Anusol HC Suppositories

1. Name Of The Medicinal Product

Anusol HC Suppositories

2. Qualitative And Quantitative Composition

Each suppository contains:

Hydrocortisone acetate 10mg

Bismuth subgallate 59mg

Bismuth oxide 24mg

Balsam Peru 49mg

Benzyl benzoate 33mg

Zinc oxide 296mg

3. Pharmaceutical Form

White/off white suppository.

4. Clinical Particulars

4.1 Therapeutic Indications

Anusol HC Suppositories are indicated for the symptomatic relief of internal haemorrhoids and pruritus ani.

4.2 Posology And Method Of Administration

Anal insertion.

ADULTS

Remove wrapper 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.

4.3 Contraindications

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

4.4 Special Warnings And Precautions For Use

Following symptomatic relief, definitive diagnosis should be established.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 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 applicable.

4.8 Undesirable Effects

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.

4.9 Overdose

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.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

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.

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 other active ingredients in Anusol HC Suppositories 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

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

6. Pharmaceutical Particulars

6.1 List Of Excipients

Each suppository contains:

Kaolin light

Suppocire BS2 pastilles (Hard fat)

6.2 Incompatibilities

None applicable.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

Printed strip pack consisting of white opaque PVC/polyethylene laminated film. Boxes of 12 and 24 suppositories.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

Administrative Data

7. Marketing Authorisation Holder

McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire

S6 3UG

United Kingdom

8. Marketing Authorisation Number(S)

PL 15513/0073

9. Date Of First Authorisation/Renewal Of The Authorisation

14^th August 1998 / 14^th January 2002

1^st June 2002 (Transfer of Ownership)

10. Date Of Revision Of The Text

25 February 2008