Anugesic Hc Cream



Anugesic HC Cream


Each 100g of cream contains zinc oxide 12.35g, balsam peru 1.85g, benzyl benzoate 1.2g, pramocaine hydrochloride 1g, bismuth oxide 0.875g, hydrocortisone acetate 0.5g.

Excipients with known effect:

Propyl parahydroxybenzoate (E216) 0.01g Methyl parahydroxybenzoate (E218) 0.11g Propylene Glycol 8.0g

For the full list of excipients, see section 6.1.



A smooth, homogeneous, buff coloured cream with the characteristic odour of balsam peru.


4.1    Therapeutic indications

Anugesic HC cream provides antiseptic, astringent, emollient and decongestant properties. In addition hydrocortisone exerts an antiinflammatory effect. Pramocaine is a rapidly acting local anaesthetic. The cream may be used to provide lubrication for suppositories.

Anugesic HC cream is indicated for the comprehensive symptomatic treatment of severe and acute discomfort or pain associated with internal and external haemorrhoids and pruritus ani.

4.2    Posology and method of administration



Apply cream to the affected area at night, in the morning and after each evacuation. Thoroughly cleanse the affected area, dry and apply cream by gently smoothing onto the affected area. For internal conditions use rectal nozzle provided and clean it after each use.

Not to be taken orally.

Elderly (over 65years):

As for adults.

Paediatric population:

Not recommended.

Method of administration For topical use.

4.3 Contraindications

Tubercular, fungal and most viral lesions including herpes simplex, vaccinia and varicella.

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

4.4    Special warnings and precautions for use

As with all products containing topical steroids the possibility of systemic absorption should be borne in mind.

Prolonged or excessive use may produce systemic corticosteroid effects and use for periods longer than seven days is not recommended.

Contains propylene glycol which may cause skin irritation

Contains E216 and E218 which may cause allergic reactions (possibly delayed)

Following symptomatic relief definite diagnosis should be established.

4.5    Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

4.6 Fertility, pregnancy and lactation


There is inadequate evidence of safety in human pregnancy and there may be a very small risk of cleft palate and intrauterine growth retardation as well as suppression of the neonatal HPA axis. There is evidence of harmful effects in animals. Use in pregnancy only when there is no safer alternative and when the disease itself carries risks for the mother or child.

4.7 Effects on ability to drive and use machines

Not relevant.

4.8 Undesirable effects

Rarely, sensitivity reactions. Patients may occasionally experience transient burning on application, especially if the anoderm is not intact.

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 the Yellow Card Scheme at

4.9 Overdose

If swallowed, fever, nausea, vomiting, stomach cramps and diarrhoea may develop 312 hours after ingestion.

Pramocaine is relatively non-toxic and less sensitising than other local anaesthetics. Hydrocortisone does not normally produce toxic effects in an acute single overdose.

Treatment of a large acute overdosage should include gastric lavage, purgation with magnesium sulfate and complete bed rest. If necessary, give oxygen and general supportive measures. Methaemoglobinaemia should be treated by intravenous methylthioninium chloride



Pharmacodynamic properties

Pharmacotherapeutic Group: Antihemorrhoidals for topical use,

ATC code: C05A A01.

Pramocaine hydrochloride is a surface anaesthetic used on the skin and mucous membranes to relieve surface pain and pruritus.

Hydrocortisone acetate has the general properties of hydrocortisone and the antiinflammatory action is of primary interest in this product.

Benzyl benzoate is used as a solubilizing agent and has mild antiseptic and preservative properties.

Bismuth oxide exerts a protective action on mucous membranes and raw surfaces. It is weakly astringent and is reported to have antiseptic properties.

Balsam peru has protective properties and a very mild antiseptic action by virtue of its content of cinnamic and benzoic acids. It is believed to promote the growth of epithelial cells.

Zinc oxide acts as an astringent and mild antiseptic.

5.2. Pharmacokinetic Properties

It is well known that topically applied corticosteroids can be absorbed percutaneously. This appears to be more likely upon repeated or prolonged use.

The remaining active ingredients in Anugesic HC Cream exert their therapeutic effect without being absorbed into the systemic circulation. These observations are supported by evidence from various studies and reviews.

5.3. Preclinical Safety Data

The results of the preclinical tests do not add anything of further significance to the prescriber.

6.1. List of excipient(s)

liquid paraffin

glyceryl monostearate

propylene glycol

polysorbate 60

sorbitan stearate

titanium dioxide (E171)

methyl parahydroxybenzoate (E218)

propyl parahydroxybenzoate (E216) purified water.

6.2    Incompatibilities

Not applicable.

6.3    Shelf life

18 months

6.4. Special Precautions for Storage

Do not store above 25°C.

6.5    Nature and contents of container

Aluminium tube externally printed and internally lacquered with plastic cap. Supplied in packs of 15, 25 and 30 g.

Not all pack sizes may be marketed.

6.6    Special precautions for disposal

No special requirements

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.


Pfizer Limited



CT13 9NJ United Kingdom

8.    Marketing Authorisation Number

PL 00057/0520

Date of First Authorisation/Renewal of Authorisation



27 June 2003