Proctosedyl

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CINCHOCAINE HYDROCHLORIDE, HYDROCORTISONE

Available from:

Sanofi Malta Limited Level2, Fort Business Centre, Mriehel Bypass, Birkirkara, Malta

ATC code:

C05AX03

INN (International Name):

CINCHOCAINE HYDROCHLORIDE 0.5 % (W/W) HYDROCORTISONE 0.5 % (W/W)

Pharmaceutical form:

OINTMENT

Composition:

CINCHOCAINE HYDROCHLORIDE 0.5 % (W/W) HYDROCORTISONE 0.5 % (W/W)

Prescription type:

OTC

Therapeutic area:

VASOPROTECTIVES

Authorization status:

Withdrawn

Authorization date:

2005-09-28

Patient Information leaflet

PROCTOSEDYL OINTMENT
Cinchocaine h_y_drochloride 0.5%w/w
Hydrocortisone 0.5%w/w
PACKAGE LEAFLET: INFORMATION FOR THE USER
3. HOW TO USE PROCTOSEDYL OINTMENT
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
any side effects not listed in this leaflet, please tell
your doctor or pharmacist
WHAT IS 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
The name of your medicine is Proctosedyl ointment.
Proctosedyl ointment contains two different medicines
called: cinchocaine hydrochloride and hydrocortisone.
• 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
DO NOT USE THIS MEDICINE AND TELL YOUR
DOCTOR IF:
You are allergic (hypersensitive) to cinchocaine
hydrochloride, hydrocortisone or any of the other
ingredients of Proctosedyl ointment (listed in
Section 6

Summary of Product characteristics

Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
__________________________________________________________________
1. TRADE NAME OF THE MEDICINAL PRODUCT
Proctosedyl
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Cinchocaine hydrochloride (micro) 0.5% w/w
Hydrocortisone (micro) 0.5% w/w
3. PHARMACEUTICAL FORM
_ _
Yellowish-white translucent greasy ointment.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The local anaesthetic cinchocaine relieves pain and relaxes
sphincteric spasm.
Pruritus and inflammation are relieved by hydrocortisone, which also
decreases
serious discharge.
Proctosedyl is, therefore, useful for the short-term relief (not more
than 7 days) of
pain, irritation and pruritus associated with haemorrhoids and
pruritus ani.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_ _
_Adults (including the elderly) and children: _
Apply the ointment in small quantities with the finger, on the painful
or pruritic
area, morning and evening and after each stool. For deep application
attach
cannula to tube, insert to full extent and squeeze tube gently from
lower end
whilst withdrawing.
The ointment may be used separately or concurrently with the
suppositories.
4.3 CONTRA-INDICATIONS
Known hypersensitivity to any of the ingredients.
Page 2 of 5
Not for use in the presence of infections.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Apply the ointment only to the region of the rectum and anus and
surrounding
skin. Hydrocortisone can cause thinning and damage to the skin
especially of the
face.
As with all preparations containing topical steroids, the possibility
of systemic
absorption should be considered. In particular, long-term continuous
therapy
should be avoided in infants. Adrenal suppression can occur even
without
occlusion.
Pheochromocytoma
crisis,
which
can
be
fatal,
has
been
reported
after
administration of corticosteroids. Corticosteroids should only be
administered to
patients with suspected or identified pheochromocytoma after an
appropriate
risk/benefit evaluation. (See Section 4.8).
Visual disturbance