ACTIKERALL fluorouracil and salicylic acid 0.5% / 10% (w/w) topical solution, bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

fluorouracil, Quantity: 0.5 g; salicylic acid, Quantity: 10 g

Available from:

Mayne Pharma International Pty Ltd

Pharmaceutical form:

Solution

Composition:

Excipient Ingredients: butyl methacrylate/methyl methacrylate copolymer (3:1); ethyl acetate; dimethyl sulfoxide; ethanol absolute; pyroxylin

Administration route:

Topical

Units in package:

1 x 25 mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

ACTIKERALL is indicated for the topical treatment of solar (actinic) keratosis

Product summary:

Visual Identification: Clear, colourless to slightly orange-white solution packaged in a 25mL brown glass bottle with a child resistant closure.; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2019-08-15

Patient Information leaflet

ACTIKERALL
®
1

This medicine is subject to additional monitoring. This will allow
quick identification of new safety
information. You can help by reporting any side effects you may get.
You can report side effects to your
doctor, or directly at www.tga.gov.au/reporting-problems.
WARNING:
ACTIKERALL® is intended for use only on mild and moderate solar
keratosis.
ACTIKERALL should not be applied on a total area greater than 25
square centimetres (cm
2
) at any one
time. Use ACTIKERALL only on the face, forehead or bald scalp. Do not
use ACTIKERALL on eyelids,
lips or mucous membranes.
ACTIKERALL
®
_FLUOROURACIL AND SALICYLIC ACID _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ACTIKERALL.
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
ACTIKERALL against the benefits
they expect it will have for you.
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 ACTIKERALL IS
USED FOR
ACTIKERALL is used to treat mild
to moderate solar keratosis lesions,
also known as actinic keratosis
lesions or sunspots.
Solar keratoses are rough, red, scaly
or crusty spots on the skin that are
caused by too much exposure to
sunlight. They are more common on
sun-exposed areas, such as the face,
nose, ears, chest, forearms and back
of the hands.
Solar keratoses are usually harmless,
but there is a risk that they may turn
into skin cancer.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is available only with
a doctor's prescription.
_HOW IT WORKS _
ACTIKERALL contains two active
substances, fluorouracil and salicylic
acid.
Fluorouracil belongs to a group of
medicines known as antimetabolites
which inhibi

Summary of Product characteristics

v 2.0
1
This medicinal product is subject to additional monitoring in
Australia. This will allow
quick identification of new safety information. Healthcare
professionals are asked to report
any suspected adverse events at www.tga.gov.au/reporting-problems.
WARNING
- ACTIKERALL
®
should only be used on a total area no greater than 25 cm
2
at a
time. Use should be limited to certain body sites and skin types. See
_4.4 Special Warnings and _
_Precautions for Use_
.
AUSTRALIAN PRODUCT INFORMATION
ACTIKERALL
® (FLUOROURACIL AND SALICYLIC ACID)
SOLUTION
1.
NAME OF THE MEDICINE
Fluorouracil,
Salicylic acid
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of solution contains 5 mg of fluorouracil and 100 mg of salicylic
acid as the active
ingredients.
Excipient with known effect: Contains 19% v/v alcohol (as ethanol
absolute).
For the full list of excipients, see
_section 6.1 List of Excipients_
.
3.
PHARMACEUTICAL FORM
ACTIKERALL is a clear, colourless to slightly orange-white solution
for topical application
only.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
ACTIKERALL is indicated for the topical treatment of solar (actinic)
keratosis.
4.2.
DOSE AND METHOD OF ADMINISTRATION
ACTIKERALL is for topical use only.
ACTIKERALL is NOT for oral, ophthalmic, intranasal, intravaginal,
intra-auditory canal or
intra-anal use.
▼
v 2.0
2
RECOMMENDED DOSING
ACTIKERALL should be applied to solar keratosis lesions or used as a
field treatment, on an
area of up to 25 cm
2
once daily until the lesions have completely cleared or for up to a
maximum of 12 weeks. Larger areas should be treated a section (not
exceeding 25 cm
2
) at a
time.
When ACTIKERALL is applied to the skin, local skin reactions such as
erythema,
inflammation, irritation (including burning), pain, pruritus, bleeding
and erosion can occur.
This is a sign that the medication is working. A response can be seen
as early as 4 weeks.
Response increases over time and data are available for treatment up
to 12 weeks. Complete
healing of the lesion(s) or optimal therape