Anusol Ointment

1. Name Of The Medicinal Product

Anusol Ointment

2. Qualitative And Quantitative Composition

Each 100g ointment contains:

Zinc Oxide 10.75 g

Bismuth Subgallate 2.25 g

Balsam Peru 1.875 g

Bismuth Oxide 0.875 g

3. Pharmaceutical Form

A light buff coloured ointment.

4. Clinical Particulars

4.1 Therapeutic Indications

Symptomatic relief of uncomplicated internal and external haemorrhoids, pruritus ani, proctitis and fissures. Also indicated post operatively in ano-rectal surgical procedures and after incision of thrombosed or sclerosed ano-rectal veins.

Anusol Ointment provides antiseptic, astringent and emollient properties which help to relieve discomfort associated with minor ano-rectal conditions.

4.2 Posology And Method Of Administration

Topical.

Adults and Elderly (over 65 years): Apply to the affected area at night, in the morning and after each evacuation until the condition is controlled. Thoroughly cleanse the affected area, dry and apply ointment. Anusol Ointment should be applied 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.

Children: Not recommended

4.3 Contraindications

Known hypersensitivity to any of the constituents.

4.4 Special Warnings And Precautions For Use

None known.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Whilst formal studies on the effect of this product during pregnancy have not been conducted, there is no epidemiological evidence of adverse effects either to the pregnant mother or foetus.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

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

4.9 Overdose

Treatment of a large acute overdose should include gastric lavage, purgation with magnesium sulphate and complete bed rest. If necessary, apply oxygen and give general supportive measures.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Anusol Ointment provides antiseptic, astringent and emollient properties which help to relieve discomfort associated with minor ano-rectal conditions.

Bismuth Oxide is weakly astringent with supposed antiseptic properties and has a protective action on mucous membranes and raw surfaces.

Zinc Oxide is an astringent and mild antiseptic and probably owes its actions to the ability of the zinc ion to precipitate protein but other mechanisms may be involved. Zinc Oxide is also used to absorb skin moisture and decrease friction and discourage growth of certain bacteria.

Balsam Peru has 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

The active ingredients 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

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

6. Pharmaceutical Particulars

6.1 List Of Excipients

Anusol Ointment contains the following excipients:-

Magnesium stearate

Cocoa butter

Lanolin anhydrous

Castor oil

Kaolin light

Petroleum Jelly White

6.2 Incompatibilities

None known.

6.3 Shelf Life

Not less than 3 years when stored in the original packing.

6.4 Special Precautions For Storage

Do not store above 25° C.

6.5 Nature And Contents Of Container

Externally printed and internally lacquered 25 g aluminium tube with plastic cap. A plastic nozzle with cap is also provided for internal application.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

Administrative Data

7. Marketing Authorisation Holder

McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire

SL6 3UG

United Kingdom

8. Marketing Authorisation Number(S)

15513/0042

9. Date Of First Authorisation/Renewal Of The Authorisation

14 March 1997

10. Date Of Revision Of The Text

25 February 2008