PROCTOSEDYL OINTMENT
Active substance(s): CINCHOCAINE HYDROCHLORIDE / HYDROCORTISONE
PACKAGE LEAFLET: INFORMATION FOR THE USER
Proctosedyl Ointment
Cinchocaine hydrochloride 0.5%w/w
Hydrocortisone 0.5%w/w
Is this leaflet hard to see or read?
Phone 0845 372 7101 for help
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 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 ointment is and what it is used for
2. What you need to know before you use
Proctosedyl Ointment
3. How to use Proctosedyl ointment
4. Possible side effects
5. How to store Proctosedyl ointment
6. Contents of the pack and other information
1. What Proctosedyl ointment is and what it
is used for
The name of your medicine is Proctosedyl ointment.
Proctosedyl ointment contains 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 ointment can be used for the short-term
relief (not more than 7 days) of:
• Pain, irritation, discharge and itching associated with
enlarged or swollen blood vessels around your back
passage (haemorrhoids)
• Itching around your back passage
2. What you need to know before you use
Proctosedyl Ointment
Do not use this medicine and tell your
doctor if:
You are allergic (hypersensitive) to cinchocaine
hydrochloride, hydrocortisone or any of the other
ingredients of Proctosedyl ointment (listed in
Section 6 below)
Signs of an allergic reaction include: a rash,
swallowing or breathing problems, swelling of your
lips, face, throat or tongue
You have any kind of infection
Do not use this medicine if any of the above apply
to you. If you are not sure, talk to your doctor or
pharmacist before using Proctosedyl.
Warnings and precautions
Talk to your doctor or pharmacist before using
Proctosedyl Ointment
• Contact your doctor if you experience blurred vision
or other visual disturbances.
Other medicines and Proctosedyl Ointment
• Please tell your doctor if you are taking or have recently
taken any other medicines, including medicines
obtained without a prescription.
• Some medicines may increase the effects of Proctosedyl
Ointment and your doctor may wish to monitor you
carefully if you are taking these medicines (including
some medicines for HIV: ritonavir, cobicistat).
This is because Proctosedyl Ointment can affect the way
some other medicines work. Also some medicines can
affect the way Proctosedyl Ointment works.
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.
Important information about some of the ingredients
of Proctosedyl ointment
This medicine contains wool fat (lanolin) which may cause
local skin reactions such as contact dermatitis. Contact
dermatitis causes redness, itching or irritation of the skin.
3. How to use Proctosedyl ointment
Always use Proctosedyl ointment 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 apply to your back passage and the
surrounding areas
PL 04425/0207 PROCTOSEDYL 30G UK LEAFLET
LEAFLET
00000
50088333H
50088333G
00000
559522
16-Nov-17
5
RI
1 of 2
N/A
140mm x 170mm
N/A
50088333H
N/A
N/A
000
8pt
Fonts:
Ocean Sans Pro SAN, Helvetica
Neue LT Std,
1
PANTONE
Reflex Blue C
50088333H
00000000
• Do not apply to the face or other parts of the body
• Apply this medicine in the morning, evening and after
each bowel movement
• If you feel the effect of your medicine is too weak or
too strong, do not change the dose yourself, but ask
your doctor
How to apply this medicine
If your doctor has asked you to apply some ointment
around your back passage and the surrounding area,
follow the instructions below on how to apply this
medicine:
• Wash your hands
• Squeeze a small amount of the ointment onto your
fingertip
• Gently rub a small layer of ointment over the sore,
painful or itching area
• Wash your hands
If your doctor has asked you to apply some ointment
deeper into your back passage, follow the instructions
below on how to apply this medicine:
• Wash your hands
• Screw the plastic nozzle provided onto the tube
• Insert the nozzle into the back passage
• Squeeze the tube gently as you slowly pull it out
• Stay still for 1 or 2 minutes
• Wash your hands and the nozzle
If you use more Proctosedyl ointment than you
should
Let your doctor know if you have used this ointment
for more than 7 days by mistake.
If you forget to use Proctosedyl ointment
If you forget to use your ointment, use it as soon as
you remember. However, if it is nearly time for the
next dose, skip the missed dose.
