Nerisone Fatty

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Diflucortolone valerate 0.1%

Available from:

LEO Pharma Limited

INN (International Name):

Diflucortolone valerate 0.1%

Dosage:

0.1 %

Pharmaceutical form:

Topical ointment

Composition:

Active: Diflucortolone valerate 0.1% Excipient: Hydrogenated castor oil Liquid paraffin Microcrystalline wax White soft paraffin

Units in package:

Tube, aluminium, 1x50g, 50 g

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Bayer Pharma AG

Therapeutic indications:

All skin diseases which respond to topical corticoid therapy (eg): contact dermatitis, contact eczema, occupational eczema vulgar, nummular, degenerative and seborrhoeic eczema, dyshidrotic eczema, eczema in varicose syndrome (but not directly onto lower limb ulcers), anal eczema, eczema in children, neurodermatitis (endogenous eczema, atopic dermatitis), psoriasis, lichen ruber planus et verrucosus, lupus erythematosus discoides, first degree burns, sunburn, insect bites.

Product summary:

Package - Contents - Shelf Life: Tube, aluminium, - 50 g - 60 months from date of manufacture stored at or below 25°C

Authorization date:

1976-06-10

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
NERISONE
®
_Cream: 1 g cream contains 1 mg diflucortolone valerate. _
_Fatty Ointment: 1 g fatty ointment contains 1 mg diflucortolone
valerate. _
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using Nerisone
®
.
It will advise you about how to use Nerisone
®
properly and when to tell your
doctor about health-related conditions.
If you have any questions or need more advice, ask your doctor,
professional
health care provider or pharmacist.
This preparation has been prescribed for you personally and you should
not
pass it on to others. It may harm them.
Keep this leaflet with the medicine. You may need to read it again.
WHAT IS NERISONE
® USED FOR
Nerisone
®
is an anti-inflammatory medicine (a corticosteroid) for use on the
skin. Nerisone
®
treats inflammatory and allergic skin reactions (eg. eczema)
that can cause redness, swelling, itchiness or soreness.
It can also be used to treat first degree burns, sunburn and insect
bites.
Nerisone
®
is available in two different formulations:
• Nerisone
®
cream
Nerisone
®
cream is particularly suitable for weeping skin conditions (ie.
skin producing fluid), and for use on exposed or hairy parts of the
body.
• Nerisone
®
fatty ointment
Nerisone
®
fatty ointment is particularly suitable for very dry skin
conditions or skin conditions that have been occurring for a long
time.
BEFORE YOU USE NERISONE
®
Do not use Nerisone
®
if you have any of the conditions listed below. If any of
these apply to you, tell your doctor before starting to use Nerisone
®
.
_ _
_YOU MUST NOT USE NERISONE_
_®_
_ IF: _
•
You are hypersensitive (allergic) to diflucortolone valerate or any of
the
other ingredients of Nerisone
®
as listed under FURTHER INFORMATION.
•
You are suffering from tuberculosis or syphilis in the area to be
treated.
•
You are suffering from a viral disease (eg. chicken-pox or shingles).
•
You have had a skin reaction after vaccination in the area to be
treated.
•
You have acne, rosacea (skin

Summary of Product characteristics

NEW ZEALAND DATA SHEET
Page 1 of 6
1 NERISONE®
NERISONE® Diflucortolone valerate 0.1 % fatty ointment
NERISONE® Diflucortolone valerate 0.1 % cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
NERISONE® Cream:
1 g white cream contains 1 mg (0.1 %) diflucortolone valerate. The
cream is an oil-in-water emulsion
containing approximately 70% water.
NERISONE® Fatty Ointment:
1 g white single-phase fatty ointment contains 1 mg (0.1 %)
diflucortolone valerate.
NERISONE® Fatty Ointment contains methyl parahydroxybenzoate and
propyl parahydroxybenzoate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Topical cream
Topical fatty ointment
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
All skin diseases which respond to topical corticoid therapy (eg):
contact dermatitis, contact eczema,
occupational eczema vulgar, nummular, degenerative and seborrhoeic
eczema, dyshidrotic eczema,
eczema in varicose syndrome (but not directly onto lower limb ulcers),
anal eczema, eczema in
children, neurodermatitis (endogenous eczema, atopic dermatitis),
psoriasis, lichen ruber planus et
verrucosus, lupus erythematosus discoides, first degree burns,
sunburn, insect bites.
4.2
Dose and method of administration
At the beginning of treatment, the NERISONE® preparation best suited
to the skin condition is
applied thinly two or perhaps three times per day. Once the clinical
picture has improved, one
application per day usually suffices.
NERISONE® is available as a cream and a fatty ointment. Which form
should be used in the individual
case will depend on the appearance of the skin: NERISONE® CREAM in
weeping skin conditions and
NERISONE® FATTY OINTMENT in very dry skin conditions.
NERISONE® CREAM has a high water and low fat content. In weeping skin
diseases it allows
secretions to drain away, thus providing for rapid subsidence and
drying up of the skin. It is also
suitable for application to moist, exposed and hairy areas of the
body.
If the skin dries out too much under protracted use of NERISONE®
CREAM, th