COMAGIS CREAM

Country: Իսրայել

language: անգլերեն

source: Ministry of Health

active_ingredient:

BIFONAZOLE; FLUOCINONIDE

MAH:

PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL

ATC_code:

D01AC10

pharmaceutical_form:

CREAM

composition:

FLUOCINONIDE 0.05 W/W; BIFONAZOLE 1.00 W/W

administration_route:

DERMAL

prescription_type:

Required

manufactured_by:

PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL

therapeutic_group:

BIFONAZOLE

therapeutic_area:

BIFONAZOLE

therapeutic_indication:

Broad-spectrum drug for relief of inflammatory conditions accompanied by fungal infection, which respond to corticoid therapy.

authorization_date:

2014-02-28

PIL

PATIENT PACKAGE INSERT
IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS
)PREPARATIONS( – 1986
The medicine is dispensed with a doctor’s
prescription only.
Comagis Cream
Each 100 grams of Comagis Cream
contains:
1 gram bifonazole
0.05 grams fluocinonide
Inactive and allergenic ingredients in
t h e
m e d i c i n e
–
s e e
s e c t i o n
2
“ I m p o r t a n t
information
about
some
of
the
ingredients
o f
t h e
medicine” and section 6 “Further
information”.
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?
Comagis Cream relieves conditions of
i n f l a m m a t i o n
a c c o m p a n i e d
by
f u n g a l
infection
that
respond
to
corticoid
therapy.
Therapeutic group: Anti-inflammatory +
antifungal.
2. BEFORE USING THE MEDICINE
Do not use the medicine:
• If you are sensitive )allergic( to the active
ingredients or any of the additional
ingredients contained in the medicine
)see section 6(.
• To treat diaper rash. If your infant has
diaper rash, refer to the doctor to receive
appropriate treatment.
• To treat nail or scalp infections.
• To treat vaginal infections.
• Do not use the medicine on large areas
of the body or for a long time.
Special warnings regarding use of the
medicine
•
Do not allow the medicine to come in
contact with the eyes.
•
Do
not
bandage,
cover
or
wrap
the
treated area in a manner that will create
an occlusive dressing, unless directed to
do so by a doctor.
Before treatment with Comagis Cream,
tell the doctor if
• you have ever experienced an allergic
reaction to any antifungal substance.
Drug interactions
If you are taking, or have recently
taken, other medicines, including non-
prescription medicines and nutritional
supplements,
tel

SPC

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Comagis Cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredients: For 100gram cream: Fluocinonide 0.05g
and Bifonazole 1.00g
Excipient with known effect: Cetostearyl Alcohol and Benzyl Alcohol.
For excipients see section 6.1.
3
PHARMACEUTICAL FORM
Cream.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Broad-spectrum drug for relief of inflammatory conditions accompanied
by fungal
infection, which respond to corticoid therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults
A small amount of the cream should be applied to the affected skin
area once daily
(preferably before retiring), using a gentle, but thorough massage.
Children
Administration of topical corticosteroids to pediatric patients should
be limited to the
least amount compatible with an effective therapeutic regimen. Chronic
corticosteroid therapy may interfere with the growth and development
of pediatric
patients.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to the active substance(s) or to any of the
excipients listed in
section 6.1
•
Treatment of infants with nappy rash.
•
Treatment of nail and scalp infections.
•
Treatment of vaginal infections.
•
Application to large areas of the body or for prolonged periods must
be
avoided.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
This product contains cetostearyl alcohol which may cause local skin
reactions (e.g.
contact dermatitis).
This product contains Benzyl alcohol which may cause allergic
reactions and mild
local irritation.
Patients with a history of hypersensitivity reactions to other
imidazole antifungal
agents (e.g. econazole, clotrimazole, miconazole) must take bifonazole
containing
products with caution.
– –
2
Systemic absorption of topical corticosteroids has produced reversible
hypothalamic-
pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's
syndrome,
hyperglycemia, and glucosuria in some patients.
Conditions which augment systemic absorption include the application
of the more
poten