Betadine 2.5% w/w – patient leaflet, side effects, dosage

1. What Betadine Cutaneous spray, powder is and what it is used for 2. What you need to know before

you use Betadine Cutaneous spray, powder

1. 3. How to use Betadine Cutaneous spray, powder
2. 4. Possible side effects
3. 5. How to store Betadine Cutaneous spray, powder
4. 6.
   1. 1. What Betadine Cutaneous spray, powder is and what it is used for

Betadine Cutaneous spray, powder contains povidone-iodine which is an antiseptic that kills a wide range of germs including bacteria, viruses and fungi.

Betadine Cutaneous spray, powder is used for the treatment and prevention of infections in minor wounds, burns and superficial lesions.

2. What you need to know before you use Betadine Cutaneous spray, powder

Do NOT use Betadine Cutaneous spray, Do NO powder:

• If you are allergic to povidone iodine

  or any of the ingredients in this medicine (listed in section 6) • 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

Do not use in children between 1 and 2 years of age unless advised to do so by the doctor.

Do not smoke or go near naked flames or heat sources when using the product.

Talk to your doctor if:

r

• 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

If you accidentally swallow the medicine, contact your doctor or hospital immediately.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse

Other medicines and Betadine

Cutaneous spray, powder

Tell your doctor or pharmacist, if you are taking/using, have recently taken/ used or might take/use any other medicines.

Other antiseptics or medications can affect how Betadine Cutaneous spray, powder works.

Avoid preparations containing hydrogen peroxide, or silver containing products, taurolidine or octenidine.

Tell your doctor or pharmacist if you are being treated with lithium. Prolonged use, especially on extensive surfaces, should be avoided in patients undergoing lithium therapy as larger amounts of iodine may be absorbed.

Tell your doctor or pharmacist if you are using Betadine Cutaneous spray, powder before any diagnostic test.

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are planning to have a baby ask your doctor for advice before using this medicine.

Do not use this medicine if you are breast-feeding as absorbed iodine can appear in your breast milk.

Driving and using machines

Betadine Cutaneous spray, powder has no impact on the ability to drive and use machines.

3. How to use Betadine Cutaneous spray, powder

Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.

For adults and children older than

2 years.

Clean the wound. Shake the can well in inverted orientation for 5 seconds before each use.

Spray evenly onto the wound area for three (3) seconds from a distance of 15 cm (6 inches).

If necessary, cover with a dressing. Apply the spray once or two times a day for up to 7 consecutive days. Spray in a well-ventilated area. Avoid breathing in the spray or spraying in or around the eyes.

Recommended cleaning after each

use:

Use a fresh dry wipe to clean the nozzle.

Do not use in infants and children between 1 & 2 years of age, unless advised to do so by your doctor. Do not smoke or go near naked flames or heat sources when using this product.

Betadine Cutaneous spray, powder does not stain. However, if it accidentally comes in contact with your clothes, wash immediately with water. Avoid contact with jewellery, especially silver containing articles.

If you forget to apply Betadine Cutaneous spray, powder apply as soon as you remember, unless it is almost time for your next application. Never double up on application to make up for the one you missed.

Do not use if the tamper evident seal is broken.

For External Use Only.

4. Possible side effects

Like all medicines, Betadine Cutaneous spray, powder can cause side effects (although not everybody gets them), such as skin irritation, redness, swelling, small blisters, itching or dry skin, 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, tongue or throat – seek medical help straight away

• Symptoms of a thyroid problem may

  include feeling nervous, moody, difficulty sleeping, hand tremors, fast or irregular heartbeat, trouble breathing, feeling very hot or sweaty, and 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 affects you can help provide more information on the safety of this medicine.

5. How to store Betadine Cutaneous spray, powder

• Do not store above 25°C

• Do not use after 6 months of first

  opening.

• Do not use this medicine after the

  expiry date which is shown on the canister 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.

• Flammable. Keep away from heat,

  hot surface sparks or open flames. Do not pierce or burn the can even when empty.

• 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.

6. Contents of the pack and other information

What Betadine Cutaneous spray,

y, powder contains

• The active substance is

  povidone-iodine

• Other ingredients: isopropyl

  myristate, n-pentane,

  propane-butane/isobutane

  What Betadine Cutaneous spray, powder

  looks like and contents of the pack

  Betadine Cutaneous spray, powder is a fine-brown powder in aluminum aerosol can.

  Pack sizes: 30 g and 80 g. Not all pack sizes may be marketed.

  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 2.5% w/w

  Cutaneous spray, powder

  Reference number:

  PL 58442/0001

295 mm

295 mm