Proctosedyl Ointment

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Framycetin sulfate; Aesculin; Cinchocaine Hydrochloride; Hydrocortisone

Tillgänglig från:

Opella Healthcare France SAS T/A Sanofi

ATC-kod:

C05AA; C05AA01

INN (International namn):

Framycetin sulfate; Aesculin; Cinchocaine Hydrochloride; Hydrocortisone

Dos:

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

Läkemedelsform:

Ointment

Terapiområde:

Corticosteroids; hydrocortisone

Bemyndigande status:

Marketed

Tillstånd datum:

1978-04-01

Bipacksedel

Proctosedyl®
Ointment
Is
this leaflet hard
to
see or
read? Phone
1
4035600
for
help.
Read
all
of
this leaflet
carefully
before
you
start
using
this
medicine
-
Keep
this
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
or
if
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
What
you
need
to
know
before
you
use
Proctosedyl
ointment
3.
How
to
use
Proctosedyl
ointment
4.
Possible side
effects
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
Smg,
Cinchocaine
hydrochloride
5mg,
Framycetin
Sulphate
10mg
and Aesculin
10mg.
Cinchocaine
hydrochloride belongs
to
a
group
of
medicines called local
It
works
by causing
numbness
in
the
area
to
which
it
is
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
2.
What
you
need
to
know
you
use
Proctosedyl
ointment
Do
not
use
this medicine and tell
your
doctor if:
You
are
allergic (hypersensitive)
to
hydrocortisone,
cinchocaine
hydrochloride,
framycetin
sulphate,
aesculin
or
any
of
the other
ingredients
of
Proctosedyl
ointment
(listed
in
Section
6
below).
I
Signs
of
an
allerg

Produktens egenskaper

Health Products Regulatory Authority
29 October 2021
CRN00C5RK
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).
Before prescribing the product any potential malignancies should be
excluded.
Health Products Regulatory Authority
29 October 2021
CRN00C5RK
Page 2 of 4
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