SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Promethazine Hydrochloride 25 mg Tablets

2    QUALITATIVE AND QUANTITATIVE    COMPOSITION

Each tablet contains 25 mg of the active substance promethazine hydrochloride.

Also contains 35.4 mg of lactose and 51.5 mg of sucrose.

For the full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Sugar coated tablet

Blue sugar-coated circular tablet

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

As symptomatic treatment of allergic conditions of the upper respiratory tract and skin including allergic rhinitis, urticaria and anaphylactic reactions to drug or 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 2 years of age (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	The use of Promethazine liquid or Promethazine 10mg tablet is recommended.
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 liquid is recommended for this age group.
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 should not be used in patients in coma or suffering from CNS depression of any cause.

Promethazine should not be given to patients with a known hypersensitivity to the active ingredient or 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.

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 care 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 pyloroduodenal obstruction.

There have been case reports of drug abuse with promethazine. The risk of abuse is greater in patients with a history of drug abuse.

As with neuroleptics, Neuroleptic Malignant Syndrome (NMS) characterized by hyperthermia, extrapyramidal disorders, muscle rigidity, altered mental status, autonomic nervous instability and elevated CPK, may occur. As this syndrome is potentially fatal, promethazine must be discontinued immediately and intensive clinical monitoring and symptomatic treatment should be initiated.

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.

Patients with rare hereditary problems of lactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption 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, 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

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.

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

Ambulant patients receiving Promethazine should not be in control of vehicles or machinery for the first few days until it is established that they are not hypersensitive to the Central Nervous System effects of the drug, and do not suffer from confusion, disorientation or dizziness.

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.

Occasionally, anticholinergic side effects such as dry mouth, blurred vision, difficulty in lachrymation, constipation and urinary retention may be seen in a few patients. Retention of urine may exacerbate the symptoms of prostatism.

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 rarer side effects include urticaria, rash, pruritus, anorexia, gastric irritation, arrhythmias, hypotension, palpitations, extrapyramidal effects, muscle spasms and tic-like movements of the head and face, confusion, depression.

Anaphylaxis, jaundice and blood dyscrasias including haemolytic anaemia rarely occur. Hypersensitivity reactions include bronchospasm, angioedema and photosensitive skin reactions have been reported; strong sunlight should be avoided during treatment.

Not known (cannot be estimated from the available data): Neuroleptic Malignant Syndrome

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

The symptoms of severe overdose 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.

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

Promethazine Hydrochloride is a potent, long acting, antihistaminic phenothiazine derivative with additional anti-emetic central sedative properties. It also has some anticholinergic, antiserotoninergic and marked local anaesthetic properties. Promethazine Hydrochloride diminishes the main actions of histamine in the body, probably by occupying the receptor sites in the effector cells to the exclusion of histamine, but does not prevent the production of histamine.

Promethazine is a H₁-receptor antagonist and thereby mediates the contraction of smooth muscle and the dilation and increased permeability of the capillaries.

5.2    Pharmacokinetic properties

Promethazine is distributed widely in the body. It enters the brain and crossesd the placenta. 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

Lactose Maize Starch

Pregelatinised Maize Starch Magnesium Stearate Bleached Shellac Talc

Titanium Dioxide

Polyvinylpyrrolidone

Opalux Blue AS-F-4312G

Sucrose

Beeswax

Carnauba Wax

Incompatibilities

Promethazine Hydrochloride is incompatible with alkaline substances which precipitate Promethazine Base.

6.3 Shelf life

Polystyrene/polypropylene containers - 36 months. PVC/Aluminium blister-packs -24 months.

6.4 Special precautions for storage

Promethazine Hydrochloride 25 mg: Store in the original package. Protect

from light. Store below 25°C.

Promethazine Hydrochloride 25 mg: Keep container well closed. Protect from light. Store below 25°C.

6.5 Nature and contents of container

Promethazine Hydrochloride 25 mg:

PVC/Aluminium foil blister-packs of 10 (max 14)

Promethazine Hydrochloride 25 mg:

High-density polystyrene with polythene lids and/or polypropylene containers with polypropylene or polythene lids and polyurethane/polythene inserts. Packs of 100, 500 and 1000.

or

PVC/Aluminium foil blister-packs of 14, 28, 30 and 56.

6.6 Special precautions for disposal

Not applicable.

7    MARKETING AUTHORISATION HOLDER

Chelonia Healthcare Limited Boumpoulinas 11, 3 ^rd Floor

NICOSIA CYPRUS P.C.1060 CYPRUS

8    MARKETING AUTHORISATION NUMBER(S)

PL 33414/0092

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

10 August 1990 / Renewed 03 December 1998

10 DATE OF REVISION OF THE TEXT

16/05/2016