Anusol Ointment

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Bismuth subgallate; Bismuth oxide; Balsam peru; Zinc oxide

Available from:

SOFIBEL

ATC code:

C05AX; C05AX04

INN (International Name):

Bismuth subgallate; Bismuth oxide; Balsam peru; Zinc oxide

Dosage:

0.875g/100g + 1.875g/100g + 10.75g/100g + 2.25 gram/100gram

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; zinc preparations

Authorization status:

Marketed

Authorization date:

1990-04-03

Patient Information leaflet

ANUSOL OINTMENT
zinc oxide, bismuth oxide, bismuth subgallate, peru balsam
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor or pharmacist
have told you.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or advice.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.

You must talk to a doctor if you do not feel better or if you feel
worse or if you have RECTAL
BLEEDING or BLOOD IN THE STOOL which has not been diagnosed as piles.
WHAT IS IN THIS LEAFLET
1.
What Anusol Ointment is and what it is used for
2.
What you need to know before you use Anusol Ointment
3.
How to use Anusol Ointment
4.
Possible side effects
5.
How to store Anusol Ointment
6.
Contents of the pack and other information
1.
WHAT ANUSOL OINTMENT IS AND WHAT IT IS USED FOR
Anusol Ointment contains the active substances zinc oxide, bismuth
oxide, bismuth
subgallate, Peru balsam. It belongs to a group of agents used for the
treatment of
haemorrhoids and anal fissures for topical use.
Anusol Ointment 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.
Anusol Ointment is for use by adults over the age of 18 years
HOW ANUSOL OINTMENT WORKS
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.
ZINC OXIDE which is an astringent which soothes and protects raw areas
and helps reduce
swelling. It also acts as an antiseptic
PERU BALSAM which is mi

Summary of Product characteristics

Health Products Regulatory Authority
12 April 2023
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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Anusol Ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substances:
Bismuth Oxide 0.875 g
Peru balsam 1.875 g (contains benzyl alcohol, benzyl benzoate and
benzyl cinnamate)
Zinc Oxide 10.75 g
Bismuth Subgallate 2.25 g
Excipients with known effect:
Wool fat (E913) (may contain butylated hydroxytoluene (E321))
Castor oil
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Ointment
A buff coloured ointment having the characteristic odour of Peru
balsam.
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
POSOLOGY:
ADULTS 18 YEARS AND OVER
Apply to the affected area at night, in the morning and after each
evacuation until the condition is controlled.
CHILDREN AND ADOLESCENTS UNDER 18 YEARS OF AGE:
Use only under medical advice.
THE ELDERLY:
As for adults.
METHOD OF ADMINISTRATION
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.
Anusol ointment should be used cautiously to avoid large amounts of
disposal via wastewater or household waste.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance(s) or to any of the
excipients listed in section 6.1
Health Products Regulatory Authority
12 April 2023
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4.4 SPECIAL WARNIN