Pfizer Healthcare Ireland

Anugesic HC Cream.

Each 100g of cream contains:

Excipients

Contains:

Propyl Hydroxybenzoate (E216) 0.11g

Methyl Hydroxybenzoate (E218) 0.01g

Propylene Glycol 8.0g

For a full list of excipients, see section 6.1.

Cream

A smooth, homogeneous buff coloured cream with the characteristic odour of Balsam Peru.

Anugesic HC Cream is indicated for the comprehensive symptomatic treatment of severe and acute discomfort or pain associated with internal and external haemorrhoids, proctitis, cryptitis, anal fissures, pruritus ani and perianal sinuses. It is also indicated post-operatively in ano-rectal surgical procedures.

For topical use only.

Adults:

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 65 years):

As for adults.

Children:

Not recommended.

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

Hypersensitivity to the active substances or to any of the excipients.

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.

Prolonged use of uninterrupted occlusions or use with extensive occlusive dressings may enhance systemic absorption.

Continuous application without interruption will result in local atrophy of the skin, striae and superficial vascular dilatation.

Contains propylene glycol which may cause skin irritation

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

Following symptomatic relief definitive diagnosis should be established.

None known.

Should not be used during pregnancy or lactation unless considered essential by the physician.

There is inadequate evidence of safety in human pregnancy and there may be a very small risk of cleft palate and intra-uterine growth retardation as well as suppression of the neonatal HPA axis. There is evidence of harmful effects in animals.

None known.

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

If swallowed, fever, nausea, vomiting, stomach cramps and diarrhoea may develop 3-12 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 sulphate and complete bed rest. If necessary, give oxygen and general supportive measures. Methaemoglobinaemia should be treated by intravenous methylthioninium chloride.

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 anti-inflammatory 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.

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.

Preclinical data does not add anything of further significance to the prescriber.

Liquid paraffin

Glyceryl monostearate

Propylene glycol (E1520)

Polysorbate 60

Sorbitan stearate

Titanium dioxide (E171)

Methyl hydroxybenzoate (E218)

Propyl hydroxybenzoate (E216)

Purified water

None known.

18 months

Do not store above 25°C. Store in the original packaging.

Externally printed and internally lacquered aluminium tube, with plastic screw cap, of 15, 25 and 30g cream.

Not all pack sizes may be marketed.

No special requirements

Pfizer Healthcare Ireland

9 Riverwalk

National Digital Park

Citywest Business Campus

Dublin 24

PA 822/9/1

1^st April 1978 / 15^th March 2010

May 2011

Ref: AU 2_0 IE