Anusol Suppositories

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

balsam peru 49 mg, bismuth oxide 24 mg, bismuth subgallate 59 mg, zinc oxide 296 mg

Available from:

McNeil Products Limited

ATC code:

C05AX04

INN (International Name):

balsam peru, zinc oxide

Pharmaceutical form:

suppository

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 piles 
and other related conditions.
■
 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 Suppositories help to relieve the swelling, 
itch and irritation of internal piles (haemorrhoids) 
and other related conditions, 
such as anal itching. It contains the following 
ingredients:
ZINC OXIDE and BISMUTH SALTS are mildly astringent 
and antiseptic. They soothe and protect raw areas.
BALSAM PERU is mildly antiseptic and has a protective 
action on sore areas and may help healing.
This product is for use by adults over the age of 
18 years.
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.
  DO NOT USE THIS MEDICINE…

■
 If you have ever had a BAD REACTION to 
Anusol or any of its ingredients.
If this 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.  
If any of these bullet points apply to you, TALK TO A 
DOCTOR OR PHARMACIST.
IF YOU ARE PREGNANT OR BREAST-FEEDING
■
 If you are pregnant, you can use this 
product but, as with all medicines at this time, 
you should discuss it with your doctor fi rst.
■
 If you are breast-feeding you can u

Summary of Product characteristics

Page 1 of 
4

SUMMARY OF PRODUCT CHARACTERISTICS

PRODUCT SUMMARY 

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. 

Page 2 of 
4

4.3. 
CONTRAINDICATIONS 

History of sensitivity to any of the constituents. 

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 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.