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
24 months
6.4 Special precautions for storage
This medicinal product does not require any special storage condition.
6.5 Nature and contents of container
Packaged in Opaque PVC/PVDC/Al blister. Pack size 56 tablets
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
Manx Healthcare Limited
Unit 2
Bosworth Avenue
Tournament Fields
Warwick
CV34 6UQ
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 14251/0313
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
30/05/2024
10 DATE OF REVISION OF THE TEXT
28/10/2025