ANUSOL HC OINTMENT

Each 100g of ointment contains:

Hydrocortisone acetate 0.25g

Bismuth subgallate 2.25g

Bismuth oxide 0.875g

Balsam Peru 1.875g

Benzyl benzoate 1.25g

Zinc oxide 10.75g

Ointment.

Buff-coloured ointment.

Anusol-HC Ointment is indicated for the comprehensive symptomatic treatment of internal and external haemorrhoids and pruritus ani.

Anal application.

ADULTS

Apply ointment to the affected area at night, in the morning and after each evacuation. Thoroughly cleanse the affected area, dry and apply ointment on a gauze dressing. For internal conditions use rectal nozzle provided. Remove the nozzle cap. Clean the nozzle after each use.

Not to be taken orally.

ELDERLY (OVER 65 YEARS)

As for adults.

CHILDREN

Not recommended.

Tubercular, fungal and most viral lesions including herpes simplex, vaccinia and varicella. History of sensitivity to any of the constituents.

Following symptomatic relief, definitive diagnosis should be established.

None known.

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.

Not applicable.

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.

Rarely, there are 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.

Hydrocortisone normally does not produce toxic effects in an acute single overdose. Treatment of a large acute overdose 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.

This product provides antiseptic, astringent, emollient and anti-inflammatory actions.

Bismuth oxide, zinc oxide, and bismuth subgallate exert a protective action on mucous membranes and raw surfaces. They are mildly astringent and are 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.

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

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

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

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

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

Magnesium stearate

Cocoa butter

Lanolin anhydrous

Castor oil

Kaolin light

White Petroleum jelly

Calcium hydrogen phosphate

None applicable.

36 months

Do not store above 25°C.

Externally printed Aluminium tube with plastic cap containing 15g, 25g or 30g ointment. A plastic nozzle with cap is also provided for internal application.

Not applicable.

McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire

SL6 3UG

United Kingdom

PL 15513/0072

14^th August 1998 / 14^th January 2002 (transfer from PL 12351/0006 granted 1 June 2002)