Elidel

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Pimecrolimus 10 mg/g;  

Available from:

Viatris Limited

INN (International Name):

Pimecrolimus 10 mg/g

Dosage:

1 %

Pharmaceutical form:

Topical cream

Composition:

Active: Pimecrolimus 10 mg/g   Excipient: Benzyl alcohol Cetyl alcohol Citric acid Glyceryl monostearate Medium-chain triglycerides Oleyl alcohol Propylene glycol Purified water Sodium cetostearyl sulfate Sodium hydroxide Stearyl alcohol

Units in package:

Tube, aluminium, physician sample pack, 2 g

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Lek Pharmaceuticals d.d.

Therapeutic indications:

Patients 3 months of age and older with atopic dermatitis (eczema) for the: · short-term treatment of signs and symptoms; and · intermittent long-term treatment of emerging and resolving lesions in atopic dermatitis where topical corticosteroids are ineffective, intolerable or inappropriate.

Product summary:

Package - Contents - Shelf Life: Tube, aluminium, physician sample pack - 2 g - 12 months from date of manufacture stored at or below 25°C 12 weeks opened stored at or below 25°C - Tube, aluminium, - 5 g - 24 months from date of manufacture stored at or below 25°C 12 weeks opened stored at or below 25°C - Tube, aluminium, - 10 g - 24 months from date of manufacture stored at or below 25°C 12 weeks opened stored at or below 25°C - Tube, aluminium, - 15 g - 24 months from date of manufacture stored at or below 25°C 12 weeks opened stored at or below 25°C - Tube, aluminium, - 30 g - 24 months from date of manufacture stored at or below 25°C 12 weeks opened stored at or below 25°C - Tube, aluminium, - 60 g - 24 months from date of manufacture stored at or below 25°C 12 weeks opened stored at or below 25°C - Tube, aluminium, - 100 g - 24 months from date of manufacture stored at or below 25°C 12 weeks opened stored at or below 25°C

Authorization date:

2001-06-25

Patient Information leaflet

Page 1 of 4
NEW ZEALAND CONSUMER MEDICINE INFORMATION
ELIDEL
®
_PIMECROLIMUS 1% W/W CREAM_
WHAT IS IN THIS
LEAFLET
Please read this leaflet carefully
before you start using ELIDEL.
This leaflet answers some common
questions about ELIDEL cream.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks to you or your child of
using ELIDEL cream against the
benefits they expect it will provide.
This leaflet has mostly been written
for patients who are using ELIDEL
on themselves, but, as ELIDEL can
be used in children as young as 3
months, the same advice and
precautions need to be exercised
when parents and carers are using
ELIDEL on children who have been
prescribed the product.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT ELIDEL CREAM
IS USED FOR
ELIDEL cream is used to treat the
early signs and symptoms of
eczema (also called atopic
dermatitis), such as itching,
redness and tiny bumps or
thickening of the skin. It is suitable
for infants of 3 months or older,
children, teenagers and adults.
ELIDEL can be used to treat
repeated episodes of eczema.
Treatment is started as soon as the
first symptoms of eczema appear,
to prevent these from progressing
to more severe symptoms that may
require the use of a steroid cream.
However, if a steroid cream is
required to treat an episode of
eczema, ELIDEL cream should be
stopped and restarted to treat any
remaining symptoms after the
steroid cream has been stopped.
ELIDEL cream is a steroid-free
medicine that treats inflammation
of the skin. It works in specific cells
in the skin that cause inflammation
and the characteristic redness and
itching of eczema.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED.
Your doctor may have prescribed it
for another purpose.
This medicine is only available with
a

Summary of Product characteristics

Page 1 of 11
NEW ZEALAND DATA SHEET
ELIDEL
®
1. PRODUCT NAME
Elidel 1% w/w (10 mg/g) topical cream
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of cream contains 10 mg of pimecrolimus.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Cream for cutaneous use.
The cream is whitish, odourless, non-staining, and easily spreadable.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
Treatment of patients 3 months of age and older with atopic dermatitis
(eczema) for the:
•
short-term treatment of signs and symptoms; and
•
intermittent long-term treatment of emerging and resolving lesions in
atopic dermatitis, where
topical corticosteroids are ineffective, intolerable or inappropriate.
_4.2_
_DOSE AND METHOD OF ADMINISTRATION_
DOSE
Apply a thin layer of Elidel cream to the affected skin twice daily
and rub in gently and completely.
Emollients are considered maintenance therapy for patients with atopic
dermatitis (eczema).
In the intermittent long-term management of atopic dermatitis
(eczema), Elidel cream treatment
should begin at first appearance of signs and symptoms of atopic
dermatitis to prevent flares of the
disease. Elidel cream should be used twice daily until signs and
symptoms resolve.
In general, the duration of treatment with Elidel cream for each
eczema episode should not exceed
6 weeks (also see ‘Use in paediatric patients’). If signs and
symptoms persist beyond 6 weeks, or
the condition worsens, Elidel cream should be stopped and patients
should be re-examined to
confirm the diagnosis of atopic dermatitis, Treatment should be
discontinued when there is no longer
evidence of the disease apart from dry skin. Treatment can be resumed
upon first recurrence of
signs and symptoms to prevent flares of the disease.
If the patient is not well controlled on Elidel cream and emollients
alone, a short course of a topical
mid-potency corticosteroid can be used. Once the flare is under
control, the patient can resume
using Elidel cream and emollients as outlined below.
Page 2 of