Patient leaflet - BETADINE THROAT SPRAY 0.45% W/V OROMUCOSAL SPRAY SOLUTION
1. What Betadine Throat Spray is and what it is used for
Betadine Throat Spray contains povidone iodine, which is an antiseptic that kills a wide range of germs, including bacteria, fungi and viruses.
Betadine Throat Spray is used for oral hygiene and treatment of acute infections of the mouth or throat caused by viruses, bacteria or fungi such as sore Throat (pharyngitis).
2. What you need to know before you use Betadine Throat Spray
Do not use Betadine Throat Spray
If you are allergic to povidone
iodine or any of the other ingredients of this medicine • If you have a thyroid problem • If you are currently receiving
radioactive iodine treatments • If you have received or will be
receiving radioactive iodine treatments within 4 weeks • If you are using products containing
mercury, such as thiomersal • In children under 1 year of age
Talk to your doctor or pharmacist,
acist, before using Betadine Throat Spray
If you have sensitivity to alcohol.
This medicine contains 40 mg of alcohol (ethanol) in each dose (spray). The amount in each dose (spray) of this medicine is equivalent to less than 1 ml of beer or wine. The small amount of alcohol in this medicine should not have any noticeable effects.
Talk to your doctor or pharmacist, Talk to your d whilst using Betadine Throat Spray if:
Symptoms do not improve after
7 days or get worse
You have an allergic or irritant
reaction such as redness, small blisters, itching or a rash which may occur immediately
You have any further questions on
the use of this medicine.
Children
Use in children under 6 years of age is not recommend unless advised otherwise by your doctor.
Do not use in children below the age of 1 year.
Other medicines and Betadine
Throat Spray
Tell your doctor or pharmacist, if you are using, have recently used or might use any other medicines.
Other antiseptics or medications can affect how Betadine Throat Spray works. Avoid preparations containing hydrogen peroxide, silver, taurolidine or octenidine.
Tell your doctor or pharmacist, if you are using Betadine Throat Spray before any diagnostic test.
Pregnancy, breast-feeding and
fertility
Do not use Betadine Throat Spray if you are pregnant, think you may be pregnant, planning to have a baby, unless advised to do so by your doctor. Do not use this medicine if you are breast-feeding.
Driving and using machines
There are no effects on the ability to drive and use machines.
3. How to use Betadine Throat Spray
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose in adults
and children 6 years and above is:
One spray onto the back of the
throat or affected area in mouth every 3-4 hours as needed, up to 3 sprays per day for a maximum of 7 days.
Use in children from 1 to less than
6 years of age:
Do not use in in children between 1 and 6 years of age unless recommended by your doctor after consideration of the
patient's condition.
Do not use if the tamper evident seal is broken.
Instructions for Use:
- 1. Remove the cap from the nozzle. For a new bottle, prime the pump spray by completely pushing down the pump several times (at least 4 times).
- 2. Tilt the head back slightly, open the mouth and aim the nozzle towards the back of the throat or affected mouth area. Hold your breath and press the pump completely down to spray.
Do not breathe in the spray.
- 3. After each use, wash the pump spray head under clean water and dry. Wipe the nozzle and place the cap back after use.
Do not spray in or around the eyes. If this happens, then
immediately rinse your eyes
with plenty of cold water.
Betadine Throat Spray does not stain. However, if accidentally comes in contact with your clothes, wash immediately with water. Avoid contact with jewellery, especially silver containing articles.
IIf you use more Betadine Throat Spray than you should
Contact your doctor or pharmacist, or your local hospital immediately. Take this leaflet and any other packaging with you so they know what you have take.
If you forget to use Betadine Throat Spray
If you forget to apply Betadine Throat Spray, apply as soon as you remember, unless it is almost time for the next application. Do not use a double dose to make up for the one you missed.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them such as cough, irritation, redness, swelling, small blisters, itching, tiredness, weakness, confusion, rapid shallow breathing, passing little or no urine, fluid retention and swelling of legs, ankle and feet.
Tell your doctor or pharmacist, immediately if you have any of the following signs or symptoms:
Allergic reactions that occur quickly
and include an itchy raised skin rash (hives), a body rash, sudden breathing problems, feeling faint, swelling of the mouth, face, lips, throat or tongue – seek medical help straight away
Symptoms of a thyroid problem may
include feeling nervous, moody, difficulty sleeping, hand tremors, fast or irregular heart-beat, trouble breathing, feeling very hot or sweaty, weight loss, weight gain and tiredness.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Betadine Throat Spray
- Store below 25°C
Do not use after 3 months of first
opening
Do not use this medicine after the
expiry date which is shown on the
bottle and carton after “EXP”. The expiry date refers to the last day of that month.
- Keep this medicine out of the sight and reach of children.
Do not throw away any medicines via wastewater or household waste. Ask your doctor or pharmacist, how to throw away medicines you no longer use. These measures will help protect the environment. • Flammable: Contains alcohol:
Keep away from open flames or heat.
6. Contents of the pack and other information
What Betadine Throat Spray contains
- The active substance is povidone iodine 0.45% w/v.
The other ingredients are Glycerol
(E422), Ethanol, Levomenthol, Eucalyptus Oil, Potassium Iodide, Purified Water.
What Betadine Throat Spray looks
like and contents of the pack
Betadine Throat Spray is a pale-brown slightly viscous liquid, supplied in a high-density polyethylene (HDPE) container with a spray pump and a polystyrene copolymer cap enclosed in a printed carton.
Contents: 50 ml.
Marketing Authorisation Holder
Taw Pharma (Ireland) Limited 104 Baggot Street Lower,
Dublin 2, D02 Y940,
Ireland
Manufacturer
Mundipharma Pharmaceuticals Limited Dhali Industrial Area, Othellou 13-15, Nicosia, 2540, Cyprus
This leaflet was last revised in July 2026
®: Betadine is a Registered Trademark.
Other sources of information
This leaflet is also available in large print, Braille or as an audio CD. To request a copy, please call the RNIB Medicine Information line (free of charge) on:
0800 198 5000
You will need to give details of the product name and reference number. These are as follows:
Product name:
Betadine Throat Spray 0.45% w/v Oromucosal spray, solution Reference number:
PL 58442/0002
295 mm
295 mm