Acnecide 5% w/w Gel

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Benzoyl Peroxide

제공처:

Galderma International

ATC 코드:

D10AE; D10AE01

INN (국제 이름):

Benzoyl Peroxide

복용량:

5 percent weight/weight

약제 형태:

Gel

치료 영역:

Peroxides; benzoyl peroxide

승인 상태:

Marketed

승인 날짜:

1984-04-17

환자 정보 전단

NOTICE RECTO
180x315
PLAN
Gel
benzoyl
peroxide
Package
leaflet:
Information
for
the
user
Acnecide
5%
w/w
Gel
benzoyl
peroxide
Read
all
of
this
leaflet
carefully
because
it
contains
important
information
for
you.
This medicine
is
available without
prescription.
However,
you
still
need
to
use
Acnecide
carefully
to
get
the best results
from
it.
-
Keep
this
leaflet.
You
may
need
to
read
it
again.
-
Ask
your
pharmacist
if
you
need
more
information
or
advice.
-
You
must
contact
a
doctor
if
your
symptoms
worsen or
do
not
improve
within
four
weeks.
-
If
any
of
the
side
effects
gets
serious,
or
if
you
notice
any
side
effect
not
listed
in
this
leaflet,
please
tell
your
doctor
or
pharmacist.
In
this leaflet
1.
What
Acnecide
is
and what
it
is
used
for
2.
What
you
need
to
know
before
you
use
Acnecide
3.
How
to
use
Acnecide
Possible side
effects
5.
How
to store
Acnecide
6.
Contents
of
the
pack
and other
information
1.
What
Acnecide
is
and what
it
is
used
for
Acnecide
contains
the
active
substance
benzoyl
peroxide
which attacks the bacteria
(germs)
known
as
Cutibacterium
acnes,
one
of
the
main
causes
of
acne.
Your
doctor
or
pharmacist
has recommended this medicine
to treat
your
acne.
Acne
appears
as
blackheads and whiteheads which
people
often
refer
to
as
pimples
or
spots.
Acne
of
the
face,
chest
or
back
may
be treated with this medicine.
2.
What
you
need
to
know before
you
use
Acnecide
Do
not
use
Acnecide
if
you
are:
Allergic
(hypersensitive)
to
benzoyl
peroxide
or
any
of
the other
ingredients
of
this medicine
(listed
in
section
6).
An
allergic
reaction
may
include
a
rash
or
itching.
Please check
by reading
the list
of
ingredients
in
section
6.
If
you
answer
yes,
you
must
inform
your
doctor
before
starting
treatment.
Please seek immediate medical
attention
if
you
experience
symptoms
of
an
allergic
reaction.
Signs
or
symptoms
of
a
severe
allergic
reaction
may
include
a
rash,
with
or
without
itching,
swelling
of
the
face,
eyelids
or
lips
and
difficulty
in
breathing.
Take
special
care
with Acnecide
Avoid
contact
with the
eyes,
mo

제품 특성 요약

Health Products Regulatory Authority
17 October 2023
CRN00DQM2
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Acnecide 5% w/w Gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Hydrous benzoyl peroxide equivalent to benzoyl peroxide 5% w/w
Excipients with known effect:
One gram of gel contains 40 mg of propylene glycol (E1520).
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Gel.
White to off-white, smooth gel.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Acnecide is indicated in the management of acne vulgaris.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Topical administration only.
Adults and children:
Before each application, the skin should be cleaned and dried. Apply
in a thin layer once or twice daily or as directed to the
affected areas.
Persons with sensitive skin should be directed to apply the gel once
daily before going to bed. The extent of any drying or
peeling may be adjusted by modifying the dosage schedule.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
1. For external use only.
2. Acnecide may cause swelling and blistering of the skin, if any of
these symptoms occur, medication has to be discontinued.
3. If no response occurs within four weeks the use of the product
should be discontinued and a doctor consulted. In any event
a single course of treatment should not extend beyond three months.
4. This product should be kept from contact with eyes, mouth, angles
of the nose or mucous membranes. If accidental contact
occurs, rinse with water.
5. Repeated exposure to sunlight or UV radiation should be avoided.
6. Fair-skinned individuals are likely to be particularly susceptible
to irritation.
Health Products Regulatory Authority
17 October 2023
CRN00DQM2
Page 2 of 4
7. If undue redness or discomfort occurs the product should not be
used until the doctor has been consulted.
8. Acnecide may bleach hair and coloured fabrics.
9. Concurrent us