Oftasteril

Package leaflet: Information for the patient

Oftasteril 50 mg/ml eye drops, solution

Povidone-iodine
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Oftasteril is and what it is used for
2. What you need to know 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 Oftasteril is and what it is used for

Oftasteril contains the active substance iodopovidone, which belongs to the group of antimicrobial and antiseptic medicines and works by killing bacteria, spores, fungi, and viruses. This medicine is used as a solution for preparing the surgical site (eyelids, eyelashes, and cheeks) and for cleaning the eye (irrigation of the cornea, conjunctiva, and eyelid fornices) in the case of eye surgery.

2. What you need to know before using Oftasteril

Do not use Oftasteril

• if you are allergic to povidone-iodine or to any of the other ingredients of this medicine (listed in section 6);
• if the patient is a newborn up to one month of age;
• for administration by injection directly into the eye or surrounding areas (intraocular or periocular); this medicine is for external use only;
• if you are using eye drops containing mercury-based preservatives;
• if you are pregnant or breastfeeding (See section “Pregnancy and breastfeeding”).

Warnings and precautions
This medicine will be administered by your doctor or by trained medical personnel.
Talk to your doctor, pharmacist, or nurse before using Oftasteril.
Use this medicine with caution:

• if there are ocular conditions that may favor absorption of iodine into the bloodstream;
• if you have thyroid gland disorders (due to the possibility of iodine absorption);
• if it is to be used in children under 30 months of age.

To maintain sterile conditions, the pouch containing the bottle should be opened only immediately before use; the bottle is no longer externally sterile if the pouch is open or damaged.
After use, the product must be discarded even if only partially used.
Children
Do not use this medicine in newborns up to one month of age.
Use this medicine with caution in children up to 30 months of age.
Other medicines and Oftasteril
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
Avoid using Oftasteril together with other antiseptic or cleansing medicines.
Do not use Oftasteril together with other medicines containing mercury-based preservatives or with sodium thiosulfate (an antidote for iodine).
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor, pharmacist, or nurse before using this medicine.
Do not use Oftasteril during pregnancy unless clearly necessary and always under direct medical supervision.
If you are breastfeeding, use of this medicine may cause adverse effects in the breastfed infant. Therefore, consult your doctor, who will decide whether treatment with the medicine should be discontinued or breastfeeding should be stopped.
Driving and using machines
Oftasteril does not affect the ability to drive or operate machinery.
OFTASTERIL contains phosphates
This medicine contains 1.5 mg of phosphate buffer per 1 ml. If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may very rarely cause calcium deposits leading to cloudy corneal spots during treatment.

3. How to use Oftasteril

This medicine will be administered to you by a doctor or another healthcare professional. If you have any doubts, consult your doctor, pharmacist, or nurse.
If you use more Oftasteril than you should
This medicine will be administered by a doctor or another healthcare professional, so it is unlikely that you will receive an excessive dose. However, if you think that you have been given too much, or if you have accidentally ingested or inhaled the medicine, inform your doctor or nurse immediately so that appropriate precautions can be taken.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
No adverse effects have been reported with this medicine, except for rare cases of local sensitivity.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the website https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Oftasteril

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after “Exp.”.
The expiry date refers to the last day of that month.
Do not store above 25°C.
Keep protected from light.
Discard the bottle after use, even if there is residual medicine remaining.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Oftasteril contains

• The active substance is iodopovidone. 100 ml of solution contain 5 g of iodopovidone (0.5% available iodine).
• The other components are: glycerol, citric acid, polysorbate 20, disodium phosphate, sodium chloride, sodium hydroxide, purified water.

Description of the appearance of Oftasteril and contents of the pack
Pack containing 1 bottle of 3.5 ml.
The bottle is contained in a double sterile pouch.
Marketing Authorization Holder and Manufacturer
ALFA INTES Industria Terapeutica Splendore S.r.l.
Via F.lli Bandiera, 26
80026 Casoria (NA)
Italy

Package leaflet: information for the physician

Oftasteril 50 mg/ml eye drops, solution

Povidone-iodine
The following information is intended for medical doctors or healthcare professionals only
Instructions for use
Using the dual packaging, transfer the product aseptically into the operating room and use as described.
Soak a sterile gauze pad with the liquid contained in the vial and begin cleansing the eyelashes and eyelid margins.
Repeat the procedure on the eyelids, cheeks, and forehead in a circular motion until the entire surgical field is cleaned.
Repeat this process three times.
Place the eyelid speculum and irrigate the cornea, conjunctiva, and palpebral fornices with the product. Wait two minutes, then remove Oftasteril from the ocular surface by irrigating the cornea, conjunctiva, and palpebral fornices with sterile polyionic saline solution.
After using the medicine, the single-use vial must be discarded even if partially used.
Overdose
In case of ocular overdose, thoroughly rinse with sterile polyionic saline solution.
Accidental ingestion or inhalation of certain disinfectants may lead to serious, sometimes fatal, consequences.
In case of recent accidental ingestion of a large amount of Oftasteril, gastric lavage should be performed; otherwise, supportive therapies should be administered.
Interactions with other medicinal products and other forms of interaction
Avoid concomitant use of other antiseptics and detergents.
Oftasteril must not be administered simultaneously with mercurial compounds or sodium thiosulfate (the latter being in fact the antidote to iodine).
For further information, please consult the Summary of Product Characteristics.