POLYCUTAN

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

CLOTRIMAZOLE; DEXAMETHASONE ACETATE; NEOMYCIN SULFATE

متاح من:

PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL

ATC رمز:

D01AC20

الشكل الصيدلاني:

CREAM

تركيب:

CLOTRIMAZOLE 1 %; NEOMYCIN SULFATE 0.645 %; DEXAMETHASONE ACETATE 0.044 %

طريقة التعاطي:

TOPICAL

نوع الوصفة الطبية :

Required

المصنعة من قبل:

PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL

المجموعة العلاجية:

COMBINATIONS

المجال العلاجي:

COMBINATIONS

الخصائص العلاجية:

Treatment of dermatitis involving also a bacterial and/or fungal infection.

تاريخ الترخيص:

2020-05-31

نشرة المعلومات

PATIENT PACKAGE INSERT
IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS
)PREPARATIONS( – 1986
The medicine is dispensed with
a doctor’s prescription only
POLYCUTAN
®
Cream
Active ingredients and quantities per
dosage unit:
Each tube contains:
Clotrimazole
1%
Neomycin sulfate
0.645%
Dexamethasone acetate
0.044%
Inactive and allergenic ingredients in the
preparation – see section 6 of the leaflet.
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 the
doctor or pharmacist.
This medicine has been prescribed for you.
Do not pass it on to others. It may harm
them, even if it seems to you that their
medical condition is similar.
1. WHAT IS THE MEDICINE INTENDED
FOR?
For the treatment of dermatitis also
involving a bacterial and/or fungal infection.
Therapeutic group
Clotrimazole – a topical imidazole antifungal
Neomycin sulfate – an aminoglycoside
antibiotic
Dexamethasone acetate – a corticosteroid
2. BEFORE USING THE MEDICINE
Do not use the medicine:
• If you are sensitive )allergic( to the
active ingredients or to any of the
additional ingredients contained in
the medicine, including cetostearyl
alcohol.
• If
you
have
a
known
sensitivity
to any other medicines from the
aminoglycoside group.
• If you are suffering from herpes simplex
or chickenpox.
•
As with any other medicines for external
use containing neomycin, do not use this
medicine for external ear inflammation if
you have a perforated ear drum.
• Do not use on the scalp.
Special warnings regarding use of the
medicine
• Before treatment with Polycutan, tell
the doctor if:
- You are pregnant or breastfeeding
- You are suffering or have suffered in the
past from an impaired immune system
function
- You are suffering or have suffered in the
past from diabetes
- You are suffering or have suffered in the
past from kidney problems
- You are suffering or have suffered in the
past from dizziness
- You are suffering or have

خصائص المنتج

PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
Polycutan
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Clotrimazole 1%
Neomycin sulfate 0.645%
Dexamethasone acetate 0.044%
Excipients with known effect:
Polycutan contains Cetostearyl alcohol and Benzyl alcohol.
For the full list of excipients, see Section 6.1
3.
PHARMACEUTICAL FORM
Dermal white cream.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of dermatitis involving also a bacterial and/or
fungal infection.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Polycutan is for external topical use only.
Apply a thin layer of the cream twice daily (morning and evening) on
the affected area and
massage into the skin. If there is no improvement within a few days or
if there is worsening, the
condition should be assessed.
ELDERLY (OVER 65 YEARS):
For Corticosteroids
Reported clinical experience has not identified differences in
responses between the elderly and
younger patients. In general, dose selection for an elderly patient
should be cautious using the
least amount compatible with an effective therapeutic regimen and
reflecting the greater
frequency of decreased hepatic, renal or cardiac function, and of
concomitant disease or other
drug therapy.
PEDIATRICS
For Corticosteroids
Pediatric patients may demonstrate greater susceptibility to topical
corticosteroid-induced
hypothalamic-pituitary-adrenal (HPA) axis suppression and Cushing's
syndrome than mature
patients, because of a larger skin surface area to body weight ratio.
Therefore, application of
topical corticosteroids to children should be limited to the least
amount compatible with an
effective therapeutic regimen.
4.3
CONTRAINDICATIONS
-
Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1.
-
Topical corticosteroids are contraindicated in tuberculosis of
the skin, varicella and herpes simplex.
-
The cream should not be applied in the external auditory canal of
patients with perforated
eardrum.
-
Do not use the cream to treat scalp infections
4.4