McNeil Healthcare (Ireland) Ltd

Anusol HC Suppositories

Each 2.8g suppository contains:

Hydrocortisone Acetate 10mg

Benzyl Benzoate 33mg

Bismuth Oxide 24mg

Balsam Peru 49mg

Zinc Oxide 296mg

Bismuth Subgallate 59mg

For a full list of excipients see section 6.1

Suppositories.

Off white suppositories .

Anusol HC Suppositories are indicated for the symptomatic relief of external and internal haemorrhoids, proctitis, cryptitis, anal fissures, pruritus ani and perianal sinuses. Also indicated post-operatively in ano-rectal surgical procedures.

Intrarectal

Adults

Remove wrapper and insert one suppository into the anus at night, in the morning and after each evacuation, up to a maximum of three a day.

Not to be taken orally.

Elderly (over 65 years)

As for adults

Children

Not recommended

Tubercular, fungal, bacterial 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.

The product should be discontinued and the patient advised to consult a medical practitioner if symptoms do not improve or worsen if rectal bleeding occurs.

Concurrent use with other corticosteroid preparations, either topically or orally, may increase the likelihood of systemic effects.

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 intrauterine growth retardation as well as suppression of the neonatal hypothalamic –pituitary-adrenal axis. There is evidence of harmful effects in animals.

Not applicable

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.

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.

Anusol HC Suppositories provide antiseptic, astringent, emollient and vascular decongestant properties. In addition, hydrocortisone exerts an anti-inflammatory effect.

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 solubilising 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 Suppositories exert their therapeutic effect without being abosorbed into the systemic circulation. These observations are supported by evidence from various studies and reviews.

Pre-clinical safety data do not add anything of further significance to the prescriber.

Each suppository contains:

Kaolin light

Hard fat (Suppocire BS2 pastilles)

None applicable

3 years

Do not store above 25°C.

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.

McNeil Healthcare (Ireland) Limited

Airton Road

Tallaght

Dublin 24

Ireland

PA 823/40/4

30 March 1990 / 30^th March 2010

June 2010