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

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

FLUOCORTOLONE PIVALATE; Fluocortolone caproate; Cinchocaine Hydrochloride

Boleh didapati daripada:

Karo Pharma AB

Kod ATC:

C05AA; C05AA08

INN (Nama Antarabangsa):

FLUOCORTOLONE PIVALATE; Fluocortolone caproate; Cinchocaine Hydrochloride

Dos:

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

Borang farmaseutikal:

Rectal ointment

Kawasan terapeutik:

Corticosteroids; fluocortolone

Status kebenaran:

Marketed

Tarikh kebenaran:

1978-04-01

Risalah maklumat

17213
PACKAGE LEAFLET: INFORMATION
FOR THE USER
ULTRAPROCT
® 0.92 MG/G +
0.95 MG/G + 5 MG/G RECTAL
OINTMENT
FLUOCORTOLONE PIVALATE
FLUOCORTOLONE CAPROATE
CINCHOCAINE HYDROCHLORIDE
READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need
to read it again.

If you have any further questions,
ask your doctor, pharmacist or
nurse.

This medicine has been
prescribed for you only. Do not
pass it on to others. It may harm
them, even if their signs of illness
are the same as yours.

If you get any side effects, talk to
your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET:
1.
WHAT ULTRAPROCT
® IS AND WHAT
IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE
YOU USE ULTRAPROCT
®
3.
HOW TO USE ULTRAPROCT
®
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE ULTRAPROCT
®
6.
CONTENTS OF THE PACK AND OTHER
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.
WHAT YOU NEED TO KNOW 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 (listed
in section 6).

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.
WARNINGS AND PRECAUTIONS. TALK TO
YOUR DOCTOR, PHARMACIST OR NURSE
BEFORE USING ULTRAPROCT

Long-term continuous treatment
should be avoided because it can
cause the skin to thin and
deterior

Ciri produk

Health Products Regulatory Authority
25 May 2021
CRN00C52P
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 0.918 mg of Fluocortolone Pivalate, 0.945 mg
of Fluocortolone Caproate and 5 mg of Cinchocaine
Hydrochloride.
EXCIPIENTS WITH KNOWN EFFECT:
1 g of oinment contains 442.937 mg castor oil refined, 75 mg castor
oil hydrogenated, 75 mg macrogol 400 monoricinoleate
and 0.200 mg perfume oil, citrus-rose, see section 4.4.
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 developmen