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XYLOPROCT 5%/0.275% OINTMENT

Active substance: LIDOCAINE

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480021328

PACKAGE LEAFLET: INFORMATION FOR THE USER

Xyloproct® 5%/0.275% Ointment
lidocaine, hydrocortisone acetate

Read all of this leaflet carefully before you start using
this medicine.
• 
Keep this leaflet. You may need to read it again.
•  you have any further questions, ask your doctor or
If
pharmacist.
• 
This medicine has been prescribed for you. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
•  any of the side effects get serious, or if you notice
If
any side effects not listed in this leaflet, please tell your
doctor or pharmacist. See section 4.
In this leaflet:
1. What Xyloproct Ointment is and what it is used for

2.  efore you use Xyloproct Ointment
B
3.  ow to use Xyloproct Ointment
H
4. Possible side effects

5.  ow to store Xyloproct Ointment
H
6. Further information


Take special care with Xyloproct Ointment
Check with your doctor or pharmacist before using
Xyloproct Ointment if:
•  our skin is very thin or fragile where the ointment is
Y
going to be put.
•  ou have an infection where the ointment is going to
Y
be put. If this applies to you, your doctor may ask you
to use another medicine as well as Xyloproct Ointment.
•  ou have ever been told that you have a rare disease
Y
of the blood pigment called ‘porphyria’ or anyone in
your family has it.
Taking other medicines
Please tell your doctor or pharmacist if you are taking, or
have recently taken, any other medicines. This includes
medicines that you buy without a prescription and herbal
medicines. This is because Xyloproct Ointment can affect
the way some medicines work and some medicines can
have an effect on Xyloproct Ointment.
In particular, tell your doctor or pharmacist if you are
taking or using any of the following medicines:
•  edicines for an uneven heart beat (such as
M
amiodarone or sotalol).
•  ther local anaesthetics.
O

1. What Xyloproct Ointment is and what it is used for
What Xyloproct Ointment is
The name of your medicine is ‘Xyloproct 5%/0.275%
Ointment’. It is referred to as ‘Xyloproct Ointment’ in the
rest of this leaflet.

Pregnancy and breast-feeding
Talk to your doctor before using Xyloproct Ointment if you
are pregnant, may become pregnant or are breast-feeding.
Your doctor will decide if you can use Xyloproct Ointment
during this time.

Xyloproct Ointment contains two medicines: lidocaine and
hydrocortisone.
•  idocaine (sometimes known as lignocaine) belongs to
L
a group of medicines called local anaesthetics.
•  ydrocortisone belongs to a group of medicines called
H
corticosteroids.

3. How to use Xyloproct Ointment
Always use Xyloproct Ointment exactly as your doctor has
told you. You should check with your doctor or pharmacist
if you are not sure. Always wash your hands well before
and after using this medicine.

What Xyloproct Ointment is used for
Xyloproct Ointment may be used in adults and children of
all ages for the following reasons:
• o relieve itching around the back passage (anus) or
t
female private parts (genitals).
• o relieve the symptoms of piles (haemorrhoids) and
t
other problems that affect the back passage. These
symptoms include pain and inflammation.

How much Xyloproct Ointment to use
•  our doctor will tell you how much ointment to use and
Y
how often to use it.
•  sually the ointment should be put on the affected
U
area several times a day.
•  p to 6 g (grams) of ointment can be used each day.
U
This is about a third of a tube.

2. Before you use Xyloproct Ointment
Do not use Xyloproct Ointment if:
Y
•  ou are allergic (hypersensitive) to lidocaine or
hydrocortisone or any of the other ingredients of
Xyloproct Ointment (listed in Section 6: Further
information).
•  ou have ever had an allergic reaction to other local
Y
anaesthetics or to other corticosteroid medicines.
Y
•  ou have an infection where the ointment is going to
be put and the infection is not being treated.
•  ou are not in hospital and you are taking medicines for
Y
an uneven heart beat (such as amiodarone or sotalol).
Do not use Xyloproct Ointment if any of the above
apply to you. If you are not sure, talk to your doctor or
pharmacist before using Xyloproct Ointment.

