RETACNYL 0.05% CREAM

Krajina: Malajzia

Jazyk: angličtina

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

Aktívna zložka:

TRETINOIN/RETINOIC ACID

Dostupné z:

ZUELLIG PHARMA SDN BHD

INN (Medzinárodný Name):

TRETINOIN/RETINOIC ACID

Počet v balení:

30gm mcg/mL; 5gm mcg/mL

Výrobca:

LABORATORIES GALDERMA

Príbalový leták

RETACNYL
®
CREAM
Tretinoin 0.025% w/w and 0.05% w/w
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
WHAT IS IN THIS LEAFLET
1.
What Retacnyl
®
Creamis used for
2.
How Retacnyl
®
Cream works
3.
Before you use Retacnyl
®
Cream
4.
How to use Retacnyl
®
Cream
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Retacnyl
®
Cream
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
®
recently taken or might take any other
medicines
Other
topical
medication,
abrasive
soaps, cleansers, soaps and cosmetics
that have a strong drying effect and
products
with
high
concentrations
of
alcohol,
astringents,
spices
or
lime
should be used with caution.
Caution should be exercised in using
preparations
containing
sulfur,
resorcinol or salicylic acid with
Retacnyl
®
Cream.
application of Retacnyl
®
Cream if you
experience allergic reaction or severe
skin irritation after using it.
-
_Things you must not do _
Retacnyl
®
Cream is not to be taken
orally and it is for affected skin use
only.
Retacnyl
®
Cream should not come into
contact with eyes, mouth, nostrils or
mucous
membrane.
If
accidental
contact occurs, immediately rinse off
with warm water.
WHAT RETACNYL CREAM IS USED FOR
-
_Things to be careful of _
Retacnyl
®
Cream
is
a
prescription
medicine for skin use only (topical). It is
for use in the local treatment of acne.
HOW RETACNYL
®
CREAM WORKS
The active substance in Retacnyl
®
Cream
is tretinoin which decreases the skin cell
cohesiveness,
resulting
in
decreased
microcomedo formation. Tretinoin also
stimulates skin cell renewal.
BEFORE YOU USE RETACNYL
®
CREAM
-
_When you must not use it _
If you are allergic to any ingredient of
the product.
_Pregnancy and lactation _
_ _
•
Do not use if you are pregnant or
thinking of becoming pregnant. Your
doctor can give you more information
•
Do not apply Retacnyl
®
Cream on the
chest if you are breast-feeding. Ask
your doctor or pharmacist for advice
before taking any medicine.
-
_Before you start to use i

Súhrn charakteristických

NOTICE RECTO 180x315
PLAN n° MT.09.DRA.0352.R02.2
R E T A C N Y L
®
t
r
e
t
i
n
o
i
n
C R E A M
Product code: MOCK UP
Product description: RETACNYL NF CRE 30
Market: EX2
Article: Leaflet
Flat size: 180x315
Font size: 10 pt
Fold size: 180x26,25
Pharmacode: TBD
DIELINES
PMS 432U
GRAPHIC DESIGNER: Bérangère BLANCO
INDUSTRIALIZATION DEPARTMENT
LABORATOIRES GALDERMA - Z.I. Galderma - 74540 ALBY-SUR-CHÉRAN -
FRANCE
PRODUCT INFORMATION
DESCRIPTION
Retacnyl Cream is a white to yellowish, supple, smooth and shiny
hydrophilic (oil-in-water emulsion) cream. Each g of Retacnyl Cream
0.025%
and Retacnyl Cream 0.05% contains respectively 0.25 mg and 0.5 mg
tretinoin as the active ingredient in a cream base containing
polyethylene
glycol stearate, glycerol stearate & PEG-100 stearate, cetyl alcohol,
stearyl alcohol, squalane, butylhydroxyanisole, butylhydroxytoluene,
propyl
parahydroxybenzoate, stearic acid, carbomer 941, glycerol, methyl
parahydroxybenzoate, disodium edetate, triethanolamine, isopropyl
myristate,
sorbic acid and purified water.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Tretinoin applied to the skin is responsible for a variety of effects
on cellular systems. It stimulates mitosis and the renewal of
epidermal cells, inhibits
the formation of keratin, promotes repair of conjunctive tissue and
can avert and even achieve regression of cutaneous tumours induced by
various
carcinogenic agents. These properties form the basis for the use of
tretinoin in dermatology in the treatment of cutaneous disorders such
as acne,
psoriasis, ichthyosis and actinic keratosis.
In acne, tretinoin acts on one of the essential aetiological factors
which is the keratinisation of the lower part of the pilosebaceous
follicle. The
keratinised cells adhere strongly to each other, obstructing the
pilosebaceous orifice which dilates, forming the microcomedone. The
sebaceous
gland, plugged by the effect of sebum production, becomes encysted,
forming a microcyst or closed comedone. This closed comedone may
evolve
into an open comedo or black