ULTRAPROCT OINTMENT
Active substance(s): CINCHOCAINE HYDROCHLORIDE / FLUOCORTOLONE HEXANOATE / FLUOCORTOLONE PIVALATE
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C. 01356
Bayer HealthCare Manufacturing S.r.l. (Segrate)
TEL 02 937228 3
Artwork date: 16/05/2017
Version n°: 01
Page: 1/2
2585A-4
REG
0013
044
Ultraproct ointment
Great Britain (Meadow)
82092803
Black
Patient information Leaflet
Ultraproct Ointment
Ultraproct® Suppositories
®
(fluocortolone pivalate, fluocortolone hexanoate
and cinchocaine hydrochloride)
called cinchocaine hydrochloride which is a local anaesthetic to
relieve pain.
Ultraproct can be used for the short-term (5-7 days) relief of
inflammation, swelling, itching and soreness of piles
(haemorrhoids) and to relieve itching of the anus (back passage).
This leaflet covers the following products:
• Ultraproct Suppositories
• Ultraproct Ointment
Read all of this leaflet carefully before you start using this
medicine.
• Keep this leaflet. You may need to read it again.
In this leaflet they are jointly referred to as Ultraproct.
• 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.
In this leaflet:
1. What Ultraproct is and what it is used for
2. Before you use Ultraproct
3. How to use Ultraproct
Do not use waterproof dressings over the affected skin.
Taking other medicines
• Please tell your doctor if you are taking or have recently taken
any other medicines, including medicines obtained without a
prescription.
Do not use Ultraproct if you:
Pregnancy and breast-feeding
• are allergic (hypersensitive) to local anaesthetics or any other
ingredients of this medicine (see section 6)
Even at the usual dose, the possibility of a very small risk to the
development of a baby in pregnant women treated with Ultraproct
cannot be entirely ruled out. Therefore, this medicine should
not be used if you are pregnant, trying to become pregnant
or are breast-feeding unless considered essential by your
doctor.
• suffer from a viral skin infection such as cold sores, herpes,
shingles or chickenpox
• have a bacterial or fungal infection for which you are not
receiving treatment
• are pregnant or breast-feeding, unless recommended
otherwise by your doctor
Tell your doctor if you believe any of the above conditions apply
to you.
5. How to store Ultraproct
Take special care with Ultraproct:
6. Further information
Ultraproct must not come into contact with your eyes. Rinse
with cold water if accidental contact occurs.
Ultraproct contains fluocortolone which belongs to a group of
medicines known as the corticosteroids which reduce
inflammation and itching. Ultraproct also contains a substance
Using dressings over the treatment area
2. Before you use Ultraproct
4. Possible side effects
1. What Ultraproct is and what it is used for
Ultraproct is not for use in infants and is not recommended for
use in children under 12 years of age unless directed by a doctor.
• Some medicines may increase the effects of Ultraproct and
your doctor may wish to monitor you carefully if you are taking
these medicines (including some medicines for HIV: ritonavir,
cobicistat).
Your doctor will prescribe the correct product to treat your
specific condition.
• 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.
Infants and Children
Driving and using machines
Ultraproct does not impair your ability to drive or operate
machinery.
Important information about some of the ingredients of
Ultraproct Ointment
Ultraproct Ointment contains castor oil and hydrogenated castor
oil, which may cause skin reactions.
Avoid using Ultraproct for a long time because it increases the
risk of side effects.
3. How to use Ultraproct
If the area treated with Ultraproct is also infected your doctor
will prescribe another medicine to treat the infection.
Wash your hands before and after using Ultraproct.
Do not use Ultraproct for more than 7 days.
C. 01356
Bayer HealthCare Manufacturing S.r.l. (Segrate)
TEL 02 937228 3
Artwork date: 16/05/2017
Version n°: 01
Page: 2/2
2585A-4
REG
0013
044
Ultraproct ointment
Great Britain (Meadow)
82092803
Black
unlikely to be harmful but contact you doctor or pharmacist if
you are concerned.
6. Further information
If you forget to use Ultraproct
What Ultraproct contains:
Before you use the ointment wash your anus and area around
it gently but thoroughly.
If you have forgotten to use your medicine, do not make up for
it by using extra. When you remember, use the next prescribed
dose and continue with your treatment schedule.
One Ultraproct Suppository contains the active ingredients
0.61mg fluocortolone pivalate, 0.63mg fluocortolone hexanoate
and 1mg cinchocaine hydrochloride.
If the ointment is to be used for the area around the anus:
If you use more Ultraproct than you should
The other ingredient is hard fat.
• Squeeze a small amount (about the size of a pea) on the tip
of your finger
• Spread it gently over the skin and just inside the anus
If you think you have used more Ultraproct than you should, or
if you have used it for longer than 7 days, tell your doctor or
pharmacist.
