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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 because it contains important
information for you.
•  eep this leaflet. You may need to read it again.
• f you have any further questions, ask your doctor or
•  his medicine has been prescribed for you only. Do
not pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
• f 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.
What is in this leaflet:
1.  hat Xyloproct Ointment is and what it is used for
2.  hat you need to know before you use Xyloproct Ointment
3.  ow to use Xyloproct Ointment
4.  ossible side effects
5.  ow to store Xyloproct Ointment
6.  ontents of the pack and other information
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.
Xyloproct Ointment contains two medicines: lidocaine and
•  idocaine (sometimes known as lignocaine) belongs to
a group of medicines called local anaesthetics.
•  ydrocortisone belongs to a group of medicines called
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
female private parts (genitals).
• o relieve the symptoms of piles (haemorrhoids) and
other problems that affect the back passage. These
symptoms include pain and inflammation.
2. What you need to know before you use
Xyloproct Ointment
Do not use Xyloproct Ointment:
• f you are allergic to lidocaine or hydrocortisone or
any of the other ingredients of this medicine (listed in
section 6).
• f you have ever had an allergic reaction to other local
anaesthetics or to other corticosteroid medicines.
• f you have an infection where the ointment is going to
be put and the infection is not being treated.
• f you are not in hospital and you are taking medicines
for an uneven heart beat (such as amiodarone or
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.

Warnings and precautions
Talk to your doctor or pharmacist before using
Xyloproct Ointment if:
•  our skin is very thin or fragile where the ointment is
going to be put.
•  ou have an infection where the ointment is going to
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
of the blood pigment called ‘porphyria’ or anyone in
your family has it.
If you are not sure if any of the above apply to you,
talk to your doctor or pharmacist before using Xyloproct
Other medicines and Xyloproct Ointment
Tell your doctor or pharmacist if you are taking, or have
recently taken, or might take 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
amiodarone or sotalol).
•  ther local anaesthetics.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor
for advice before taking this medicine. Your doctor will
decide if you can use Xyloproct Ointment during this time.
Driving and using machines
It is unlikely that using Xyloproct Ointment will affect your
ability to drive or operate machinery. However, depending on
how much is applied, Xyloproct Ointment may slightly affect
your alertness and co-ordination temporarily. If affected, you
should not drive, use tools or operate machinery.
Xyloproct Ointment contains cetyl alcohol and stearyl
May cause local skin reactions (e.g. contact dermatitis).
3. How to use Xyloproct Ointment
Always use Xyloproct Ointment exactly as your doctor has
told you. Check with your doctor or pharmacist if you are
not sure. Always wash your hands well before and after
using this medicine.
How much Xyloproct Ointment to use
•  our doctor will tell you how much ointment to use and
how often to use it.
•  sually the ointment should be put on the affected
area several times a day.
•  p to 6 g (grams) of ointment can be used each day.
This is about a third of a tube.
How long to use Xyloproct Ointment for
•  yloproct Ointment should only be used for limited
periods of time.
•  ith longer periods of treatment (up to 3 weeks)
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.
• 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
tell you if you need to use this.
• f your doctor tells you to use the applicator, be careful
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.
If you use more Xyloproct Ointment than you should
• f you use too much ointment talk to your doctor as
soon as possible.
• 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.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine 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.
•  welling of the face, lips, tongue or other parts of the body.
•  hortness of breath, wheezing or trouble breathing.
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.
•  leeding from your back passage.
Other possible side effects:
•  edness, swelling and itching where Xyloproct Ointment
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:
By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Xyloproct Ointment
•  eep this medicine out of the sight and reach of children.
•  o not use this medicine after the expiry date which is
stated on the tube after EXP. The expiry date refers to
the last day of that month.
•  yloproct Ointment can be stored between 2°C and
8°C (in a refrigerator).
•  hen you start using the ointment, the tube can be
stored at room temperature (below 25°C) for up to
2 months. Any remaining ointment should then be
•  edicines 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.
6. Contents of the pack and other information
What Xyloproct Ointment contains
The active substances are lidocaine and hydrocortisone
acetate. Each gram of Xyloproct Ointment contains
50 mg (milligrams) of lidocaine and 2.75 mg of hydrocortisone

The other ingredients are zinc oxide, aluminium acetate,
stearyl alcohol, cetyl alcohol, purified water and macrogol
(3350 and 400).
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
AstraZeneca UK Limited, 600 Capability Green, Luton,
LU1 3LU, UK.
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
Product name Xyloproct Ointment
Reference number 17901/0179
This is a service provided by the
Royal National Institute of Blind
This leaflet was last revised in March 2015
© AstraZeneca 2015
Xyloproct is a trade mark of the AstraZeneca group of
PAI 14 0053a

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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.