XYLOPROCT 5%/0.275% OINTMENT

Active substance: LIDOCAINE

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48 076 00 28

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.
• If you have any further questions, ask your doctor or
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.
• If any of the side effects get serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor or pharmacist.

Take special care with Xyloproct Ointment
Check with your doctor or pharmacist before using
Xyloproct Ointment if:
• Your skin is very thin or fragile where the ointment is
going to be put.
• You 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.
• You have ever been told that you have a rare disease
of the blood pigment called ‘porphyria’ or anyone in your
family has it.

In this leaflet:
1. What Xyloproct Ointment is and what it is used for
2. Before you use Xyloproct Ointment
3. How to use Xyloproct Ointment
4. Possible side effects
5. How to store Xyloproct Ointment
6. Further information

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.

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
hydrocortisone.
• Lidocaine (sometimes known as lignocaine) belongs to a
group of medicines called local anaesthetics.
• Hydrocortisone belongs to a group of medicines called
corticosteroids.
What Xyloproct Ointment is used for
• Xyloproct Ointment can be used to relieve itching
around the back passage (anus) or female private parts
(genitals).
• It can also be used to relieve the symptoms of piles
(haemorrhoids) and other problems that affect the
back passage. These symptoms include pain and
inflammation.

2. Before you use Xyloproct Ointment
Do not use Xyloproct Ointment if:
• You are allergic (hypersensitive) to lidocaine or
hydrocortisone or any of the other ingredients of
Xyloproct Ointment (listed in Section 6: Further
information).
• You have ever had an allergic reaction to other local
anaesthetics or to other corticosteroid medicines.
• You have an infection where the ointment is going to be
put and the infection is not being treated.
• You are not in hospital and you are taking medicines for
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.

In particular, tell your doctor or pharmacist if you are taking
or using any of the following medicines:
• Medicines for an uneven heart beat (such as amiodarone
or sotalol).
• Other local anaesthetics.
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.

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.
How much Xyloproct Ointment to use
• Your doctor will tell you how much ointment to use and
how often to use it.
• Usually the ointment should be put on the affected area
several times a day.
• Up 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
• Xyloproct Ointment should only be used for limited
periods of time.
• With 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.
• If you get irritation, your doctor may do a patch test to
see if it is being caused by Xyloproct Ointment.

Using the applicator
• The ointment comes with an applicator. Your doctor will
tell you if you need to use this.
• If 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.
• Clean the applicator very well after each use.
If you use more Xyloproct Ointment than you should
• If you use too much ointment talk to your doctor as soon
as possible.
• It 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:
• Sudden onset of rash, itching or hives on the skin.
• Swelling of the face, lips, tongue or other parts of
the body.
• Shortness 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:
• Soreness in your back passage.
• Bleeding from your back passage.
Other possible side effects:
• Redness, swelling and itching where Xyloproct Ointment
has been put on your body.
If any of the side effects get serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.

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.

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).
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:
Xyloproct Ointment
Product name
Reference number 17901/0179
This is a service provided by the Royal
National Institute of Blind People.

Leaflet prepared: October 2009
© AstraZeneca 2009
Xyloproct is a trade mark of the AstraZeneca group of
companies.
PAI 09 0049

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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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