Oftasteril 50 mg/ml eye drops solution
Spain
Table of Contents
Patient Information Leaflet
Introduction
Package leaflet: Information for the patient
Oftasteril 50mg/ml eye drops, solution
Povidone-Iodine
Read the entire leaflet carefully before you start 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 they have the same symptoms as you, because it may harm them.
- If you experience any side effects, talk to your doctor, pharmacist, or nurse, including any side effects not listed in this leaflet. See section 4.
Leaflet contents
- What Oftasteril is and what it is used for
- What you need to know before using Oftasteril
- How to use Oftasteril
- Possible side effects
- How to store Oftasteril
- Contents of the pack and other information
1. What Oftasteril is and what it is used for
Oftasteril contains the active substance povidone iodine, which belongs to the group of antimicrobial and antiseptic medicines, and kills bacteria, spores, fungi, and viruses. This medicine is used as an antiseptic solution on the eyelids, eyelashes, cheeks, and ocular surface (including eyebrow margins) prior to eye surgery and/or intravitreal injection.
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 premature newborn, particularly a baby born weighing less than 1,500 g (very low birth weight) and who is smaller than expected 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); this medicine is for external use only.
Warnings and precautions
This medicine will be administered by your doctor or trained personnel.
Talk to your doctor, pharmacist, or nurse before starting to use Oftasteril.
Use this medicine with caution:
- if you are using topical ophthalmic medications containing 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 may be used in infants, children, and adolescents.
This medicine must not be used in premature newborns, particularly babies born weighing less than 1,500 g (very low birth weight) and who are smaller than expected for the number of weeks of pregnancy (small for gestational age).
Cases of respiratory problems (apnea or breathing interruption) have been reported in children undergoing strabismus surgery under general anesthesia following instillation of 5% povidone-iodine eye drops into one or both eyes. Healthcare professionals should be aware of these reactions.
Other medicines and Oftasteril
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might need to take any other medicines.
Avoid using Oftasteril together with other medicines or antiseptic soaps.
Do not use Oftasteril together with other medicines containing mercury-based preservatives.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor, pharmacist, or nurse before using this medicine.
Do not use Oftasteril during pregnancy except when strictly necessary and always under the direct supervision of your doctor. Small amounts may be used if absolutely required.
If you are breastfeeding, this medicine may cause unwanted effects in the infant. Breastfeeding must be interrupted for 24 hours after using povidone-iodine.
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 phosphates per ml. If you have severe damage to the transparent front part of the eye (cornea), treatment with phosphates may, in very rare cases, lead to cloudy patches in the cornea due to calcium deposition.
3. How to use Oftasteril
This medicine 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 medicine 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 high a dose, or if you have accidentally swallowed or inhaled the medicine, inform your doctor or nurse immediately. They will take the appropriate precautions.
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
The most serious adverse reaction that could occur with Oftasteril is a hypersensitivity reaction.
Adverse events are classified by frequency as follows:
- 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)
- Frequency not known (cannot be estimated from the available data)
Immune system disorders:
Frequency not known: hypersensitivity, anaphylactic reactions (allergy-type reactions including difficulty breathing or swallowing, swelling of the face, lips, throat or tongue, skin rash with irritation and hives: red, raised, itchy bumps (urticaria), rapid swelling of cutaneous, mucosal and submucosal tissues (angioedema).
Endocrine disorders:
Frequency not known: Regular and prolonged use may lead to toxic levels of iodine, with a risk 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 at 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 punctate epitheliopathy (superficial punctate inflammation of the eye surface), eye irritation, dry keratoconjunctivitis (dry eye syndrome), and residual yellowish discoloration of the conjunctiva.
Skin and subcutaneous tissue disorders:
Frequency not known: cases of contact dermatitis (symptoms such as erythema, blisters, itching), angioedema (a reaction similar to hives affecting deeper skin layers), and cases of transient and reversible brown skin discoloration have been reported.
Reporting of adverse effects
If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse 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, bag, and bottle after "EXP". The expiry date refers to the last day of the month indicated.
Do not store above 25 °C. Do not refrigerate or freeze.
Discard the bottle after use, even if there is residual medicine remaining.
Medicines should not be disposed of via wastewater or household waste. If you are unsure how to dispose of unused medicines and packaging, please consult your pharmacist. 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 contains 5 g of povidone iodine.
- The other components 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 transparent solution with a reddish-brown colour.
Presentation of the product and contents of the pack
Pack containing 1 bottle of 4.0 ml of eye drops solution.
The bottle is supplied 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
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
BRILL PHARMA, S.L.
C/ Munner, 8
08022 Barcelona
(Spain)
This medicinal product 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 colirio en solución
Netherlands – Povidon Jodium Alfa Intes 50 mg/ml oogdruppels, oplossing
Poland – Oftasteril
Portugal – Ophthajod 50 mg/ml colírio, solução
Date of the most recent review of this summary: March 2023
Package leaflet: information for the physician
Oftasteril 50 mg/ml eye drops solution
This information is intended for healthcare professionals only
Dosage and method of administration
Using the double sterile pouch, transfer the product to the operating room using an aseptic technique and use as described.
Soak a sterile gauze pad with the solution from the bottle and begin cleaning the eyelashes and eyelid margins.
Repeat the procedure for the eyelids, cheeks, and forehead (including eyebrow margins) using circular motions until the entire surgical field is clean. Repeat the process three times.
Insert 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 saline solution.
Discard the bottle after use, even if only partially used.
Overdose
In case of ocular overdose, rinse thoroughly with sterile saline solution.
Accidental ingestion or inhalation of some disinfectants may lead to serious, sometimes fatal, consequences.
Known acute symptoms and signs following accidental ingestion include: abdominal pain, anuria, collapse, pulmonary edema, and metabolic abnormalities.
In case of recent accidental ingestion of a significant amount of Oftasteril, gastric lavage should be performed; otherwise, symptomatic treatment should be administered.
Interaction with other medicinal products 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 simultaneously with mercury-based compounds: combined iodine/mercury preservatives must be avoided due to the risk of forming caustic compounds. Particular care should be taken with mercury-based preservatives used in many ophthalmic preparations.
When administered in volumes larger than those resulting from a single ocular instillation, povidone iodine may interfere with thyroid function tests.
Refer to the Product Information Leaflet for further details.