A
1. Name Of The Medicinal Product
Anusol Suppositories
2. Qualitative And Quantitative Composition
Each suppository contains:
Zinc oxide 296 mg
Bismuth subgallate 59 mg
Balsam peru 49 mg
Bismuth oxide 24 mg
3. Pharmaceutical Form
Suppository
4. Clinical Particulars
4.1 Therapeutic Indications
For the relief of internal haemorrhoids and other related ano-rectal conditions.
4.2 Posology And Method Of Administration
Anal insertion
Adults
Remove wrapper and insert one suppository into the anus at night, in the morning and after each evacuation. Not to be taken orally.
Elderly (over 65 years)
As for adults
Children
Not recommended.
4.3 Contraindications
History of sensitivity to any of the constituents.
4.4 Special Warnings And Precautions For Use
None known.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
None known.
4.6 Pregnancy And Lactation
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.
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
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.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Anusol Suppositories provide antiseptic, astringent and emollient properties which help to relieve discomfort associated with minor ano-rectal conditions.
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.
5.2 Pharmacokinetic Properties
The active ingredients in Anusol Suppositories 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 active ingredients of Anusol are well known constituents of medicinal products and their safety profile is well documented.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Hard Fat (Suppocire BS2)
Kaolin light
Titanium Dioxide
Miglyol 812
6.2 Incompatibilities
None known.
6.3 Shelf Life
3 years.
6.4 Special Precautions For Storage
Store at a temperature not exceeding 25oC.
6.5 Nature And Contents Of Container
12 and 24 pack printed strip pack consisting of white opaque PVC/polyethylene laminated film.
6.6 Special Precautions For Disposal And Other Handling
No special requirements.
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 15513/0043
9. Date Of First Authorisation/Renewal Of The Authorisation
15th September 1997 / 19th July 2001
10. Date Of Revision Of The Text
22 February 2008
Anusol Suppositories
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