ESOMED GEL

Pajjiż: Iżrael

Lingwa: Ingliż

Sors: Ministry of Health

Ingredjent attiv:

HYDROQUINONE

Disponibbli minn:

PADAGIS ISRAEL AGENCIES LTD, ISRAEL

Kodiċi ATC:

D11AX11

Għamla farmaċewtika:

GEL

Kompożizzjoni:

HYDROQUINONE 4 %W/W

Rotta amministrattiva:

TOPICAL

Tip ta 'preskrizzjoni:

Required

Manifatturat minn:

BEN SHIMON FLORIS LTD, ISRAEL

Żona terapewtika:

HYDROQUINONE

Indikazzjonijiet terapewtiċi:

Lightening skin spots.

Data ta 'l-awtorizzazzjoni:

2020-07-31

Karatteristiċi tal-prodott

Page 1 of 5
SUMMARY OF THE DRUG’S CHARACTERISTICS
1. DRUG NAME
Esomed Gel
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
The
active
substance
is
hydroquinone.
Each
gram
of
cream
contains
40mg
of
hydroquinone (4% w/w of hydroquinone).
For the complete list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Gel
4. CLINICAL INFORMATION
4.1 INDICATION AND USAGE
Esomed gel is indicated for the Lightening of skin spots. It is
intended for external use
only. Not for ophthalmic use.
4.2 DOSAGE AND METHOD OF ADMINISTRATION
Adults and children over 12 years:
Esomed gel
should be as a thin layer of gel, to hyperpigmented, small surfaces.
Always avoid contact with eyes and mucous membranes.
Starting with one application per day for 10 or 15 days exclusively on
the
stain and continue treatment with two applications daily, once in the
morning and once
in the overnight.
If improvement is not observed after 2 months of treatment, this
should be
discontinued.
The duration of treatment is recommended for 60 to 90 days.
This medicine should not be used under any circumstances for more than
6 months.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or any of the excipients
listed in section 6.1.
Esomed gel is contraindicated for treatment of chemical
hyperpigmentation such as
ochronosis and colloid degeneration (colloid
milium), whether of occupational or
cosmetic origin.
Esomed gel is contraindicated during pregnancy as there is not enough
data available
about the use of hydroquinone in pregnant mothers.
Page 2 of 5
4.4 WARNINGS AND SPECIAL PRECAUTIONS
It should not be applied on open wounds, mucous membrane, or skin
affected by eczema,
irritation or sunburn.
Avoid contact with the eyes and the mucous membrane. In the event of
accidental contact
with the eyes, wash with plenty of water to avoid possible dark
patches on the cornea. If
it comes into contact with the lips, you may notice a bitter taste and
a slight anaesthetic
effect.
If the pigmented zone is very large, it should be split up and treated
in different