How long to use Xyloproct Ointment for
•  yloproct Ointment should only be used for limited
X
periods of time.
•  ith longer periods of treatment (up to 3 weeks)
W
your doctor may suggest that you have a break from
treatment, especially if you are getting irritation around
or inside where the ointment is applied.
I
• f you get irritation, your doctor may do a patch test to
see if it is being caused by Xyloproct Ointment.
Using the applicator
•  he ointment comes with an applicator. Your doctor will
T
tell you if you need to use this.
• f your doctor tells you to use the applicator, be careful
I
not to put too much ointment inside the back passage,
especially if it is being given to a child.
•  lean the applicator very well after each use.
C

223071
UK
01
22 January 2014
480021328
AZL005/A
Pharma Code:

5471
Xyloproct Leaflet

14:06

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If you use more Xyloproct Ointment than you should
• f you use too much ointment talk to your doctor as
I
soon as possible.
I
• t is particularly important to talk to your doctor as soon
as possible if a child has been given too much ointment.
This is because fits have sometimes happened in
children who have been given too much.
4. Possible side effects
Like all medicines, Xyloproct Ointment can cause side
effects, although not everybody gets them.
Stop using Xyloproct Ointment and talk to your doctor
straight away if you notice any of the following – you
may need urgent medical treatment:
•  udden onset of rash, itching or hives on the skin.
S
S
•  welling of the face, lips, tongue or other parts of
the body.
•  hortness of breath, wheezing or trouble breathing.
S
This may mean that you are having an allergic reaction.
Stop using Xyloproct Ointment and talk to your doctor
if you notice any of the following:
•  oreness in your back passage.
S
•  leeding from your back passage.
B
Other possible side effects:
•  edness, swelling and itching where Xyloproct Ointment
R
has been put on your body.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
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. How to store Xyloproct Ointment
• The ointment should be kept in a safe place where

children cannot reach and see it.
• Xyloproct Ointment can be stored between 2°C and

8°C (in a refrigerator).

• When you start using the ointment, the tube can be
stored at room temperature (up to 25°C) for up to
2 months. Any remaining ointment should then be
discarded.
• Do not use Xyloproct Ointment after the expiry date

which is stated on the tube.

• Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose
of medicines that are no longer required. This will help
to protect the environment.

What Xyloproct Ointment looks like and contents of
the pack
Xyloproct Ointment is white to slightly yellow in colour. It
comes in an aluminium tube that contains 20 g (grams) of
the ointment. An applicator is provided.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation for Xyloproct Ointment is held
by AstraZeneca UK Limited, 600 Capability Green, Luton,
LU1 3LU, UK.
Xyloproct Ointment is manufactured by AstraZeneca AB,
S‑151 85, Södertälje, Sweden.

To listen to or request a copy of this
leaflet in Braille, large print or audio
please call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the following
information:
Product name Xyloproct Ointment
Reference number 17901/0179
This is a service provided by the
Royal National Institute of Blind
People.
Leaflet prepared: January 2014
© AstraZeneca 2014
Xyloproct is a trade mark of the AstraZeneca group of
companies.
PAI 14 0007

6. Further information
What Xyloproct Ointment contains
The active substances in Xyloproct Ointment are
lidocaine and hydrocortisone acetate. Each gram of
Xyloproct Ointment contains 50 mg (milligrams) of
lidocaine and 2.75 mg of hydrocortisone acetate.
The other ingredients are zinc oxide, aluminium acetate,
stearyl alcohol, cetyl alcohol, purified water and macrogol
(3350 and 400).

223071
UK
01
22 January 2014
480021328
AZL005/A
Pharma Code:

5471
Xyloproct Leaflet

14:06

Black

Profile

Technical
Info

Font information
Font family: Nimbus Sans
Body text size: 10 pt

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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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