RETRIEVE tretinoin 0.5mg/g cream tube

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

tretinoin, Quantity: 0.5 mg/g

Available from:

iNova Pharmaceuticals (Australia) Pty Ltd

INN (International Name):

Tretinoin

Pharmaceutical form:

Cream

Composition:

Excipient Ingredients: cetyl alcohol; isopropyl palmitate; self-emulsifying glyceryl monostearate; sorbitan monostearate; polysorbate 60; dl-alpha-tocopheryl acetate; disodium edetate; propylene glycol; diazolidinyl urea; methyl hydroxybenzoate; propyl hydroxybenzoate; purified water; retinol palmitate

Administration route:

Topical

Units in package:

50g, 5g, 10g

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

ReTrieve is indicated for the adjunctive treatment of dry photoaged skin and related conditions.

Product summary:

Visual Identification: Smooth off-white to pale yellow cream; Container Type: Tube; Container Material: Al; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-09-20

Patient Information leaflet

RETRIEVE
® CREAM
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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 RETRIEVE?
Retrieve contains the active ingredient tretinoin. Retrieve is used
for the treatment of dry, sun-damaged skin.
For more information, see Section 1. Why am I using Retrieve? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE RETRIEVE?
Do not use if you have ever had an allergic reaction to Retrieve 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
Retrieve? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Retrieve 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 RETRIEVE?
•
The usual dose is to apply a thin layer to the affected skin area(s).
•
Apply once a day before going to bed.
•
Carefully follow the exact instructions given to you by your doctor or
pharmacist.
More instructions can be found in Section 4. How do I use Retrieve? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING RETRIEVE?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Retrieve.
•
Protect your skin when you are in the sun. If you are outdoors, wear
protective clothing and apply a
broad-spectrum 30+ SPF sunscreen. Reapply sunscreen regularly.
THINGS YOU
SHOULD NOT DO
•
Do not apply to the eyes, around eyelids, mouth, lips, mucosa, or
angles of the nose.
•
Do not apply other skin preparations on top of the nightly
application.
•
Do not apply more often than or longer time than what your doctor has
told you.
•
Do not use to treat any other complaint unless your doctor tells you
to.
•
D

Summary of Product characteristics

1
AUSTRALIAN
PRODUCT
INFORMATION
–
RETRIEVE
®
(TRETINOIN)
CREAM
1
NAME OF THE MEDICINE
Tretinoin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tretinoin is a yellow to light orange crystalline powder. It is
practically insoluble in water,
sparingly soluble in methylene chloride and slightly soluble in
ethanol (96 per cent).
ReTrieve Cream contains tretinoin 0.05% w/w (0.5mg/g) in a smooth,
off-white to pale yellow
hydrophilic cream base of cetyl alcohol, diazolidinyl urea, disodium
edetate, dl-alpha tocopheryl
acetate, glyceryl monostearate, isopropyl palmitate, methyl
hydroxybenzoate, polysorbate 60,
propylene glycol, propyl hydroxybenzoate, retinol palmitate, sorbitan
monostearate and purified
water.
Excipient with known effect:
Hydroxybenzoates, diazolidinyl urea.
3
PHARMACEUTICAL FORM
Cream, topical.
Tretinoin (ReTrieve) 0.05% w/w cream – Smooth off-white to pale
yellow.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Adjunctive treatment of dry photoaged skin and related conditions.
4.2
D
OSE AND METHOD OF ADMINISTRATION
ReTrieve should be applied sparingly to the affected areas once daily
at bedtime. Treatment with
tretinoin
should
be
individualised
according
to
tolerance
and
response.
No
other
topical
preparations should be applied over the nightly inunction, but
suitable moisturisers may be used
during the day.
Begin the treatment program slowly, as follows:
1. Wash the affected areas prior to any application with mild soap
free cleansers and pat dry.
2. First night: apply, leave for five minutes, then wash off.
3. Second night: apply, leave for ten minutes, then wash off.
4. Third, fourth, fifth and sixth nights: increase the treatment time
each night by 30 minutes until
the application is left on for two hours.
2
5. If, after a two hour application, no redness or irritation has
developed on the skin the following
day, then the application may be left on overnight and washed off next
morning.
6. If excessive skin reactions occur, adjust the schedule to alternate
nights until the skin
accommodates.