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ANUSOL OINTMENT

Active substance(s): BISMUTH OXIDE / BISMUTH SUBGALLATE / PERU BALSAM / ZINC OXIDE

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CRR: 341985
Ref: F310606
Date: 28/01/2016
This product is for use by adults over the age of
18 years old.
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 are allergic to Anusol or any of the other
ingredients of this medicine. See section 6 c
■ Speak to your doctor:
■ If you have rectal bleeding or blood in the
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 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.

F310606 - PIL ANUSOL Ointment 25g UKv12.1.indd 1

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 or any of the
other ingredients of this medicine (listed in
section 6).
If the above applies to you, get advice from a
doctor or pharmacist without using Anusol.


which can be used to apply the ointment into
the back passage (anus).
■ For external piles – after washing and drying
the affected area, the ointment should be
applied using a gauze dressing.
■ For internal piles – after washing and drying
the affected area, screw the nozzle provided
onto the tube, remove the nozzle cap; insert
the nozzle into the back passage and squeeze
gently. Clean the nozzle after each use.
■ Wash your hands before and after using Anusol.

Children (under 18 years):

This medicine is not recommended for
children under 18 years old.

Talk to your doctor or pharmacist…

If you have rectal bleeding or blood in the
stool 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.

Adults and the elderly:



Age

Dose

Adults and
the elderly

Anusol Ointment should be
applied sparingly to the
affected area at night, in the
morning and after each bowel
movement.

If you are pregnant or breast-feeding


If you are pregnant or breast-feeding, only
use this medicine on the advice of your
doctor.

 ome of the ingredients can cause
S
problems



Castor oil may cause skin reactions.
Lanolin anhydrous may cause local skin
reactions e.g. contact dermatitis which is
a local irritation at the site of use.

3 How to use this medicine
Anusol Ointment is for topical use only, which
means it is applied directly to the affected area.
■ Wash the anal area and dry gently with a soft
towel before using the medicine.
■ There is a nozzle supplied with the product



Do NOT take orally

If anyone has swallowed this product

If anyone accidentally swallows Anusol
Ointment, contact a doctor or your nearest
Accident and Emergency Department (Casualty),
taking this leaflet and pack with you.

If you forget to use this medicine

Anusol Ointment should be used on an as
required basis. However, if you were unable
to use this product when needed, do not
use a double dose next time you use it.

4 Possible side-effects

Like all medicines, this medicine can cause side
effects, although not everybody gets them.

28/01/16 17:02

If you experience the following, stop using
the medicine and talk to your doctor:
Rare: may affect up to 1 in 1,000 people
■ Hypersensitivity reactions (such as rash).

Other effects which may occur but it is
unknown how often:


 urning, redness, irritation, itching, or pain
B
may occur when applying the ointment. This
does not usually last a long time, so if this lasts
longer than a few days, tell your doctor.

Reporting of side effects

If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard
The following details are applicable for Malta:
ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, rue D’Argens
GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail:postlicensing.medicinesauthority@gov.mt
By reporting side effects you can help provide
more information on the safety of this medicine.

5 Storing this medicine

Keep out of the sight and reach of children.
Do not store above 25°C.
Do not use your medicine after the date shown as
an expiry date on the packaging.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.

F310606 - PIL ANUSOL Ointment 25g UKv12.1.indd 2

6 Further information
What’s in this medicine?

The active substances are per 100 g: Zinc oxide
10.75 g, Bismuth subgallate 2.25g, Balsam peru
1.875 g, Bismuth oxide 0.875 g.
Other ingredients are: Magnesium stearate,
cocoa butter, lanolin anhydrous, castor oil, kaolin
light and petroleum jelly white.

What the medicine looks like

Anusol Ointment is a light ‘buff’ coloured
ointment available in 25 g tubes.
Product Licence holder: McNeil Products Ltd
Maidenhead, Berkshire, SL6 3UG, UK.
Manufacturer: Famar Orléans,
5 avenue de Concyr, 45071 Orleans, Cedex 2, France.
This leaflet was revised November 2015.
Anusol is a registered trade mark.

A Healthy Living Plan for Piles Sufferers
What are piles?
Piles (haemorrhoids) are swollen blood vessels which
occur inside or outside the back passage (anus).

Symptoms

Some people have piles without experiencing any
symptoms, but sufferers may notice the following:
■ Bleeding: Although streaks of bright red blood on
the toilet paper are not uncommon in people with
piles, it may be a sign of a more serious condition
and you should see your doctor to check this.
■ Swelling: The swollen blood vessels may be felt
as a lump or blockage in the anus.
■ Pain, itching and irritation in the anal region.
At least 40% of people suffer from piles at some
time in their lives. However, many people are too
embarrassed to seek advice or treatment and, as
a result, suffer unnecessary discomfort.
Fortunately, there is much you can do to ease the
situation and relieve the symptoms.

What causes piles?

A number of factors can contribute to the
development of piles:
■ The most common cause is straining during bowel
movement, usually as a result of constipation.
■ During pregnancy, the growing baby exerts
increased pressure on the anal vessels, which
can lead to piles.
■ Heredity: you may be more likely to develop
piles if your family has a history of suffering.

A Healthy Living Plan for Piles Sufferers

You can reduce the risk of piles by following
a healthy diet and lifestyle that helps to keep
your bowels working regularly and prevents
constipation. This can also help to speed recovery
from piles.
■ Eat a high fibre diet including foods like brown
rice, wholemeal bread, wholewheat pasta etc.
■ Eat plenty of fresh fruit, vegetables and salads.
■ Drink plenty of water.
■ Don’t eat too much salty, fatty or sugary foods
such as crisps, burgers and cakes.
■ Cut back on the amount of alcohol, tea and
coffee you drink.
■ Exercise regularly.
A healthy diet and lifestyle will reduce the
likelihood of constipation and encourage a
regular bowel habit. Go to the toilet regularly and
try to avoid straining. Leaning forward from the
hips may help.
For external and internal piles, Ointment can be
used. If internal haemorrhoids are the problem,
Suppositories deliver a measured dose to the
affected area.
For further information, please contact:
McNeil Products Ltd
Maidenhead, Berkshire, SL6 3UG, UK.
F310606-30
15-0408

28/01/16 17:02

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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