Oftasteril

Leaflet accompanying the packaging: Patient information

Oftasteril, 50 mg/ml, eye drops, solution

iodinated povidone

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• -Keep this leaflet, you may need to read it again.
• Ask your doctor, pharmacist, or nurse if you have any questions.
• This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in the leaflet, tell your doctor, pharmacist, or nurse. This includes any possible side effects not listed in the leaflet. See section 4.

Table of contents of the leaflet:

• 1. What is Oftasteril and what is it used for
• 2. Important information before using Oftasteril
• 3. How to use Oftasteril
• 4. Possible side effects
• 5. How to store Oftasteril
• 6. Contents of the pack and other information

1. What is Oftasteril and what is it used for

Oftasteril contains the active substance iodinated povidone, which belongs to the group of antimicrobial and antiseptic medicines. Its action involves killing bacteria, spores, fungi, and viruses. This medicine is used as a solution for the antiseptic preparation of eyelids, eyelashes, cheeks, and eye surfaces (including the eyebrow edges) before eye surgery or intraocular injection.

2. Important information before using Oftasteril

When not to use Oftasteril

• if you are allergic to iodinated povidone or any of the other ingredients of this medicine (listed in section 6);
• in premature infants, especially those with a birth weight of less than 1500 g (very low birth weight) and infants who are too small for their gestational age;
• for injection directly into the eye or areas around the eye (periorbital or peribulbar) - the medicine is intended for external use only.

Warnings and precautions

This medicine will be administered by a doctor or a trained medical staff member. Before starting treatment with Oftasteril, discuss it with your doctor, pharmacist, or nurse. Be cautious when using this medicine:

• if you are using eye medicines containing mercury-based preservatives;
• in patients with thyroid problems or elderly patients (due to the possibility of iodine absorption).

Children

The dose for adults can be used in infants, children, and adolescents. This medicine should not be used in premature infants, especially those with a birth weight of less than 1500 g (very low birth weight) and infants who are too small for their gestational age. In children undergoing eye surgery for strabismus, who have received general anesthesia, cases of respiratory problems (apnea or respiratory arrest) have been reported after administration of eye drops containing 5% iodinated povidone. Healthcare professionals should be aware of these reactions.

Oftasteril and other medicines

Tell your doctor, pharmacist, or nurse about all medicines you are taking, have recently taken, or plan to take. Avoid using Oftasteril with other antiseptic medicines or detergents. Do not use Oftasteril with other medicines containing mercury-based preservatives.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor, pharmacist, or nurse for advice before using this medicine. Do not use Oftasteril during pregnancy unless absolutely necessary and under direct medical supervision. If necessary, use small amounts. Using this medicine in breastfeeding women may cause side effects in the baby. After using iodinated povidone, breastfeeding should be stopped for 24 hours.

Driving and using machines

Oftasteril has no influence on the ability to drive and use machines.

Oftasteril contains phosphates

This medicine contains 1.5 mg of phosphates per milliliter. In patients with severe damage to the transparent layer in the front of the eye (cornea), phosphates may rarely cause the formation of cloudy spots on the cornea due to calcium deposition during treatment.

3. How to use Oftasteril

This medicine will be administered by a doctor or a medical staff member. If you have any questions, ask your doctor or pharmacist.

Using more Oftasteril than recommended

This medicine will be administered by a doctor or a medical staff member; overdose is therefore unlikely. If you think you have been given too much medicine or have accidentally ingested or inhaled it, tell your doctor immediately, who will take appropriate precautions.

4. Possible side effects

Like all medicines, Oftasteril can cause side effects, although not everybody gets them. The most serious side effect that can occur when using Oftasteril is an allergic reaction. Side effects are categorized by frequency as follows:

• Very common (≥1/10)
• Common (≥1/100 to <1>
• Uncommon (≥1/1,000 to <1>
• Rare (≥1/10,000 to <1>
• Very rare (<1>
• Not known (frequency cannot be estimated from the available data).