1g of Ultraproct Ointment contains the active ingredients 0.92mg
fluocortolone pivalate, 0.95mg fluocortolone hexanoate and 5mg
cinchocaine hydrochloride.
4. Possible side effects
The other ingredients are polyethylene glycol 400 monoricinoleate,
castor oil, hydrogenated castor oil, 2-octyldodecanol, citrus rose
perfume oil.
Ointment:
The ointment should be applied twice a day.
You can apply it three or four times a day during the first day of
the treatment to obtain quick relief.
• Do not rub it in
If the ointment is to be used inside the anus:
• Attach the nozzle onto the tube
• Squeeze the tube until the nozzle is full of ointment
• Insert the nozzle carefully into the anus until the whole length
of the nozzle is inside
• While squeezing the tube gently, slowly withdraw the nozzle
• Wash the nozzle in hot soapy water and rinse thoroughly
Suppositories
You should use one suppository per day, preferably after a bowel
movement.
If your discomfort is severe you can insert two or three
suppositories per day at the beginning of your treatment.
If the suppositories become too soft due to warm temperature,
you can harden them by putting into cold water or into a fridge
for a while.
• Find the small tear in the foil and remove the covering foil by
tearing it in half
Ultraproct can cause side effects although not everybody gets
them.
Rarely an allergic reaction to Ultraproct may occur. If you feel
you have experienced an allergic reaction, stop using this
medicine and inform your doctor or pharmacist immediately.
Thinning of the skin may occur if Ultraproct is applied for long
periods of time.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting
side effects you can help provide more information on the safety
of this medicine.
5. How to store Ultraproct
• Insert the whole suppository into the anus gently
• To make insertion easier you can stand with one foot raised
on a chair or squat down.
Keep out of the reach and sight of children.
If accidentally swallowed
Suppositories: Store in a refrigerator.
If you or someone else accidentally swallows Ultraproct it is
Ointment: Do not store above 25° C.
Do not use after the expiry date on the pack.
What Ultraproct looks like and contents of the pack:
Ultraproct Suppositories are yellowish white in colour and are
available in packs of twelve.
Ultraproct Ointment is yellowish white in colour and available in
30 g tubes with an applicator.
Marketing authorisation holder:
Meadow Laboratories Limited
Unit 13, Falcon Business Centre
Ashton Road
Romford
Essex RM3 8UR
United Kingdom
Manufacturer:
Bayer Healthcare Manufacturing S.r.l.
Via E. Schering 21
20090 Segrate (MI)
Italy
This leaflet was last revised in March 2017.
REG
Bayer HealthCare Manufacturing S.r.l. (Segrate)
TEL 02 937228 3
Artwork date: 16/05/2017
Version n°: 01
Page: 1/2
2585A-4
REG
0013
044
Ultraproct ointment
Great Britain (Meadow)
82092803
Black
Patient information Leaflet
Ultraproct Ointment
Ultraproct® Suppositories
®
(fluocortolone pivalate, fluocortolone hexanoate
and cinchocaine hydrochloride)
called cinchocaine hydrochloride which is a local anaesthetic to
relieve pain.
Ultraproct can be used for the short-term (5-7 days) relief of
inflammation, swelling, itching and soreness of piles
(haemorrhoids) and to relieve itching of the anus (back passage).
This leaflet covers the following products:
• Ultraproct Suppositories
• Ultraproct Ointment
Read all of this leaflet carefully before you start using this
medicine.
• Keep this leaflet. You may need to read it again.
In this leaflet they are jointly referred to as Ultraproct.
• 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.
In this leaflet:
1. What Ultraproct is and what it is used for
2. Before you use Ultraproct
3. How to use Ultraproct
Do not use waterproof dressings over the affected skin.
Taking other medicines
• Please tell your doctor if you are taking or have recently taken
any other medicines, including medicines obtained without a
prescription.
Do not use Ultraproct if you:
Pregnancy and breast-feeding
• are allergic (hypersensitive) to local anaesthetics or any other
ingredients of this medicine (see section 6)
Even at the usual dose, the possibility of a very small risk to the
development of a baby in pregnant women treated with Ultraproct
cannot be entirely ruled out. Therefore, this medicine should
not be used if you are pregnant, trying to become pregnant
or are breast-feeding unless considered essential by your
doctor.
• suffer from a viral skin infection such as cold sores, herpes,
shingles or chickenpox
• have a bacterial or fungal infection for which you are not
receiving treatment
• are pregnant or breast-feeding, unless recommended
otherwise by your doctor
Tell your doctor if you believe any of the above conditions apply
to you.
5. How to store Ultraproct
Take special care with Ultraproct:
6. Further information
Ultraproct must not come into contact with your eyes. Rinse
with cold water if accidental contact occurs.
