Nizoral 20mg/g Cream

País: Malta

Idioma: inglés

Fuente: Medicines Authority

Disponible desde:

STADA Arzneimittel AG Stadastraße 2-18, 61118 Bad Vilbel, Germany

Código ATC:

D01AC08

Designación común internacional (DCI):

KETOCONAZOLE 2 % (W/W)

formulario farmacéutico:

CREAM

Composición:

KETOCONAZOLE 2 % (W/W)

tipo de receta:

OTC

Área terapéutica:

ANTIFUNGALS FOR DERMATOLOGICAL USE

Estado de Autorización:

Authorised

Fecha de autorización:

2007-03-02

Información para el usuario

PACKAGE LEAFLET: INFORMATION FOR THE USER
NIZORAL® 20MG/G CREAM
ketoconazole
Read all of this leaflet carefully before you start using this
medicine
because it
contains important information for you.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It
may harm them, even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1.
What Nizoral cream is and what it is used for
2.
What you need to know
before you use Nizoral Cream
3.
How to use Nizoral Cream
4.
Possible side effects
5.
How to store Nizoral Cream
6.
Contents of the pack and other information
1. WHAT NIZORAL CREAM IS AND WHAT IT IS USED FOR
Nizoral Cream is used to treat fungal infections of the skin which may
appear on
the hands, feet, genital area, trunk, groin, scalp, face, chest or
back. These can
be caused by a variety of fungi or yeasts and Nizoral Cream works by
destroying
the fungus that causes the infection.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE NIZORAL CREAM
This product is suitable for most adults, but a few people should not
use it. If you
are in any doubt, talk to your doctor or pharmacist.
DO NOT USE THIS PRODUCT
•
If you have ever had an allergic (hypersensitivity) reaction to any of
the
ingredients.
IF THIS APPLIES TO YOU, GET ADVICE FROM A DOCTOR OR PHARMACIST WITHOUT
USING NIZORAL CREAM.
PREGNANCY AND BREAST-FEEDING
•
You can use Nizoral Cream if you are pregnant, think you might be
pregnant or
are breast-feeding.
TAKE SPECIAL CARE WITH NIZORAL CREAM
•
If you have been regularly using a lotion or cream, which contains a
steroid
(such as _betamethasone_ or _hydrocortisone_) to control your skin
infection, you
should wait for two weeks before starting treatment with Nizoral
Cream. This
will stop your conditio

Ficha técnica

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Nizoral 20mg/g Cream
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ketoconazole 2% w/w (each gram of cream contains 20 mg)
Excipients;
Propylene glycol, 20% w/w
Stearyl alcohol, 7.5% w/w
Cetyl alcohol, 2.0% w/w
For a full list of excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
Cream
White odourless cream.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nizoral cream is indicated for topical application in the treatment of
dermatophyte
infections of the skin such as _Tinea corporis, Tinea cruris, Tinea
manus _and _Tinea pedis _
infections due to _Trichophyton, Microsporon _and _Epidermophyton
species. _
_ _
Nizoral cream is also indicated for the treatment of cutaneous
candidosis (including
external application in vulvitis), _Tinea (pityriasis) versicolor _and
in the treatment of
seborrhoeic dermatitis, a skin condition related to the presence of
_Malassezia furfur _
(previously called _Pityrosporum ovale_).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Nizoral Cream is for use in adults
For cutaneous administration
Cutaneous candidosis,
_Tinea corporis, Tinea cruris, Tinea manus, Tinea pedis _
and
_Tinea (pityriasis) _
_versicolor_
: it is recommended that Nizoral cream 2% Cream be applied once or
twice daily to cover
the affected and immediate surrounding area.
The usual duration of treatment is:
Tinea versicolor 2–3 weeks;
Yeast infections 2-3 weeks;
Tinea cruris2-4 weeks;
Tinea corporis 3–4 weeks;
Tinea pedis 4-6 weeks
Seborrheic dermatitis:
Nizoral cream 2% should be applied to the affected areas once or twice
daily.
The usual initial duration of treatment for seborrhoeic dermatitis is
2- to 4 weeks.
Maintenance therapy can be applied (once weekly) in seborrheic
dermatitis.
Treatment should be continued, until a few days after disappearance of
all symptoms.
The diagnosis should be reconsidered if no clinical improvement is
noted after 4 weeks.
General measures in regard to hygiene should be observed to control
sources of
infection or re