Povidone iodine 5% w/v eye drops solution

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Povidone iodine is and what it is used for
2. What you need to know before you use Povidone iodine
3. How to use Povidone iodine
4. Possible side effects
5. How to store Povidone iodine
6. Contents of the pack and other information

• if you are allergic to povidone iodine or any of the other ingredients of this medicine (listed in section 6);
• if the patient is a new born infant up to one month of age;
• for administration by injection directly into the eye or in the areas around the eye (intraocular or periocular), the medicine is for external use;
• if you are using eye drops that contain mercury-based preservatives;
• if you are pregnant or breast-feeding (See section “Pregnancy and breast-feeding”).

This medicine will be given to you by your doctor or trained staff.

Talk to your doctor, pharmacist or nurse before using povidone iodine.

Use this medicine with caution:

• if you suffer any eye conditions that can promote the absorption of iodine into the blood;
• if you suffer from thyroid gland problems (due to the possibility of iodine absorption);
• if it is to be used on children less than 30 months of age.

To maintain the conditions of sterility, the bag containing the bottle should only be opened shortly before use; the bottle is not sterile externally if the pouch that contains it is open or damaged. After use, the product must be thrown away even if used only partially.

Do not use this medicine in infants up to one month of age.

Use this medicine with caution in children up to 30 months of age.

Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicines.

Avoid using Povidone iodine together with other antiseptic medicines or detergents.

Do not use Povidone iodine together with other medicines that contain mercury-based preservatives or together with sodium thiosulfate (iodine antidote).

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

Do not use Povidone iodine during pregnancy except in cases of real need and always under the direct supervision of your doctor.

If you are breastfeeding, the use of this medicine may cause unwanted effects in the infant. Therefore, contact your doctor who will have to evaluate whether to stop treatment with the medicine or stop breastfeeding.

Povidone iodine does not affect the ability to drive and use machines.

This medicine contains 1.5 mg phosphates in each ml.

If you suffer from severe damage to the clear layer at the front of the eye (the cornea), phosphates may cause in very rare cases cloudy patches on the cornea due to calcium build-up during treatment.

This medicine will be given to you by a doctor or other healthcare professional, it is unlikely that you will be given an overdose. However, if you think that you have been given an excessive dose or have accidentally swallowed or inhaled the medicine, immediately notify your doctor or nurse who will take the appropriate precautions.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly 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.

• The active substance is povidone iodine. 100 ml of solution contains 5 g of povidone iodine.
• The other ingredients are: glycerol, citric acid, polysorbate 20, dibasic sodium phosphate dodecahydrate, sodium chloride, potassium iodate, sodium hydroxide, purified water.

Pack containing 1 bottle of 4.0 ml eye drops, solution.

The bottle is contained in a double sterile bag.