Ultraproct

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Cinchocaine hydrochloride 5 mg/g; Fluocortolone hexanoate 0.945 mg/g; Fluocortolone pivalate 0.918 mg/g

Available from:

AFT Pharmaceuticals Ltd

INN (International Name):

Cinchocaine hydrochloride 5 mg/g

Pharmaceutical form:

Topical ointment

Composition:

Active: Cinchocaine hydrochloride 5 mg/g Fluocortolone hexanoate 0.945 mg/g Fluocortolone pivalate 0.918 mg/g Excipient: Castor oil Hydrogenated castor oil Macrogol 400 monoricinoleate Octyldodecanol Citrus rose perfume oil.

Units in package:

Tube, aluminium, 10 g

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Pharmasynthese SA

Therapeutic indications:

· Treatment of haemorrhoids.

Product summary:

Package - Contents - Shelf Life: Tube, aluminium, - 10 g - 24 months from date of manufacture stored at or below 25°C - Tube, aluminium, - 30 g - 24 months from date of manufacture stored at or below 25°C

Authorization date:

1969-12-31

Patient Information leaflet

NEW ZEALAND CONSUMER MEDICINE INFORMATION
ULTRAPROCT
®
Fluocortolone pivalate, Fluocortolone hexanoate, Cinchocaine
hydrochloride
Ointment and Suppositories
The ointment contains 0.92 mg fluocortolone pivalate, 0.95 mg
fluocortolone hexanoate and 5 mg cinchocaine hydrochloride per
1 g of ULTRAPROCT®
Each suppository contains 0.612 mg fluocortolone pivalate, 0.63 mg
fluocortolone hexanoate, and 1 mg cinchocaine hydrochloride.
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using
ULTRAPROCT®. It will advise you about how to use ULTRAPROCT®
properly and when to tell your doctor about health-related
conditions. If you have any questions or need more advice, ask your
doctor, professional health care provider, or pharmacist.
This preparation has been prescribed for you personally, and you
should not pass it on to others. It may harm them.
WHAT IS ULTRAPROCT® USED FOR
ULTRAPROCT® is used for patients suffering from haemorrhoids,
superficial anal fissures, and proctitis.
BEFORE YOU USE ULTRAPROCT®
_WHEN YOU MUST NOT USE IT_
Do not use ULTRAPROCT® if:
•
You are pregnant or think you might be pregnant. Corticosteroid
preparations such as ULTRAPROCT® should not be applied
during the first three months of pregnancy.
•
You are allergic to any of the ingredients of ULTRAPROCT®.
•
You suffer from tuberculous or syphilitic processes in the area to
be treated; virus diseases (e.g. vaccinia, chickenpox).
If any of these conditions appear while using ULTRAPROCT®, stop
using it at once and consult your doctor.
If you are not sure whether you should start using ULTRAPROCT®,
talk to your doctor.
_BEFORE YOU START TO USE IT_
Tell your doctor if:
•
You have or have had any medical conditions, especially fungal
infections such as thrush, in the area of the anus. ULTRAPROCT®
does not treat this condition. Your doctor may need to provide
additional treatment for this condition.
•
You are pregnant or plan to become pregnant or are breast-
feeding. Your doctor can discuss with you the risks

Summary of Product characteristics

NEW ZEALAND DATA SHEET
Page 1 of 5
1
ULTRAPROCT®
ULTRAPROCT® fluocortolone pivalate 0.918 mg/g, fluocortolone
hexanoate 0.945 mg/g and 5 mg/g
cinchocaine hydrochloride ointment
ULTRAPROCT® 0.612 mg fluocortolone pivalate, 0.63 mg fluocortolone
hexanoate and 1 mg
cinchocaine hydrochloride suppositories
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ointment: 1 g colourless to faintly yellowish ointment contains 0.92
mg fluocortolone pivalate, 0.95
mg fluocortolone hexanoate and 5 mg cinchocaine hydrochloride.
Suppositories: 1 yellowish white suppository contains 0.61 mg
fluocortolone pivalate, 0.63 mg
fluocortolone hexanoate and 1 mg cinchocaine hydrochloride.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Topical ointment
Suppositories
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
Haemorrhoids, superficial anal fissures, proctitis.
4.2
Dose and method of administration
The anal region should be cleaned thoroughly before using
ULTRAPROCT®, which is best applied
after defaecation. There is usually a rapid improvement, but this
should not mislead one into
stopping treatment too soon. To avoid relapses, ULTRAPROCT® should be
continued for at least one
week, though less frequently (ointment once a day or one suppository
every other day), even when
the symptoms have completely disappeared. However, duration of
treatment should, as far as
possible, not exceed 4 weeks.
_Ointment _
Generally, ULTRAPROCT® ointment is applied twice daily. On the first
day for faster symptomatic
relief, it can be applied up to four times a day. A little ointment
(about the size of a pea) is smeared
around the anus and in the anal ring with a finger, using the
fingertip to overcome the resistance of
the sphincter. Before applying within the rectum, the enclosed nozzle
should be screwed on to the
tube. However, for very inflamed and hence painful lesions, it is
advisable initially to apply the
ointment internally with the finger. Protruding lumps should be
smeared thickly and pressed
carefully back with the finger