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ANUSOL SOOTHING RELIEF OINTMENT

Active substance(s): BENZYL BENZOATE / BISMUTH OXIDE / BISMUTH SUBGALLATE / HYDROCORTISONE ACETATE / PERU BALSAM / ZINC OXIDE

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Transcript
CRR: 341982
Ref: F310615
Date: 13 Jan 2016

Hydrocortisone acetate, Zinc oxide, Bismuth oxide,
Bismuth subgallate, Balsam Peru, Benzyl benzoate
This medicine is used for the relief of uncomplicated
internal and external piles and 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
■ If you have fungal, viral or bacterial skin sores. See
section 2 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
■ If your symptoms have worsened or not improved within
7 days of using this product.
■ If you are pregnant or breastfeeding.
■ If you are under 18 years of age. 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 Soothing Relief Ointment is a medicine which is
used to reduce the symptoms of internal and external piles
(haemorrhoids). It contains the following ingredients:
Hydrocortisone acetate is a mild steroid which helps reduce
inflammation.
Zinc oxide and Bismuth salts are mildly astringent and
antiseptic and soothe and protect raw areas.
Balsam Peru is mildly antiseptic and has a protective action
on sore areas and may help healing.
Benzyl benzoate has mild antiseptic properties.
This medicine helps relieve the pain, swelling, itch and
irritation of internal and external piles (haemorrhoids) and
other related conditions, such as anal itching. This product is
for use by adults over the age of 18 years.

F310615_PIL ANUSOL Soothing Relief Ointment 15g UK v3.0.indd 1

2 Before using this medicine

3 How to use 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.

Anusol Soothing Relief 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 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 ressing.
■ 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.

Do not use this medicine…
If you are allergic to Anusol or any of the other
ingredients of this medicine (listed in section 6).
Do not use on broken or infected skin. Common skin
infections include anal warts, genital herpes, thrush
and jock itch.
■ If you are pregnant or breastfeeding.
■ If you are under 18 years of age.
If any of these applies, get advice from a doctor or
pharmacist without using Anusol.



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 symptoms worsen or do not improve after you have
used the medicine for 7 days.
■ If you are taking or using any other medicines
including:
■ corticosteroids (a type of anti-inflammatory
medicine), e.g. betamethasone or hydrocortisone
(used in eczema and dermatitis), dexamethasone,
prednisolone.
If you are not sure about the medicine you are using then
talk to your pharmacist or doctor for advice.
If any of these bullet points apply to you now or in the past,
talk to a doctor or pharmacist.


If you are pregnant or breast-feeding


If you are pregnant or breastfeeding do not use this

medicine.

Some of the ingredients can cause 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.

Children (under 18 years):
This medicine is not for use in children
under 18 years of age.

Adults and the elderly:
Age

Dose

Adults and
the elderly

Anusol Soothing Relief
Ointment can be applied
sparingly to the affected
area at night, in the
morning and after each
bowel movement
■ Do not use more than 4 times a day.
■ Do not use for more than 7 consecutive days.

If anyone has swallowed this product

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

If you forget to use the medicine

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

13/01/16 10:28

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

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:


Burning, redness, irritation, itching, or pain 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
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.

6 Further information
What's in this medicine?

The active substances are per 100 g:
Hydrocortisone acetate 0.25 g, Zinc oxide 10.75 g, Bismuth

F310615_PIL ANUSOL Soothing Relief Ointment 15g UK v3.0.indd 2

subgallate 2.25 g, Balsam Peru 1.875 g, Bismuth oxide
0.875 g and Benzyl benzoate 1.25 g.
Other ingredients are: Magnesium stearate, cocoa
butter, lanolin anhydrous, castor oil, kaolin light,
calcium hydrogen phosphate and petroleum jelly white.

What the medicine looks like
Anusol Soothing Relief Ointment is a whitish ointment
available in 15 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.

7 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 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.

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.


Healthy Tips 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.

What causes piles?
A number of factors can contribute to the development of
piles:

F310615-90
15-0417

13/01/16 10:28

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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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