Do not use a double dose to make up for a forgotten
dose.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Proctosedyl ointment can cause
side effects, although not everybody gets them.
Tell your doctor or pharmacist if the following side
effect gets serious or lasts longer than a few days,
or you notice any side effects not listed in this
leaflet:
• Skin rash
• Thinning of the skin
• Blurred vision
If you have used this ointment for a long time, it is
possible that you could get something called ‘adrenal
suppression’. Signs include lack of appetite, pain in the
stomach, weight loss, feeling sick or being sick, lack of
concentration, a feeling of hunger, nervousness and fits.
Reporting of Side Effects
If you get any side effects, talk to your doctor or
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 or
search for MHRA Yellow Card in the Google Play or
Apple App Store.
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.
PL 04425/0207 PROCTOSEDYL 30G UK LEAFLET
LEAFLET
00000
50088333H
50088333G
00000
5. How to store Proctosedyl ointment
Keep this medicine in a safe place where children can
not see or reach it.
Do not use Proctosedyl ointment after the expiry date
which is stated on the label, carton or tube after EXP.
The expiry date refers to the last day of that month.
Store below 25°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 ointment contains
• Each gram of ointment contains 5 milligrams of the
active substance, cinchocaine hydrochloride and
5 milligrams of the active substance hydrocortisone
• The other ingredients are wool fat (lanolin), liquid
paraffin and white soft paraffin
What Proctosedyl ointment looks like and contents
of the pack
Proctosedyl ointment is a yellowish-white translucent
greasy ointment. It is available in a 30 gram
aluminium tube with a plastic nozzle.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK.
Tel: 0845 372 7101
email: [email protected]
Manufacturer
Sanofi Winthrop Industrie
196, rue du Maréchal Juin
45200 Amilly
This leaflet does not contain all the information about
your medicine. If you have any questions or are not
sure about anything, ask your doctor or pharmacist.
This leaflet was last revised in September 2017
© Sanofi 1998-2017
559522
16-Nov-17
5
RI
2 of 2
N/A
140mm x 170mm
N/A
50088333H
N/A
N/A
000
8pt
Fonts:
Ocean Sans Pro SAN, Helvetica
Neue LT Std,
1
PANTONE
Reflex Blue C
50088333H
00000000
Proctosedyl Ointment
Cinchocaine hydrochloride 0.5%w/w
Hydrocortisone 0.5%w/w
Is this leaflet hard to see or read?
Phone 0845 372 7101 for help
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 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 ointment is and what it is used for
2. What you need to know before you use
Proctosedyl Ointment
3. How to use Proctosedyl ointment
4. Possible side effects
5. How to store Proctosedyl ointment
6. Contents of the pack and other information
1. What Proctosedyl ointment is and what it
is used for
The name of your medicine is Proctosedyl ointment.
Proctosedyl ointment contains 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 ointment can be used for the short-term
relief (not more than 7 days) of:
• Pain, irritation, discharge and itching associated with
enlarged or swollen blood vessels around your back
passage (haemorrhoids)
• Itching around your back passage
2. What you need to know before you use
Proctosedyl Ointment
Do not use this medicine and tell your
doctor if:
You are allergic (hypersensitive) to cinchocaine
hydrochloride, hydrocortisone or any of the other
ingredients of Proctosedyl ointment (listed in
Section 6 below)
Signs of an allergic reaction include: a rash,
swallowing or breathing problems, swelling of your
lips, face, throat or tongue
You have any kind of infection
Do not use this medicine if any of the above apply
to you. If you are not sure, talk to your doctor or
pharmacist before using Proctosedyl.
Warnings and precautions
Talk to your doctor or pharmacist before using
Proctosedyl Ointment
• Contact your doctor if you experience blurred vision
or other visual disturbances.
Other medicines and Proctosedyl Ointment
• Please tell your doctor if you are taking or have recently
taken any other medicines, including medicines
obtained without a prescription.
• Some medicines may increase the effects of Proctosedyl
Ointment and your doctor may wish to monitor you
carefully if you are taking these medicines (including
some medicines for HIV: ritonavir, cobicistat).
This is because Proctosedyl Ointment can affect the way
some other medicines work. Also some medicines can
affect the way Proctosedyl Ointment works.
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.
