PICATO ingenol mebutate 0.05% (w/w) gel tube

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ingenol mebutate

Available from:

LEO Pharma Pty Ltd

INN (International Name):

Ingenol mebutate

Authorization status:

Registered

Patient Information leaflet

PICATO
®
GEL, 0.05%
1
PICATO
®
GEL, 0.05%
Ingenol (_in' jen ol_) mebutate (_me bue' tate_)
_ _
CONSUMER MEDICINE INFORMATION (CMI)
PLEASE READ THIS LEAFLET CAREFULLY
BEFORE YOU START YOUR TREATMENT.
Picato
®
gel, 0.05% is the brand
name. The generic name of the
active ingredient is ingenol
mebutate.
KEEP THIS LEAFLET. You may want
to read it again.
WHAT IS IN THIS LEAFLET?
This leaflet answers some common
questions about using the medicine
Picato
®
gel, 0.05%. 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 of you using Picato
®
gel
against the benefits it is expected
to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING PICATO
®
GEL TALK TO YOUR
DOCTOR OR PHARMACIST.
WHAT PICATO
®
GEL, 0.05%
IS USED FOR
Picato
®
gel, 0.05% is used as a
topical treatment of solar keratoses
(sun spots) on the body of adults.
Solar keratoses are thickened,
scaly patches of skin caused by
too much sun exposure. Solar
keratoses are also known as actinic
keratoses.
Picato
®
gel contains the active
ingredient ingenol mebutate.
The ingenol mebutate in Picato
®
gel
treats the lesions in the area where
the gel is applied.
IT IS NOT RECOMMENDED THAT
PICATO
®
GEL, 0.05% IS USED
ON THE FACE OR SCALP – IT IS
TOO STRONG.
_ _
Picato
®
gel, 0.05% is only available
with a doctor’s prescription.
This medicine is not expected to
affect your ability to drive a car or
operate machinery.
This medicine is not addictive.
BEFORE YOU USE PICATO
®
GEL
_WHEN YOU MUST NOT USE _
_PICATO_
_® _
_GEL_
_ _
DO NOT USE PICATO
®
GEL IF YOU are
allergic to ingenol mebutate or any
of the other ingredients listed at the
end of this leaflet (see PRODUCT
DESCRIPTION).
Some of the symptoms of an
allergic reaction include shortness
of breath, wheezing or difficulty
breathing; swelling of the face, lips,
tongue or other parts of the body;
rash, itching or “hives” on the skin.
DO NOT USE PICATO
®
GEL ON BROKEN

Summary of Product characteristics

1
AUSTRALIAN PI – PICATO
®
(INGENOL MEBUTATE) GEL
1
NAME OF THE MEDICINE
Ingenol mebutate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Picato® gel 0.015% - each gram of gel contains 150 micrograms of
ingenol mebutate. Each tube
contains 70 micrograms of ingenol mebutate in 0.47 g of gel.
Picato® gel 0.05% - each gram of gel contains 500 micrograms of
ingenol mebutate. Each tube
contains 235 micrograms of ingenol mebutate in 0.47 g of gel.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Gel.
Picato® gel is a clear colourless gel intended for topical
administration.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Picato® gel is indicated for the topical treatment of solar (actinic)
keratoses in adults.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Picato® gel is indicated for TOPICAL USE ONLY. Picato® gel is NOT
for oral, ophthalmic, intravaginal
or anal use.
DOSE
ADULTS
FOR THE TREATMENT OF SOLAR (ACTINIC) KERATOSES ON THE FACE AND SCALP
Picato® gel, 0.015% should be applied to the affected area once daily
for 3 consecutive days.
FOR THE TREATMENT OF SOLAR (ACTINIC) KERATOSES ON THE BODY
Picato® gel, 0.05% should be applied to the affected area once daily
for 2 consecutive days.
CHILDREN
There is no relevant use of Picato® gel in the paediatric population.
eDoc-000756024 - Version
2. 0
2
APPLICATION INSTRUCTIONS FOR THE FACE AND SCALP AND BODY
Picato® gel should be applied to the treatment area as defined by the
treating physician. Each tube
contains enough gel to cover an area of approximately 25 cm
2
(e.g. 5 cm x 5 cm). Tubes should not
be re-used once opened.

Patients should be instructed to squeeze the gel from the single use
tube onto the fingertip
and then spread it evenly over the area to be treated, avoiding
touching the treatment area
and allowing it to dry for 15 minutes.

Picato® gel should not be applied immediately before or after taking
a shower or less than 2
hours before bedtime.

Patients should be instructed to wash their hands with so