Proctosedyl Ointment

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Hydrocortisone; Cinchocaine Hydrochloride; Aesculin; Framycetin sulphate

Available from:

Phoenix Labs

ATC code:

C05AA; C05AA01

INN (International Name):

Hydrocortisone; Cinchocaine Hydrochloride; Aesculin; Framycetin sulphate

Pharmaceutical form:

Ointment

Therapeutic area:

Corticosteroids; hydrocortisone

Authorization status:

Marketed

Authorization date:

1978-04-01

Patient Information leaflet

PROCTOSEDYL® OINTMENT
Hydrocortisone/Cinchocaine hydrochloride/Framycetin sulphate/Aesculin
Is this leaflet hard to see or read? Phone [phone] for help.
Read all of this leaflet carefully before you start using this
medicine.
•
Keep this leaflet. You may need to read it again
•
If you have any further questions, ask your doctor or pharmacist
•
This medicine has been prescribed for you. Do not pass it on to
others.
It may harm them, even if their symptoms are the same as yours.
•
If any of the side effects gets serious, or you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist
IN THIS LEAFLET:
1.
What Proctosedyl ointment is and what it is used for
2.
What you need to know before you use Proctosedyl ointment
3.
How to use Proctosedyl ointment
4.
Possible side effects
5.
How to store Proctosedyl ointment
6.
Contents of the pack and other information
1.
WHAT PROCTOSEDYL OINTMENT IS AND WHAT IT IS USED FOR
The name of your medicine is Proctosedyl ointment. Proctosedyl
ointment contains four
different medicines called: hydrocortisone 5mg, Cinchocaine
hydrochloride 5mg, Framycetin
Sulphate 10 mg and Aesculin 10mg.
•
Cinchocaine hydrochloride belongs to a group of medicines called local
anaesthetics. It works
by causing numbness in the area to which it is applied. This stops you
feeling pain in this area
and helps lessen the spasm of the back passage.
•
Hydrocortisone belongs to a group of medicines called corticosteroids.
It works by lowering
the production of substances that cause inflammation. This helps lower
swelling, itiching and
discharge.
Proctosedyl ointment can be used for the short-term relief (not more
than 7 days) of:
•
Pain, irritation, discharge and itching associated with enlarged or
swollen blood vessels
around your back passage (haemorrhoids).
•
Itching around your back passage.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE PROCTOSEDYL OINTMENT
DO NOT USE THIS MEDICINE AND TELL YOUR DOCTOR IF:
•
You are allergic (hypersensitive) to hydrocortiso

Summary of Product characteristics

Health Products Regulatory Authority
15 December 2023
CRN00DH6H
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Proctosedyl Ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of ointment contains 5 mg of Hydrocortisone, 5 mg of
Cinchocaine Hydrochlroide, 10 mg of Aesculin and 10 mg of
Framycetin Sulphate.
Excipients - Contains wool fat 10% w/w
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Ointment.
Yellowish white, translucent, homogeneous ointment.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the local management of pain, pruritus and inflammation associated
with internal or external haemorrhoids, and such
haemorrhoidal complications as fissures, proctitis, perianal eczema,
and post-operative states.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Dosage:
Application to external surface or by means of the cannula into the
rectum, twice daily and after each bowel movement.
Treatment should last for a week.
Administration:
Topical, Intrarectal and Perianal
4.3 CONTRAINDICATIONS
1. Use in the presence of untreated infections of viral, bacterial,
tuberculous, parasitic or fungal origin.
2. Use in patients hypersensitive to the active ingredient or any of
the excipients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Continuous treatment for longer than three weeks should be avoided in
patients under the age of three years because of the
possibility of adrenocortical suppression and growth retardation.
Continuous application without interruption will result in local
atrophy of the skin, striae, and superficial vascular dilation.
Prolonged use of an anti-infective may result in the development of
super-infection due to organisms, including fungi, resistant
to that anti-infective.
May cause local skin reactions (e.g. contact dermatitis).
Health Products Regulatory Authority
15 December 2023
CRN00DH6H
Page 2 of 4
Before prescribing the product any potential malignancies should be
excluded.
Pheochromocytoma crisis, which can be fatal, has been reported af