CLINDOXYL GEL

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

GlaxoSmithKline South Africa (Pty) Limited

Dosage:

See ingredients

Pharmaceutical form:

GEL

Composition:

EACH 100,0 g GEL CONTAINS BENZOYL PEROXIDE 6,670 g CLINDAMYCIN PHOSPHATE EQUIVALENT TO CLINDAMYCIN 1,0 g

Authorization status:

Registered

Authorization date:

2013-01-03

Patient Information leaflet

G
LAXO
S
MITH
K
LINE
S
OUTH
A
FRICA
(P
TY
)
L
IMITED
Submission Date
28 MAY 2015
Type
Clinical
CLINDOXYL GEL
Implementation Date
28 MAY 2015
Category
Notification Reg 9 & 10
GEL
APPROVAL DATE
Reference
CONFIDENTIAL
1.3.2 PATIENT INFORMATION LEAFLET _ _
Page 1 of 5
PATIENT INFORMATION LEAFLET
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 further questions, please ask your doctor or your
pharmacist.

CLINDOXYL GEL has been prescribed for you personally and you should
not share
your medicine with other people. It may harm them, even if their
symptoms are the
same as yours.
SCHEDULING STATUS:
S4
PROPRIETARY NAME AND DOSAGE FORM:
CLINDOXYL
® GEL
COMPOSITION OF THE MEDICINE, THAT IS, WHAT CLINDOXYL GEL CONTAINS:
The active substances in 100 g CLINDOXYL GEL are:

Clindamycin phosphate equivalent to clindamycin 1,00 g

Hydrous benzoyl peroxide equivalent to anhydrous benzoyl peroxide 5,00
g
The other ingredients are:
Carbomer,
dimethicone,
disodium lauryl sulfosuccinate, edetate disodium, glycerol,
colloidal hydrated silica, poloxamer 182, purified water and sodium
hydroxide.
APPROVED INDICATION AND USE, THAT IS, WHAT CLINDOXYL GEL IS USED
FOR:
G
LAXO
S
MITH
K
LINE
S
OUTH
A
FRICA
(P
TY
)
L
IMITED
Submission Date
28 MAY 2015
Type
Clinical
CLINDOXYL GEL
Implementation Date
28 MAY 2015
Category
Notification Reg 9 & 10
GEL
APPROVAL DATE
Reference
CONFIDENTIAL
1.3.2 PATIENT INFORMATION LEAFLET _ _
Page 2 of 5
CLINDOXYL GEL belongs to a group of medicines known as anti-acne
preparations.
Clindamycin is an antibiotic.
Benzoyl peroxide acts to reduce comedomes (blackheads and whiteheads).
INSTRUCTION BEFORE USING CLINDOXYL GEL:
CLINDOXYL GEL may not be right for some people. If the answer to any
of the
following questions is YES, please check with your doctor or
pharmacist before you start
using the product.

Are you allergic to any of the ingredients listed above?

Are you using any other acne treatments which the do

Summary of Product characteristics

G
LAXO
S
MITH
K
LINE
S
OUTH
A
FRICA
(P
TY
)
L
IMITED
Submission Date
28 MAY 2015
Type
Clinical
CLINDOXYL GEL
Implementation Date
28 MAY 2015
Category
Notification Reg 9 & 10
GEL
APPROVAL DATE
Reference
CONFIDENTIAL
1.3.1.1 PACKAGE INSERT_ _
Page 1 of 7
CLINDOXYL
® GEL
SCHEDULING STATUS:
S4
PROPRIETARY NAME AND DOSAGE FORM:
CLINDOXYL
® GEL
COMPOSITION:
Each 100 g contains:
Clindamycin phosphate equivalent to clindamycin 1,00 g and hydrous
benzoyl peroxide
equivalent to anhydrous benzoyl peroxide 5,00 g.
PHARMACOLOGICAL CLASSIFICATION:
A 13.11 Acne preparations
PHARMACOLOGICAL ACTION:
PHARMACODYNAMIC PROPERTIES:
Clindamycin is a lincosamide antibiotic with bacteriostatic action
against Gram-positive
aerobes and a wide range of anaerobic bacteria. Lincosamides such as
clindamycin
bind to the 23S subunit of the bacterial ribosome and inhibit the
early stages of protein
synthesis. The action of clindamycin is predominantly bacteriostatic
although high
concentrations
may
be
slowly
bactericidal
against
sensitive
strains.
Although
clindamycin
phosphate
is
inactive
_in _
_vitro_,
rapid
_in _
_vivo_
hydrolysis
converts
this
compound to the antibacterial active clindamycin.
G
LAXO
S
MITH
K
LINE
S
OUTH
A
FRICA
(P
TY
)
L
IMITED
Submission Date
28 MAY 2015
Type
Clinical
CLINDOXYL GEL
Implementation Date
28 MAY 2015
Category
Notification Reg 9 & 10
GEL
APPROVAL DATE
Reference
CONFIDENTIAL
1.3.1.1 PACKAGE INSERT_ _
Page 2 of 7
Clindamycin activity has been demonstrated against most strains of
_Propionibacterium _
_acnes. _Clindamycin _in vitro_ inhibits all _P acnes _cultures tested
(MIC 0,4 µg/ml). Benzoyl
peroxide is keratolytic and an oxidising agent acting against _
Propionibacterium acnes, _
the organism implicated in acne vulgaris. Furthermore it is
sebostatic, counteracting the
excessive sebum production associated with acne.
PHARMACOKINETIC PROPERTIES:
In a maximised percutaneous absorption study the mean plasma
clindamycin levels
during a four week dosing period for CLINDOXYL GEL were negligible
(0,043 % of
applied d