Povidone iodine 5% w/v Eye Drops Solution – Summary of Product Characteristics (SmPC) for healthcare professionals

1 NAME OF THE MEDICINAL PRODUCT

Povidone iodine 5% w/v Eye Drops Solution

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 4ml single use container provides 200 mg of povidone iodine. One millilitre of solution contains 50mg povidone iodine.

Excipient with known effect

Dibasic sodium phosphate dodecahydrate 1.5mg/ml (see section 4.8).

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Sterile eye drops, solution.

Clear, red-brown solution.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

For the pre-operative preparation of the surgical field (eyelids, lashes and cheeks) and irrigation of the ocular surface (cornea, conjunctiva and palpebral fornixes).

4.2 Posology and method of administration

Posology

Adults (including the elderly)

To be applied topically to the area around the eyes and ocular surfaces prior to surgery. See “Method of Administration" for further details.

Paediatric population

The adult dose may be used in infants, children and adolescents.

Method of Administration

Wash hands thoroughly before use.

Saturate sterile wadding with the povidone iodine solution contained in the bottle and start preparing lashes and eyelid margins.

Repeat the process for the eyelids, cheeks and forehead in a circular manner until the entire surgical field is cleaned.

Repeat this process three times.

Irrigate the cornea, conjunctiva and palpebral fornixes with the ophthalmic solution. Leave the solution on the area for two minutes. Remove the povidone iodine from the ocular surface by irrigating the cornea, conjunctiva and palpebral fornixes with sterile sodium chloride 0.9% solution until the characteristic colour of the iodine solution disappears.

Do not touch the eye with the container nozzle.

4.3 Contraindications

This medicinal product must not be used in the following situations:

• Hypersensitivity to the active substance or to any of the excipients listed in section

  6.1.

• The product is contraindicated in infants up to one month of age.
• Do not administer simultaneously with eye drops containing mercurial preservatives, i.e., thiomersal.
• Generally contraindicated in pregnancy and lactation (see section 4.6).
• Povidone Iodine 5% w/v Eye Drops Solution is contraindicated for intra-ocular or peri-ocular injection.

4.4 Special warnings and precautions for use

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 (e.g. 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.

Precautions for use

After the medicinal product has been left in contact with the conjunctiva and conjunctival sacs for two minutes, flush thoroughly with sterile sodium chloride 0.9% solution.

Concomitant use with topical ophthalmic formulations containing mercury-based preservatives is to be avoided.

Use with caution in patients with thyroid dysfunction and in elderly patients, who are at risk of thyroid dysfunction development. Monitoring of thyroid function should be considered, particularly during regular repeated use of the medicinal product.

Use with caution in all ocular conditions that may promote the systemic absorption of iodine, especially in infants aged less than 30 months.

Cross-reactions with iodinated contrast agents have not been reported.

The Povidone iodine package remains externally sterile until the sachets are opened, the bottle is not externally sterile if the bag containing it is open or damaged.

4.5 Interaction with other medicinal products and other forms of interaction

Concomitant or subsequent use with other antiseptics and detergents should be avoided, because of the potential for interference (antagonism, inactivation).

Special caution is needed in relation to iodine incompatibilities. In particular, do not use at the same time as a mercury-based derivative: the combination iodine/mercury-based preservatives must be avoided due to the risk of forming caustic compounds. Such mercury-based preservatives are common in many ophthalmic preparations.

Avoid the use of products containing sodium thiosulphate, a substance that acts as an iodine antidote.

Povidone iodine is unstable at an alkaline pH.

When administered at volumes greater than those arising from single ocular instillation, povidone iodine may interfere with thyroid function tests.

4.6 Fertility, pregnancy and lactation

Pregnancy

Animal studies have not shown teratogenic effects. Given the absence of teratogenic effects in animals, malformation effects are not expected in humans (see section 5.3).

Currently, relevant clinical data is not sufficiently available to assess the potential malformation impact of povidone iodine when it is administered within the last trimester of pregnancy. The foetal thyroid begins to accumulate iodine around the 14^th week of gestation.

No effects during pregnancy are anticipated since systemic exposure to iodine in negligible. Povidone Iodine 5% w/v Eye Drops Solution can be used with caution during pregnancy. If repeated procedures are anticipated, then alternative forms of antisepsis should be considered in pregnant or breast-feeding women.

Breast-feeding

Whilst it is anticipated that there are no effects on the breastfed new-born/infant since the systemic exposure of the lactating mother to iodine is negligible. However, During the possibility of discontinuing breast-feeding or treatment with the product should be considered.

Fertility

No effects on fertility are anticipated, since systemic exposure to iodine is negligible.

4.7 Effects on ability to drive and use machines

Not Relevant

4.8 Undesirable effects

The most serious adverse reaction that can occur with Povidone Iodine 5% w/v Eye Drops is a hypersensitivity reaction.

