Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Bausch & Lomb U.K. Ltd, 106 London Road, Kingston-Upon-Thames, Surrey, KT2 6TN
This medicinal product must not be used in the following situations:
For ophthalmic use only.
There is no experience of ocular instillation, other than for pre-procedural antisepsis.
The use of Minims 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.
After the medicinal product has been left in contact with the conjunctiva and conjunctival sacs for two minutes, flush thoroughly with sterile 0.9% NaCL solution.
Concomitant use with topical ophthalmic formulations containing mercury-based preservatives is to be avoided.
Minims Povidone Iodine should be used with caution in patients suffering from thyroid dysfunction and in elderly patients, who are at increased risk of 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. Hypersensitivity (anaphylactoid reactions) to iodinated contrast agents or anaphylactic reaction to shellfish are not contraindications for Minims Povidone Iodine 5% w/v eye drops administration.
Concomitant or subsequent use with other antiseptic agents 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 a mercury-based derivative: the combination iodine/mercury-based preservatives must be avoided, due to the risk of caustic compounds formation.
Particularly, special care must be taken in relation to the mercurial preservatives used in many ophthalmic preparations.
When administered at volumes greater than those arising from single ocular instillation, povidone iodine may interfere with thyroid function tests.
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 first trimester of pregnancy. The foetal thyroid begins to accumulate iodine around the 14th week of amenorrhoea.
No effects during pregnancy are anticipated, since systemic exposure to iodine is negligible. Minims Povidone Iodine 5% w/v eye drops, solution can be used during pregnancy.
In pregnant or breastfeeding women an alternative form of antisepsis should be considered if multiple repeat injections requiring conjunctival and periorbital application are anticipated.
No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to iodine is negligible.
No effects on fertility are anticipated, since systemic exposure to iodine is negligible.
Not relevant.
The most serious adverse reaction that occur with Minims 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).
Not known: hypersensitivity, anaphylactic reactions (urticaria, Quincke’s oedema, anaphylactic shock and anaphylactoid reaction).
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.
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.
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 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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
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.
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