Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Povidone iodine 5% w/v eye drops solution
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Povidone iodine may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for Povidone iodine Eye Drops Solution contains the active substance povidone iodine which belongs to the group of antimicrobial and antiseptic medicines and which works by killing bacteria, spores, fungi and viruses. This medicine is used as a solution for the preparation of the operating ophthalmic field (eyelids, eyelashes and cheeks) and for cleaning the eye and its surroundings in case of eye surgery.
What you need to know before you take it
e Povidone iodine Do not use Povidone iodine
- 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"). Warnings and precautions 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);
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- 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. Children 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. Other medicines and Povidone iodine 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). Pregnancy and breastfeeding 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. Driving and using machines Povidone iodine does not affect the ability to drive and use machines. Povidone iodine contains phosphates 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.
How to take it
Povidone iodine This medicine will be given to you by a doctor or other healthcare professional. Check with your doctor or pharmacist if you are not sure. If you use more Povidone iodine than you should 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.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Very rare (may affect up to 1 in 10,000 people):
- Mild allergic type reactions (hypersensitivity).
- Cloudy patches on the clear layer at the front of the eye (the cornea) due to calcium build-up during treatment in patients with severe damage to the cornea.
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Codice
Prodotto
Formulazione
FG XXX-01
Povidone iodine 5%
Collirio, soluzione Foglietto Ill.vo
Carta
Dimensioni LxH
160 x 200 Versione Data
N. Col.
mm
Col. 1
1
Elaborato Col. 2
Destinazione
Braille
UK Col. 3
Col. 4
Col. 5
nero
0.1
0.3
0.4
0.5
17.05.2022
05.08.2023
10.04.2025
14.04.2025
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0.7
0.8
Not known (frequency cannot be estimated from the available data):
- Allergic type reactions, including difficulty breathing or swallowing, swelling of the face, lips, throat or tongue (anaphylactic shock and anaphylactoid reaction), skin rash with irritation and hives – red, raised, itchy bumps (urticaria).
- Effect on the thyroid due to regular and prolonged application of povidone iodine, causing the thyroid gland to not make enough thyroid hormones to meet the body's needs or in some cases resulting in an overactive thyroid gland (hypothyroidism), particularly in pre-term infants and neonates;
- Redness of the whites of the eyes (conjunctival redness);
- Eye irritation, superficial pinpoint inflammation of the surface of the eye (superficial punctate keratitis and epitheliopathy), dry eye syndrome (keratoconjunctivitis sicca);
- Residual yellow discoloration of the eyes and transient brown discoloration of the skin.
- Irritant effect on the membrane that lines the eyelid and the white of the eye causing redness, blisters and itching (contact dermatitis). Reporting of side effects 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.
How to store it
Povidone iodine Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton, sachet and bottle after "EXP". The expiry date refers to the last day of that month. Do not store above 25° C. Throw away the bottle after first use, even if it contains residual medicine. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Contents of the pack and other information
What Povidone iodine contains
- 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. What Povidone iodine looks like and contents of the pack Pack containing 1 bottle of 4.0 ml eye drops, solution. The bottle is contained in a double sterile bag. Marketing Authorization Holder Alfa Intes Limited Second Floor, 150 Fleet Street – London – United Kingdom Distributor: Penlan Pharmaceuticals Ltd, 45-47 Monument Hill, Weybridge, KT13 8RN, UK Manufacturer ALFA INTES Industria Terapeutica Splendore S.r.l. Via F.lli Bandiera, 26 – 80026 Casoria (NA) – Italy
Package leaflet: information for the physician
irrigating the cornea, conjunctiva, and fornixes with sterile sodium chloride 0.9% solution. Do not touch the eye with the container nozzle. After using the medicine, the single-use bottle should be thrown away even if partially used. Overdose In case of ocular overdose, wash abundantly with sterile sodium chloride 0.9% solution. The accidental ingestion or inhalation of some disinfectants can have serious, sometimes fatal consequences. In case of recent accidental ingestion of a large quantity of povidone iodine, gastric lavage should be used, otherwise supportive therapies should be used. Interactions with other medicines and other forms of interaction Avoid the simultaneous use of other antiseptics and detergents. Povidone iodine should not be administered simultaneously with mercurial derivatives and sodium thiosulfate (the latter is in fact the antidote of iodine). For more information, see the Summary of Product Characteristics.
Povidone iodine
5% w/v eye drops solution povidone, iodinated The following information is intended for healthcare professionals only Instructions for Use Wash hands thoroughly before use. Using the double package, transfer the product to the operating room with aseptic technique and use as described. Saturate the sterile cotton wool with the liquid contained in the bottle and start preparing the lashes and eyelid margins. Repeat for the eyelids, cheeks and forehead in a circular manner until the entire operating field is cleaned. Repeat three times. Place the blepharostat and irrigate the cornea, conjunctiva and eyelid fornix with product. Wait two minutes, then remove Povidone iodine from the ocular surface by
This leaflet was last revised in: April 2025.
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Frequently asked questions about Povidone iodine 5% w/v eye drops solution
How do I take Povidone iodine 5% w/v eye drops solution?
Povidone iodine 5% w/v eye drops solution comes as eye drops. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Povidone iodine 5% w/v eye drops solution?
The active substance in Povidone iodine 5% w/v eye drops solution is povidone iodine.
Are there equivalent medicines to Povidone iodine 5% w/v eye drops solution?
Medicines with the same active substance, strength and form include: Minims Povidone Iodine 5% w/v Eye Drops, Solution. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Povidone iodine 5% w/v eye drops solution, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Povidone iodine 5% w/v eye drops solution without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: povidone iodine
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
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 14th 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).
System Organ Class
Frequency
Adverse Reaction
Immune System Disorders
Very Rare
Hypersensitivity
Not Known
Anaphylactic reactions (urticaria, Quinck'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. Hypothyroidism
Eye Disorders
Very Rare
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
conjunctival hyperaemia, superficial punctate keratitis, eye irritation, superficial punctate epitheliopathy, keratoconjunctivitis sicca, residual yellow colouration of the conjunctiva
Skin and subcutaneous tissue disorders
Not known
contact dermatitis (with such symptoms as erythema, blisters, itching), angioedema, reversible, transient brown coloration of the skin
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.
💬 Ask about this leaflet
Ask anything about Povidone iodine 5% w/v eye drops solution. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.