DERMACOMBIN OINTMENT

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

GRAMICIDIN; NEOMYCIN AS SULFATE; NYSTATIN; TRIAMCINOLONE ACETONIDE

Available from:

TARO PHARMACEUTICAL INDUSTRIES LTD

ATC code:

D07CB01

Pharmaceutical form:

OINTMENT

Composition:

TRIAMCINOLONE ACETONIDE 1 MG/G; NEOMYCIN AS SULFATE 2.5 MG/G; GRAMICIDIN 0.25 MG/G; NYSTATIN 100000 IU/G

Administration route:

DERMAL

Prescription type:

Required

Manufactured by:

TARO PHARMACEUTICAL INDUSTRIES LTD

Therapeutic group:

TRIAMCINOLONE AND ANTIBIOTICS

Therapeutic area:

TRIAMCINOLONE AND ANTIBIOTICS

Therapeutic indications:

For the relief of corticosteroid-responsive inflammatory or pruritic dermatoses caused, threatened or complicated by infection due to bacteria and/or candida

Authorization date:

2021-03-31

Patient Information leaflet

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
The medicine is dispensed with a doctor's prescription only
DERMACOMBIN CREAM
DERMACOMBIN OINTMENT
ACTIVE INGREDIENTS
Each gram contains:
neomycin (as sulfate) 2.50 mg
triamcinolone acetonide 1.00 mg
gramicidin 0.25 mg
nystatin 100,000 IU
Inactive ingredients and allergens: see section 2 under ‘Important
information about some of
this medicine’s ingredients’ and section 6 ‘Additional
information'.
_ _
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet
contains concise information about this medicine. If you have any
further questions, consult
your 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 to
yours.
1. WHAT IS THIS MEDICINE INTENDED FOR?
For the relief of corticosteroid-responsive inflammatory or pruritic
dermatoses accompanied
by infection due to bacteria and/or candida.
THERAPEUTIC GROUP:
Neomycin is an aminoglycoside antibiotic.
Triamcinolone is a corticosteroid.
Gramicidin is a polypeptide antibiotic.
Nystatin is an antifungal.
2. BEFORE USING THE MEDICINE:
DO NOT USE THIS MEDICINE:

If you are sensitive (allergic) to the active ingredients (neomycin,
triamcinolone,
gramicidin or nystatin) or to any of the other ingredients in this
medicine (see section 6).

If you have primary skin infections.

If you have tuberculosis.

If you have any serious skin lesions, most types of viral lesions of
the skin (including
chickenpox (varicella), cold sores or genital herpes (herpes
simplex)), and fungal skin
lesions except caused by yeast infections.

In your eyes.

In the outer area of your ear if you have an ear infection or holes in
your eardrums (see
section 4).

Under covered skin dressing if you have skin swelling and infections.
SPECIAL WARNINGS ABOUT USING THIS MEDICINE
BEFORE OR WHEN USING DERMACOMBIN, TELL YOUR DOCTOR IF:

You have

Summary of Product characteristics

1
NAME OF THE MEDICINAL PRODUCT
DERMACOMBIN CREAM
DERMACOMBIN OINTMENT
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mg/g triamcinolone acetonide, 100,000 units/g nystatin, 2.5 mg/g
neomycin (as
sulphate), 0.25 mg/g gramicidin
Excipients:
CREAM:
purified water, petrolatum white, cetomacrogol emulsifying wax,
paraffin
liquid, sodium phosphate dibasic, propylene glycol, citric acid, ethyl
alcohol 95%,
perfume, methyl paraben, propyl paraben.
OINTMENT:
Paraffin liquid, polyethylene oxidized wax
.
INDICATIONS AND CLINICAL USE
For
the relief of corticosteroid-responsive inflammatory or pruritic
dermatoses caused,
threatened or complicated by infection due to bacteria and/or candida
.
Dermacombin Cream
and
Dermacombin Ointment
contain
antibiotic
ingredients,
gramicidin
and neomycin.
To
reduce
the
development
of
drug-resistant
bacteria
and maintain the effectiveness of gramicidin and neomycin, Dermacombin
Cream
and Dermacombin Ointment should only be used for the authorized
indication and
clinical use.
DOSAGE AND ADMINISTRATION
POSOLOGY
Apply a small quantity two or three times daily.
Do not apply more than prescribed by
physician. For external use only.
CONTRAINDICATIONS
Dermacombin Cream and Dermacombin Ointment are contraindicated as
follow:
In Patients who are hypersensitive to this drug or to any ingredient
in the formulation or
component of the container. For a complete listing, see
"
QUALITATIVE AND
QUANTITATIVE COMPOSITION"
.
•
In Tuberculous and most viral lesions of the skin (including herpes
simplex,
vaccinia and varicella) and fungal skin lesions except candidiasis.
•
In primary skin infections.
•
For ophthalmic use.
•
For application to the external auditory canal of patients with
perforated
eardrums or patients with otitis media.
2
•
As Occlusive therapy in patients with atopic dermatitis.
WARNINGS AND PRECAUTIONS
GENERAL
Patients should be advised to inform subsequent physicians of the
prior use of
corticosteroids. Dermacombin Cream and Dermacombin Ointment should not
be used
under occlusive dressi