Active ingredient(s):
terbinafine hydrochloride
Consumer Medicine Information (CMI)
This leaflet provides important information about using Tinasil 1%. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using Tinasil 1%.
Where to find information in this leaflet:
1. Why am I using Tinasil 1%?
Tinasil 1% contains the active ingredient terbinafine hydrochloride. Tinasil 1% is a topical antifungal.
Tinasil 1% is used to treat tinea of the feet, body and groin region. Tinea, commonly
known as ringworm, is an infection of the skin caused by a type of fungi called dermatophytes.
Tinea between the toes is commonly known as athlete's foot.
Terbinafine is also useful to treat candida (yeast) infections of the skin. Yeasts
are another type of fungus.
2. What should I know before I use Tinasil 1%?
Warnings
Do not use Tinasil 1%:
if you are allergic to terbinafine hydrochloride, or any of the ingredients listed
at the end of this leaflet. Always check the ingredients to make sure you can use
this medicine.
if you find that the tube seal has been broken or missing. The product has tamper-evident
packaging to help protect you from product tampering.
on children under the age of 12 years old.
Check with your doctor or pharmacist if you:
have any other medical conditions
take any medicines for any other conditions.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Do not use this product if you are pregnant or may become pregnant or if you are breastfeeding.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Tinasil 1%.
4. How do I use Tinasil 1%?
How much to use
Apply Tinasil 1% once daily.
Clean and thoroughly dry the affected areas on your skin.
Apply a sufficient amount of the cream on the affected skin and surrounding area.
Use only a thin layer of cream and rub in gently.
If you need to apply Tinasil 1% between your toes, fingers or buttocks, under a breast
or armpit, or in the groin region, cover the area with gauze after the cream has been
applied. This is particularly useful at bedtime. How long you need to apply Tinasil
1% for depends on the type of infection you have:
Tinea (athlete’s foot, ringworm, jock itch) - 7 days
Tinea infection on the sole of the foot - 2-4 weeks
Candida (yeast) infections - 1-2 weeks
You should apply Tinasil 1% only to the skin outside of the body. Wash your hands
after use.
Avoid applying the cream near your eyes or touching your eyes while you still have
the cream on your hands. In case of accidental contact with the eyes rinse the eyes
thoroughly with running water and if any symptoms persist see your doctor.
Follow the instructions provided with the medicine.
Do not exceed the recommended dosage.
If you accidently take Tinasil 1%
If Tinasil 1% has been accidently swallowed, particularly by a child, contact your
doctor or phone the Poisons Information Centre (by calling 13 11 26).
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using Tinasil 1%?
Things you should do
While the signs of the infection may disappear after only using Tinasil 1% for a few
days, it is important to continue use for the recommended period. The reason is that,
if you use it for only a few days, you may not remove all of the fungi from the affected
areas, and as a result, the infection may return soon after you stop using the product.
If there is no improvement in your condition after using Tinasil 1% for the recommended
time, see your doctor or pharmacist.
Looking after your medicine
Store below 25°C
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
When to discard your medicine (as relevant)
Do not use after the expiry date shown on the pack.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions.
Less serious/common side effects
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
7. Product details
This medicine is available over-the-counter without a doctor's prescription.
What Tinasil 1% contains
|
Active ingredient
(main ingredient)
|
Terbinafine hydrochloride
|
|
Other ingredients
(inactive ingredients)
|
sorbitan monostearate
cetyl palmitate
polysorbate 60
cetyl alcohol
stearyl alcohol
isopropyl myristate
sodium hydroxide
|
|
Potential allergens
|
benzyl alcohol
|
What Tinasil 1% looks like
Tinasil 1% is a white to almost white cream (AUST R 272452).
Sponsor
Southern Cross Pharma Pty Ltd
Suite 2, Level 2, 19-23 Prospect Street
Box Hill VIC 3128
Who distributes Tinasil 1%
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
TINASIL® is a Viatris company trade mark
This leaflet was prepared in August 2023.