Anusol Ointment

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

balsam peru 1.875 % (w/v), bismuth oxide 0.875 % (w/v), bismuth subgallate 2.25 % (w/v), zinc oxide 10.75 % (w/v)

Available from:

McNeil Products Limited

ATC code:

C05AX04

INN (International Name):

balsam peru, zinc oxide

Pharmaceutical form:

ointment

Authorization status:

Authorised

Authorization date:

2006-08-10

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 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 swelling, itch and irritation of
internal and external piles (haemorrhoids) and
other minor ano-rectal conditions such as anal
itching and fissures. It can be used 
post-operatively following ano-rectal surgery.
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 have ever had a BAD REACTION to 
Anusol or any of its ingredients.
If the above applies to you, GET ADVICE FROM A
DOCTOR OR PHARMACIST WITHOUT USING ANUSOL.
 TALK TO YOUR DOCTOR OR PHARMACIST…
■
 If you have RECTAL BLEEDING or if YOU ARE 
IN DOUBT WHETHER ANY BLEEDING YOU HAVE 
EXPERIENCED IS CAUSED BY PILES

Summary of Product characteristics

Page 1 of 
4

SUMMARY OF PRODUCT CHARACTERISTICS

PRODUCT SUMMARY 

1. 
NAME OF THE MEDICINAL PRODUCT 

Anusol Ointment 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each 100g ointment contains: 

Zinc Oxide 
10.75 g 
Bismuth Subgallate  
2.25 g 
Balsam Peru 
1.875 g  
Bismuth Oxide 
0.875 g 

3. 
PHARMACEUTICAL FORM 

A light buff coloured ointment. 

4. 
CLINICAL PARTICULARS 

4.1. 
THERAPEUTIC INDICATIONS 

Symptomatic relief of uncomplicated internal and external haemorrhoids, 
pruritus ani, proctitis and fissures. Also indicated post operatively in ano-
rectal surgical procedures and after incision of thrombosed or sclerosed ano-
rectal veins. 

Anusol Ointment provides antiseptic, astringent and emollient properties 
which help to relieve discomfort associated with minor ano-rectal conditions. 

4.2. 
POSOLOGY AND METHOD OF ADMINISTRATION 

Topical. 

ADULTS AND ELDERLY (OVER 65 YEARS): 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. Remove the nozzle cap.  Clean the nozzle after each 
use. Not to be taken orally. 

CHILDREN: Not recommended 

4.3. 
CONTRAINDICATIONS 

Known hypersensitivity to any of the constituents. 

Page 2 of 
4

4.4. 
SPECIAL WARNINGS AND PRECAUTIONS FOR USE 

None known. 

4.5. 
INTERACTIONS 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 pregnancy have not 
been conducted, there is no epidemiological evidence of adverse effects either