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PROCTOSEDYL SUPPOSITORIES

Active substance: HYDROCORTISONE MICRO

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LIQUID MANUFACTURIN

G

Packaging code : 302304
Old packaging code :301743

Format : 157x210-PL3P8V
Plant barcode : 304

Update : 13/04/2015

Colors :

Reflex blue

Product : PROCTOSEDYL 5-5MG SUP
Packaging type : Leaflet

Fonts : Ocean sans Pro SAN

Country : UK
Languages : EN

Min font size used : 9 pt

Graphic designer : CR
Plant : Colomiers

Logo version :

PACKAGE LEAFLET: INFORMATION FOR THE USER

Proctosedyl Suppositories

2. What you need to know before you use
Proctosedyl Suppositories

Cinchocaine hydrochloride 5mg
Hydrocortisone 5mg

Do not take use this medicine and tell your
doctor if:
(hypersensitive) to cinchocaine
Is this leaflet hard to see or read? ✕ You are allergichydrocortisone or any of the other
hydrochloride,
ingredients of Proctosedyl Suppositories (listed in
Phone 0845 372 7101 for help
section 6 below)
Read all of this leaflet carefully before you start
Signs of an allergic reaction include: a rash,
using this medicine
swallowing or breathing problems, swelling of your
• Keep this leaflet. You may need to read it again.
lips, face, throat or tongue
• If you have any further questions, ask your doctor or
✕ You have any kind of infection
pharmacist.
Do not use this medicine if any of the above apply
• This medicine has been prescribed for you. Do not
pass it on to others. It may harm them even if their to you. If you are not sure, talk to your doctor or
pharmacist before using Proctosedyl Suppositories
symptoms are the same as yours.

1. What Proctosedyl Suppositories are and
what they are used for
The name of your medicine is Proctosedyl
Suppositories. Proctosedyl Suppositories contain two
different medicines called: cinchocaine hydrochloride
and hydrocortisone.
• Cinchocaine hydrochloride belongs to a group of
medicines called local anaesthetics. It works by
causing numbness in the area to which it is applied.
This stops you feeling pain in this area and helps
lessen the spasm of the back passage
• Hydrocortisone belongs to a group of medicines
called corticosteroids. It works by lowering the
production of substances that cause inflammation.
This helps lower swelling, itching and discharge
Proctosedyl Suppositories can be used for the short
term relief (not more than 7 days) of:
• Pain, irritation, discharge and itching associated
with enlarged or swollen vessels around your back
passage (haemorrhoids)
• Itching around your back passage

Other medicines and Proctosedyl
Suppositories
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines. This
includes medicines you buy without a prescription,
including herbal medicines. This is because
Proctosedyl Suppositories can affect the way some
other medicines work. Also some medicines can affect
the way Proctosedyl Suppositories work.
Pregnancy and breast-feeding
Talk to your doctor before using this medicine if
• You are pregnant, might become pregnant or think
you may be pregnant
• You are breast-feeding or planning to breast-feed.
Ask your doctor or pharmacist for advice before taking
any medicine if you are pregnant or breast-feeding.
3. How to take Proctosedyl Suppositories
Always take Proctosedyl Suppositories exactly as your
doctor has told you. You should check with your doctor
or pharmacist if you are not sure.
Using this medicine
• Do not use for longer than 7 days
• Only insert into your back passage
• Insert one suppository in the morning, evening and
after each bowel movement
• Wash your hands before and after inserting the
suppository
• If you feel the effect of your medicine is too weak or
too strong, do not change the dose yourself, but ask
your doctor
If you take more Proctosedyl Suppositories than
you should
Let your doctor know if you have used the
suppositories for more than 7 days by mistake.
If you accidently insert too many suppositories or
a suppository is swallowed, contact your doctor or
pharmacist immediately.
302304 - 304

• If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
What is in this leaflet
1. What Proctosedyl Suppositories are and what they
are used for
2. What you need to know before you use Proctosedyl
Suppositories
3. How to use Proctosedyl Suppositories
4. Possible side effects
5. How to store Proctosedyl Suppositories
6. Contents of the pack and other information

1

LIQUID MANUFACTURIN

G

Packaging code : 302304
Old packaging code :301743

Format : 157x210-PL3P8V
Plant barcode : 304

Update : 13/04/2015

Colors :

Product : PROCTOSEDYL 5-5MG SUP

Reflex blue

Packaging type : Leaflet

Fonts : Ocean sans Pro SAN

Country : UK
Languages : EN

Min font size used : 9 pt

Graphic designer : CR
Plant : Colomiers

Logo version :

If you forget to use Proctosedyl Suppositories
If you forget to use your suppository, insert it as soon
as you remember. However, if it is nearly time for the
next dose, skip the missed dose.
Do not insert more than one suppository to make up
for a forgotten dose.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

6. Contents of the pack and other information

What Proctosedyl Suppositories contain
• Each suppository contains 5 milligrams of the
active substance, cinchocaine hydrochloride and 5
milligrams of the active substance hydrocortisone
• The other ingredient is hard fat
What Proctosedyl Suppositories look like and
contents of the pack
4. Possible side effects
The suppositories are smooth and off-white in colour.
Like all medicines, Proctosedyl Suppositories can cause Proctosedyl Suppositories are available in packs of 12.
Not all pack sizes may be marketed
side effects, although not everybody gets them.
Tell your doctor or pharmacist if the following side Marketing Authorisation Holder and Manufacturer
effect gets serious or lasts longer than a few days, Marketing Authorisation Holder
Sanofi
or if you notice any side effects not listed in this
One Onslow Street
leaflet:
Guildford
• Itching or burning sensation around the back
Surrey
passage area
GU1 4YS
If you have used Proctosedyl Suppositories for a long
UK
time, it is possible that you could get something called
Tel:0845 372 7101
‘adrenal suppression’. Signs include lack of appetite,
Email:uk-medicalinformation@sanofi.com
pain in the stomach, weight loss, feeling sick or
Manufacturer
being sick, lack of concentration, a feeling of hunger,
Unither Liquid Manufacturing
nervousness and fits.
1-3 Allee De la Neste
Reporting of side effects
Z.I. En Sigal
31770 Colomiers
If you get any side effects, talk to your doctor,
France
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet.
This leaflet does not contain all the information about
your medicine. If you have any questions or are not
United Kingdom
You can also report side effects directly via the Yellow sure about anything, ask your doctor or pharmacist.
Card Scheme at: www.mhra.gov.uk/yellowcard
This leaflet was last revised in April 2015
©Sanofi, 1998-2015
Malta
You can also report side effects directly via ADR
Reporting www.medicinesauthority.gov.mt/adrportal
By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Proctosedyl Suppositories

302304 - 304

Keep this medicine in a safe place where children can
not see or reach it.
Do not use Proctosedyl Suppositories after the expiry
date which is stated on the label or carton after EXP.
The expiry date refers to the last day of that month.
Store at 2°C - 8°C.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose
of medicines no longer required. These measures will
help to protect the environment.

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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