OFTASTERIL 50 mg/ml EYE DROPS SOLUTION

2. What you need to know before you use Oftasteril

Do not use Oftasteril

• 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 premature newborn, in particular a baby born with a weight of less than 1,500 g (very low birth weight) and who is smaller than usual for the number of weeks of pregnancy (small for gestational age);
• for administration by injection directly into the eye or into the areas surrounding the eye (intraocular or periocular); the medicine is for external use.

Warnings and Precautions

This medicine will be administered by your doctor or a trained healthcare professional.

Consult your doctor, pharmacist, or nurse before starting to use Oftasteril.

Use this medicine with caution:

• if you are using topical ophthalmic medicines that contain mercury-based preservatives;
• if you have thyroid gland problems or if you are an elderly patient (due to the possibility of iodine absorption);

Children

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

This medicine must not be used in premature newborns, in particular babies born with a weight of less than 1,500 g (very low birth weight) and who are smaller than usual for the number of weeks of pregnancy (small for gestational age).

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

Other medicines and Oftasteril

Tell your doctor, pharmacist, or nurse if you are using, have recently used, or might use any other medicines.

Avoid using Oftasteril with other antiseptic medicines or soaps.

Do not use Oftasteril with other medicines that contain mercury-based preservatives.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, 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 Oftasteril during pregnancy unless strictly necessary and under the direct supervision of your doctor. Small amounts may be used if absolutely necessary.

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

Driving and using machines

Oftasteril does not affect the ability to drive and use machines.

Oftasteril contains phosphates

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

3. How to use Oftasteril

This medicine will be administered by a doctor or another healthcare professional. In case of doubt, consult your doctor or pharmacist.

If you use more Oftasteril than you should

This medicine will be administered by a doctor or another healthcare professional. It is unlikely that you will receive an overdose. However, if you think you have been given too much medicine or have accidentally swallowed or inhaled the medicine, 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The most serious side effect that may occur with Oftasteril is a hypersensitivity reaction.

Adverse events are classified 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>
• Frequency not known (cannot be estimated from the 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, raised, and itchy bumps (urticaria), rapid swelling of the skin, mucous, and submucous tissues (angioedema).

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 neonates. Exceptional cases of hypothyroidism (the thyroid gland does not produce enough thyroid hormones to meet the body's needs) have been reported.

Eye disorders:

Very rare:In very rare cases, some patients with severe damage to the transparent layer of the front part of the eye (the cornea) have developed cloudy patches 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 punctate epitheliopathy (superficial punctate inflammation of the eye surface), eye irritation, dry keratoconjunctivitis (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), angioedema (a reaction similar to urticaria that affects deeper layers of the skin), and cases of transient and reversible brown discoloration of the skin have been reported.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Vigilance System for Human Use: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Oftasteril

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, pouch, and bottle after “EXP”. The expiry date is the last day of the month stated.

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

Discard the bottle after use, even if it contains residual 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

Composition of Oftasteril

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

Oftasteril is a clear, reddish-brown solution.

Appearance of the product and contents of the pack

A pack containing 1 bottle of 4.0 ml eye drops solution.

The bottle is presented in a double sterile pouch.

Marketing Authorisation Holder

ALFA INTES Industria Terapeutica Splendore S.r.l.

Via F.lli Bandiera, 26

80026 Casoria (NA)

Italy

Manufacturer

ALFA INTES Industria Terapeutica Splendore S.r.l.

Via F.lli Bandiera, 26

80026 Casoria (NA)

Italy

You can obtain further information on this medicine from the representative of the Marketing Authorisation Holder:

BRILL PHARMA, S.L.

C/ Munner, 8

08022 Barcelona

(Spain)

This medicine is authorised in the Member States of the European Economic Area under the following names:

Germany - Oftasteril 50 mg/ml Augentropfen, Lösung

Belgium - Povidone Iodine Alfa Intes 50 mg/ml Augentropfen, Lösung

Spain - Oftasteril 50 mg/ml eye drops solution

Netherlands - Povidon Jodium Alfa Intes 50 mg/ml oogdruppels, oplossing

Poland - Oftasteril

Portugal - Ophthajod 50 mg/ml colírio, solução

Date of last revision of this leaflet:March 2023

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Package Leaflet: Information for the doctor

Oftasteril 50mg/ml Eye Drops Solution

This information is intended for healthcare professionals only

Dosage and administration

Using the double pouch, 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 start preparing the eyelashes 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 blepharostat 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.

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

Overdose

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

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

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, gastric lavage should be performed; otherwise, symptomatic treatments should be carried out.

Interaction with other medicines 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 regarding incompatibilities with iodine. In particular, do not use a mercury-based derivative at the same time: combined iodine/mercury preservatives should be avoided due to the risk of forming caustic compounds. In particular, be careful with mercury-based preservatives used in many ophthalmic preparations.

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

Consult the Summary of Product Characteristics for further information.