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Phenergan 25 mg tablets

Active Ingredient:
promethazine hydrochloride
SANOFI Consumer Healthcare See contact details
ATC code: 
About Medicine
{healthcare_pro_orange} This information is for use by healthcare professionals
Last updated on emc: 10 Jul 2023
1. Name of the medicinal product

Phenergan 25 mg Tablets

2. Qualitative and quantitative composition

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

Excipient(s) with known effect:

Also contains 173.52 mg of lactose monohydrate.

For the full list of excipients, see section 6.1.

3. Pharmaceutical form


Pale blue film coated tablets marked PN 25 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

Paediatric population

Not for use in children under the age of 2 years (see section 4.3). The use of Phenergan Elixir is recommended for children aged 2 – 5 years.

As an antihistamine in allergy:

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 twice a day as required.

*Single doses are best taken at night.

As an antiemetic:

Children 5 – 10 years

The use of Phenergan Elixir or Phenergan 10 mg Tablets 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 5 – 10 years

25 mg as a single night time dose.

Children over 10 years and adults (including elderly)

25 mg or 50 mg as a single night time dose.

Method of administration

For oral administration.

4.3 Contraindications

• Phenergan should not be given to patients with a known hypersensitivity to promethazine or to any of the excipients listed in section 6.1.

• Phenergan 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.

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

4.4 Special warnings and precautions for use

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

Caution should be used in patients with:

• asthma, bronchitis or bronchiectasis. Phenergan 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


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 prolongation

Phenothiazine derivatives may potentiate QT interval prolongation which increases the risk of onset of serious ventricular arrhythmias of the torsade de pointes type, which is potentially fatal (sudden death). QT prolongation is exacerbated, in particular, in the presence of bradycardia, hypokalaemia, and acquired (i.e. drug induced) QT prolongation. If the clinical situation permits, medical and laboratory evaluations should be performed to rule out possible risk factors before initiating treatment with a phenothiazine derivative and as deemed necessary during treatment (see section 4.8).

Photosensitivity reactions

Due to the risk of photosensitivity, exposure to strong sunlight or ultraviolet light should be avoided during or shortly after treatment (see section 4.8).

Paediatric population

The use of promethazine should be avoided in children and adolescents with signs and symptoms suggestive of Reye's Syndrome.

Excipient(s) with known effect

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

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. Combination with alcohol enhances the sedative effects of H1 antihistamines.

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.

Special caution is required when promethazine is used concurrently with drugs known to cause QT prolongation (such as antiarrhythmics, antimicrobials, antidepressants, antipsychotics) to avoid exacerbation of risk of QT prolongation.

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.


Phenergan is excreted in breast milk (see section 5.2). There are risks of neonatal irritability and excitement. Phenergan is not recommended for use in breast-feeding.

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).

Immune system disorders

Allergic reactions, including urticaria, rash, pruritus and anaphylactic reactions have been reported.

Skin and subcutaneous tissue disorders

Photosensitive skin reactions have been reported.

Nervous system disorders

Somnolence, dizziness, headaches, extrapyramidal effects including restless legs syndrome, muscle spasms and tic-like movements of the head and face.

The elderly are particularly susceptible to the anticholinergic effects and confusion due to promethazine.

Psychiatric disorders

Restlessness, nightmares, and disorientation.

Infants (newborn and premature) are susceptible to the anticholinergic effects of promethazine, while other children may display paradoxical hyperexcitability.

Eye disorders

Blurred vision

Gastrointestinal disorders

Epigastric irritation/discomfort, dry mouth

Renal and urinary disorders

Urinary retention

Metabolism and nutrition disorders


Cardiac disorders

Palpitations, arrhythmias (including QT prolongation and torsade de pointes)

Vascular disorders


Hepatobiliary disorders


Blood and lymphatic system disorders

Blood dyscrasias including haemolytic anaemia rarely occur. Agranulocytosis.

General and administration site conditions


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: or search for MHRA Yellow Card in the Google Play or Apple App Store.

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. Tachycardia may develop. Cardiorespiratory depression is uncommon. High doses (supratherapeutic doses) can cause ventricular arrhythmias including QT prolongation and torsade de pointes (see section 4.8).


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.

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 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 (E171)

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° C. Store in the original carton in order to protect from light.

6.5 Nature and contents of container

Opaque white 250µ m uPVC coated with 40gsm PVdC. 20µ m 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 and other handling

No special requirements

7. Marketing authorisation holder

Opella Healthcare UK Limited, trading as Sanofi

410 Thames Valley Park Drive,



RG6 1PT,

United Kingdom.

8. Marketing authorisation number(s)

PL 53886/0055

9. Date of first authorisation/renewal of the authorisation

Date of first authorisation: 02 February 1993

Date of latest renewal: 17 July 2006

10. Date of revision of the text




SANOFI Consumer Healthcare
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410, Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK
+44 (0)118 354 3000
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+44 (0)800 035 2525
Medical Information e-mail
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