Phenergan^TM 25 mg Tablets.

Promethazine hydrochloride 25 mg.

Pale blue film coated tablets marked PN 25 on one side.

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 adjunct in preoperative sedation in surgery and obstetrics.

As an antiemetic.

For short term use:

Sedation and treatment of insomnia in adults.

As a paediatric sedative.

Route of administration: Oral.

Not for use in children under the age of 2 years because the safety of such use has not been established.

As an antihistamine in allergy:

*Single doses are best taken at night.

As an antiemetic:

Short term sedation:

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.

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.

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 false-positive 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.

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.

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.

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.

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.

Potent, long acting, antihistamine with additional anti-emetic central sedative and anti-cholinergic 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.

No additional preclinical data of relevance to the prescriber.

Lactose

Maize starch

Povidone K30

Magnesium stearate

Polyethylene glycol 200

Opaspray M-1-4210A (contains Titanium dioxide- E171, Hypromellose- E464 and Indigo carmine aluminium lake FD&C Blue no 2- E132 )

Hypromellose (Pharmacoat 606).

None stated.

60 months.

Protect from light. Store below 30^oC.

Opaque white 250µm uPVC coated with 40gsm PVdC. 20µm hard temper aluminium foil (coated with vinyl heat seal lacquer) backing of 56 tablets.

None stated.

Sanofi-aventis

One Onslow Street

Guildford

Surrey

GU1 4YS

UK

PL 04425/0281

17 July 2006

1 March 2007

P