Ultraproct 0.92mg/g + 0.95mg/g + 5mg/g Rectal Ointment

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

FLUOCORTOLONE PIVALATE; Fluocortolone caproate; Cinchocaine hydrochloride

Tillgänglig från:

Bayer Limited

ATC-kod:

C05AA; C05AA08

INN (International namn):

FLUOCORTOLONE PIVALATE; Fluocortolone caproate; Cinchocaine hydrochloride

Dos:

0.92mg/g +0.95mg/g + 5mg/g milligram(s)/gram

Läkemedelsform:

Rectal ointment

Receptbelagda typ:

Product subject to prescription which may not be renewed (A)

Terapiområde:

Corticosteroids; fluocortolone

Bemyndigande status:

Marketed

Tillstånd datum:

1978-04-01

Bipacksedel

Bayer Limited
The Atrium
Blackthorn Road
Dublin 18
Telephone:
[phone]
Fax:
[phone]
www.bayer.ie
15660

PATIENT
INFORMATION
LEAFLET
ULTRAPROCT
® 0.92 MG/G +
0.95MG/G + 5 MG/G RECTAL
OINTMENT
FLUOCORTOLONE PIVALATE
FLUOCORTOLONE CAPROATE
CINCHOCAINE HYDROCHLORIDE
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 you experience any side effect
and this becomes serious, 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
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE ULTRAPROCT
6.
FURTHER INFORMATION
1.
WHAT ULTRAPROCT IS AND WHAT IT
IS USED FOR
Ultraproct contains a substance which
reduces inflammation (fluocortolone),
and a local anaesthetic (cinchocaine)
which relieves pain.
This medicine is used for the relief of
the inflammation, swelling, itching and
soreness of piles (haemorrhoids) and
to relieve itching of the anus (back
passage). Ultraproct is intended for
short term treatment.
2.
BEFORE YOU USE ULTRAPROCT
DO NOT USE ULTRAPROCT IF YOU:

are allergic (hypersensitive) to
fluocortolone pivalate, fluocortolone
caproate, cinchocaine hydrochloride,
other local anaesthetics or any of the
other ingredients of Ultraproct.

have a viral infection (e.g. herpes,
shingles, chicken-pox)

have any bacterial or fungal
infections of the skin for which you are
not receiving treatment
TAKE SPECIAL CARE WITH ULTRAPROCT

Long-term continuous treatment
should be avoided because it can
cause the skin to thin and
deteriorate in the affected area
(see section 4. “Possible Side
Effects”) and some of the medicine
may be absorbed into the blood
stream. Ultraproct should not
normally be used for longer than 1
week.

If the

Produktens egenskaper

Health Products Regulatory Authority
16 April 2019
CRN008LLS
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ultraproct 0.92mg/g + 0.95mg/g + 5mg/g Rectal Ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1g of ointment contains 0.92 mg of Fluocortolone Pivalate, 0.95 mg of
Fluocortolone Caproate and 5 mg of Cinchocaine
Hydrochloride.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Rectal Ointment.
A colourless to faintly yellow ointment.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the management of symptoms of internal or external haemorrhoids,
anal fissures and proctitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The anal region should be cleaned thoroughly before using Ultraproct,
which is best applied after defaecation.
Usual application twice daily, on the first day, for faster
symptomatic relief, up to four times. Protruding lumps should be
smeared and carefully pressed back with the finger.
Duration of treatment should not usually exceed 1 week. Specific
treatment of the condition giving rise to the haemorrhoids
may be required.
Before applying within the rectum, the enclosed applicator should be
screwed onto the tube (for use and cleaning of the
applicator see section 6.6).
4.3 CONTRAINDICATIONS
Use in the presence of untreated infections of bacterial, viral,
tuberculous or fungal origin.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Additional specific therapy is required in bacterial and/or fungal
infections.
There have been a few reports in the literature of the development of
cataracts in patients who have been using corticosteroids
for prolonged periods of time.
Although, it is not possible to rule out systemic corticosteroids as a
known factor, prescribers should be aware of the possible
role of corticosteroids in cataract development.
Visual disturbance may be reported with systemic and topical
corticosteroid use. If a patient presents with symptoms such as
blurred vision or other visual disturbances, the patient should be
considered f