Anusol Suppositories

1. Name Of The Medicinal Product

Anusol Suppositories

2. Qualitative And Quantitative Composition

Each suppository contains:

Zinc oxide 296 mg

Bismuth subgallate 59 mg

Balsam peru 49 mg

Bismuth oxide 24 mg

3. Pharmaceutical Form

Suppository

4. Clinical Particulars

4.1 Therapeutic Indications

For the relief of internal haemorrhoids and other related ano-rectal conditions.

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

History of sensitivity 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 human pregnancy have not been conducted, there is no epidemiological evidence of adverse effect, 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, give oxygen and general supportive measures.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

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

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

The active ingredients in Anusol 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

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

Hard Fat (Suppocire BS2)

Kaolin light

Titanium Dioxide

Miglyol 812

6.2 Incompatibilities

None known.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Store at a temperature not exceeding 25^oC.

6.5 Nature And Contents Of Container

12 and 24 pack printed strip pack consisting of white opaque PVC/polyethylene laminated film.

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)

PL 15513/0043

9. Date Of First Authorisation/Renewal Of The Authorisation

15^th September 1997 / 19^th July 2001

10. Date Of Revision Of The Text

22 February 2008