Aklief 50 microgram/g cream

البلد: مالطا

اللغة: الإنجليزية

المصدر: Medicines Authority

العنصر النشط:

TRIFAROTENE

متاح من:

Galderma International Tour Europlaza - 20 Avenue Andre Prothin, La Defense 4, 92 927 Paris La Defense Cedex, France

ATC رمز:

D10AD06

INN (الاسم الدولي):

TRIFAROTENE 50 mg

الشكل الصيدلاني:

CREAM

تركيب:

TRIFAROTENE 50 mg

نوع الوصفة الطبية :

POM

المجال العلاجي:

ANTI-ACNE PREPARATIONS

ملخص المنتج:

Licence number in the source country: NOT APPLICAPABLE

الوضع إذن:

Authorised

تاريخ الترخيص:

2021-11-16

نشرة المعلومات

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AKLIEF 50 MICROGRAM/G CREAM
trifarotene
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Aklief is and what it is used for
2.
What you need to know before you use Aklief
3.
How to use Aklief
4.
Possible side effects
5.
How to store Aklief
6.
Contents of the pack and other information
1.
WHAT AKLIEF IS AND WHAT IT IS USED FOR
Aklief contains the active substance trifarotene that belongs to a
group of medicines called retinoids.
Aklief is used for the cutaneous treatment of
_Acne Vulgaris_
of the face and/or the trunk in patients
from 12 years of age and older, when many comedones (whiteheads and
blackheads), papules and
pustules (inflammatory pimples) are present.
2
WHAT YOU NEED TO KNOW BEFORE YOU USE AKLIEF
_ _
DO NOT USE AKLIEF:
- If you are a woman planning pregnancy or if you are pregnant (see
section “Pregnancy and breast-
feeding”)
- If you are allergic to trifarotene or any of the other ingredients
of this medicine (listed in section 6)
WARNINGS AND PRECAUTIONS
•
Redness, peeling, dryness, and stinging/burning may be experienced
with the use of Aklief
cream (see section 4 “Possible side effects”). Talk to a doctor if
you experience these
symptoms. You are recommended to apply a moisturizer from the
in

خصائص المنتج

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Aklief 50 microgram/g cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of cream contains 50 micrograms of Trifarotene.
UExcipient(s) with known effect
One gram of cream contains 300 milligrams of propylene glycol (E1520)
and 50 milligrams of
ethanol.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Cream
White and homogenous cream
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Aklief is indicated for the cutaneous treatment of
_Acne Vulgaris_
of the face and/or the trunk in patients
from 12 years of age and older, when many comedones, papules and
pustules are present.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Apply a thin layer of Aklief cream to the affected areas of the face
and/or trunk once a day, in the
evening, on clean and dry skin.
It is recommended that the physician assesses the continued
improvement of the patient after three
months of treatment.
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_Special populations _
_ _
_Elderly patients _
The safety and efficacy of Aklief in geriatric patients aged 65 years
and above have not been
established.
_Renal and hepatic impairment _
Aklief has not been studied in patients with renal and hepatic
impairment.
_ _
_ _
_Paediatric population _
The safety and efficacy of Aklief in children below 12 years old have
not been established.
UMethod of administration
For cutaneous use only.
Before using the pump for the first time, prime it by pressing down
several times until a small amount
of medicine is dispensed (up to 10 times maximum). The pump is now
ready to use.
Apply a thin layer of Aklief cream to the affected areas of the face
(forehead, nose, chin and right and
left cheeks) and all affected areas of the trunk once a day, in the
evening, on clean and dry skin:
-
One pump actuation should be enough to cover the face (i.e. forehead,
cheeks, nose, and chin).
-
Two pump actuations should be enough to cover the upper trunk (i.e.
reachable upper back,
shoulders and chest). One