ACNATAC clindamycin (as phosphate) 1.0% w/w and tretinoin 0.025% w/w topical gel, tube

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

tretinoin, Quantity: 0.25 mg; clindamycin phosphate, Quantity: 12 mg (Equivalent: clindamycin, Qty 10 mg)

Available from:

Viatris Pty Ltd

INN (International Name):

Clindamycin phosphate,Tretinoin

Pharmaceutical form:

Gel

Composition:

Excipient Ingredients: purified water; disodium edetate; methyl hydroxybenzoate; carbomer 981; butylated hydroxytoluene; polysorbate 80; citric acid; glycerol; propyl hydroxybenzoate; trometamol

Administration route:

Topical

Units in package:

1 x 30g tube, 1 x 60g tube

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

ACNATAC is indicated for the topical treatment of acne vulgaris when comedones, papules and pustules are present in patients 12 years or older. Consideration should be given to official guidance on the appropriate use of antibacterial agents and acne treatment.

Product summary:

Visual Identification: Translucent yellow gel; Container Type: Tube; Container Material: Al; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2016-03-29

Patient Information leaflet

ACNATAC
® TOPICAL GEL
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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 ACNATAC?
ACNATAC contains the active ingredients clindamycin (as phosphate) and
tretinoin. ACNATAC is used on the skin to treat acne in
patients 12 years and older. For more information, see Section 1. Why
am I using ACNATAC? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ACNATAC?
Do not use if you have ever had an allergic reaction to ACNATAC 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 ACNATAC? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with ACNATAC 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 ACNATAC?
•
Follow all directions given to you by your doctor and pharmacist
carefully.
•
Use ACNATAC once daily at night time on the affected area. Do not
exceed the recommended dose.
More instructions can be found in Section 4. How do I use ACNATAC? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ACNATAC?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
ACNATAC.
•
If you become pregnant while you are using this medicine, stop
treatment immediately and tell your
doctor.
•
Women must use adequate contraceptive methods to minimise the risk of
becoming pregnant while using
ACNATAC and at least one month after discontinuing ACNATAC.
THINGS YOU
SHOULD NOT DO
•
Do not give this medicine to anyone else, even if their symptoms seem
to be the same as yours.
•
Do not use it to treat any other complaints unless your doctor t

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
ACNATAC
®
_Clindamycin (as phosphate) 1% w/w and tretinoin 0.025% w/w _
1
NAME OF THE MEDICINE
Clindamycin phosphate and tretinoin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACNATAC is a fixed combination product containing the following active
ingredients: clindamycin phosphate
1.2% w/w (equivalent to 1% w/w of clindamycin) and tretinoin 0.025%
w/w. Each gram of ACNATAC contains
12 mg clindamycin phosphate (equivalent to 10 mg clindamycin) and
tretinoin 0.25mg.
Excipients with known effect: hydroxybenzoates (as antimicrobial
preservatives).
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
ACNATAC is an aqueous translucent yellow gel.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ACNATAC is indicated for the topical treatment of acne vulgaris when
comedones, papules and pustules are
present in patients 12 years or older.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents and acne
treatment.
4.2
DOSE AND METHOD OF ADMINISTRATION
ACNATAC is indicated for external (dermatological use only). Patients
should avoid the eyes, eyelids, lips and
nostrils when applying ACNATAC. After applying ACNATAC the patient
should wash their hands thoroughly.
Patient should minimise their exposure to sunlight and use appropriate
sunscreen products with a SPF (Sun
Protection Factor) of at least 30, together with suitable protective
apparel (e.g. a hat).
ADULTS AND ADOLESCENTS (E.G. 12 YEARS AND OLDER)
Once daily at night time the affected area should be washed with mild
soap and dried. A small amount of
ACNATAC should be squeezed onto one fingertip; dotted onto the
affected area, then gently rubbed over the
skin to ensure the entire affected area is covered. As guidance: a
pea-sized amount of ACNATAC should be
enough to cover the entire face.
Treatment with ACNATAC should not exceed 12 weeks of continuous use
without careful evaluation. It should
be noted that therapeutic improvement may not be observed for seve