TOLAK 4% ONCE DAILY fluorouracil 40 mg/g cream tube

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

fluorouracil, Quantity: 40 mg/g

Available from:

Aspen Pharmacare Australia Pty Ltd

Pharmaceutical form:

Cream

Composition:

Excipient Ingredients: stearoyl macrogolglycerides; butylated hydroxytoluene; cetyl alcohol; citric acid; glycerol; isopropyl myristate; methyl hydroxybenzoate; propyl hydroxybenzoate; purified water; Arachis Oil; sodium hydroxide; stearic acid; stearyl alcohol; methyl gluceth-10

Administration route:

Topical

Units in package:

STARTER PACK 20 g, 40 g, 20 g

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

TOLAK 4% ONCE DAILY is indicated for the topical treatment of actinic keratosis (AK) of the face, ears, and/or scalp in adults.

Product summary:

Visual Identification: White to off-white cream; Container Type: Tube; Container Material: Epoxy-coated 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:

Registered

Authorization date:

2021-01-18

Patient Information leaflet

TOLAK® 4% ONCE DAILY cream
1
TOLAK® 4% ONCE DAILY CREAM
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 TOLAK 4% ONCE DAILY?
TOLAK 4% ONCE DAILY contains the active ingredient fluorouracil. TOLAK
4% ONCE DAILY is used to treat a skin condition called
actinic keratosis, also known as solar keratoses or sunspots.
Fluorouracil belongs to a group of medicines known as
antimetabolites that inhibit the growth of cells (cytostatic agent).
For more information, see Section 1. Why am I using TOLAK 4% ONCE
DAILY?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE TOLAK 4% ONCE DAILY?
Do not use if you have ever had an allergic reaction to fluorouracil
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
TOLAK 4% ONCE DAILY?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with TOLAK 4% ONCE DAILY 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 TOLAK 4% ONCE DAILY?
TOLAK 4% ONCE DAILY is usually used for 4 weeks. Apply the cream once
daily to cover the areas of your skin to be treated.
More instructions can be found in Section 4. How do I use TOLAK 4%
ONCE DAILY?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING TOLAK 4% ONCE DAILY?
THINGS YOU
SHOULD DO
It is likely that the area of the skin treated will become red,
probably followed by inflammation/swelling,
possibly some discomfort, skin erosion and eventually, healing. This
is the expected normal response to
treatment and it shows that TOLAK 4% ONCE DAILY is working. Talk to
your doctor if your skin becomes
much worse, you experience pain or if you are worried. Your doctor may
pre

Summary of Product characteristics

Tolak Once Daily Cream 4% Product Information
Page 1 of 13
AUSTRALIAN PRODUCT INFORMATION
TOLAK
® 4% ONCE DAILY (FLUOROURACIL) CREAM
1.
NAME OF THE MEDICINE
Fluorouracil
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
TOLAK 4% ONCE DAILY cream contains fluorouracil (5-FU) 4% w/w
(equivalent to
40 mg/g).
Excipients with known effect:
Methyl hydroxybenzoate, propyl hydroxybenzoate, and, arachis oil
(peanut oil).
For the full list of excipients, see section 6.1
_List of excipients_
.
3.
PHARMACEUTICAL FORM
Cream, white to off-white in appearance.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
TOLAK 4% ONCE DAILY is indicated for the topical treatment of actinic
keratosis (AK) of
the face, ears, and/or scalp in adults.
4.2.
DOSE AND METHOD OF ADMINISTRATION
TOLAK 4% ONCE DAILY should be applied once daily in an amount
sufficient to cover the
whole area of the face and/or ears and/or scalp where AK lesions have
been identified with a
thin film, using the fingertips to gently massage the medication
uniformly into the skin.
DURATION OF TREATMENT
Apply TOLAK 4% ONCE DAILY for a period of 4 weeks as tolerated.
The development of an inflammatory response is associated with the
pharmacological action
of 5-FU on dysplastic AK cells. This is characterised by local skin
reactions that peaks at
4 weeks of treatment and resolves within 2-4 weeks after the end of
treatment (see
section 4.4
_Special Warnings and Precautions for Use_
and section 4.8
_Adverse Effects _
_(Undesirable Effects)_
for normal pattern of response).
Tolak Once Daily Cream 4% Product Information
Page 2 of 13
In case of severe discomfort during treatment or where skin reactions
last more than 4 weeks,
symptomatic treatment (such as emollients or topical corticosteroids)
should be offered.
The number of retreatments with TOLAK 4% ONCE DAILY is the decision of
the treating
physician. When assessing options to treat recurrent lesions, the
physician should consider
that repeated treatment with TOLAK 4% ONCE DAILY in case of recurrence
has not been
formally ass