Nizoral Shampoo

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

KETOCONAZOLE

Available from:

Janssen-Cilag International NV

ATC code:

D01AC08

INN (International Name):

KETOCONAZOLE

Pharmaceutical form:

CUTANEOUS LIQUID

Composition:

KETOCONAZOLE 2 percent weight/weight

Prescription type:

OTC

Therapeutic area:

ANTIFUNGALS FOR DERMATOLOGICAL USE

Authorization status:

Authorised

Authorization date:

2007-03-02

Patient Information leaflet

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.
•
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 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 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 TAKE NIZORAL SHAMPOO
This product is suitable for most adults and adolescents aged 12 years
and over,
but a few people

Summary of Product characteristics

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.
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
tinea (pityriasis) versicolor.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Paediatric population
The safe and effective use 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.
Seborrhoea capitis
Apply the shampoo to the affected scalp, leave for three minutes, then
rinse.
Seborrhoeic dermatitis
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.
Tinea 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
Shampoo, to prevent any potential rebound effect.
Keep out of 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 FERTILITY, PREGNANCY AND LACTATION
There are no adequate and well-controlled studies in pregnant or
lactating women. Data on a
limited number of exposed pregnancies indicate