ANUSOL Ointment

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

BISMUTH SUBGALLATE, BISMUTH OXIDE, BALSAM PERU, ZINC OXIDE

Available from:

McNeil Healthcare (Ireland) Ltd

ATC code:

C05AX04

INN (International Name):

BISMUTH SUBGALLATE, BISMUTH OXIDE, BALSAM PERU, ZINC OXIDE

Pharmaceutical form:

Ointment

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Other agents for treatment of hemorrhoids and anal fissures for topical use

Authorization status:

Transfer Pending

Authorization date:

1995-04-03

Patient Information leaflet

ZINC OXIDE, BISMUTH OXIDE,  
BISMUTH SUBGALLATE, BALSAM PERU
■
 This medicine is used for the relief of internal and 
external piles and other minor ano-rectal conditions 
such as anal itching.
■
 This medicine is for use in adults over the age  
of 18 years.
■
 DO NOT USE THIS MEDICINE:
■
 If you have had a BAD REACTION to Anusol or any of 
the ingredients in it. _See section 6_ 
c
■
 SPEAK TO YOUR DOCTOR:
■
 If you have RECTAL BLEEDING or blood in your stool 
which has not been diagnosed as piles. 
_See section 2_

c
■
 FOLLOW THE INSTRUCTIONS ON HOW TO USE THIS PRODUCT 
CAREFULLY. _See section 3_ 
c
NOW READ THIS WHOLE LEAFLET CAREFULLY BEFORE YOU USE 
THIS MEDICINE. Keep the leaflet: you might need it again.
1 
WHAT THE MEDICINE IS FOR
Anusol Ointment is a medicine which is used to 
relieve the pain, swelling, itch and irritation of 
internal and external piles (haemorrhoids) and 
other minor ano-rectal conditions such as anal 
itching and fissures as diagnosed by a doctor. It can be 
used post-operatively following ano-rectal surgery as 
advised by a doctor.
It contains the following ingredients:
ZINC OXIDE which is an astringent which soothes and 
protects raw areas and helps reduce swelling. 
It also acts as an antiseptic.
BALSAM PERU which is mildly antiseptic and has a 
protective action on sore areas and may help healing.
BISMUTH SALTS which is astringent and antiseptic and 
also protects raw, irritated areas around the anal area.
This product is for use by adults over the age of  
18 years old.
2 
BEFORE USING THIS MEDICINE
This medicine is suitable for most people but a few 
people should not use it. If you are in any doubt, talk to 
your doctor or pharmacist.
X
 DO NOT USE THIS MEDICINE…

■
 If you are allergic to Anusol Ointment or any of 
the other  ingredients of this medicine (listed in 
section 6.1).
If the 

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Anusol Ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 100 g of Anusol Ointment contains:
Active substances:
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Ointment
A cream coloured ointment having the characteristic odour of Balsam Peru.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Anusol Ointment provides antiseptic, astringent and emollient properties which help to relieve discomfort associated with
minor ano-rectal conditions. Anusol Ointment 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 ointment. Anusol Ointment should be applied on 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
0.875 g
Balsam Peru
1.875 g
Zinc Oxide
10.75 g
Bismuth Subgallate
Excipient:
Wool fat
2.25 g
8.625 g
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 13/06/2016_
_CRN 2171627_
_page number: 1_
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance(s) or to any of