PROCTOSEDYL SUPPOSITORIES Strip Pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

cinchocaine hydrochloride, Quantity: 5 mg; hydrocortisone, Quantity: 5 mg

Available from:

AFT Pharmaceuticals Pty Ltd

Pharmaceutical form:

Suppository, moulded

Composition:

Excipient Ingredients: Hard fat

Administration route:

Rectal

Units in package:

12 x 1.8g

Prescription type:

(S2) Pharmacy Medicine

Therapeutic indications:

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

Product summary:

Visual Identification: Uniform, smooth, off-white suppository.; Container Type: Strip Pack; Container Life Time: 18 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1992-06-26

Patient Information leaflet

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
of infection.
PROCTO

Summary of Product characteristics

1
proctosedylsupp-oint-ccdsv2-piv9-27may22
AUSTRALIAN PRODUCT INFORMATION – PROCTOSEDYL OINTMENT
AND SUPPOSITORIES (CINCHOCAINE HYDROCHLORIDE,
HYDROCORTISONE)
1
NAME OF THE MEDICINE
cinchocaine hydrochloride, hydrocortisone
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains cinchocaine hydrochloride BP 5mg and
hydrocortisone BP 5mg.
Each gram of ointment contains cinchocaine hydrochloride BP 5mg and
hydrocortisone BP 5mg.
3
PHARMACEUTICAL FORM
Proctosedyl is supplied as smooth, off-white suppositories or as an
odourless yellowish-white
translucent greasy ointment.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
For symptomatic relief of external and internal haemorrhoids, anal
pruritus, anal fissure. Pre
and post-operative treatment of haemorrhoidectomy patients.
Post-partum haemorrhoidal conditions. Non-infective proctitis.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Suppository or ointment applications: Three times daily for first
week, after morning stool,
noon and evening. PROCTOSEDYL should not be used for longer than 7
days unless prescribed
by a doctor.
If a longer period of treatment is required, the following dosage
regime should be implemented.
This length of treatment should only occur upon medical advice:
Twice daily for second week, after morning stool and evening; and once
daily for third week
after morning stool. Duration of treatment should, as far as possible,
not exceed three weeks.
SUPPOSITORIES:
Insert one suppository in the rectum.
OINTMENT:
2
proctosedylsupp-oint-ccdsv2-piv9-27may22
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 in the rectum to full extent and squeeze tube from the
lower end whilst
withdrawing.
4.3
C
ONTRAINDICATIONS
Hypersensitivity to hydrocortisone or cinchocaine or any of the
excipients (see Section 2
Qualitative and Quantitative Composition). All steroid preparations
are contraindicated in
un