POVIDONE IODINE

For external use only. The outer surface of the product container is not sterile. Use of the container in a sterile field should be avoided. Posology Adults (including the elderly) Apply topically to the area around the eyes. Instil the solution onto the cornea, conjunctiva and conjunctival sacs and leave for two minutes before rinsing.

See “Method of Administration” for further details. Paediatric population No available data. Method of administration • Wash hands thoroughly before use. • Twist off the cap of the single-dose container to open it, and empty the contents into a sterile container.

• Saturate a sterile cotton swab or sterile wadding with solution and prepare the peri- ocular areas, cheeks and forehead. • Using a sterile syringe or dropper, gently instil the solution onto the cornea, conjunctiva and conjunctival sacs.

• Allow the solution to spread, by asking the patient to close their eyes and roll their eyes around. 9% w/v solution until the characteristic colour of the iodine solution disappears. • After use the remaining solution should be discarded.

The most serious adverse reaction that occurs with Povidone Iodine 5% w/v eye drops, solution is hypersensitivity reaction. Adverse events are categorized by frequency as follows: - Very common (≥ 1/10) - Common (≥ 1/100 to < 1/10) - Uncommon (≥ 1/1,000 to < 1/100) - Rare (≥ 1/10,000 to < 1/1,000) - Very rare (< 1/10,000) - Not known (cannot be estimated from the available data) Immune System Disorders: Not known: hypersensitivity, anaphylactic reactions (urticaria, Quincke's oedema, anaphylactic shock and anaphylactoid reaction).

Endocrine Disorders:

Not known: Regular and prolonged application may lead to toxic levels of iodine likely to develop abnormal thyroid function, particularly in pre-term infants and neonates. Exceptional cases of hypothyroidism have been reported.

Eye disorders:

Not known: conjunctival hyperemia, superficial punctate keratitis, eye irritation, superficial punctate epitheliopathy, keratoconjunctivitis sicca, residual yellow coloration of the conjunctiva. Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas.

Skin and subcutaneous tissue disorders Not known: contact dermatitis (with such symptoms as erythema, blisters, itching), angioedema, cases of reversible, transient brown coloration of the skin have been reported. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for ‘MHRA Yellow Card’ in the Google Play or Apple App Store.

Special warnings For ophthalmic use only. There is no experience of ocular instillation, other than for pre-procedural antisepsis. The use of Povidone Iodine 5% w/v eye drops, solution is restricted to cutaneous- conjunctival surface antisepsis ONLY.

Repeated applications of povidone-iodine to ocular surface related to long term ophthalmic therapy with intravitreal injections may result in tear film abnormalities or aggravate existing tear film abnormalities. Patients with dry eye syndrome should be monitored for any exacerbation of their condition and treated appropriately.

9% sodium chloride solution. Concomitant use with topical ophthalmic formulations containing mercury-based preservatives is to be avoided. Povidone Iodine 5% w/v eye drops, solution should be used with caution in patients suffering from thyroid dysfunction development.

Monitoring of thyroid function should be considered, particularly during regular repeated use of the medicinal product. Cross-reactions with iodinated contrast agents have not been reported. Use with caution in all circumstances that may favour systemic passage, especially in children under 30 months of age.

1; • In new-born babies under 1 month of age; • Povidone Iodine 5% w/v eye drops, solution is contraindicated for intra-ocular or peri-ocular injection; • Concomitant use of topical agents containing mercury derivatives.