Active ingredient:
povidone iodine
Consumer Medicine Information (CMI)
This leaflet provides important information about using Betadine Sore Throat Gargle.
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 Betadine Sore Throat Gargle.
Where to find information in this leaflet:
1. Why am I using Betadine Sore Throat Gargle?
Betadine Sore Throat Gargle contains the active ingredient povidone-iodine.
Betadine Sore Throat Gargle is a concentrated anti‐bacterial formula used as an aid
in the treatment of sore throats.
It contains alcohol (30.5% w/v.)
2. What should I know before I use Betadine Sore Throat?
Warnings
BETADINE SORE THROAT GARGLE MUST NOT BE SWALLOWED.
Do not use Betadine Sore Throat Gargle if:
you are allergic to povidone or any of the ingredients listed at the end of this leaflet.
Always check the ingredients to make sure you can use this medicine.
you have a severe sore throat accompanied by fever, headache, nausea or vomiting or
any sore throat persisting for more than 2 days may be serious. In such cases consult
a doctor.
you have a known hypersensitivity to povidone iodine, iodine, polyvinylpyrrolidone
or to any excipient. If irritation, redness or swelling develops, discontinue treatment
and consult a doctor.
you have a known to have thyroid disease including goiter, thyroid nodules, or other
thyroid diseases (especially elderly patients) as there may be a risk of developing
hyperthyroidism from the administration of large amounts of iodine.
The maximum treatment duration of 14 days should not be exceeded. Prolonged treatment
could result in a normal microbial flora imbalance in the oral cavity with a risk
of bacterial or fungal dissemination.
it should not be used for 4 weeks prior to treatment for cancer of the thyroid
you are pregnant or breastfeeding.
Not for use on children 6 years and under
DO NOT USE IF CAP SEAL IS BROKEN OR AFTER EXPIRY DATE.
Check with your doctor if you:
have any other medical conditions
take any medicines for any other conditions
currently have or have ever had a kidney problem as using this product may cause toxic
levels of iodine to be absorbed into your blood.
Povidone-iodine preparations are expected to react with unsaturated organic compounds
(e.g. blood, pus) and can lead to ineffectiveness of the preparation.
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
Check with your doctor if you are pregnant or intend to become pregnant.
During pregnancy and lactation, povidone-iodine preparations should only be used if
strictly prescribed by the doctor and its use should be kept to the absolute minimum.
Absorbed iodine can cross the placental barrier and can be secreted in breast milk.
If you are not sure whether any of the above apply to you, speak to your doctor or
pharmacist before using.
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.
Some medicines may interfere with Betadine Sore Throat Gargle and affect how it works.
Lithium (for depression) can interact with Betadine Sore Throat Gargle to affect the
function of the thyroid gland. Therefore, concurrent use should be avoided.
Do not use other wound-treatment preparations containing enzymatic components at
the same time as a povidone-iodine preparation as this can lead to ineffectiveness
of both the preparations. The same thing can happen if disinfectants containing silver,
hydrogen peroxide or taurolidine are used at the same time.
Concomitant use with mercury derivatives is contraindicated. Mercurial and iodine
antiseptics can create a caustic complex during their concomitant use. The interaction
depends on the organomercurial stability at cutaneous level and on the individual
sensitivity.
The joined use of a hydrogen-peroxide mouthwash and povidone-iodine mouthwash can
lead to a weakening of the effects of both substances.
Do not use concomitantly or immediately after application of octenidine containing
antiseptics in same or adjacent sites, as this may lead to transient dark discoloration
in the areas involved.
Due to the oxidative effect of povidone-iodine preparations may show inaccurate results
with diagnostic tests for the determination of blood or glucose in the stool or the
urine.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Betadine Sore Throat Gargle.
4. How do I use Betadine Sore Throat Gargle?
How much to use
This gargle must be diluted before use; a convenient measure is included in the pack.
Dilute 1mL to 20mL with water using the measure provided (or alternatively add 20
drops to 20mL water) and gargle for 30 seconds.
This product is not intended for routine use as a breath freshener or mouthwash.
Betadine Sore Throat Gargle will not permanently stain teeth, skin or natural fabrics.
When to use Betadine Sore Throat Gargle
The maximum treatment duration of 14 days should not be exceeded. Prolonged treatment
could result in a normal microbial flora imbalance in the mouth
If you use too much Betadine Sore Throat Gargle
If you think that you have used too much Betadine Sore Throat Gargle, you may need
urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
New Zealand 0800 POISON or 0800 764766), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using Betadine Sore Throat Gargle?
Things you should do
Tell your doctor if you are due to have a thyroid test since absorption of iodine
from povidone-iodine solution may interfere with thyroid function tests.
Due to the oxidative effect of povidone-iodine preparations may show inaccurate results
with diagnostic tests for the determination of blood or glucose in the stool or the
urine.
During the use of povidone-iodine preparations the iodine uptake of the thyroid can
be lowered; this can lead to interference with various diagnostic investigations on
the thyroid and can make a planned treatment of the thyroid with iodine impossible.
Avoid inhalation.
Avoid contact with the eyes.
Remind any doctor, dentist or pharmacist you visit that you are using Betadine Sore
Throat Gargle.
Driving or using machines
Betadine has no influence on the ability to drive and use machines.
Looking after your medicine
Keep your medicine in a cool dry place where temperature stays below 25°C
Do not heat the solution.
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.
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.
Do not use this medicine after the expiry date.
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 about side effects.
Less serious side effects
Serious 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 .
New Zealand:
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 Betadine Sore Throat Gargle contains
|
Active ingredient
(main ingredient)
|
Povidone iodine
|
|
Other ingredients
(inactive ingredients)
|
citric acid monohydrate
dibasic sodium phosphate dodecahydrate
ethanol
glycerol
menthol
methyl salicylate
purified water
sodium hydroxide
|
|
Potential allergens
|
N/A
|
This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo
dyes.
Do not take this medicine if you are allergic to any of these ingredients.
What Betadine Sore Throat Gargle looks like
A brown solution in 15 or 40 mL bottles.
(AUST R 29566)
(TT50-0462/11)
Who distributes Betadine Sore Throat Gargle?
Betadine Sore Throat Gargle is supplied in Australia by:
Nova Pharmaceuticals (Australia) Pty Limited
Level 10, 12 Help Street
Chatswood NSW 2067
Toll-free: 1800 630 056
Betadine Sore Throat Gargle is supplied in New Zealand by:
iNova Pharmaceuticals (New Zealand) Limited
C/-Simpson Grierson
Private Bag 92518
88 Shortland Street
Auckland 1141
Toll free (NZ): 0508 375 394
This leaflet was prepared in August 2024