ELIDEL pimecrolimus 1% w/w cream tube

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

pimecrolimus, Quantity: 10 mg/g

Available from:

Viatris Pty Ltd

INN (International Name):

Pimecrolimus

Pharmaceutical form:

Cream

Composition:

Excipient Ingredients: sodium hydroxide; citric acid; benzyl alcohol; sodium cetostearyl sulfate; mono- and di- glycerides; cetyl alcohol; stearyl alcohol; propylene glycol; oleyl alcohol; medium chain triglycerides; purified water

Administration route:

Topical

Units in package:

30g tube, 15g tube, 100g tube, 5g tube (sample)

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Elidel 1% cream is indicated for patients 3 months of age and older with atopic dermatitis (eczema) for: short term treatment of signs and symptoms; intermittent long-term treatment of emerging and resolving lesions in atopic dermatitis where the use of a topical corticosteroid is not yet warranted, no longer needed, or is inadvisable (according to the usage restrictions in the respective topical corticosteroid Product Information).

Product summary:

Visual Identification: White cream; Container Type: Tube; Container Material: Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2003-06-05

Patient Information leaflet

ELIDEL
®
E
L
I
D
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®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING ELIDEL?
ELIDEL contains the active ingredient pimecrolimus. ELIDEL is used to
treat the early signs and symptoms of eczema such as
itching, redness and tiny bumps or thickening of the skin in infants
of 3 months or older, children, teenagers and adults.
For more information, see Section 1. Why am I using ELIDEL? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ELIDEL?
Do not use if you have ever had an allergic reaction to pimecrolimus
or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
ELIDEL? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with ELIDEL and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE ELIDEL?
•
Apply a thin layer of the cream to the affected skin twice daily for
as long as your doctor tells you to.
•
Do not cover the treated skin with occlusive dressings. However, you
can wear normal clothing.
More instructions can be found in Section 4. How do I use ELIDEL? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ELIDEL?
THINGS YOU
SHOULD DO
•
Remind any doctor and pharmacist you visit that you are using ELIDEL.
•
Tell your doctor If you become pregnant while you are using this
medicine.
•
Tell your doctor if you develop lumps/painful sores anywhere in your
body, or develop any moles/skin
infection, or you notice changes in existing moles.
THINGS YOU
SHOULD NOT DO
•
Do not use this medicine continuously for long periods without
interruption.
•
Avoid exposure to the sun of skin areas treated with ELIDEL. Do not
use a sunlamp o

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
ELIDEL
®
_pimecrolimus 1% w/w _
1
NAME OF THE MEDICINE
Pimecrolimus
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of Elidel cream contains 10 mg of pimecrolimus as the active
ingredient.
Excipients with known effect: benzyl alcohol as a preservative.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Elidel is in a whitish cream base.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Elidel cream is indicated for patients 3 months of age and older with
atopic dermatitis (eczema) for:
•
short term treatment of signs and symptoms
•
intermittent long-term treatment of emerging and resolving lesions in
atopic dermatitis where the use
of a topical corticosteroid is not yet warranted, no longer needed, or
is inadvisable (according to the
usage restrictions in the respective topical corticosteroid Product
Information).
4.2
DOSE AND METHOD OF ADMINISTRATION
Apply a thin layer of Elidel to the affected skin twice daily and rub
in gently and completely. Elidel cream
may be used on all skin areas, including the head and face, neck and
intertriginous areas.
Elidel cream should only be applied to areas of eczema (see
SECTION 4.4
SPECIAL WARNINGS AND
PRECAUTIONS FOR USE
). The amount of cream to apply can be limited by using the fingertip
dosing
unit: a fingertip unit is the amount of cream expressed from a tube
and applied from the distal skin crease to
the tip of the palmar aspect of an adult index finger. A fingertip
unit of cream is sufficient to cover the surface
corresponding to two hand areas of eczema.
Carers should wash their hands after application of Elidel to their
children.
Emollients can be applied after using Elidel cream.
Elidel cream should be initiated at the first sign of itching
(pruritus), such as persistent scratching or rubbing,
and/or persistent redness (erythema), and/or thickening of the skin
(infiltration), to prevent progression to
flares of atopic dermatitis. Treatment should be discontinued when
there is no longer