Prospect: information for the patient

Oftasteril 50mg/ml eye drop solution

Povidone Iodine

Read this prospect carefully before starting to use this medication, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor, pharmacist, or nurse.

-This medication has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section4.

1. What Oftasteril is and for what it is used

2. What you need to know before starting to use Oftasteril

3. How to use Oftasteril

4. Possible adverse effects

5. Storage of Oftasteril

6. Contents of the package and additional information

Oftasterilcontains the active ingredient povidone iodine, which belongs to the group of antimicrobial and antiseptic medications, and eliminates bacteria, spores, fungi, and viruses. This medication is used as an antiseptic solution on eyelids, eyelashes, cheeks, and the ocular surface (including the margins of the eyebrows) before eye surgery and/or intravitreal injection.

No use Oftasteril

-If you are allergic to povidone iodine or any of the other components of this medication (listed in section6);

-If the patient is a premature newborn, particularly a baby born with a weight less than 1.500g (very low birth weight) and is smaller than usual for the number of weeks of pregnancy (small for gestational age);

-For administration by direct injection into the eye or surrounding areas (intraocular or periocular); the medication is for external use.

Warnings and precautions

This medication will be administered by your doctor or trained personnel.

Consult your doctor, pharmacist, or nurse before starting to useOftasteril.

Use this medication with caution:

- if you are using topical ophthalmic medications that contain mercury preservatives;

- if you have thyroid problems or are an elderly patient (due to the possibility of iodine absorption);

Children

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

This medication should not be used in premature newborns, particularly babies born with a weight less than 1.500g (very low birth weight) and are smaller than usual for the number of weeks of pregnancy (small for gestational age).

After instillation of 5% povidone iodine solution in the eye or eyes, cases of respiratory problems (apnea or interruption of breathing) have been reported in children undergoing strabismus surgery under general anesthesia. Healthcare professionals should be aware of these reactions.

Other medications and Oftasteril

Inform your doctor, pharmacist, or nurse if you are using, have used recently, or may need to use any other medication.

Avoid using Oftasteril with other medications or antiseptic soaps.

Do not use Oftasteril with other medications that contain mercury preservatives.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor, pharmacist, or nurse before using this medication.

Do not use Oftasteril during pregnancy except in cases of real need and always under the direct supervision of your doctor. Small amounts may be used if strictly necessary.

If you are breastfeeding, this medication may cause unwanted effects in the baby. After using povidone iodine, breastfeeding should be interrupted for 24hours.

Driving and operating machinery

Oftasteril does not affect the ability to drive and operate machinery.

Oftasteril contains phosphates

This medication contains 1.5mg of phosphates in each ml. If you suffer from severe damage to the transparent layer of the front part of the eye (cornea), treatment with phosphates, in rare cases, may cause cloudy patches in the cornea due to calcium.

This medication will be administered by a doctor or other healthcare professional. If in doubt, consult your doctor or pharmacist.

If you use more Oftasteril than you should

This medication will be administered by a doctor or other healthcare professional. It is unlikely that you will receive an overdose. However, if you think you have been given too much of the medication or have accidentally swallowed or inhaled the medication, inform your doctor or nurse immediately, who will take the necessary precautions.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The most serious adverse reaction that could occur withOftasterilis an allergic reaction.

Adverse events are classified by frequency in the following way:

- Very common (≥1/10)

- Common (≥1/100 to <1%

- Uncommon (≥1/1,000 to <1%

- Rare (≥1/10,000 to <1%

- Very rare (<1%

- Frequency not known (cannot be estimated from available data)

Immune system disorders:

Frequency not known: hypersensitivity, anaphylactic reactions (allergic reactions, including difficulty breathing or swallowing, swelling of the face, lips, throat, or tongue, skin rash with irritation and hives: red, elevated, itchy bumps (urticaria), rapid swelling of skin, mucous, and submucous tissues (Quincke's edema).

Endocrine disorders:

Frequency not known: Regular and prolonged application may lead to toxic levels of iodine with a probability of developing abnormal thyroid function, especially in premature infants and newborns. There have been exceptional cases of hypothyroidism (the thyroid gland does not produce enough thyroid hormones to meet the body's needs).

