DAKTARIN CREAM

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

MICONAZOLE NITRATE

Available from:

J-C HEALTH CARE LTD

ATC code:

D01AC02

Pharmaceutical form:

CREAM

Composition:

MICONAZOLE NITRATE 20 MG/G

Administration route:

DERMAL

Prescription type:

Not required

Manufactured by:

JANSSEN PHARMACEUTICA N.V.,BELGIUM

Therapeutic group:

MICONAZOLE

Therapeutic area:

MICONAZOLE

Therapeutic indications:

Broad spectrum antimycotic

Authorization date:

2015-10-31

Patient Information leaflet

PATIENT PACKAGE INSERT IN
ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) - 1986
This medicine is dispensed
without a doctor’s prescription
DAKTARIN
® CREAM
ACTIVE INGREDIENT -
Each gram contains 20 mg (2%) miconazole nitrate
Inactive and allergenic ingredients: see section 6 “Further
Information”.
READ THIS 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.
You must use it in the correct manner. Consult the pharmacist
if you need further information. Refer to the doctor if signs
of the illness (symptoms) worsen or if they do not improve
after one month.
1. WHAT IS THE MEDICINE INTENDED FOR?
Daktarin Cream is intended for the treatment of external
infections caused by fungi.
What is Daktarin
Daktarin Cream is a medicine which is used for the treatment
of fungi and fungi-associated bacterial infections of the skin.
Skin infections may appear on the hands, feet, outer ear,
trunk or groin, including athlete’s foot, jock itch, and intertrigo.
The cream contains miconazole nitrate, which works by
destroying both the fungi that cause the infection and some
of the associated bacteria, which may also be present in the
infected areas. The cream also has moisturizing properties to
help soothe red and cracked skin.
THERAPEUTIC GROUP:
Skin anti-infective.
2. BEFORE USING THE MEDICINE
The medicine is suitable for most adults and children, but
certain people should not use it. If you are in any doubt
whatsoever, consult your doctor or pharmacist.
DO NOT USE THE MEDICINE IF:
You are sensitive (allergic) to the active ingredient, to
similar antifungal medicines or to any of the additional
ingredients contained in the medicine (see section 6
“Further Information”).
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
∙ Avoid contact with the eyes.
∙ Daktarin may cause severe allergic reactions. You must
be aware of the signs of an allergic reaction when you use
Daktarin

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Daktarin Cream.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Miconazole nitrate 2% w/w.
Excipients: Benzoic acid, Butylated hydroxyanisole
For a full list of excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Cream
White homogeneous cream.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Broad spectrum antimycotic
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Route of administration: _
Cutaneous use.
Recommended dosage:
For all ages:
Fungal infections of the skin: Apply some cream to the lesions two
times
daily.
Rub the cream into the skin
with
your finger until it has fully
penetrated. The duration of therapy varies from 2 to 6 weeks depending
on the
localisation and the severity of the lesion. Treatment should be
continued at
least one week after disappearance of all signs and symptoms.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substances, other imidazole derivatives
or to any
of the excipients listed in section 6.1
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Daktarin Cream must not come into contact with the mucosa of the eyes.
Severe
hypersensitivity
reactions,
including
anaphylaxis
and
angioedema,
have been reported during treatment with Daktarin Cream and with other
miconazole topical formulations (see Adverse Reactions).
If
a
reaction
suggesting
hypersensitivity
or
irritation
should
occur,
the
treatment should be discontinued.
2
Benzoic
acid
(E210)
is
mildly
irritant
to
the
skin,
eyes
and
mucous
membranes.
Butylated hydroxyanisole (E320) may cause local skin reactions (e.g.
contact
dermatitis), or irritation to the eyes and mucous membranes.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Miconazole administered systemically is known to inhibit CYP3A4/2C9.
Due
to the limited systemic availability after topical application,
clinically relevant
interactions are rare. However, in patients on oral anticoagulants,
such as
warfarin, caution should be exercised and anticoagulant effect should
be
monitored.
4