NIZORAL DANDRUFF 20 mg/g Shampoo

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

KETOCONAZOLE

थमां उपलब्ध:

McNeil Healthcare (Ireland) Ltd

ए.टी.सी कोड:

D01AC08

INN (इंटरनेशनल नाम):

KETOCONAZOLE

डोज़:

20 mg/g

फार्मास्यूटिकल फॉर्म:

Shampoo

प्रिस्क्रिप्शन प्रकार:

Product not subject to medical prescription

चिकित्सीय क्षेत्र:

Imidazole and triazole derivatives

प्राधिकरण का दर्जा:

Authorised

प्राधिकरण की तारीख:

2008-08-15

सूचना पत्रक

TOP
■
 If you have been regularly using a lotion or cream,

which contains a steroid (such as 
_betamethasone_

or 
_hydrocortisone_
) to control your dandruf
f or

seborrhoeic dermatitis, gradually use it less over

2 – 3 weeks as you start to use Nizoral Dandruf
f 
Shampoo. This will stop your condition flaring up

while Nizoral Dandruf
f Shampoo starts to work. If

you have any questions about stopping your steroid

lotion or cream, 
SPEAK TO YOUR DOCTOR OR PHARMACIST.
DRIVING AND USING MACHINES
Using Nizoral Dandruf
f Shampoo will not af
fect 
your ability to drive or use machines.
3
 HOW TO USE NIZORAL DANDRUF
F 
SHAMPOO
CHECK THE TABLE BELOW TO SEE HOW MUCH 
PR
ODUCT TO USE.
■
 For external use only
.
■
 Do not use more often than directed in the table. If 
you need to use a shampoo to wash your hair more 
often, use your usual shampoo. If your hair is very 
thick, you can wash with your usual shampoo and 
then use Nizoral Dandruf
f Shampoo.

ADULTS AND ADOLESCENTS AGED 12 YEARS AND 
OVER
.
AGE

HOW TO APPLY
ADULTS AND 
ADOLESCENTS AGED 
12 YEARS AND OVER
. 
(FOR DANDRUF
F AND 
DRY/GR
EASY SCALING 
OF THE SKIN).
■ 
W
et hair thoroughly
.
■ 
Apply a small amount of Nizoral 
Dandruf
f Shampoo
 to your scalp 
and massage into a lather
.
■ 
Leave the lather on your scalp for 
3 – 5 minutes.
■ 
Rinse thoroughly
.
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 dandruf
f and 
seborrhoeic dermatitis seem to have more 
_Malassezia_
. 
The shampoo also treats the inflammation associated 
with dandruf
f, relieving scalp redness and itching.
This product is for use in adults and adolescents aged

12 
years 
and over
.
2
 BEFOR
E YOU USE NIZORAL 
DANDRUF
F SHAMPOO
This product is suitable for most adults and adolescents 
aged 12 years and over
, but a few people should not 
u

उत्पाद विशेषताएं

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nizoral Dandruff 20mg/g Shampoo
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of shampoo contains 20mg of ketoconazole
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Shampoo
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, and seborrhoeic dermatitis of the body.
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.
Method of administration
Cutaneous.
4.3 CONTRAINDICATIONS
Use in patients hypersensitive to any of the ingredients.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 16/07/2015_
_CRN 2165267_
_page number: 1_
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 Dandruff Shampoo, to prevent any
potential rebound effect.
Avoid contact with the eyes. If the shampoo should get into the eyes, they should be bathed with water.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
No interaction studies have been performed.
4.6 FER