PROCTOSEDYL OINTMENT tube

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

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

Available from:

AFT Pharmaceuticals Pty Ltd

Pharmaceutical form:

Ointment

Composition:

Excipient Ingredients: Wool fat; white soft paraffin; liquid paraffin

Administration route:

Rectal

Units in package:

10 x 2g, 30g, 15 g, 50 x 2g (Hospital pack), 2g, 5 x 2g

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: Odourless, yellowish-white, translucent, greasy ointment, free from foreign particles.; Container Type: Tube; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

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

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PRODUCT INFORMATION
PROCTOSEDYL OINTMENT AND SUPPOSITORIES
NAME OF DRUG
PROCTOSEDYL (cinchocaine hydrochloride, hydrocortisone)
DESCRIPTION
PROCTOSEDYL is supplied as suppositories or as an odourless
yellowish-white translucent
greasy ointment.
Each suppository contains cinchocaine hydrochloride BP 5mg,
hydrocortisone BP 5mg and
the excipient hard fat.
Each gram of ointment contains cinchocaine hydrochloride BP 5mg,
hydrocortisone BP 5mg
and the excipients white soft paraffin, liquid paraffin and wool fat.
PHARMACOLOGY
The rationale of the combination is to combine the local anaesthetic,
analgesic and
spasmolytic effect of cinchocaine with the antipruritic and
anti-inflammatory action of
hydrocortisone. These ingredients are presented in emollient vehicles.
Cinchocaine hydrochloride is a potent local anaesthetic agent with
anti-pyretic properties
resulting from its inhibition of the transmission of nerve impulses.
It is recognised as being
one of the longest acting of those agents commonly employed. It is
included in
PROCTOSEDYL for the relief of pain and spasm.
Topical corticosteroids have anti-inflammatory, anti-pruritic and
vasoconstrictive actions.
Hydrocortisone is a low potency glucocorticoid which is safe and
effective as a topical anti-
inflammatory drug in the concentration employed in PROCTOSEDYL.
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.
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CONTRAINDICATIONS
Hypersensitivity to hydrocortisone or cinchocaine or any of the
excipients (see
DESCRIPTION). All steroid preparations are contraindicated in
uncontrolled infections,
bacterial, viral (eg. herpes simplex, herpes zoster and vaccinia),
fungal, or parasitic infections
and when infective pathologies of