BENZAC 2.5 %

Χώρα: Ισραήλ

Γλώσσα: Αγγλικά

Πηγή: Ministry of Health

Δραστική ουσία:

BENZOYL PEROXIDE

Διαθέσιμο από:

RAFA LABORATORIES LTD

Φαρμακολογική κατηγορία (ATC):

D10AE01

Φαρμακοτεχνική μορφή:

GEL

Σύνθεση:

BENZOYL PEROXIDE 2.5 %W/W

Οδός χορήγησης:

TOPICAL

Τρόπος διάθεσης:

Not required

Κατασκευάζεται από:

LABORATOIRES GALDERMA, FRANCE

Θεραπευτική ομάδα:

BENZOYL PEROXIDE

Θεραπευτική περιοχή:

BENZOYL PEROXIDE

Θεραπευτικές ενδείξεις:

For the topical treatment of acne vulgaris.

Ημερομηνία της άδειας:

2011-11-30

Φύλλο οδηγιών χρήσης

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

Αρχείο Π.Χ.Π.

_ _
1
Benzac-DL-Jan 2016-01
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
BENZAC 2.5%
BENZAC 5%
BENZAC 10%
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
BENZAC 2.5% GEL: benzoyl peroxide 2.5 %w/w
BENZAC 5% GEL: benzoyl peroxide 5 %w/w
BENZAC 10% GEL: benzoyl peroxide 10 % w/w
Excipient with known effect: propylene glycol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gel for topical use.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
For the topical treatment of acne vulgaris.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
To be adapted according to treatment response and individual tolerance
(see section 4.4).
In general, 1 to 2 daily applications.
Benzac 2.5 % and 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 2.5 %
and Benzac 5 %.
Apply Benzac by massaging gently with the fingertips until fully
absorbed.
Wash hands after use.
Keep away from heat and flame.
4.3.
CONTRAINDICATIONS
Patients with known hypersensitivity to benzoyl peroxide or to any of
the excipients listed in section 6.1.
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
For external use only.
Specific information for patients may prevent early and unjustified
interruption of treatment.
_ _
2
This product may cause mild irritation (slight burning sensation,
redness and desquamation of the skin),
especially at the beginning of treatment. It does not indicate
intolerance or allergy to the topical treatment as
long as it remains moderate. However, individual sensitivity should be
determined by a patch test (repeated
applications to a small area of the skin for 10 to 15 consecutive
days).
To reduce irritation as much as possible:

Do not apply to skin irri