Adverse reactions are listed by System Organ Class. Frequencies are defined using the following convention: 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).

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. Healthcare professionals are asked to report any suspected adverse reactions 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.

4.9 Overdose

In case of ocular overdose, irrigate the eye with plenty of sterile saline or water.

Accidental ingestion or inhalation of some disinfectants can have serious, sometimes fatal consequences.

In case of accidental ingestion of a considerable quantity of Povidone iodine, gastric lavage should be used, otherwise supportive therapies should be practised.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Ophthalmologicals, other anti-infectives

ATC code: S01AX18.

Broad-spectrum antiseptic, bactericidal, virucidal and fungicide.

Antiseptic group: Halogen oxidant (iodophore).

Mechanism of action

Povidone iodine is an iodophore that has an established use as a broad-spectrum antiseptic, mainly for the treatment of contaminated wounds and for the preoperative preparation of the skin, mucous membranes and the ocular surface. The organic complex contains approximately 10% of active available iodine.

Its spectrum of activity is iodine which gradually and slowly released exerts:

• bactericidal effect in less than 5 minutes in vitro, for all bacteria,

• fungicide effect for yeasts and filamentous fungi.

  Solutions of povidone iodine gradually release iodine to exert an antimicrobial effect against bacteria, fungi, viruses, and spores. Although povidone iodine is less potent than preparations containing free iodine, it is also less toxic.

  Organic materials (proteins, serum and blood) reduce the activity of free iodine, the active form of the medicinal product. Iodophors are unstable at alkaline pH.

  Pharmacodynamic effects

  Povidone iodine is a complex of the polymer polyvinylpyrrolidone (povidone) with iodine which, after application, continues to deliver iodine to the ocular surface over the short time that the solution is in contact with the eye.

  After application, exposure of the ocular surface to iodine arises from the presence of free iodine in solution, and iodine bound to the polymer, which serves as a reservoir. As the preparation comes in contact with the eye, more and more iodine dissociates from the polymer.

  Mechanisms of resistance

  There are no reports of bacterial cross-resistance to antibiotics arising from exposure to povidone iodine, or iodine, or of co-resistance due to any known genetic linkage of resistance determinants.

  There are limited reports of contamination of iodophors with Pseudomonas species, in nutrient restricted environments, such as hospital wastewater, indicating that resistance to povidone iodine can occur. However, this is of limited relevance to the use of povidone iodine in ocular antisepsis.

5.2 Pharmacokinetic properties

The available iodine in povidone iodine is able to cross the conjunctival barrier to a limited extent. At the concentration used, the potential for systemic exposure to iodine is very low.

Conjunctival and peri-ocular sterilisation with Povidone iodine (1.25% or 10%) results in increased urinary elimination of iodide. Elimination is almost exclusively by the renal route. Povidone alone is unlikely to be absorbed systemically.

5.3 Preclinical safety data

Preclinical data from safety pharmacology studies, repeated dose toxicity tests and mutagenicity studies did not provide evidence of a particular risk to humans. Animal studies did not show any teratogenic effects.

In oral sub-acute and chronic toxicity studies, including rat studies, the only effects observed after discontinuation of povidone iodine were in most cases transient and dose-dependent increases in serum iodine-bound protein and non-specific histopathological changes in the thyroid gland.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Glycerol

Citric acid

Polysorbate 20

Dibasic sodium phosphate dodecahydrate

Sodium chloride

Potassium iodate

Sodium hydroxide

Purified water.

6.2 Incompatibilities

This medicinal product must not be mixed with other medicinal products.

Due to the risk of formation of caustic compounds, do not use with ophthalmic preparations containing mercuric-based preservatives, for example thiomersal.

Iodine is an oxidant, which can lead to chemical incompatibilities with other substances.

Povidone iodine is inactivated or becomes unstable in the presence of sodium thiosulphate, heat, light or alkaline pH.

6.3 Shelf life

Unopened: 24 months.

Once opened – use immediately -Discard immediately after first use.

6.4 Special precautions for storage

Do not store above 25°C.

Store in the original package and keep away from light.

6.5 Nature and contents of container

Cardboard box containing 1 polyethylene sterile, single-use bottle of 4.0 ml eye drops, solution and a package leaflet. The bottle is contained in a double sterile sachet.

6.6 Special precautions for disposal

For single use only. Discard immediately after first use.

Any unused product or waste material should be disposed of in accordance with local requirements.

Taking advantage of the double sachet, transfer the product to the operating theatre using aseptic techniques and used as described in section 4.2.

7 MARKETING AUTHORISATION HOLDER

Alfa Intes Limited

Second Floor, 150 Fleet Street

London

United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

PL 54537/0001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

05/01/2023

10 DATE OF REVISION OF THE TEXT

05/01/2023