McNeil Healthcare (Ireland) Ltd

Anusol Suppositories

Each Suppository contains:

Bismuth Oxide Anhydrous 24 mg

Zinc Oxide 296 mg

Balsam Peru 49 mg

Bismuth Subgallate 59 mg

For a full list of excipients see section 6.1.

Suppository

White or off-white suppositories having the characteristic odour of Balsam Peru.

Indicated for the symptomatic relief of uncomplicated internal haemorrhoids, or post-operatively after ano-rectal procedures using surgical or sclerosing techniques

Adults and children 12 years and over:

Remove wrapper and insert into the anus at night, in the morning and after each evacuation. Not to be taken orally.

Children under 12 years:

Not recommended, except under medical advice.

The Elderly:

As for adults

Anusol Suppositories are contra-indicated in patients with known hypersensitivity to any of the constituents.

None applicable

None known

Whilst formal studies on the effect of the product during human pregnancy have not been conducted, there is no epidemiological evidence of adverse effect, either to the pregnant mother or the foetus. Due to minimal absorption of the ingredients into the systemic circulation no adverse effects are expected.

No special comment, Anusol Suppositories are unlikely to produce an effect.

Side effects do not occur very often, occasionally a mild irritation or a burning sensation may be experienced, especially if the anoderm is not intact. Very rarely there are sensitivity reactions such as a rash. These sensations will usually stop when use of the suppositories are stopped. If anything unusual happens, or the condition worsens the individual should consult their doctor.

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.

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

Bismuth oxide is a weak 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.

No pharmacokinetic data is available because of minimal absorption of the ingredients.

Absorption

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.

Distribution

Not applicable

Metabolism and Elimination

Not applicable

Pharmacokinetics in Renal Impairment

Not applicable

Pharmacokinetics in the Elderly

As for adults

Mutagenicity, Carcinogenicity and Teratogenicity

As the active ingredients exert their therapeutic effect without being absorbed into the systemic system it is not believed that mutagenicity, carcinogenicity or teratogenicity present significant risks.

Fertility

As the active ingredients exert their therapeutic effect without being absorbed into the systemic system it is not believed that there is a risk to fertility.

Hard Fat (Suppocaire BS2 Pastilles)

Kaolin Light

Titanium Dioxide (E171)

Miglyol 812

Not applicable

3 years

Do not store above 25°C.

12 or 24 Anusol Suppositories are presented in a printed strip pack, consisting of PVC/polyethylene laminated film.

No special requirements

McNeil Healthcare (Ireland) Limited

Airton Road

Tallaght

Dublin 24

Ireland

PA 823/23/3

03 April 1990 / 3 April 2010

June 2010