ANUSOL

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

BISMUTH OXIDE ; BALSAM PERU ; ZINC OXIDE

Available from:

Church & Dwight UK Limited

ATC code:

C05AX04

INN (International Name):

BISMUTH OXIDE ; BALSAM PERU ; ZINC OXIDE

Dosage:

2.14/1.8/1 Grams

Pharmaceutical form:

Cream

Prescription type:

Product not subject to medical prescription

Therapeutic area:

zinc preparations

Authorization status:

Marketed

Authorization date:

1990-04-03

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Anusol Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 100 g of cream contains:
Active substances:
Excipients:
Propylene Glycol
8.00 g
Methyl Parahydroxybenzoate (E218)
0.11 g
Propy Parahydroxybenzoate (E216)
0.01 g
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream
A smooth, homogeneous, buff coloured cream with the characteristic
odour of Balsam Peru.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
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.
Bismuth oxide
2.14 g
Zinc Oxide
10.75 g
Balsam Peru
1.80 g
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