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PROCTOSEDYL SUPPOSITORIES

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

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LIQUID MANUFACTURIN

G

Packaging code : 303224
Old packaging code :303148

Format : 157x210-PL3P8V
Plant barcode : 224

Update : 03/05/2017 - 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 : DG
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

303224 - 224

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
Warnings and precautions
any side effects not listed in this leaflet, please tell
Talk to your doctor or pharmacist before using
your doctor or pharmacist.
Proctosedyl Suppositories.
What is in this leaflet
• Contact your doctor if you experience blurred vision
1. What Proctosedyl Suppositories are and what they
or other visual disturbances.
are used for
2. What you need to know before you use Proctosedyl
Other medicines and Proctosedyl
Suppositories
Suppositories
3. How to use Proctosedyl Suppositories
4. Possible side effects
• Please tell your doctor if you are taking or have
5. How to store Proctosedyl Suppositories
recently taken any other medicines, including
6. Contents of the pack and other information
medicines obtained without a prescription.

Some medicines may increase the effects of
1. What Proctosedyl Suppositories are and
Proctosedyl Suppositories and your doctor may
what they are used for
wish to monitor you carefully if you are taking
these medicines (including some medicines for HIV:
The name of your medicine is Proctosedyl
ritonavir, cobicistat).
Suppositories. Proctosedyl Suppositories contain two
different medicines called: cinchocaine hydrochloride This is because Proctosedyl Suppositories can affect the
and hydrocortisone.
way some other medicines work. Also some medicines
can affect the way Proctosedyl Suppositories works.
• Cinchocaine hydrochloride belongs to a group of
medicines called local anaesthetics. It works by
Pregnancy and breast-feeding
causing numbness in the area to which it is applied. Talk to your doctor before using this medicine if
This stops you feeling pain in this area and helps
• You are pregnant, might become pregnant or think
lessen the spasm of the back passage
you may be pregnant
• Hydrocortisone belongs to a group of medicines
• You are breast-feeding or planning to breast-feed.
called corticosteroids. It works by lowering the
Ask your doctor or pharmacist for advice before taking
production of substances that cause inflammation. any medicine if you are pregnant or breast-feeding.
This helps lower swelling, itching and discharge
3. How to take Proctosedyl Suppositories
Proctosedyl Suppositories can be used for the short
term relief (not more than 7 days) of:
Always take Proctosedyl Suppositories exactly as your
• Pain, irritation, discharge and itching associated
doctor has told you. You should check with your doctor
with enlarged or swollen vessels around your back
or pharmacist if you are not sure.
passage (haemorrhoids)
• Itching around your back passage
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
1

LIQUID MANUFACTURIN

G

Packaging code : 303224
Old packaging code :303148

Format : 157x210-PL3P8V
Plant barcode : 224

Update : 03/05/2017 - 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 : DG
Plant : Colomiers

Logo version :

• 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.
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.

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.
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
The suppositories are smooth and off-white in colour.
Proctosedyl Suppositories are available in packs of 12.
Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturer
4. Possible side effects
Marketing Authorisation Holder
Like all medicines, Proctosedyl Suppositories can cause Sanofi
side effects, although not everybody gets them.
One Onslow Street
Tell your doctor or pharmacist if the following side Guildford
effect gets serious or lasts longer than a few days, Surrey
GU1 4YS
or if you notice any side effects not listed in this
UK
leaflet:
Tel:0845 372 7101
• Itching or burning sensation around the back
Email:uk-medicalinformation@sanofi.com
passage area
Manufacturer
• Skin rash
Unither Liquid Manufacturing
• Blurred vision
1-3 Allee De la Neste
If you have used Proctosedyl Suppositories for a long
Z.I. En Sigal
time, it is possible that you could get something called 31770 Colomiers
‘adrenal suppression’. Signs include lack of appetite,
France
pain in the stomach, weight loss, feeling sick or
being sick, lack of concentration, a feeling of hunger, This leaflet does not contain all the information about
your medicine. If you have any questions or are not
nervousness and fits.
sure about anything, ask your doctor or pharmacist.
Reporting of side effects
This leaflet was last revised in May 2017
If you get any side effects, talk to your doctor,
©Sanofi, 1998-2017
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet.
United Kingdom
You can also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard
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.

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.

303224 - 224

5. How to store Proctosedyl Suppositories

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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