ANUSOL Cream

ANUSOL cream contains -

A buff coloured cream

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. Also indicated post-operatively in ano-rectal surgical procedures and after incision of thrombosed or sclerosed ano-rectal veins.

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 cream. ANUSOL cream is prepared in a vanishing cream base and may be gently smoothed on to the affected area without the need to apply 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.

Known hypersensitivity to any of the constituents.

None known.

None known.

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.

None known.

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

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 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.

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.

The active ingredients of ANUSOL are well known constituents of medicinal products and their safety profiles are well documented.

Glycerol monostearate Ph Eur

Liquid paraffin Ph Eur

Propylene glycol Ph Eur

Polysorbate 60 Ph Eur

Sorbitan stearate BP

Titanium dioxide Ph Eur

Methyl p-hydroxybenzoate Ph Eur

Propyl p-hydroxybenzoate Ph Eur

Purified water Ph Eur

None known.

3 years when stored in the original packaging.

Store at a temperature not exceeding 25°C.

Pack size 23g, 30g or 43g, externally printed and internally lacquered aluminium tube with plastic cap. A plastic nozzle with cap is also provided for internal application.

No special requirements.

McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire SL6 3UG

United Kingdom

PL 15513/0041

15 September 1997

25 February 2008