Ultraproct contains fluocortolone which belongs to a group of
medicines known as the corticosteroids which reduce
inflammation and itching. Ultraproct also contains a substance
Using dressings over the treatment area
2. Before you use Ultraproct
4. Possible side effects
1. What Ultraproct is and what it is used for
Ultraproct is not for use in infants and is not recommended for
use in children under 12 years of age unless directed by a doctor.
• Some medicines may increase the effects of Ultraproct and
your doctor may wish to monitor you carefully if you are taking
these medicines (including some medicines for HIV: ritonavir,
cobicistat).
Your doctor will prescribe the correct product to treat your
specific condition.
• 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.
Infants and Children
Driving and using machines
Ultraproct does not impair your ability to drive or operate
machinery.
Important information about some of the ingredients of
Ultraproct Ointment
Ultraproct Ointment contains castor oil and hydrogenated castor
oil, which may cause skin reactions.
Avoid using Ultraproct for a long time because it increases the
risk of side effects.
3. How to use Ultraproct
If the area treated with Ultraproct is also infected your doctor
will prescribe another medicine to treat the infection.
Wash your hands before and after using Ultraproct.
Do not use Ultraproct for more than 7 days.
C. 01356
Bayer HealthCare Manufacturing S.r.l. (Segrate)
TEL 02 937228 3
Artwork date: 16/05/2017
Version n°: 01
Page: 2/2
2585A-4
REG
0013
044
Ultraproct ointment
Great Britain (Meadow)
82092803
Black
unlikely to be harmful but contact you doctor or pharmacist if
you are concerned.
6. Further information
If you forget to use Ultraproct
What Ultraproct contains:
Before you use the ointment wash your anus and area around
it gently but thoroughly.
If you have forgotten to use your medicine, do not make up for
it by using extra. When you remember, use the next prescribed
dose and continue with your treatment schedule.
One Ultraproct Suppository contains the active ingredients
0.61mg fluocortolone pivalate, 0.63mg fluocortolone hexanoate
and 1mg cinchocaine hydrochloride.
If the ointment is to be used for the area around the anus:
If you use more Ultraproct than you should
The other ingredient is hard fat.
• Squeeze a small amount (about the size of a pea) on the tip
of your finger
• Spread it gently over the skin and just inside the anus
If you think you have used more Ultraproct than you should, or
if you have used it for longer than 7 days, tell your doctor or
pharmacist.
1g of Ultraproct Ointment contains the active ingredients 0.92mg
fluocortolone pivalate, 0.95mg fluocortolone hexanoate and 5mg
cinchocaine hydrochloride.
4. Possible side effects
The other ingredients are polyethylene glycol 400 monoricinoleate,
castor oil, hydrogenated castor oil, 2-octyldodecanol, citrus rose
perfume oil.
Ointment:
The ointment should be applied twice a day.
You can apply it three or four times a day during the first day of
the treatment to obtain quick relief.
• Do not rub it in
If the ointment is to be used inside the anus:
• Attach the nozzle onto the tube
• Squeeze the tube until the nozzle is full of ointment
• Insert the nozzle carefully into the anus until the whole length
of the nozzle is inside
• While squeezing the tube gently, slowly withdraw the nozzle
• Wash the nozzle in hot soapy water and rinse thoroughly
Suppositories
You should use one suppository per day, preferably after a bowel
movement.
If your discomfort is severe you can insert two or three
suppositories per day at the beginning of your treatment.
If the suppositories become too soft due to warm temperature,
you can harden them by putting into cold water or into a fridge
for a while.
• Find the small tear in the foil and remove the covering foil by
tearing it in half
Ultraproct can cause side effects although not everybody gets
them.
Rarely an allergic reaction to Ultraproct may occur. If you feel
you have experienced an allergic reaction, stop using this
medicine and inform your doctor or pharmacist immediately.
Thinning of the skin may occur if Ultraproct is applied for long
periods of time.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting
side effects you can help provide more information on the safety
of this medicine.
5. How to store Ultraproct
• Insert the whole suppository into the anus gently
• To make insertion easier you can stand with one foot raised
on a chair or squat down.
Keep out of the reach and sight of children.
If accidentally swallowed
Suppositories: Store in a refrigerator.
If you or someone else accidentally swallows Ultraproct it is
Ointment: Do not store above 25° C.
Do not use after the expiry date on the pack.
What Ultraproct looks like and contents of the pack:
Ultraproct Suppositories are yellowish white in colour and are
available in packs of twelve.
Ultraproct Ointment is yellowish white in colour and available in
30 g tubes with an applicator.
Marketing authorisation holder:
Meadow Laboratories Limited
Unit 13, Falcon Business Centre
Ashton Road
Romford
Essex RM3 8UR
United Kingdom
Manufacturer:
Bayer Healthcare Manufacturing S.r.l.
Via E. Schering 21
20090 Segrate (MI)
Italy
This leaflet was last revised in March 2017.
REG
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
