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PROCTOSEDYL SUPPOSITORIES

Active substance(s): CINCHOCAINE HYDROCHLORIDE MICRO / HYDROCORTISONE MICRO

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LIQUID MANUFACTURIN

G

Packaging code : 302850
Old packaging code :302304

Format : 157x210-PL3P8V
Plant barcode : 850

Update : 19/07/2016 - V1

Colors :

Product : PROCTOSEDYL 5-5MG SUP

Reflex blue
Découpe

Packaging type : Leaflet

Fonts : Ocean sans Pro SAN

Country : UK
Languages : EN

Min font size used : 9 pt

Graphic designer : MM
Plant : Colomiers

Logo version :

PACKAGE LEAFLET: INFORMATION FOR THE USER

Proctosedyl Suppositories
Cinchocaine hydrochloride 5mg
Hydrocortisone 5mg

2. What you need to know before you use
Proctosedyl Suppositories
Do not take use this medicine and tell your
doctor if:

Is this leaflet hard to see or read?
Phone 0845 372 7101 for help

302850 - 850

You are allergic (hypersensitive) to cinchocaine
hydrochloride, hydrocortisone or any of the other
ingredients of Proctosedyl Suppositories (listed in
Read all of this leaflet carefully before you start
section 6 below)
using this medicine
Signs of an allergic reaction include: a rash,
• Keep this leaflet. You may need to read it again.
swallowing or breathing problems, swelling of your
• If you have any further questions, ask your doctor or
lips, face, throat or tongue
pharmacist.
You have any kind of infection
• This medicine has been prescribed for you. Do not
Do not use this medicine if any of the above apply
pass it on to others. It may harm them even if their to you. If you are not sure, talk to your doctor or
symptoms are the same as yours.
pharmacist before using Proctosedyl Suppositories
• If any of the side effects gets serious, or if you notice
Other medicines and Proctosedyl
any side effects not listed in this leaflet, please tell
Suppositories
your doctor or pharmacist.
Please tell your doctor or pharmacist if you are taking
What is in this leaflet
or have recently taken any other medicines. This
1. What Proctosedyl Suppositories are and what they
includes medicines you buy without a prescription,
are used for
2. What you need to know before you use Proctosedyl including herbal medicines. This is because
Proctosedyl Suppositories can affect the way some
Suppositories
other medicines work. Also some medicines can affect
3. How to use Proctosedyl Suppositories
the way Proctosedyl Suppositories work.
4. Possible side effects
5. How to store Proctosedyl Suppositories
Pregnancy and breast-feeding
6. Contents of the pack and other information
Talk to your doctor before using this medicine if
• You are pregnant, might become pregnant or think
1. What Proctosedyl Suppositories are and
you may be pregnant
what they are used for
• You are breast-feeding or planning to breast-feed.
Ask your doctor or pharmacist for advice before taking
The name of your medicine is Proctosedyl
any medicine if you are pregnant or breast-feeding.
Suppositories. Proctosedyl Suppositories contain two
different medicines called: cinchocaine hydrochloride
3. How to take Proctosedyl Suppositories
and hydrocortisone.
Always take Proctosedyl Suppositories exactly as your
• Cinchocaine hydrochloride belongs to a group of
doctor has told you. You should check with your doctor
medicines called local anaesthetics. It works by
causing numbness in the area to which it is applied. or pharmacist if you are not sure.
This stops you feeling pain in this area and helps
Using this medicine
lessen the spasm of the back passage
• Do not use for longer than 7 days
• Hydrocortisone belongs to a group of medicines
• Only insert into your back passage
called corticosteroids. It works by lowering the
• Insert one suppository in the morning, evening and
production of substances that cause inflammation.
after each bowel movement
This helps lower swelling, itching and discharge
• Wash your hands before and after inserting the
suppository
Proctosedyl Suppositories can be used for the short
• If you feel the effect of your medicine is too weak or
term relief (not more than 7 days) of:
too strong, do not change the dose yourself, but ask
• Pain, irritation, discharge and itching associated
your doctor
with enlarged or swollen vessels around your back
passage (haemorrhoids)
If you take more Proctosedyl Suppositories than
• Itching around your back passage
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.
1

LIQUID MANUFACTURIN

G

Packaging code : 302850
Old packaging code :302304

Format : 157x210-PL3P8V
Plant barcode : 850

Update : 19/07/2016 - V1

Colors :

Product : PROCTOSEDYL 5-5MG SUP

Reflex blue
Découpe

Packaging type : Leaflet

Fonts : Ocean sans Pro SAN

Country : UK
Languages : EN

Min font size used : 9 pt

Graphic designer : MM
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
• Skin rash
UK
If you have used Proctosedyl Suppositories for a long
Tel:0845 372 7101
time, it is possible that you could get something called
Email:uk-medicalinformation@sanofi.com
‘adrenal suppression’. Signs include lack of appetite,
Manufacturer
pain in the stomach, weight loss, feeling sick or
Unither Liquid Manufacturing
being sick, lack of concentration, a feeling of hunger,
1-3 Allee De la Neste
nervousness and fits.
Z.I. En Sigal
Reporting of side effects
31770 Colomiers
France
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
This leaflet does not contain all the information about
effects not listed in this leaflet.
your medicine. If you have any questions or are not
sure about anything, ask your doctor or pharmacist.
United Kingdom
You can also report side effects directly via the Yellow This leaflet was last revised in May 2016
Card Scheme at: www.mhra.gov.uk/yellowcard
©Sanofi, 1998-2016
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

302850 - 850

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.

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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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