Proctosedyl

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Cinchocaine 0.5%{relative}; Hydrocortisone 0.5%{relative};  

Available from:

AFT Pharmaceuticals Ltd

INN (International Name):

Cinchocaine 0.5% w/w

Pharmaceutical form:

Rectal ointment

Composition:

Active: Cinchocaine 0.5%{relative} Hydrocortisone 0.5%{relative}   Excipient: Lanolin Liquid paraffin White soft paraffin

Units in package:

Tube, aluminium, 15 g

Class:

Pharmacy only

Prescription type:

Pharmacy only

Manufactured by:

Pharmasynthese SA

Therapeutic indications:

For symptomatic relief of external and internal haemorrhoids, anal pruritus, anal fissure, perianal eczema. Pre and post-operative treatment of haemorrhoidectomy patients. Post-partum haemorrhoidal conditions. Non-infective proctitis.

Product summary:

Package - Contents - Shelf Life: Tube, aluminium, - 15 g - 36 months from date of manufacture stored at or below 30°C protect from light - Tube, aluminium, - 30 g - 36 months from date of manufacture stored at or below 30°C protect from light - Tube, plastic, 5 x 2g single dose unit pack - 5 dose units - 24 months from date of manufacture stored at or below 30°C protect from light

Authorization date:

1969-12-31

Patient Information leaflet

PROCTOSEDYL
®
1
PROCTOSEDYL
®
_Hydrocortisone and cinchocaine hydrochloride _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about PROCTOSEDYL.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor or pharmacist
has weighed the risks of you taking
this medicine against the benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT PROCTOSEDYL
IS USED FOR
PROCTOSEDYL Ointment and
Suppositories are used for the relief
of the discomfort of haemorrhoids
(piles) and other painful conditions
of the anus (rear end), such as
fissures (tears). Haemorrhoids often
result when people strain while
trying to open their bowel (defecate).
This problem is often, but not
always, associated with low-fibre
diets.
PROCTOSEDYL Ointment and
Suppositories contain the active
ingredients hydrocortisone, a steroid,
and cinchocaine hydrochloride, a
local anaesthetic. These work
together to reduce swelling, numb
pain and relieve itching.
Your doctor or pharmacist, however,
may recommend PROCTOSEDYL
for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN RECOMMENDED FOR YOU.
BEFORE YOU USE IT
_WHEN YOU MUST NOT USE IT _
DO NOT USE PROCTOSEDYL IF YOU
ARE ALLERGIC TO IT OR ANY OF THE
INGREDIENTS LISTED AT THE END OF THIS
LEAFLET.
Some symptoms of an allergic
reaction include skin rash, itching,
shortness of breath or swelling of the
face, lips or tongue, which may cause
difficulty in swallowing or breathing.
AS FOR ALL STEROID PREPARATIONS, DO
NOT USE PROCTOSEDYL WHEN
UNCONTROLLED INFECTIONS, BACTERIAL,
VIRAL INFECTIONS (EG. HERPES,
COWPOX), FUNGAL, OR PARASITIC
INFECTIONS OR INFECTIONS AFFECTING
THE ANUS OR SURROUNDING AREA ARE
PRESENT EG SEXUALLY-TRANSMITTED
DISEASES.
PROCTOSEDYL use may hide signs
o

Summary of Product characteristics

New Zealand Data Sheet
January 2018
Proctosedyl - Cinchocaine hydrochloride + hydrocortisone
Property of the Sanofi group - strictly confidential
proctosedylointsupp-nz-ccsi-v2-dsv6-11jan18
Page 1
NEW ZEALAND DATA SHEET
1
PROCTOSEDYL® (0.5% W/W/0.5 % W/W OINTMENT AND 5 MG/5
MG SUPPOSITORIES)
PROCTOSEDYL 5 mg/5 mg suppository
PROCTOSEDYL 0.5% w/w/0.5% w/w rectal ointment
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository or gram of ointment contains the following active
ingredients: cinchocaine
hydrochloride BP 5mg, hydrocortisone BP 5mg.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
PROCTOSEDYL is available as smooth off-white suppositories and as an
odourless,
yellowish- white, translucent, greasy ointment.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For symptomatic relief of external and internal haemorrhoids, anal
pruritus, anal fissure, perianal
eczema.
Pre and post-operative treatment of haemorrhoidectomy patients.
Post-partum haemorrhoidal
conditions.
Non-infective proctitis.
4.2
DOSE AND METHOD OF ADMINISTRATION
New Zealand Data Sheet
January 2018
Proctosedyl - Cinchocaine hydrochloride + hydrocortisone
Property of the Sanofi group - strictly confidential
proctosedylointsupp-nz-ccsi-v2-dsv6-11jan18
Page 2
Dose
Suppositories or ointment applications: three times daily for first
week, after morning stool, noon
and evening; twice daily for second week, after morning stool and
evening; and once daily for
third week after morning stool. Except on medical advice, duration of
treatment should, as far as
possible, not exceed three weeks.
Method of administration
Suppositories:
Insert one suppository in the rectum.
Ointment:
15g and 30g tubes: apply a small quantity of ointment (only that
necessary to cover the affected
area), with the finger, to the painful or pruritic area. For deeper
application, attach cannula, gently
insert the cannula in the rectum and squeeze tube from the lower end
whilst withdrawing.
However, for very inflamed and painful lesions, it is advisable