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ULTRAPROCT OINTMENT

Active substance: FLUOCORTOLONE PIVALATE

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Patient information Leaflet
®

Ultraproct Ointment
Ultraproct® Suppositories
(fluocortolone pivalate, fluocortolone hexanoate and
cinchocaine hydrochloride)

Read all of this leaflet carefully before you start using this
medicine.
• Keep this leaflet. You may need to read it again.

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
In this leaflet they are jointly referred to as Ultraproct.
Your doctor will prescribe the correct product to treat your specific
condition.

2. Before you use Ultraproct

• If you have any further questions, ask your doctor or pharmacist.

Do not use Ultraproct if you:

• 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.

• are allergic (hypersensitive) to local anaesthetics or any other
ingredients of this medicine (see section 6)

• 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.

• suffer from a viral skin infection such as cold sores, herpes,
shingles or chickenpox

Using dressings over the treatment area
Do not use waterproof dressings over the affected skin.
Taking other medicines
Ultraproct has not been shown to interact negatively with any
other medicines. As a general precaution you should always tell
your doctor or pharmacist if you are taking or have recently taken
any other medicines, including medicines obtained without a
prescription.
Pregnancy and breast-feeding
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.
Driving and using machines
Ultraproct does not impair your ability to drive or operate
machinery.

• have a bacterial or fungal infection for which you are not
receiving treatment

Important information about some of the ingredients of
Ultraproct Ointment

• are pregnant or breast-feeding, unless recommended
otherwise by your doctor

Ultraproct Ointment contains castor oil and hydrogenated castor
oil, which may cause skin reactions.

3. How to use Ultraproct

Tell your doctor if you believe any of the above conditions apply
to you.

3. How to use Ultraproct

4. Possible side effects

Take special care with Ultraproct:

5. How to store Ultraproct

Ultraproct must not come into contact with your eyes. Rinse
with cold water if accidental contact occurs.

In this leaflet:
1. What Ultraproct is and what it is used for
2. Before you use Ultraproct

6. Further information

1. What Ultraproct is and what it is used for
Ultraproct contains fluocortolone which belongs to a group of
medicines known as the corticosteroids which reduce inflammation
and itching. Ultraproct also contains a substance called
cinchocaine hydrochloride which is a local anaesthetic to relieve
pain.

Wash your hands before and after using Ultraproct.
Do not use Ultraproct for more than 7 days.

Avoid using Ultraproct for a long time because it increases the
risk of side effects.

Ointment:

If the area treated with Ultraproct is also infected your doctor will
prescribe another medicine to treat the infection.

You can apply it three or four times a day during the first day of
the treatment to obtain quick relief.

Infants and Children

Before you use the ointment wash your anus and area around it
gently but thoroughly.

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.

The ointment should be applied twice a day.

437989/GB/8

If the ointment is to be used for the area around the anus:

If you use more Ultraproct than you should

• Squeeze a small amount (about the size of a pea) on the tip of
your finger

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.

• Spread it gently over the skin and just inside the anus
• Do not rub it in
If the ointment is to be used inside the anus:
• Attach the nozzle onto the tube

4. Possible side effects

1g of Ultraproct Ointment contains the active ingredients 0.92mg
fluocortolone pivalate, 0.95mg fluocortolone hexanoate and 5mg
cinchocaine hydrochloride.
The other ingredients are polyethylene glycol 400 monoricinoleate,
castor oil, hydrogenated castor oil, 2-octyldodecanol, citrus rose
perfume oil.
What Ultraproct looks like and contents of the pack:

Ultraproct can cause side effects although not everybody gets
them.

Ultraproct Suppositories are yellowish white in colour and are
available in packs of twelve.

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.

Ultraproct Ointment is yellowish white in colour and available in
30 g tubes with an applicator.

• Wash the nozzle in hot soapy water and rinse thoroughly

Thinning of the skin may occur if Ultraproct is applied for long
periods of time.

Suppositories

Reporting of side effects

You should use one suppository per day, preferably after a bowel
movement.

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.

Marketing authorisation holder:
Meadow Laboratories Limited
Unit 13, Falcon Business Centre
Ashton Road
Romford
Essex RM3 8UR
United Kingdom

• 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

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
• 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.

5. How to store Ultraproct
Keep out of the reach and sight of children.

Manufacturer:
Bayer Healthcare Manufacturing S.r.l.
Via E. Schering 21
20090 Segrate (MI)
Italy

Do not use after the expiry date on the pack.
Suppositories: Store in a refrigerator.

This leaflet was last revised in November 2014.

Ointment: Do not store above 25° C.

If accidentally swallowed
If you or someone else accidentally swallows Ultraproct it is
unlikely to be harmful but contact you doctor or pharmacist if
you are concerned.

6. Further information

If you forget to use Ultraproct

One Ultraproct Suppository contains the active ingredients
0.61mg fluocortolone pivalate, 0.63mg fluocortolone hexanoate
and 1mg cinchocaine hydrochloride.

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.

What Ultraproct contains:

The other ingredient is hard fat.

437989/GB/8

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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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