Nizoral 20mg/g Shampoo

Страна: Мальта

мова: англійська

Джерело: Medicines Authority

Активний інгредієнт:

KETOCONAZOLE

Доступна з:

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

Код атс:

D01AC08

ІПН (Міжнародна Ім'я):

KETOCONAZOLE 20 mg/g

Фармацевтична форма:

SHAMPOO

Склад:

KETOCONAZOLE 20 mg/g

Тип рецепту:

OTC

Терапевтична области:

ANTIFUNGALS FOR DERMATOLOGICAL USE

Статус Авторизація:

Authorised

Дата Авторизація:

2007-03-02

інформаційний буклет

PACKAGE LEAFLET: INFORMATION FOR THE USER
NIZORAL 20MG/G SHAMPOO
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.
•
Ask your pharmacist if you need more information or advice.
•
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 Shampoo is and what it is used for
2.
What you need to know before you take Nizoral Shampoo
3.
How to use Nizoral Shampoo
4.
Possible side effects
5.
How to store Nizoral Shampoo
6.
Contents of the pack and other information
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 localized 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 children of 12 years and older.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE NIZORAL SHAMPOO
This product is suitable for most adults and adolescents aged 12 years
and over,
but a few people should not use it. If you are in any doubt, talk to
your doctor or
pharmacist.
DO NOT USE NIZORAL SHAMPOO
•
If you are allergic to ketoconazole or

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1
.
NAME OF THE MEDICINAL PRODUCT
Nizoral 20mg/g Shampoo
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains 20 mg of ketoconazole.
Excipient with known effect: each gram shampoo contains 2 mg perfume
bouquet
which contains 0.08 µg
benzyl alcohol, 1.2 µg benzoic acid and 0.2 µg butylated
hydroxytoluene as well as the following
fragrances: alpha-isomethyl ionone, amyl cinnamal, amylcinnamyl
alcohol, benzyl alcohol, benzyl
benzoate, benzyl cinnamate, cinnamal, cinnamyl alcohol, citral,
citronellol, eugenol, evernia prunastri
(oakmoss) extract, geraniol, hexyl cinnamal, hydroxycitronellal,
limonene and linalool.
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Shampoo
Pink viscous shampoo
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prevention
and
treatment
of
infections
in
which
the
yeast
_Malassezia_
(previously
called
as
_Pityrosporum_
) infection maybe a factor, such as dandruff and seborrhoeic
dermatitis. Treatment of
_ _
pityriasis versicolor (localized).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Paediatric population
The safety and efficacy of Nizoral 20mg/g Shampoo in infants and
children under the age of 12 years
has not been established.
Nizoral shampoo is for use in adults and adolescents aged 12 years and
over.
Seborrhoeic dermatitis & Pityriasis capitis
Wash the affected area 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.
Pityriasis versicolor
Use once daily for 1 to 5 days.
Method of administration
Cutaneous use. Usually, a palmful of shampoo suffices for one wash.
4.3 CONTRAINDICATIONS
Use in patients showing hypersensitivity 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 20mg/g
Shampo