BENZAC 5 %

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

BENZOYL PEROXIDE

متاح من:

A.M.I. MEDICAL TECHNOLOGIES LIMITED, ISRAEL

ATC رمز:

D10AE

الشكل الصيدلاني:

GEL

تركيب:

BENZOYL PEROXIDE 5 %W/W

طريقة التعاطي:

TOPICAL

نوع الوصفة الطبية :

Not required

المصنعة من قبل:

LABORATOIRES GALDERMA, FRANCE

المجموعة العلاجية:

PEROXIDES

الخصائص العلاجية:

For the topical treatment of acne vulgaris.

تاريخ الترخيص:

2021-11-30

نشرة المعلومات

BENZ GEL PL SH 280623
PATIENT PACKAGE INSERT IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS
)PREPARATIONS( – 1986
The medicine is dispensed without
a doctor’s prescription
BENZAC 5% )W/W(
Gel
The active ingredient and its concentration:
Benzoyl peroxide 5%
For information regarding inactive ingredients and
allergens, see section 6.
See also
‘
Important information about some of the
ingredients of the medicine
’
in section 2.
Read the entire leaflet carefully before using the
medicine.
This leaflet contains concise information about the
medicine. If you have additional questions, refer to
the doctor or pharmacist.
The gel is not generally indicated for children under
12 years of age.
Use the medicine in accordance with the instructions
in the Dosage section of this leaflet. Consult a
pharmacist if you need further information.
Refer to the doctor if the symptoms worsen or are
not improving.
1. WHAT IS THE MEDICINE INTENDED FOR?
For the topical treatment of acne vulgaris.
Therapeutic group: Topical preparations for acne
treatment – peroxides.
2. BEFORE USING THE MEDICINE
Do not use this medicine if:
You are sensitive )allergic) to the active ingredient
or to any of the additional ingredients contained in
the medicine )for the list of additional ingredients,
see section 6). An allergic reaction may be
manifested by, for example, rash or itching.
Special warnings regarding use of the medicine:
• Avoid contact of the gel and the eyes )including
the eyelids), mouth, nostrils or other mucous
membranes. If contact is accidentally made
between the gel and these areas, immediately
rinse the area thoroughly with warm water.
• Do not use the gel on damaged or inflamed skin or
on open wounds.
• The use of the medicine may cause swelling and
blistering of the skin. If these symptoms occur, the
use of the medicine should be discontinued.
• The gel has a bleaching quality, therefore, avoid
contact of the gel with the hair, or with colored
fabrics )e.g., clothing, towels, bed linens). Make
sure to wash your h

خصائص المنتج

Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Benzac 5%
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Benzoyl peroxide 5 %w/w
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Topical Gel
White to off-white, gel
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the topical treatment of acne vulgaris.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For external use only.
Adults and children:
Before each application, the skin should be cleaned and dried. Apply
in a thin layer once
or twice daily or as directed to the affected areas. Persons with
sensitive skin should be
directed to apply the gel once daily before going to bed. The extent
of any drying or
peeling may be adjusted by modifying the dosage schedule.
Benzac 5 % should preferably be used in the following cases:
−
for emerging acne in teenagers,
−
In subjects with sensitive skin, notably children and blond-haired or
red-haired subjects,
−
at the start of treatment, during a trial period, to ensure that the
product is well tolerated,
−
for maintenance treatment of acne scars.
1 application every 2-3 days as maintenance treatment for Benzac 5 %.
Apply Benzac by massaging gently with the fingertips until fully
absorbed.
Wash hands after use.
Keep away from heat and flame.
_._
_ _
Page 2 of 5
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
For external use only.
Benzac may cause swelling and blistering of the skin, if any of these
symptoms occur,
medication has to be discontinued.
A mild burning sensation will probably be felt on first application
and some reddening
and peeling of the skin will occur within a few days. During the first
weeks of treatment a
sudden increase in peeling will occur in most patients. This is not
harmful and will
normally subside within a day or two if treatment is temporarily
discontinued. If severe
irritation occurs, patients should be directed to use the medic