(akna-tek)
clindamycin (as phosphate) 1% w/w and tretinoin 0.025% w/w; (klin-da-mye-sin fos-fate)
and (tret-ˈi-noin)
CONSUMER MEDICINE INFORMATION
What is in this leaflet
This leaflet answers some common questions about ACNATAC.
It does not contain all the available information. It does not take the place of talking
to your doctor or pharmacist.
The information in this leaflet was last updated on the date listed on the final page.
More recent information on the medicine may be available.
You should ensure that you speak to your pharmacist or doctor to obtain the most up
to date information on the medicine.
Those updates may contain important information about the medicine and its use of
which you should be aware.
All medicines have risks and benefits. Your doctor has weighed the risks of you using
ACNATAC 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 ACNATAC is used for
ACNATAC is used on the skin to treat acne in patients 12 years and older.
ACNATAC contains two active ingredients: clindamycin (as phosphate) and tretinoin.
Clindamycin is an antimicrobial agent. It limits the growth of bacteria associated
with acne and the inflammation caused by these bacteria.
Tretinoin normalises the growth of superficial skin cells and causes normal shedding
of the cells that clog the hair follicles in areas with acne. This prevents the build-up
of sebum and the formation of early acne lesions (blackheads and whiteheads).
ACNATAC combines clindamycin and tretinoin and therefore is more effective at treating
acne than when these active ingredients are used separately.
Ask your doctor if you have any questions about why ACNATAC has been prescribed for
you. Your doctor may have prescribed it for another purpose.
This medicine is not addictive.
ACNATAC is only available with a doctor's prescription.
There is not enough information to recommend the use of this medicine in children
under 12 years of age.
Before you use ACNATAC
When you must not use it
Do not use ACNATAC if you have ever had an allergic reaction to:
clindamycin or
tretinoin or
any of the other ingredients listed at the end of this leaflet or
lincomycin.
Do not use ACNATAC:
if you are suffering from acute eczema which is characterised by inflamed, itchy,
red, dry and scaly skin.
if you are suffering from rosacea, a skin disease which affects the face and is characterised
by redness, pimples and peeling.
if you are suffering from other acute inflammatory conditions of the skin (e.g. folliculitis),
especially around the mouth (perioral dermatitis).
if your skin is sunburnt.
if you are using any other medication on your skin which may lead to skin irritation
e.g. an exfoliator.
if you are pregnant.
if you may become pregnant.
if you are breast-feeding.
if you have a chronic inflammatory bowel disease (e.g. Crohn's disease or ulcerative
colitis).
if you are suffering from certain special forms of acne vulgaris characterised by
pustular and deep cystic nodular acne lesions (acne conglobata and acne fulminans).
if you have or have had severe diarrhoea associated with the use of antibiotics.
Do not use this medicine after the expiry date printed on the pack or if the packaging
is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
Before you start to use it
You must tell your doctor if:
you have allergies to any medicines, foods, preservatives or dyes.
you suffer from eczema, rosacea and/or perioral dermatitis.
you are using other topical preparations such as soaps, cleansers, creams, lotions,
gels or ointments (including cosmetics).
This includes any that you buy without a prescription from a pharmacy, supermarket
or health food shop. Some topical preparations are not compatible with ACNATAC and
may interact with it. Others may increase your chance of experiencing side effects.
If you have used any preparations that contain sulfur, salicylic acid, benzoyl peroxide
or rescinol or any chemical abrasives, you will need to wait until the effect of those
has subsided until you start using this medicine. Your doctor will tell you when you
can start using ACNATAC.
you have or have had severe diarrhoea associated with the use of antibiotics.
you are breastfeeding, pregnant or planning to become pregnant.
Female patients should seek advice from a doctor or pharmacist on appropriate contraceptive
methods before using ACNATAC to prevent pregnancy.
If you have not told your doctor about any of the above, tell them before you start
using the medicine. Your doctor can discuss with you the risks and benefits involved
and will advise you whether or not to use ACNATAC.
Taking other medicines
Tell your doctor if you are taking any other medicines, including medicines that you
can buy without a prescription from a pharmacy, supermarket or health food shop.
In particular, tell your doctor if you are taking or using:
a corticosteroid.
any erythromycin-containing products.
medicinal products containing other antibiotics.
neuromuscular blocking medicines e.g. muscle relaxants used in anaesthesia.
medicines to thin the blood e.g. warfarin (increased coagulation tests and/or bleeding
have been reported).
These medicines may be affected by ACNATAC or may affect how ACNATAC works.
Your doctor and pharmacist have more information on medicines to be careful with or
avoid while using this medicine.
How to use ACNATAC
How much to use
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.
How to apply it
ACNATAC is for application to the skin only.
Wash your hands.
Wash the affected area with a mild soap and water, and gently pat dry.
Squeeze a small amount of ACNATAC onto one fingertip and dot onto the affected area.
For example, a pea-sized amount should be enough to cover the entire face.
Gently smooth it over the skin to ensure the entire affected area is covered.
Keep ACNATAC away from your lips, eyes, eyelids, mouth, nostrils and other mucous
membranes. In case of accidental contact with the eyes, rinse with plenty of lukewarm
water.
Wash your hands after using ACNATAC.
How long to use it for
You may not notice improvement in your condition for several weeks after starting
treatment. Do not be alarmed with this and continue treatment with ACNATAC. Typically,
it may take several weeks to have an optimal effect. In some cases, it may take up
to 12 weeks. If you have any concerns speak with your doctor or pharmacist.