Eye disorders:

Very rare:In very rare cases, some patients with severe damage to the transparent layer of the front of the eye (the cornea) have developed cloudy spots in the cornea due to calcium accumulation during treatment.

Frequency not known:Conjunctival hyperemia (redness of the white part of the eyes), superficial punctate keratitis, and superficial epitheliopathy (superficial inflammation of the eye surface), eye irritation, dry eye syndrome (dry eye syndrome), and residual yellow discoloration of the conjunctiva.

Skin and subcutaneous tissue disorders:

Frequency not known: Cases of contact dermatitis (with symptoms such as erythema, blisters, itching) and angioedema (a reaction similar to urticaria affecting deeper layers of the skin) have been reported, as well as cases of reversible and transient brown discoloration of the skin.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is an adverse reaction that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaRAM.es.By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box, bag, and bottle after “EXP”. The expiration date is the last day of the month indicated.

Do not store above 25°C. Do not refrigerate or freeze.

Dispose of the bottle after use, even if it contains residual medication.

Medications should not be disposed of through drains or in the trash. If in doubt, ask your pharmacist how to dispose of containers and medications that you no longer need. This will help protect the environment.

Composition of Oftasteril

- The active ingredient is povidone iodine. 100 ml of solution contains 5 g of povidone iodine.

- The other components are: glycerol (E 422), citric acid monohydrate (E 330), polisorbate 20 (E 432), sodium dodecahydrogenephosphate (E 339), sodium chloride, potassium iodate, sodium hydroxide (for pH adjustment) (E 524) and purified water.

Oftasteril is a transparent, brownish-red solution.

Appearance of the product and contents of the package

Package containing 1 bottle of 4.0 ml eye drops in solution.

The bottle is presented in a double sterile bag.

Marketing Authorization Holder

ALFA INTES Industria Terapeutica Splendore S.r.l.

Via F.lli Bandiera, 26

80026 Casoria (NA)

Italy

Responsible for manufacturing

ALFA INTES Industria Terapeutica Splendore S.r.l.

Via F.lli Bandiera, 26

80026 Casoria (NA)

Italy

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

BRILL PHARMA, S.L.

C/ Munner, 8

08022 Barcelona

(Spain)

This medicine is authorized in the Member States of the European Economic Area with the following names:

Germany - Oftasteril 50 mg/ml Eye Drops, Solution

Belgium - Povidone Iodine Alfa Intes 50 mg/ml Eye Drops, Solution

Spain - Oftasteril 50 mg/ml eye drops in solution

Netherlands - Povidon Jodium Alfa Intes 50 mg/ml eye drops, solution

Poland - Oftasteril

Portugal - Ophthajod 50 mg/ml eye drops, solution

Last review date of this leaflet:March 2023

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Leaflet for healthcare professionals

Oftasteril 50 mg/ml eye drops in solution

This information is intended solely for healthcare professionals

Dosage and administration

Using the double bag, transfer the product to the operating room with an aseptic technique and use it as described.

Saturate a sterile gauze with the solution from the bottle and begin to prepare the eyelids and the margins of the eyelids.

Repeat the procedure for the eyelids, cheeks, and forehead (including the margins of the eyebrows) with circular movements until the entire surgical field is clean. Repeat the process three times.

Place the blepharostato and irrigate the cornea, conjunctiva, and palpebral fornices with the product. Wait two minutes and then remove Oftasteril from the ocular surface by irrigating the cornea, conjunctiva, and palpebral fornices with a sterile saline solution.

Dispose of the bottle after use, even if it has only been used partially.

Overdose

In case of ocular overdose, rinse abundantly with a sterile saline solution.

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

The known acute symptoms and signs due to accidental ingestion are: abdominal pain, anuria, collapse, pulmonary edema, and metabolic abnormalities.

In case of recent accidental ingestion of a considerable amount of Oftasteril, a gastric lavage should be performed; otherwise, symptomatic treatments should be performed.

Interaction with other medications and other forms of interaction

Concomitant or subsequent use with other antiseptics should be avoided due to the possibility of interference (antagonism, inactivation).

Special caution is required in relation to incompatibilities with iodine. In particular, do not use at the same time a mercury derivative: combined iodine/mercury preservatives should be avoided due to the risk of forming caustic compounds. In particular, special care should be taken with mercury preservatives used in many eye drops.

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

See the Product Technical File for more information.