Pfizer Healthcare Ireland

Anugesic HC Suppositories.

Each 2.8 g suppository contains:

For a full list of excipients, see section 6.1

Suppository.

The product is a buff coloured suppository.

Anugesic HC Suppositories are 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. Also indicated post-operatively in ano-rectal surgical procedures.

Intrarectal.

Adults:

Remove plastic cover and insert one suppository into the anus at night, in the morning and after each evacuation.

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.

History of sensitivity to any of the constituents.

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.

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.

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 Suppositories 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.

Calcium Hydrogen Phosphate

Hard Fat A

Hard Fat C

Theobroma Oil

None known.

2 years

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

Printed strip pack consisting of white opaque pvc/polythene laminated film.

There are six suppositories in a strip and two strips (12 suppositories) in a box.

No special requirements

Pfizer Healthcare Ireland

9 Riverwaalk

National Digital Park

Citywest Business Campus

Dublin 24

PA 822/9/2

1^st April 1978/15^th March 2010

June 2011

Ref AU 1_0 IE