1.    NAME OF THE MEDICINAL PRODUCT

Anugesic HC Suppositories.

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 2.8g suppository contains pramocaine hydrochloride USP 27mg, hydrocortisone acetate EP 5mg, benzyl benzoate EP 33mg, bismuth oxide 24mg, bismuth subgallate BP 59mg, balsam peru EP 49mg, zinc oxide EP 296mg.

For a full list of excipients, see section 6.1

3.    PHARMACEUTICAL FORM

Buff coloured suppositories having the characteristic odour of balsam peru.

4.    CLINICAL PARTICULARS

4.1.    Therapeutic Indications

Anugesic HC Suppositories provide antiseptic, astringent, emollient and decongestant properties. In addition hydrocortisone exerts an anti-inflammatory effect. Pramocaine is a rapidly acting local anaesthetic.

Anugesic HC Suppositories are indicated for the comprehensive symptomatic treatment of severe and acute discomfort or pain associated with internal and external haemorrhoids and pruritus ani.

4.2.    Posology and Method of Administration

For rectal use. Not to be taken orally.

Adults:

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

Elderly (over 65 years):

As for adults.

Children:

Not recommended.

4.3.    Contra-Indications

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 Special 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 Fertility, 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

None known.

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, sensitivity reactions.

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

Overdose

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 Methylithionium Chloride.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic Properties

Pramocaine hydrochloride is a surface anaesthetic used on the skin and mucous membranes to relieve surface pain and pruritis.

Hydrocortisone acetate has the general properties of hydrocortisone and the antiinflammatory 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, 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.

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 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.

5.3. Pre-Clinical Safety Data

The results of the preclinical tests do not add anything of further significance to the prescriber.

6.    PHARMACEUTICAL PARTICULARS

6.1.    List of Excipients

Calcium hydrogen phosphate, hard fat “A”, hard fat “C” and Theobroma oil.

6.2.    Incompatibilities

None known.

6.3.    Shelf Life

2 years.

6.4.    Special Precautions for Storage

Store below 25°C.

6.5.    Nature and Contents of Container

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

6.6.    Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product

No special instructions needed.

7.    MARKETING AUTHORISATION HOLDER

Pfizer Limited Sandwich

Kent

CT13 9NJ United Kingdom

8.    MARKETING AUTHORISATION NUMBER(S)

PL 00057/0521

9.    DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION

1 July 2003

10 DATE OF REVISION OF THE TEXT

03/10/2011