McNeil Healthcare (Ireland) Ltd

Anusol Cream

Each 100 g of cream contains:

Bismuth Oxide 2.14 g

Zinc Oxide Ph Eur 10.75 g

Balsam Peru Ph Eur 1.80 g

Excipients:

Propylene glycol 8.00g

Methyl Parahydroxybenzoate (E218) 0.11g

Propyl Parahydroxybenzoate (E216) 0.01g

For a full list of excipients, see section 6.1

Cream

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

Anusol Cream provides antiseptic, astringent and emollient properties which help to relieve discomfort associated with minor ano-rectal conditions. Anusol Cream also provides lubricating properties for use with suppositories.

Indicated for the symptomatic relief of uncomplicated internal and external haemorrhoids, pruritus ani, proctitis and fissures as diagnosed by a doctor. Also indicated post-operatively in ano-rectal surgical procedures and after incision of thrombosed sclerosed ano-rectal veins as advised by a doctor.

Adults and children 12 years and over:

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 cream. Anusol Cream is prepared in a vanishing cream base and may be gently smoothed onto the affected area without the need to apply a gauze dressing. For internal conditions use rectal nozzle provided and clean it after each use. Not to be taken orally.

Children under 12 years:

Not recommended, except under medical advice.

The Elderly:

As for adults

Use in patients with known hypersensitivity to any of the constituents.

Patients with rectal bleeding or blood in the stool should talk to their doctor before using this product as these conditions may be the symptom of a more serious underlying disorder.

If symptoms persist or worsen patients should consult their doctor.

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 Cream is 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 cream is 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 Cream provides antiseptic, astringent and emollient properties which help to relieve discomfort associated with minor ano-rectal conditions. It also provides lubricating properties for use with suppositories.

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 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

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.

Glycerol Monostearate

Liquid Paraffin

Propylene Glycol

Polysorbate 60

Sorbitan Stearate

Titanium Dioxide(E171)

Methyl-p-Hydroxybenzoate

Propyl-p-Hydroxybenzoate

Purified Water

Not applicable

3 years

Do not store above 25ºC.

23 g and 43 g pack. Anusol Cream is presented in a collapsible tube made from lacquered aluminium with a white urea-formaldehyde cap. The tube is accompanied by a plastic applicator nozzle.

No special requirements

McNeil Healthcare (Ireland) Limited

Airton Road

Tallaght

Dublin 24

Ireland

PA 823/23/1

3 April 1990/3 April 2010

June 2010