TEVADERM

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

DIFLUCORTOLONE VALERATE; ISOCONAZOLE NITRATE

Available from:

TEVA ISRAEL LTD

ATC code:

D07AC06

Pharmaceutical form:

CREAM

Composition:

DIFLUCORTOLONE VALERATE 0.1 %; ISOCONAZOLE NITRATE 1 %

Administration route:

DERMAL

Prescription type:

Required

Manufactured by:

TEVA ISRAEL LTD, ISRAEL

Therapeutic group:

DIFLUCORTOLONE

Therapeutic area:

DIFLUCORTOLONE

Therapeutic indications:

For the local treatment of inflammatory skin conditions accompanied by secondary fungal infections.

Authorization date:

2021-07-31

Patient Information leaflet

PATIENT LEAFLET IN
ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS
(PREPARATIONS) – 1986
The medicine is dispensed with a
doctor's prescription only
TEVADERM
®
Skin cream
COMPOSITION
Isoconazole nitrate 1% w/w
Diflucortolone valerate 0.1% w/w
For information regarding inactive
ingredients and allergens, see
section 2 - “Important information
about some ingredients of the
medicine” and section 6 - “Additional
information”.
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 the pharmacist.
This medicine has been prescribed
for your treatment. 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?
Topical treatment of inflammatory
conditions of the skin accompanied
by a secondary fungal infection.
THERAPEUTIC CLASS
Isoconazole nitrate - an antifungal of
the imidazole group.
Diflucortolone
valerate
-
a
corticosteroid.
2. BEFORE USING THE MEDICINE
DO NOT USE THE PREPARATION IF:
•
You are sensitive (allergic)
to isoconazole nitrate or to
diflucortolone valerate, or to
any of the other ingredients
the medicine contains (listed
in section 6).
•
You
have
skin
lesions
associated with a tuberculosis
or syphilis infection in the area
to be treated.
•
You have a viral infection, e.g.
herpes, shingles or chickenpox
(varicella, herpes zoster).
•
You have a chronic skin
inflammation of the face
(rosacea), a skin inflammation
around the mouth (perioral
dermatitis) or a skin reaction
following vaccination in the area
to be treated.
•
Do not use the medicine in the
first trimester of pregnancy.
SPECIAL WARNINGS REGARDING THE USE
OF THE MEDICINE
CONSULT A DOCTOR BEFORE STARTING
TREATMENT WITH TEVADERM. When
using Tevaderm, it is important to
know the following:
•
If you also have a bacterial
infection of the skin, your doctor
will prescribe you another medicine
to treat this infection, in add