SOOLANTRA

País: Israel

Língua: inglês

Origem: Ministry of Health

Ingredientes ativos:

IVERMECTIN

Disponível em:

A.M.I. MEDICAL TECHNOLOGIES LIMITED, ISRAEL

Código ATC:

P02CF01

Forma farmacêutica:

CREAM

Composição:

IVERMECTIN 1 %W/W

Via de administração:

TOPICAL

Tipo de prescrição:

Required

Fabricado por:

LABORATOIRES GALDERMA, FRANCE

Área terapêutica:

IVERMECTIN

Indicações terapêuticas:

Soolantra is indicated in the topical treatment of inflammatory (papulopustular) lesions caused by rosacea in adults.

Data de autorização:

2021-06-17

Folheto informativo - Bula

NOTICE
VERSO
180x498,75
PLAN
n°
MT.09.DRA.2223.R01.2
60
1522
gall
167-59-36606-99
2023
30
gall
Glycerol,
palmitate,
alcohol,
Macrogol
cetostearyl
ether,
Stearyl
alcohol,
Sorbit
ybenzoate,
Propyl
parahydroxybenzoate,
Disodium
edetate,
Citric
acid
monohydrate,
Sodium
hydroxide,
Purified
water.
ye
gall
(www.health.gov.il)
(exp.
Patient
Leaflet
According
to
the
Pharmacists’
Regulations
(Preparations)
1986
This
medicine
is
sold
with
a
prescription
only
Soolantra®
Cream
1%
Active
ingredients:
1
g
of
cream
contains:
10mg/g
For
the
list
of
the
additional
ingredients,
see
section
6.
See
also
‘Important
information
about
some
of
the
medicine’s
ingredients’
in
section
2.
Read
the
leaflet
carefully
in
its
entirety
before
using
the
medicine.
This
leaflet
contains
concise
information
about
the
medicine.
If
you
have
any
further
questions,
please
refer
to
your
doctor
or
pharmacist.
This
medicine
has
been
prescribed
for
you.
Do
not
pass
it
on
to
others.
It
may
harm
them,
even
if
you
think
their
medical
condition
is
similar
to
yours.
1.
What
is
the
medicine
intended
for?
Soolantra
is
indicated
in
the
topical
treatment
of
inflammatory
(papulopustular)
lesions
caused
by
rosacea
in
adults.
Therapeutic
group:
skin
preparations.
Soolantra
contains
the
active
substance
ivermectin
that
belongs
to
a
group
of
medicines
called
avermectins.
2.
Before
using
the
medicine
Do
not
use
the
medicine
if:
e
You
are
sensitive
(allergic)
to
the
active
ingredient
or
to
any
of
the
other
ingredients
the
medicine
contains
(for
a
list
of
the
other
ingredients,
see
section
6).
Special
warnings
regarding
the
use
of
this
medicine:
Consult
your
doctor
or
pharmacist
before
using
Soolantra.
If
you
experienced
a
severe
skin
reaction
or
serious
worsening
of
the
rosacea
symptoms
your
doctor
may
decide
to
discontinue
the
treatment
with
the
medicine.
At
the
start
of
treatment,
some
patients
may
experience
worsening
of
the
symptoms
of
rosacea;
however,
this
is
uncommon
and
usually
resolves
within
1
week
of
the
treatment.
Talk
to
your
doctor
if
this
happens.
C

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Soolantra
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of cream contains 10 mg of ivermectin.
Excipient(s) with known effect:
One gram of cream contains 35 mg of cetyl alcohol, 25 mg of stearyl
alcohol, 2
mg of methyl parahydroxybenzoate (E218), 1 mg of propyl
parahydroxybenzoate
(E216) and 20 mg of propylene glycol.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Cream.
White to pale yellow cream.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Soolantra is indicated in the topical treatment of inflammatory
(papulopustular)
lesions caused by rosacea in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
One application a day for up to 4 months. Soolantra should be applied
daily over
the treatment course. The treatment course may be repeated.
In case of no improvement after 3 months, the treatment should be
discontinued.
_Special population_
_Renal impairment_
No dosage adjustment is necessary.
_ _
_Hepatic impairment_
Caution should be exercised in patients with severe hepatic
impairment.
_Elderly patients_
No dosage adjustment is necessary in the geriatric population (see
also section
4.8).
_Paediatric population_
Soolantra is not indicated for children and adolescents under 18 years
old. The
safety and efficacy of Soolantra in children and adolescents aged less
than 18
years have not been established. No data are available.
Method of administration
Cutaneous use only.
Cutaneous application of a pea-size amount of medicinal product to
each of the
five areas of the face: forehead, chin, nose, and each cheek. The
medicinal
product should be spread as a thin layer across the entire face,
avoiding the eyes,
lips and mucosa.
Soolantra should be applied only to the face.
Hands should be washed after applying the medicinal product.
Cosmetics may be applied after the medicinal product has dried.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in
section 6.1.
4.4
S