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ANUSOL PLUS HC OINTMENT

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

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Transcript
CRR: 342001
Ref: F310612
Date: 12 Jan 2016

Hydrocortisone acetate, Zinc oxide, Bismuth oxide,
Bismuth subgallate, Balsam Peru, Benzyl benzoate

This medicine is used for the relief of 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.
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 Plus HC 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 swelling, itch
and irritation of internal and external piles
(haemorrhoids) and other related conditions, such

F310612 - PIL ANUSOL Plus HC Ointment 15g UKv9.0.indd 1

as anal itching. This product is for use by adults
over the age of 18 years.

3 How to use this medicine

2 Before using this medicine

Anusol Plus HC 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 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.

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 are allergic to Anusol or any of the other
ingredients of this medicine (listed in section 6).
■ If you have fungal, viral or bacterial skin sores.
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
drug e.g. hydrocortisone)
If you are not sure about the medicine you are
taking or using, show the bottle or pack to your
pharmacist.
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 breast-feeding 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 recommended for
children under 18 years of age.

Adults and the elderly:
Age

Dose

Adults and
the elderly

Anusol Plus HC Ointment
can be applied sparingly
to the affected area at
night, in the morning and
after each bowel
movement

■ Do
■ Do

not use more than 4 times a day.
not use for more than 7 consecutive days.

If anyone has swallowed this product
If anyone accidentally swallows Anusol Plus HC
Ointment, contact a doctor or your nearest
Accident and Emergency department (Casualty),
taking this leaflet and pack with you.

12/01/16 16:02

If you forget to use the medicine
Anusol Plus HC 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.

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

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 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.

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.

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).

What the medicine looks like

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

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.
What are piles?
■ Cut back on the amount of alcohol, tea and
Piles (haemorrhoids) are swollen blood vessels which
coffee you drink.
occur inside or outside the back passage (anus).
■ Exercise regularly.
A healthy diet and lifestyle will reduce the likelihood
Symptoms
of constipation and encourage a regular bowel habit.
Some people have piles without experiencing any
Go to the toilet regularly and try to avoid straining.
symptoms, but sufferers may notice the following:
Leaning forward from the hips may help.
■ Bleeding: Although streaks of bright red blood on
For external and internal piles, Ointment can be used. If
the toilet paper are not uncommon in people with
piles, it may be sign of a more serious condition and internal haemorrhoids are the problem, Suppositories
deliver a measured dose to the affected area.
you should see your doctor to check this.
For further information, please contact:
■ Swelling: The swollen blood vessels may be felt
McNeil Products Ltd, Maidenhead, Berkshire,
as a lump or blockage in the anus.
SL6 3UG, UK.
■ Pain, itching and irritation in the anal region.

■ 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.

F310612 - PIL ANUSOL Plus HC Ointment 15g UKv9.0.indd 2

Anusol Plus HC 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.

Healthy Tips for Piles Sufferers

7 A Healthy Living Plan for
Piles Sufferers

At least 40% of people suffer from piles at some
time in their lives. However, many people are too

F310612-117
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F310612 - PIL ANUSOL Plus HC Ointment 15g UKv9.0.indd 3

Client
Change request #
Product

JNJ
CRD to come next
ANUSOL HC PLUS OINTMENT
15 G UK

Component #
ATW version
Component type
Dimensions
Drawing #
Safety code type & #
Client code
Main font type
Minimum font size
Colours
Recto 1
Verso 1

F310612
Old: F310418
9.0
Flat Leaflet
148 x 210 mm
NOTP002
Laetus 117
15-0414
MetaPlusBook Roman
7,5 pts

BLACK

BLACK

PMS 2592

PMS 2592

Recto 2

Verso 2

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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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