Immune system disorders:
Frequency not known: hypersensitivity, anaphylactic reactions (allergic reactions, including difficulty breathing or swallowing; face, lip, throat, or tongue swelling; skin rash with irritation and urticaria – red, elevated, itchy hives; sudden skin, mucous membrane, and submucosal tissue swelling – angioedema)).
Endocrine disorders:
Frequency not known:Regular and prolonged use may result in toxic iodine levels, which can cause thyroid dysfunction, especially in premature infants and newborns. Isolated cases of hypothyroidism (a condition in which the thyroid gland does not produce enough thyroid hormones) have been reported.
Eye disorders:
Very rare:In very rare cases, in some patients with severe damage to the transparent layer in the front of the eye (cornea), cloudy spots on the cornea have occurred due to calcium deposition during treatment.
Frequency not known:conjunctival hyperemia (redness of the whites of the eyes), superficial punctate keratitis, and superficial epitheliopathy (superficial punctate inflammation of the eye surface), eye irritation, dry keratoconjunctivitis (dry eye syndrome), residual yellowing of the conjunctiva.
Skin and subcutaneous tissue disorders
Frequency not known:contact dermatitis (with symptoms such as redness, blisters, itching), angioedema (a reaction similar to hives affecting deeper skin layers), cases of reversible, transient brown skin discoloration.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Oftasteril

Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton, sachet, and bottle after "Expiry date (EXP)". The expiry date refers to the last day of the month. Do not store above 25°C. Do not store in the refrigerator or freeze. The bottle should be discarded after use, even if it contains remaining medicine. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Oftasteril contains

• The active substance is iodinated povidone. 100 ml of solution contains 5 g of iodinated povidone.
• The other ingredients are: glycerol (E 422), citric acid monohydrate (E 330), polysorbate 20 (E 432), disodium phosphate dodecahydrate (E 339), sodium chloride, potassium iodide, sodium hydroxide (for pH adjustment) (E 524), purified water.

Oftasteril is a clear, reddish-brown solution.

What Oftasteril looks like and contents of the pack

The pack contains one 4.0 ml bottle of eye drops, solution. The bottle is in a double sterile sachet.

Marketing authorization holder

Alfa Intes Industria Terapeutica Splendore S.r.l., Via Fratelli Bandiera 26 - 80026 Casoria (NA) - Italy - Tel.: +39 081 584 60 60

Manufacturer

Alfa Intes Industria Terapeutica Splendore S.r.l., Via Fratelli Bandiera 26 - 80026 Casoria (NA) - Italy

Representative of the marketing authorization holder

Solinea Sp. z o.o., Elizówka, ul. Szafranowa 6, 21-003 Ciecierzyn, Poland, Tel.: +48 81 463 48 82

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Netherlands: Povidon Jodium Alfa Intes 50 mg/ml oogdruppels, oplossing
Belgium: Povidone Iodine Alfa Intes 50 mg/ml Augentropfen, Lösung
Germany: Oftasteril 50 mg/ml Augentropfen, Lösung
Spain: Oftasteril 50 mg/ml colirio en solución
Portugal: Ophthajod 50 mg/ml colírio, solução

Date of last revision of the leaflet: ----------------------------------------------------------------------------------------------------------------------------------

Leaflet accompanying the packaging: information for the doctor

Oftasteril, 50 mg/ml, eye drops, solution

iodinated povidone

Information intended for healthcare professionals only:

Dosage and administration

Using a double sachet, transfer the product to the operating room using aseptic technique and use as described. Soak a sterile cotton swab with the solution from the bottle and start preparing the eyelashes and eyelid edges. Repeat for the eyelids, cheeks, and forehead (including the eyebrow edges), making circular motions until the entire surgical field is cleaned. Repeat three times. Install an eye speculum and rinse the cornea, conjunctiva, and eyelid conjunctival fornix with the product. Wait two minutes, then remove Oftasteril from the eye surface by rinsing the cornea, conjunctiva, and eyelid conjunctival fornix with sterile physiological saline solution. Discard the bottle after use, even if only partially used.

Overdose

In case of overdose during administration to the eye, rinse the eye abundantly with sterile physiological saline solution. Accidental ingestion or inhalation of some disinfectants can have serious consequences and sometimes lead to death. Known acute objective and subjective symptoms caused by accidental ingestion include: abdominal pain, anuria, shock, pulmonary edema, and metabolic disorders. In case of recent accidental ingestion of a large amount of Oftasteril, gastric lavage should be performed; in other cases, supportive treatment should be applied.

Interactions with other medicinal products and other forms of interaction

Avoid concomitant or subsequent use with other antiseptic agents due to the possibility of interference (antagonistic action, inactivation). Particular caution is required due to pharmaceutical incompatibilities with iodine. In particular, do not use mercury-based derivatives at the same time: avoid combining iodine with mercury-based preservatives due to the risk of forming corrosive compounds. Pay particular attention to mercury-based preservatives used in many ophthalmic preparations. When used in volumes higher than those resulting from a single administration to the eye, iodinated povidone may interfere with thyroid function test results.

Further information can be found in the Summary of Product Characteristics.