Anugesic HC Cream

1. Name Of The Medicinal Product

ANUGESIC HC CREAM

2. Qualitative And Quantitative Composition

Each 100g of cream contains zinc oxide EP 12.35g, balsam peru EP 1.85g, benzyl benzoate EP 1.2g, pramocaine hydrochloride USP 1g, bismuth oxide 0.875g, hydrocortisone acetate EP 0.5g.

Excipients

Contains:

Propyl Hydroxybenzoate (E216) 0.11g

Methyl Hydroxybenzoate (E218) 0.01g

Propylene Glycol 8.0g

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

A smooth, homogeneous, buff coloured cream with the characteristic odour of balsam peru.

4. Clinical Particulars

4.1 Therapeutic Indications

Anugesic HC cream provides antiseptic, astringent, emollient and decongestant properties. In addition hydrocortisone exerts an anti-inflammatory effect. Pramocaine is a rapidly acting local anaesthetic. The cream may be used to provide lubrication for suppositories.

Anugesic HC cream is indicated for the comprehensive symptomatic treatment of severe and acute discomfort or pain associated with internal and external haemorrhoids and pruritus ani.

4.2 Posology And Method Of Administration

For topical use.

Adults:

Apply cream to the affected area at night, in the morning and after each evacuation. Thoroughly cleanse the affected area, dry and apply cream by gently smoothing onto the affected area. For internal conditions use rectal nozzle provided and clean it after each use.

Not to be taken orally.

Elderly (over 65 years):

As for adults.

Children:

Not recommended.

4.3 Contraindications

Tubercular, fungal and most viral lesions including herpes simplex, vaccinia and varicella. History of sensitivity to any of the constituents.

Hypersensitivity to the active substances or to any of the excipients.

4.4 Special Warnings And Precautions For Use

As with all products containing topical steroids the possibility of systemic absorption should be borne in mind.

Prolonged or excessive use may produce systemic corticosteroid effects and use for periods longer than seven days is not recommended.

Contains propylene glycol which may cause skin irritation

Contains E216 and E218 which may cause allergic reactions (possibly delayed)

Following symptomatic relief definite diagnosis should be established.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

There is inadequate evidence of safety in human pregnancy and there may be a very small risk of cleft palate and intrauterine growth retardation as well as suppression of the neonatal HPA axis. There is evidence of harmful effects in animals. Use in pregnancy only when there is no safer alternative and when the disease itself carries risks for the mother or child.

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

If swallowed, fever, nausea, vomiting, stomach cramps and diarrhoea may develop 3-12 hours after ingestion.

Pramocaine is relatively non-toxic and less sensitising than other local anaesthetics. Hydrocortisone does not normally produce toxic effects in an acute single overdose.

Treatment of a large acute overdosage should include gastric lavage, purgation with magnesium sulphate and complete bed rest. If necessary, give oxygen and general supportive measures. Methaemoglobinaemia should be treated by intravenous methylthioninium chloride

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic Group ; Antihemorrhoidals for topical use,

ATC code: C05A A01.

Pramocaine hydrochloride is a surface anaesthetic used on the skin and mucous membranes to relieve surface pain and pruritis.

Hydrocortisone acetate has the general properties of hydrocortisone and the anti-inflammatory action is of primary interest in this product.

Benzyl benzoate is used as a solubilizing agent and has mild antiseptic and preservative properties.

Bismuth oxide exerts a protective action on mucous membranes and raw surfaces. It is weakly astringent and is 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.

Zinc oxide acts as an astringent and mild antiseptic.

5.2 Pharmacokinetic Properties

It is well known that topically applied corticosteroids can be absorbed percutaneously. This appears to be more likely upon repeated or prolonged use.

The remaining active ingredients in Anugesic HC Cream 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 results of the preclinical tests do not add anything of further significance to the prescriber.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Liquid paraffin, glyceryl monostearate, propylene glycol, polysorbate 60, sorbitan stearate, titanium dioxide E171, methyl hydroxybenzoate, propyl hydroxybenzoate and purified water.

6.2 Incompatibilities

None known

6.3 Shelf Life

18 months

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

Aluminium tube externally printed and internally lacquered with plastic cap. Supplied in packs of 15, 25 and 30 g.

6.6 Special Precautions For Disposal And Other Handling

No special instructions needed.

7. Marketing Authorisation Holder

Pfizer Limited

Sandwich

Kent CT13 9NJ

United Kingdom

8. Marketing Authorisation Number(S)

PL 00057/0520

9. Date Of First Authorisation/Renewal Of The Authorisation

27^th June 2003

10. Date Of Revision Of The Text

August 2011

Ref: AU 3_0 UK