1. Name Of The Medicinal Product
ANUSOL HC OINTMENT
2. Qualitative And Quantitative Composition
Each 100g of ointment contains:
Hydrocortisone acetate 0.25g
Bismuth subgallate 2.25g
Bismuth oxide 0.875g
Balsam Peru 1.875g
Benzyl benzoate 1.25g
Zinc oxide 10.75g
3. Pharmaceutical Form
Ointment.
Buff-coloured ointment.
4. Clinical Particulars
4.1 Therapeutic Indications
Anusol-HC Ointment is indicated for the comprehensive symptomatic treatment of internal and external haemorrhoids and pruritus ani.
4.2 Posology And Method Of Administration
Anal application.
ADULTS
Apply ointment to the affected area at night, in the morning and after each evacuation. Thoroughly cleanse the affected area, dry and apply ointment on 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.
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.
4.4 Special Warnings And Precautions For Use
Following symptomatic relief, definitive 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
Not applicable.
4.8 Undesirable Effects
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.
Rarely, there are 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.
Hydrocortisone normally does not produce toxic effects in an acute single 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. Methaemoglobinaemia should be treated by intravenous methylthioninium chloride.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
This product provides antiseptic, astringent, emollient and anti-inflammatory actions.
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.
Benzyl benzoate is used as a solubilizing agent and has mild antiseptic and preservative properties.
Hydrocortisone acetate has the general properties of hydrocortisone and the anti-inflammatory action is of primary interest in this product.
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 other active ingredients in Anusol HC Ointment 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
Preclinical safety data do not add anything of further significance to the prescriber.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Magnesium stearate
Cocoa butter
Lanolin anhydrous
Castor oil
Kaolin light
White Petroleum jelly
Calcium hydrogen phosphate
6.2 Incompatibilities
None applicable.
6.3 Shelf Life
36 months
6.4 Special Precautions For Storage
Do not store above 25°C.
6.5 Nature And Contents Of Container
Externally printed Aluminium tube with plastic cap containing 15g, 25g or 30g ointment. A plastic nozzle with cap is also provided for internal application.
6.6 Special Precautions For Disposal And Other Handling
Not applicable.
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 15513/0072
9. Date Of First Authorisation/Renewal Of The Authorisation
14th August 1998 / 14th January 2002 (transfer from PL 12351/0006 granted 1 June 2002)
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