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

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

FLUOCORTOLONE PIVALATE; Fluocortolone caproate; Cinchocaine hydrochloride

Tilgjengelig fra:

LEO Pharma A/S

ATC-kode:

C05AA; C05AA08

INN (International Name):

FLUOCORTOLONE PIVALATE; Fluocortolone caproate; Cinchocaine hydrochloride

Dosering :

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

Legemiddelform:

Rectal ointment

Terapeutisk område:

Corticosteroids; fluocortolone

Autorisasjon status:

Marketed

Autorisasjon dato:

1978-04-01

Informasjon til brukeren

IIT001-01 - Page 1 + 2 - 165 x 300 mm – DRA_90036
IIT001-01 - 28/01/2019 - OMA: Updated for CI project (CAPA 173674)
Insert, 50 g
165 x 300 mm
IIT001-01
09/08/2018
JUG
28/01/2019
OMA
100%
All products
Used for:
Segrate keyline DRA_90036
Comments:
Approval:
Date:
Production site approval:
Graphic approval:
Revision info:
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START USING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
R Keep this leaflet. You may need to read it
again.
R If you have any further questions, ask your
doctor, pharmacist or nurse.
R 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.
R 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:
R 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).
R have a viral infection (e.g. herpes, shingles,
chicken-pox).
R 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 BEFO

Preparatomtale

Health Products Regulatory Authority
30 September 2019
CRN008YXP
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.
The excipients (castor oil refined, castor oil hydrogenated,
macrogol-400-monoricinoleate and perfume oil citrus-rose) in
Ultraproct rectal ointment may reduce the effectiveness of latex
products such