NIZORAL CREAM

Țară: Israel

Limbă: engleză

Sursă: Ministry of Health

Ingredient activ:

KETOCONAZOLE

Disponibil de la:

DEVRIES & CO. LTD

Codul ATC:

D01AC08

Forma farmaceutică:

CREAM

Compoziție:

KETOCONAZOLE 20 MG/G

Calea de administrare:

TOPICAL

Tip de prescriptie medicala:

Required

Produs de:

STADA ARZNEIMITTEL AG, GERMANY

Grupul Terapeutică:

KETOCONAZOLE

Zonă Terapeutică:

KETOCONAZOLE

Indicații terapeutice:

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 spp, Microsporon spp and Epidermophyton spp. Nizoral cream is also indicated for the treatment of cutaneous candidosis (including vulvitis), tinea (pityriasis) versicolor and seborrhoeic dermatitis caused by Malassezia (previously called Pityrosporum) spp.

Data de autorizare:

2014-09-30

Prospect

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
Nizoral
®
Cream
Active ingredient and its concentration
ketoconazole 20 mg/gr
Inactive and allergenic ingredients in the preparation – see in
section 2 “Important
information about some of the ingredients of the medicine” and
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.
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?
The medicine is intended for the treatment of fungal infections of the
skin, cutaneous
candidosis, tinea versicolor and seborrheic dermatitis.
Therapeutic group:
An antifungal preparation from the imidazole group.
2.
BEFORE USING THE MEDICINE
Do not use the medicine:
•
If you are sensitive (allergic) to the active ingredient ketoconazole
or to any of the
additional ingredients contained in the medicine. For the list of
additional
ingredients, see section 6 “Further information”.
•
To treat eye inflammations.
Do not use this medicine if any of the above apply to your condition.
If you are not
sure, consult the doctor or pharmacist before using the medicine.
Special warnings regarding use of the medicine
Before using Nizoral Cream, tell the doctor if
•
You recently used a cream, ointment or lotion containing steroids on
your skin
infection
•
Continue applying a mild steroid (such as hydrocortisone) cream,
ointment or lotion
in the morning whilst applying Nizoral Cream in the evening. The mild
steroid
treatment can then be gradually stopped over a period of 2-3 weeks.
If you have any questions about stopping your steroid cream, ointment
or lotion,
consult a doctor or pharmacist.
Children and

Caracteristicilor produsului

Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nizoral Cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ketoconazole 2% w/w (each gram of cream contains 20 mg).
For a full list of excipients, see 6.1.
3
PHARMACEUTICAL FORM
Cream
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
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 spp, Microsporom spp and Epidermophyton spp.
Nizoral cream is also indicated for the treatment of cutaneous
candidosis (including
vulvitis), tinea (pityriasis) versicolor and seborrhoeic dermatitis
caused by Malassezia
(previously called Pityrosporum) spp.
4.2
Posology and method of administration
Ketoconazole cream is for use in adults.
Cutaneous candidosis, tinea corporis, tinea cruris, tinea manus, tinea
pedis and tinea
(pityriasis) versicolor: it is recommended that Nizoral 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 cruris 2-4 weeks, tinea corporis 3-4 weeks, tinea pedis
4-6 weeks.
Seborrhoeic dermatitis: Nizoral cream should be applied to the
affected area once or
twice daily.
The usual initial duration of treatment in seborrhoeic dermatitis is 2
to 4 weeks.
Maintenance therapy can be applied intermittently (once weekly) in
seborrhoeic
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 of treatment. General measures in regard to hygiene should be
observed to
control sources of infection or reinfection.
Seborrhoeic dermatitis is a chronic condition and relapse is highly
likely.
Method of administration: Cutaneous administration.
Paediatric patients
The safety and efficacy of Nizoral Cream in children (17 years of age
and younger)
has not been established.
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