Important information about some of the ingredients
of Proctosedyl ointment
This medicine contains wool fat (lanolin) which may cause
local skin reactions such as contact dermatitis. Contact
dermatitis causes redness, itching or irritation of the skin.
3. How to use Proctosedyl ointment
Always use Proctosedyl ointment 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 apply to your back passage and the
surrounding areas
PL 04425/0207 PROCTOSEDYL 30G UK LEAFLET
LEAFLET
00000
50088333H
50088333G
00000
559522
16-Nov-17
5
RI
1 of 2
N/A
140mm x 170mm
N/A
50088333H
N/A
N/A
000
8pt
Fonts:
Ocean Sans Pro SAN, Helvetica
Neue LT Std,
1
PANTONE
Reflex Blue C
50088333H
00000000
• Do not apply to the face or other parts of the body
• Apply this medicine in the morning, evening and after
each bowel movement
• If you feel the effect of your medicine is too weak or
too strong, do not change the dose yourself, but ask
your doctor
How to apply this medicine
If your doctor has asked you to apply some ointment
around your back passage and the surrounding area,
follow the instructions below on how to apply this
medicine:
• Wash your hands
• Squeeze a small amount of the ointment onto your
fingertip
• Gently rub a small layer of ointment over the sore,
painful or itching area
• Wash your hands
If your doctor has asked you to apply some ointment
deeper into your back passage, follow the instructions
below on how to apply this medicine:
• Wash your hands
• Screw the plastic nozzle provided onto the tube
• Insert the nozzle into the back passage
• Squeeze the tube gently as you slowly pull it out
• Stay still for 1 or 2 minutes
• Wash your hands and the nozzle
If you use more Proctosedyl ointment than you
should
Let your doctor know if you have used this ointment
for more than 7 days by mistake.
If you forget to use Proctosedyl ointment
If you forget to use your ointment, use it as soon as
you remember. However, if it is nearly time for the
next dose, skip the missed dose.
Do not use a double dose to make up for a forgotten
dose.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Proctosedyl ointment can cause
side effects, although not everybody gets them.
Tell your doctor or pharmacist if the following side
effect gets serious or lasts longer than a few days,
or you notice any side effects not listed in this
leaflet:
• Skin rash
• Thinning of the skin
• Blurred vision
If you have used this ointment for a long time, it is
possible that you could get something called ‘adrenal
suppression’. Signs include lack of appetite, pain in the
stomach, weight loss, feeling sick or being sick, lack of
concentration, a feeling of hunger, nervousness and fits.
Reporting of Side Effects
If you get any side effects, talk to your doctor or
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 or
search for MHRA Yellow Card in the Google Play or
Apple App Store.
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.
PL 04425/0207 PROCTOSEDYL 30G UK LEAFLET
LEAFLET
00000
50088333H
50088333G
00000
5. How to store Proctosedyl ointment
Keep this medicine in a safe place where children can
not see or reach it.
Do not use Proctosedyl ointment after the expiry date
which is stated on the label, carton or tube after EXP.
The expiry date refers to the last day of that month.
Store below 25°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 ointment contains
• Each gram of ointment contains 5 milligrams of the
active substance, cinchocaine hydrochloride and
5 milligrams of the active substance hydrocortisone
• The other ingredients are wool fat (lanolin), liquid
paraffin and white soft paraffin
What Proctosedyl ointment looks like and contents
of the pack
Proctosedyl ointment is a yellowish-white translucent
greasy ointment. It is available in a 30 gram
aluminium tube with a plastic nozzle.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK.
Tel: 0845 372 7101
email: [email protected]
Manufacturer
Sanofi Winthrop Industrie
196, rue du Maréchal Juin
45200 Amilly
This leaflet does not contain all the information about
your medicine. If you have any questions or are not
sure about anything, ask your doctor or pharmacist.
This leaflet was last revised in September 2017
© Sanofi 1998-2017
559522
16-Nov-17
5
RI
2 of 2
N/A
140mm x 170mm
N/A
50088333H
N/A
N/A
000
8pt
Fonts:
Ocean Sans Pro SAN, Helvetica
Neue LT Std,
1
PANTONE
Reflex Blue C
50088333H
00000000
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