Proctosedyl Ointment

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Hydrocortisone; Cinchocaine hydrochloride; Aesculin; Framycetin sulfate

Available from:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC code:

C05AA; C05AA01

INN (International Name):

Hydrocortisone; Cinchocaine hydrochloride; Aesculin; Framycetin sulfate

Dosage:

0.5%w/v+0.5%w/v+1%w/v+1%w/v percent weight/weight

Pharmaceutical form:

Ointment

Prescription type:

Product subject to prescription which may not be renewed (A)

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 if you notice 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: hydrocortisone 5mg, Cinchocaine hydrochloride
5mg, Framycetin
Sulphate 10mg 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,
itching 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 hydrocortisone, cinchocai

Summary of Product characteristics

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.
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