SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Phenergan 10 mg Tablets

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 10mg of the active substance Promethazine hydrochloride.

Also contains 69.41mg of lactose monohydrate.

For full list of excipients, see section 6.1

3    PHARMACEUTICAL FORM

Film-coated tablet (Tablet)

Pale blue film coated tablets marked PN 10 on one 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.

Not for use in children under the age of 2 years (see section 4.3)

Children 2-5 years	The use of Phenergan Elixir 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 Phenergan Elixir 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 Phenergan Elixir 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.

4.3 Contraindications

Phenergan should not be used in patients in coma or suffering from CNS depression of any cause.

Phenergan should not be given to patients with a known hypersensitivity to promethazine or to 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.

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

4.4 Special warnings and precautions for use

Phenergan 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.

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.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

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

4.5 Interaction with other medicinal products and other forms of interaction

Phenergan will enhance the action of any anticholinergic agent, tricyclic antidepressant, sedative or hypnotic. Alcohol should be avoided during treatment. Phenergan may interfere with immunological urine pregnancy tests to produce falsepositive or false-negative results. Phenergan 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

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.

4.7

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

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. 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: Anthihistamines 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 PARTICULARS

6.1    List of excipients

Lactose monohydrate Maize starch Povidone K30 Magnesium stearate Polyethylene glycol 200 Hypromellose (Pharmacoat 606)

Colouring agent: Opaspray M-1-4210A Titanium dioxide (E 171)

Hypromellose (E464)

Indigo carmine aluminium lake FD&C Blue no 2 (E132)

6.2    Incompatibilities

Not applicable

6.3    Shelf life

3 years.

6.4    Special precautions for storage

Store below 30^oC. Store in the original carton in order to protect from light.

6.5    Nature and contents of container

High density polyethylene bottles or securitainers containing 50 or 500 tablets.

Opaque white 250pm uPVC coated with 40gsm PVdC, 20pm hard temper aluminium foil (coated with vinyl heat seal lacquer) backing, in cartons of 56 tablets. Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements

7    MARKETING AUTHORISATION HOLDER

Aventis Pharma Limited

One Onslow Street

Guildford

Surrey

GUI 4YS

UK

Or trading as:-

Sanofi-aventis or Sanofi

One Onslow Street

Guildford

Surrey

GU1 4YS

UK

8    MARKETING AUTHORISATION NUMBER(S)

PL 04425/0631

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 3 October 2008

10 DATE OF REVISION OF THE TEXT

16/11/2015