NIZORAL SHAMPOO

Land: Israël

Taal: Engels

Bron: Ministry of Health

Werkstoffen:

KETOCONAZOLE

Beschikbaar vanaf:

J-C HEALTH CARE LTD

ATC-code:

D01AC08

farmaceutische vorm:

SHAMPOO

Samenstelling:

KETOCONAZOLE 20 MG / 1 G

Toedieningsweg:

TOPICAL- SCALP

Prescription-type:

Required

Geproduceerd door:

JANSSEN PHARMACEUTICA N.V.,BELGIUM

Therapeutische categorie:

KETOCONAZOLE

Therapeutisch gebied:

KETOCONAZOLE

therapeutische indicaties:

Topical treatment of seborrhoeic dermatitis including dandruff resulting from proven fungal infection including Pityriasis versicolor.

Autorisatie datum:

2012-08-31

Bijsluiter

DO NOT EXCEED THE RECOMMENDED DOSE.
For external use only. Do not swallow Nizoral
Shampoo.
In the event that you accidentally swallowed
the preparation, refer to a doctor.
If you accidentally swallowed Nizoral
Shampoo, or if a child has accidentally
swallowed the medicine, refer immediately to
a doctor or proceed to a hospital emergency
room, and bring the package of the medicine
with you.
Be sure to adhere to the treatment as
recommended by the doctor.
Do not take medicines in the dark! Check
the label and the dose each time you take
medicine. Wear glasses if you need them.
If you have further questions regarding
use of the medicine, consult a doctor or
pharmacist.
4. SIDE EFFECTS:
As with any medicine, use of Nizoral Shampoo
may cause side effects in some users. Do
not be alarmed when reading the list of
side effects. You may not suffer from any of
them.
Stop treatment with Nizoral Shampoo and
refer to a doctor immediately in the event
that you detect one of the following. It is
possible that you will need immediate medical
attention:
- Allergic reaction, swelling of the face, lips,
mouth, tongue or throat that may cause
problems with swallowing or breathing.
- Severe irritation or reddening of the skin
where the shampoo has been used, or other
signs of allergy during the first few days of
treatment.
- Peeling or blistering of the skin.
Additional side effects:
Uncommon side effects:
Infection of the hair follicles, increase in
production of tears, hair loss or thinning of
the hair, dry skin, skin rash, burning sensation
on skin, changes in how your hair feels
Rare side effects:
Taste impairment, irritation of the eyes, acne,
flaking skin
Side effects whose frequency is unknown:
Urticaria, changes in hair color
If a side effect occurs, if one of the side effects
worsens or if you suffer from a side effect
not mentioned in this leaflet, consult with the
doctor.
5. HOW SHOULD THE MEDICINE BE
STORED?
∙ Avoid poisoning! This medicine, and any
other medicine, should be kept in a safe
place out of the reach of chil

Productkenmerken

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NIZORAL_SHAMPOO_SPC_APPROVED ON JUNE 2015
רשואו קדבנ ונכותו תואירבה דרשמ י"ע
עבקנ הז ןולע טמרופ
ינויב
2015
NIZORAL SHAMPOO
PRODUCT INFORMATION
1.
TRADE NAME OF THE MEDICINAL PRODUCT
Nizoral Shampoo
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains 20 mg ketoconazole
For Excipients, see
_List of Excipients_
.
3.
PHARMACEUTICAL FORM
Shampoo for topical application to the scalp or skin
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Topical treatment of Seborrhoeic Dermatitis including dandruff
resulting from proven fungal infection including Pityriasis
versicolor.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
DOSAGE
Usually, a palmful of shampoo suffices for one wash.
TREATMENT
Adults, Elderly and Adolescence :
Pityriasis versicolor: once daily for a maximum of 5 days.

Seborrheic dermatitis and dandruff: twice weekly for 2 to 4 weeks.
SPECIAL POPULATIONS
PEDIATRICS
The safe and effective use of Nizoral Shampoo 2% in infants and
children
under the age of 12 years has not been established.
ADMINISTRATION
Topical application to the scalp or skin.
The infected areas of the skin or the scalp should be thoroughly
washed with
NIZORAL Shampoo 2%, which should be left on the skin/scalp for 3 to 5
minutes before rinsing.
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NIZORAL_SHAMPOO_SPC_APPROVED ON JUNE 2015
4.3
CONTRAINDICATIONS
NIZORAL Shampoo 2% is contraindicated in individuals with known
hypersensitivity to any of its ingredients.
4.4
SPECIAL WARNING 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 the period of 2 to 3 weeks, while using NIZORAL
Shampoo 2%, to prevent any potential rebound effect.
Avoid contact with the eyes.
If the shampoo should get into the eyes, they should be irrigated
with water.
4.5
INTERACTIONS WITH OTHER MEDICAMENTS AND OTHER FORMS OF INTERACTION
None known.
4.6
PREGNANCY AND LACTATION
There are no adequate and well-controlled stu