ADAFERIN CREAM

País: Israel

Língua: inglês

Origem: Ministry of Health

Ingredientes ativos:

ADAPALENE

Disponível em:

A.M.I. MEDICAL TECHNOLOGIES LIMITED, ISRAEL

Código ATC:

D10AD03

Forma farmacêutica:

CREAM

Composição:

ADAPALENE 0.1 %W/W

Via de administração:

TOPICAL

Tipo de prescrição:

Required

Fabricado por:

LABORATORIES GALDERMA, FRANCE

Grupo terapêutico:

ADAPALENE

Área terapêutica:

ADAPALENE

Indicações terapêuticas:

For the cutaneous treatment of acne vulgaris, where comedones, papules and postules predominate. Acne of the face, chest or back is appropriate for treatment. The treatment is limited up to six months in adolescents over 12 years.

Data de autorização:

2022-02-28

Folheto informativo - Bula

PATIENT PACKAGE INSERT IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS( – 1986
This medicine is sold with a doctor’s prescription only
Adaferin Cream
Active ingredient and its concentration:
Adapalene 0.1% w/w
Each 1 gram contains 1 mg Adapalene
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 further questions, 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.
1. WHAT IS THE MEDICINE INTENDED FOR?
Adaferin Cream is intended for treatment of acne. The
preparation works only on inflamed areas where lumps
are apparent on the skin as a result of the development of
acne vulgaris.
Therapeutic group
Derivative of vitamin A )retinoid( for external use.
2. BEFORE USING THE MEDICINE
Do not use the medicine if:
• You are sensitive )allergic( to the active ingredient
or to any of the additional ingredients the medicine
contains )for the list of the additional ingredients – see
section 6(.
• Do not use on infants and children under the age of
12 years old.
• You are pregnant.
• You are planning a pregnancy.
Special warnings regarding the use of this medicine:
• Adaferin Cream may cause extra sensitivity upon exposure
to sun or UV light. Therefore, avoid exposure to the sun
)or artificial UV light( and make sure to use appropriate
protective measures )long clothing, hat, sunscreens, etc.(.
• If you suffer from sunburnt skin due to exposure to the
sun, avoid using Adaferin Cream until full recovery.
• Do not apply Adaferin Cream on open wounds, cuts,
burns, grazed skin and inflamed skin )including eczema(.
• Do not use Adaferin Cream in severe cases of acne.
• Avoid contact with the eyes, mucous membranes )such
as

Características técnicas

Adaferin cream -DL-August 2020-03
Summary of Product Characteristics
1. NAME OF THE MEDICINAL PRODUCT
Adaferin Cream
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Adapalene 0.1% w/w.
1g cream contains 1mg adapalene.
Excipients with known effect:
Methyl parahydroxybenzoate
Propyl parahydroxybenzoate
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Cream
White shiny cream
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the cutaneous treatment of acne vulgaris, where comedones, papules
and
postules predominate. Acne of the face, chest or back is appropriate
for treatment.
The treatment is limited up to six months in adolescents over 12
years.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adaferin Cream should be applied to the acne affected areas once a day
before
retiring and after washing. A thin film of cream should be applied,
with the fingertips,
avoiding the eyes and lips (see 4.4 _Special warnings and special
precautions for use_,
below). Ensure that the affected areas are dry before application.
Since it is customary to alternate therapies in the treatment of acne,
it is
recommended that the physician assess the continued improvement of the
patient
after three months of treatment with Adaferin Cream.
With patients for whom it is necessary to reduce the frequency of
application or to
temporarily discontinue treatment, frequency of application may be
restored or
therapy resumed once it is judged that the patient can again tolerate
the treatment.
If patients use cosmetics, these should be non-comedogenic and
non-astringent.
_Paediatric population:_ The safety and effectiveness of Adaferin
Cream have not been
studied in children below 12 years of age.
4.3 CONTRAINDICATIONS
Pregnancy (see section 4.6)
Women planning a pregnancy
Hypersensitivity to the active substance or to any of the excipients
listed in section
6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If a reaction suggesting sensitivity or severe irritation occurs, use
of the medication
should be discontinued. If the degree of