Nizoral 20mg/g Shampoo

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Ketoconazole

متاح من:

Imbat Limited

ATC رمز:

D01AC; D01AC08

INN (الاسم الدولي):

Ketoconazole

جرعة:

20 milligram(s)/gram

الشكل الصيدلاني:

Shampoo

نوع الوصفة الطبية :

Product not subject to medical prescription

المجال العلاجي:

Imidazole and triazole derivatives; ketoconazole

الوضع إذن:

Authorised

تاريخ الترخيص:

2009-04-17

نشرة المعلومات

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
NIZORAL
®
20MG/G SHAMPOO
(ketoconazole)
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
You need to use Nizoral Shampoo carefully to get the best results
from it.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or advice.

You must contact a doctor if your symptoms worsen or do
not improve.

If any of the side effects get serious or if you notice any side
effects not listed in this leaflet, please contact your doctor or
pharmacist.
IN THIS LEAFLET
1.
What Nizoral Shampoo is and what it is used for.
2.
Before you use Nizoral Shampoo
3.
How to use Nizoral Shampoo
4.
Possible side effects
5.
How to store Nizoral Shampoo
6.
Further information
NOW READ THIS WHOLE LEAFLET CAREFULLY BEFORE YOU USE THIS
PRODUCT. Keep the leaflet: you might need it again.
1.
WHAT NIZORAL SHAMPOO IS AND WHAT IT IS
USED FOR
Nizoral Shampoo is used to treat and prevent dandruff and dry or
greasy scaling of the scalp (seborrhoeic dermatitis), which is a
more severe kind of dandruff. It is also used to treat the irregular
white to brown patches which occur on the body and sometimes
appear after being in the sun (tinea/pityriasis versicolor).
The shampoo contains ketoconazole, which is an antifungal that
targets an increased number of yeasts on the skin called
_Malassezia_. These yeasts occur naturally on everyone’s skin,
however, people with dandruff and seborrhoeic dermatitis seem to
have more _Malassezia_. Tinea versicolor (otherwise known as
pityriasis versicolor), a condition which causes white to brown
patches to develop on parts of the body, is also associated with
_Malassezia_. The shampoo also treats the inflammation associated
with dandruff, relieving scalp redness and itching.
This product is for use in adults and adolescents aged 12 years
and over.
2.
BEFORE YOU USE NIZORAL SHAMPOO
This product is suitable for most adults and adolescents aged 12
years and over, but a few peo

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nizoral 20mg/g Shampoo
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of shampoo contains 20mg ketoconazole.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Shampoo
_Product imported from the UK:_
Pink, viscous shampoo.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the prevention and treatment of infections in which_ Malassezia_
(previously called_ Pityrosporum_) infection may be a
factor, such as seborrhoea capitis, seborrhoeic dermatitis of the body
or tinea (pityriasis) versicolor.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Nizoral Shampoo is for use in adults and adolescents aged 12 years and
over.
Seborrhoea capitis
Apply the shampoo to the affected scalp, leave for three minutes, then
rinse.
Seborrhoeic dermatitis
Wash the affected areas with shampoo and leave for 3 to 5 minutes
before rinsing.
Treatment should be repeated twice weekly for 2 to 4 weeks.
For prophylaxis use once, every 1 to 2 weeks.
Tinea versicolor
Use once daily for up to 5 days.
For prophylaxis, use once daily for 3 days before prolonged exposure
to the sun.
Method of administration
Cutaneous use.
4.3 CONTRAINDICATIONS
Use in patients hypersensitive to any of the ingredients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
In patients who have been on prolonged treatment with topical
corticosteroids, it is recommended that the steroid
therapy be gradually withdrawn over a period of 2 to 3 weeks, while
using Nizoral Shampoo, to prevent any potential
rebound effect.
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