To get the best results with ACNATAC it is necessary to use it properly and not stop
using it as soon as your acne starts to get better.
Treatment with ACNATAC should not exceed 12 weeks of continuous use without careful
evaluation by your doctor.
How often to use it
Adults and adolescents 12 years and older: apply once daily at night time.
Children under 12 years: this medicine is not recommended for children under 12 years.
If you forget to use it
If you miss a dose, use ACNATAC when the next dose is due at the usual time.
Do not use a double dose to make up for the dose that you missed.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to use your medicine, ask your pharmacist for some
hints.
If you swallow it
Immediately telephone your doctor or the Poisons Information Centre (telephone 131
126) if you think you or anyone else may have swallowed ACNATAC. Do this even if there
are no signs or symptoms of discomfort or poisoning.
If you apply too much
You could experience stomach pain, nausea, vomiting or diarrhoea. If this occurs discontinue
the use of ACNATAC and contact your doctor.
If you apply ACNATAC excessively you may experience marked redness, peeling or discomfort.
If this occurs, gently wash the skin with a mild soap and lukewarm water. Discontinue
ACNATAC for several days and wait until symptoms have resolved before resuming therapy.
Discuss any worries you may have about this with your doctor or pharmacist.
While you are using ACNATAC
Things you must do
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are using ACNATAC.
Tell any other doctors, dentists, and pharmacists who treat you that you are using
ACNATAC.
Women must use adequate contraceptive methods to minimise the risk of becoming pregnant
while using ACNATAC and at least one month after discontinuing ACNATAC.
If you become pregnant while you are using this medicine, stop treatment immediately
and tell your doctor.
Your doctor can discuss with you the risks of using it while you are pregnant.
Things you must 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 tells you to.
Do not apply to any irritated areas of your skin; for example, if you have cuts, grazes,
sunburn or eczema.
Do not use medicated soaps cleansers or scrubbing solutions with strong drying effect
during treatment with ACNATAC. You should be careful when using the following that
may have a drying effect: abrasive soaps, soaps and cosmetics and products with high
concentrations of alcohol, astringents, spices or lime.
Things to be careful of
ACNATAC may make your skin more susceptible to sunburn and other adverse effects of
the sun. Therefore, minimise your exposure to sunlight and always use appropriate
broad-spectrum sunscreen with at least 30 Sun Protection Factor (SPF30+), together
with suitable protective clothing (e.g. a hat) when outdoors.
If you are sunburnt do not use ACNATAC until your skin has fully recovered.
Avoid the use of sun lamps, UV lamps or sun beds during treatment.
ACNATAC is administered on the skin and is unlikely to have an effect on the ability
to drive or operate machines.
Side effects
Check with your doctor or pharmacist as soon as possible if you have any problems
while using ACNATAC, even if you don't think the problems are connected with the medicine
or are not listed in this leaflet.
All medicines can have side effects. Sometimes they are serious, most of the time
they are not. You may need medical attention if you get some of the side effects.
Do not be alarmed by the list of possible side effects. You may not experience any
of them. Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you experience any of the following and they continue to worry
you:
acne
dry skin
redness of the skin
increased sebum production
sensitivity to sunlight (that may result in sunburn)
itching
rash
scaling of the skin
cold - like symptoms e.g. cough, sinusitis
application site skin reactions such as burning, inflamed skin, dryness, redness of
the skin. These symptoms are often mild and temporary when starting treatment with
ACNATAC. Talk to your doctor if these symptoms are prolonged or intense.
Stop using ACNATAC and tell your doctor immediately if you notice any of the following:
cold sores (herpes simplex)
symptoms of underactive thyroid gland: fatigue, weakness, weight gain, dry hair, rough
pale skin, hair loss, increased sensitivity to cold
headache
eye irritation
nausea
abdominal cramps
vomiting
diarrhoea
pain
severe or persistent skin irritation such as very red, swollen, itchy, scaly, blistered,
crusted skin
skin bleeding
loss of skin pigmentation
application site symptoms such as swelling, superficial skin damage, discolouration
feeling hot.
Stop using ACNATAC and immediately contact your doctor if you become pregnant.
STOP using ACNATAC and tell your doctor immediately or go to Accident and Emergency
at your nearest hospital if you have an allergic reaction.
Some of the symptoms of an allergic reaction may 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.
After using ACNATAC
Storage
Keep ACNATAC in a cool dry place where the temperature stays below 25°C. Do not refrigerate
or freeze this medicine.
Discard after 3 months of first opening the tube.
Do not store ACNATAC or any other medicine in the bathroom or near a sink. Do not
leave it on a window sill or in the car.
Heat and dampness can destroy some medicines.
Keep ACNATAC where young children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
Disposal
If your doctor tells you to stop using ACNATAC or the expiry date has passed, ask
your pharmacist what to do with any medicine that is left over.
Product description
What it looks like
ACNATAC is an aqueous translucent yellow gel that is available in tubes of 30 grams
and 60 grams.
Ingredients
ACNATAC contains 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 0.25 mg.
ACNATAC also contains the following inactive ingredients:
glycerol
carbomer 981
trometamol
propyl hydroxybenzoate
methyl hydroxybenzoate
polysorbate 80
disodium edetate
citric acid
butylated hydroxytoluene
purified water.
Sponsor
Mylan Health Pty Ltd
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point, NSW 2000
Australia
www.mylan.com.au
Phone: 1800 314 527
This leaflet was prepared in March 2018.
Australian Registration Number: AUST R 232394.