SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

ANUSOL SOOTHING RELIEF OINTMENT

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 100 g of ointment contains the following active ingredients:-

Hydrocortisone acetate    0.25 g

Benzyl benzoate    1.25 g

Bismuth subgallate    2.25 g

Bismuth oxide    0.875 g

Balsam peru    1.875 g

Zinc oxide    10.75 g

For full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Ointment.

A smooth, homogeneous buff coloured ointment with the characteristic odour of Balsam Peru.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Symptomatic treatment of uncomplicated internal and external haemorrhoids and pruritus ani.

Posology and method of administration

Topical administration.

ADULTS (over 18 years)

To be applied sparingly to the affected area at night, in the morning and after each evacuation up to a maximum of 4 applications a day. 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. Use for a maximum period of one week.

ELDERLY (over 65 years)

As for adults

CHILDREN (under 18 years)

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.

Do not use in pregnancy or breastfeeding.

4.4    Special warnings and precautions for use

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 or if rectal bleeding occurs.

Interaction with other medicinal products and other forms of interaction

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

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 hypothalamic-pituitary-adrenal axis. There is evidence of harmful effects in animals. To be used in pregnancy only when there is no safer alternative and when the disease itself carries risks for the mother or child.

Do not use in pregnancy or breastfeeding.

4.7 Effects on ability to drive and use machines

No effects have been reported on ability to drive or use machinery.

4.8 Undesirable effects

Rarely, sensitivity reactions may occur. 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 312 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 oxygen and general supportive measures should be given. Methaemoglobinaemia should be treated by intravenous methylthioninium chloride.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

This product provides antiseptic, astringent, emollient and decongestant properties. In addition hydrocortisone exerts 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 contents 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 this anti-inflammatory action is of primary interest of this product.

ATC code: D07B, corticosteroids, combinations with antiseptics.

5.2 Pharmacokinetic properties

Systemic absorption of hydrocortisone acetate from the rectum may occur but estimates of the extent of absorption have been variable and have always been less than 30%. Following absorption it is metabolised in the liver and most body tissues before being excreted in the urine. Biological half life is approximately 100 minutes and it is 90% bound to plasma protein.

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

Preclinical safety data

The active ingredients of Anusol are well known constituents of medicinalproducts and their safety profile is well documented.

There are no preclinical data of relevance to the prescriber, which are additional to those already included in other sections of the SmPC.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Kaolin light Magnesium stearate Castor oil Cocoa butter Lanolin anhydrous Petroleum jelly white Calcium hydrogen phosphate

6.2 Incompatibilities

No incompatibilities have been reported.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Do not store above 25 °C

6.5 Nature and contents of container

Externally printed aluminium tube with wadded plastic cap, containing 15 g of ointment. A plastic nozzle with cap is also provided for internal application.

6.6 Special precautions for disposal

No Special Requirements.

7    MARKETING AUTHORISATION HOLDER

MCNEIL PRODUCTS LIMITED FOUNDATION PARK ROXBOROUGH WAY MAIDENHEAD BERKSHIRE SL6 3UG

UNITED KINGDOM

8 MARKETING AUTHORISATION NUMBER(S)

PL 15513/0372

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

10 DATE OF REVISION OF THE TEXT