Zindaclin 1% Gel

国家: 马来西亚

语言: 英文

来源: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

有效成分:

CLINDAMYCIN PHOSPHATE

可用日期:

Orient Europharma (M) Sdn Bhd

INN（国际名称）:

CLINDAMYCIN PHOSPHATE

每包单位数:

30 gm

厂商:

DR. AUGUST WOLFF GMBH & CO. ARZNEIMITTEL

资料单张

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
______________________________________________________________________________
1
ZINDACLIN GEL
Clindamycin Phosphate (1% w/w)
________________________________________________________________________________________________________
WHAT IS IN THIS LEAFLET
1.
What
_Zindaclin Gel_
is used for
2.
How
_Zindaclin Gel_
works
_3._
_ _
Before you use
_Zindaclin Gel _
4.
How to use
_Zindaclin Gel_
5.
While you are using it
6.
Side effects
_7._
_ _
Storage and Disposal of
_Zindaclin Gel _
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _ZINDACLIN GEL_ IS USED FOR
Zindaclin Gel is used to treat mild to
moderate acne (spots).
WHAT IS ACNE?
Acne is an extremely common skin
condition most common in
adolescence, but not restricted to this
stage of life. During adolescence,
glands in the skin produce extra
grease in response to sex hormones
in the body, and this can cause
blocked pores, resulting in
blackheads. When this happens the
pores are invaded by bacteria. The
chemicals produced by these bacteria
go into deeper layers of the skin and
produce red spots filled with pus.
HOW _ZINDACLIN GEL_ WORKS
Zindaclin Gel contains an antibiotic
clindamycin that reduces the number
of bacteria and stops the skin pores
becoming blocked and new spots
forming. Zindaclin Gel may also help
to reduce the redness of the spots you
already have. It will take some time
once you have started using
Zindaclin Gel before you see your
acne improving.
BEFORE YOU USE _ZINDACLIN GEL_
_When you must not use it _
➢
If you are allergic (hypersensitive)
to the active substance clindamycin
phosphate or
any of the other ingredients (see
section
_inactive ingredients_
).
➢
If you are allergic (hypersensitive)
to lincomycin, another type of
antibiotic.
An allergic reaction may include a
rash, red skin, itching, swelling or
breathing difficulties. Zindaclin Gel
should not be used by children under
the age of 12 years.
_ _
_Before you start to use it _
➢
Before y

产品特点

Mock-up 06_22 ZINDACLIN 1% GEL, MY ❶ • 148 x 270 mm • BLACK •
Zindaclin
®
1% Gel
(Clindamycin Phosphate)
Package Insert
1. Name of the Medicinal Product
ZINDACLIN 1% GEL
2. Qualitative and quantitative composition
The gel contains clindamycin phosphate
equivalent clindamycin 1% w/w.
Can also be expressed as 1 g of gel contains
10 mg clindamycin (1% w/w) equivalent to
11.88 mg clindamycin phosphate
For excipients see section 6.1
3. Pharmaceutical form
Gel. A white translucent gel.
4. Clinical particulars
_4.1 Therapeutic indications_
ZINDACLIN is indicated for the treatment
of mild to moderate acne vulgaris.
_4.2 Posology and method of administration_
Adults and adolescents
Apply a thin film of ZINDACLIN
once daily to the affected area.
Patient response should be reviewed
periodically.
Children
ZINDACLIN is not indicated for use in
children below the age of 12 years.
Cutaneous use.
Patient response should be reviewed
after 6-8 weeks of treatment and the
duration of treatment should be limited to
12 weeks.
_4.3 Contraindications_
ZINDACLIN is contra-indicated in
patients with a hypersensitivity to the
active substance clindamycin or to
any of the excipients in the medicinal
product. Although cross-sensitization to
lincomycin has not been demonstrated,
it is recommended that ZINDACLIN
should not be used in patients who have
demonstrated lincomycin sensitivity.
_4.4 Special warnings and precautions for use_
Oral and parenteral clindamycin,
as well as most other antibiotics,
have been associated with severe
pseudomembranous colitis. Topical
clindamycin has very rarely been
associated with pseudomembranous
colitis; however if diarrhoea occurs
the product should be discontinued
immediately.
Studies indicate a toxin(s) produced by
_Clostridium difficile _is the major cause
of antibiotic-associated colitis. Colitis is
usually characterized by severe persistent
diarrhoea and abdominal cramps.
Should antibiotic-associated colitis occur,
appropriate diagnostic and therapeutic
measures (such as vancomycin treatment)