INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo NIZORELLE® shampoo

SCHEDULING STATUS
Not scheduled

PROPRIETARY NAME
(and dosage form):

NIZORELLE® shampoo

COMPOSITION
The active ingredient is
ketoconazole 1% (i.e. 10 mg of ketoconazole per 1 g of shampoo). It also contains a conditioner for normal hair. The preservative used is quaternium-15 0,05% w/w
Anti-oxidant: Butylated hydroxytoluene 0,1% w/w.

PHARMACOLOGICAL CLASSIFICATION
A.20.2.2 Fungicides.

PHARMACOLOGICAL ACTION
NIZORELLE is a synthetic imidazole dioxolane derivative. It works by interfering with the development of fungal cell membranes. NIZORELLE has an effect on the yeast known as Pityrosporum ovale (Malassezia ovalis) which is considered to be associated with dandruff.
There is no evidence of systemic absorption of ketoconazole as a result of unrestricted or extended use of NIZORELLE.

INDICATIONS
NIZORELLE is a medicine used for the prevention and treatment of dandruff caused by fungal infections of the scalp, as well as for the relief of associated symptoms such as flaking, scaling and itching.

CONTRA-INDICATIONS
Known hypersensitivity to ketoconazole or any of the other ingredients which may be recognised by severe itching and red-skin after application of the shampoo.

WARNINGS
As with other shampoos, avoid contact in the eyes. If this happens, however, rinse the eyes with water. If a severe rash or irritation appear after application, stop using the shampoo.

DOSAGE AND DIRECTIONS FOR USE
Wet hair. Apply sufficient shampoo to produce a generous lather. Gently massage over the entire scalp. Allow the shampoo to soak in for 3 to 5 minutes before rinsing.
Use regularly, at least twice a week for 8 weeks to treat the infection. To prevent the infection reappearing, use once a week or once every two weeks.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
A local burning sensation, itching, contact dermatitis (due to irritation or allergy) or oily hair may occur on exposed areas.
Although ketoconazole is not absorbed through the skin, the use of NIZORELLE is not recommended during pregnancy, as safety in pregnancy and lactation has not been established.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Not expected since NIZORELLE is intended for external use only.
In the event of accidental ingestion, only supportive measures should be carried out. To avoid aspiration, neither emesis nor gastric lavage should be performed.

IDENTIFICATION
An opaque, pearlescent blue to blue-green liquid with a slight perfume odour.

PRESENTATION
Opaque plastic bottles containing 60 mL or 100 mL of shampoo or sachets containing 6 mL of shampoo (10 to 20 sachets per carton).

STORAGE INSTRUCTIONS
Store below 25°C.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER
31/20.2.2/0293

NAME AND BUSINESS ADDRESS OF THE APPLICANT
JANSSEN PHARMACEUTICA (PTY) LTD
(Reg. No. 80/11122/07)
15th ROAD
HALFWAY HOUSE
1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT
2 March 1998

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        Davbar

Updated on this site: January 2001

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