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OFTASTERIL 50 mg/ml EYE DROPS SOLUTION

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About the medicine

How to use OFTASTERIL 50 mg/ml EYE DROPS SOLUTION

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Package Leaflet: Information for the Patient

Oftasteril 50mg/ml Eye Drops Solution

Povidone Iodine

Read the package leaflet carefully before you start using this medicine because it contains important information for you.

  • Keep this package leaflet, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

  1. What is Oftasteril and what is it used for
  2. What you need to know before you use Oftasteril
  3. How to use Oftasteril
  4. Possible side effects
  5. Storage of Oftasteril
  6. Contents of the pack and other information

1. What is Oftasteril and what is it used for

Oftasteril contains the active substance povidone iodine, which belongs to the group of antimicrobial and antiseptic medicines, and eliminates bacteria, spores, fungi, and viruses. This medicine is used as an antiseptic solution for eyelids, eyelashes, cheeks, and the ocular surface (including the margins of the eyebrows) before ocular surgery and/or intravitreal injection.

Doctor consultation

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Discuss your symptoms and treatment with a doctor online.

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.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

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.

Online doctors for OFTASTERIL 50 mg/ml EYE DROPS SOLUTION

Discuss questions about OFTASTERIL 50 mg/ml EYE DROPS SOLUTION, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Doctor

Hocine Lokchiri

General medicine 21 years exp.

Dr. Hocine Lokchiri is a French consultant with over 20 years of experience in General and Emergency Medicine. He works with adults and children, helping patients with urgent symptoms, infections, sudden health changes and everyday medical concerns that require timely evaluation. His background includes clinical practice in France, Switzerland and the United Arab Emirates, which allows him to navigate different healthcare systems and manage a wide range of conditions with confidence. Patients value his calm, structured approach, clear explanations and evidence-based decision-making.

Online consultations with Dr. Lokchiri are suitable for many situations when someone needs quick medical guidance, reassurance or a clear next step. Common reasons for booking include:

  • fever, chills, fatigue and viral symptoms
  • cough, sore throat, nasal congestion, breathing discomfort
  • bronchitis and mild asthma flare-ups
  • nausea, diarrhoea, abdominal pain, digestive infections
  • rashes, allergic reactions, redness, insect bites
  • muscle or joint pain, mild injuries, sprains
  • headache, dizziness, migraine symptoms
  • stress-related symptoms, sleep disturbances
  • questions about test results and treatment plans
  • management of chronic conditions in stable phases
Many patients reach out when symptoms appear suddenly and cause concern, when a child becomes unwell unexpectedly, when a rash changes or spreads, or when it’s unclear whether an in-person examination is necessary. His emergency medicine background is particularly valuable online, helping patients understand risk levels, identify warning signs and choose safe next steps.

Some situations are not suitable for online care. If a patient has loss of consciousness, severe chest pain, uncontrolled bleeding, seizures, major trauma or symptoms suggesting a stroke or heart attack, he will advise seeking immediate local emergency services. This improves safety and ensures patients receive the right level of care.

Dr. Lokchiri’s professional training includes:

  • Advanced Trauma Life Support (ATLS)
  • Basic and Advanced Cardiac Life Support (BLS/ACLS)
  • Pediatric Advanced Life Support (PALS)
  • Prehospital Trauma Life Support (PHTLS)
  • eFAST and critical care transthoracic echocardiography
  • aviation medicine
He is an active member of several professional organisations, including the French Society of Emergency Medicine (SFMU), the French Association for Emergency Physicians (AMUF) and the Swiss Society of Emergency and Rescue Medicine (SGNOR). In consultations, he works with clarity and precision, helping patients understand their symptoms, possible risks and the safest treatment options.
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Chikeluo Okeke

General medicine 4 years exp.

Dr Chikeluo Okeke is an internal medicine doctor with extensive international clinical experience. Originally from Nigeria, he has worked across multiple European healthcare systems and currently practises in Sweden. This professional path has given him a strong understanding of different medical approaches and the ability to work effectively with patients from diverse cultural and linguistic backgrounds.

Dr Okeke focuses on general internal medicine and adult primary care, combining clinical accuracy with careful attention to lifestyle, personal context, and everyday health concerns. His consultations are particularly well suited for people who seek medical advice online, live abroad, or need clear guidance without unnecessary complexity.

He provides online consultations covering symptom assessment, prevention, and long-term management of chronic conditions, helping patients understand what is happening and decide on appropriate next steps.

Common reasons for consultation:

  • General internal medicine concerns and initial health assessment.
  • Acute symptoms such as fever, cough, infections, pain, or weakness.
  • Chronic conditions and treatment adjustment.
  • Blood pressure issues, fatigue, metabolic concerns.
  • Preventive consultations and routine check-ups.
  • Interpretation of laboratory results and medical reports.
  • Medical advice for patients receiving care online.

Dr Okeke is known for his clear communication, calm approach, and cultural awareness. He listens carefully, explains medical decisions in a structured way, and supports patients in making informed choices about their health.

Online consultations with Dr Chikeluo Okeke offer reliable internal medicine care without geographic limitations, focused on medical relevance, clarity, and patient comfort.

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Doctor

Andrei Popov

General medicine 7 years exp.

Dr. Andrei Popov is a family physician with specialized training in the management of chronic pain. He provides video consultations for adults in Spain and across Europe: whether you have been living with pain for months that no one has been able to properly explain, or you need to resolve a health issue without waiting weeks for an appointment.

His approach is clear: to listen, organize your case, and provide you with a practical roadmap based on evidence-based medicine and adapted to your medical history and personal needs.

Pain: how he can help

  • Chronic pain (more than 3 months
  • Migraine and recurrent or high-intensity headaches
  •  Neck, lower back, back and joint pain
  •  Post-traumatic pain after injuries or surgeries
  •  Pain of neurological origin: neuralgia, neuropathic pain, fibromyalgia

General medicine

  • Frequent respiratory infections (cold, flu, persistent cough)
  • Hypertension, diabetes and metabolic disorders
  • Review of laboratory tests and MRI/CT reports (explained in clear language)
  • Preventive medicine and health monitoring
  • Second opinions and treatment adjustments (when clinically appropriate)

What the consultation is like
 Each session lasts up to 30 minutes. We review symptoms, medical history, medications and any tests you provide, and you finish the consultation with a clear treatment plan, defined next steps, and criteria to understand when follow-up may be needed. If warning signs are detected, he will clearly advise whether you need in-person care or urgent medical attention.

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Doctor

Yevgen Yakovenko

General surgery 12 years exp.

Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

Areas of medical expertise:

  • Acute and chronic pain: headaches, muscle and joint pain, back pain, abdominal pain, postoperative pain. Identifying the cause, selecting treatment, and creating a care plan.
  • Internal medicine: heart, lungs, gastrointestinal tract, urinary system. Management of chronic conditions, symptom control, second opinions.
  • Pre- and postoperative care: risk assessment, decision-making support, follow-up after surgery, rehabilitation strategies.
  • General and paediatric surgery: hernias, appendicitis, congenital conditions, both planned and urgent surgeries.
  • Injuries and trauma: bruises, fractures, sprains, soft tissue damage, wound care, dressing, referral when in-person care is required.
  • Oncological surgery: diagnosis review, treatment planning, and long-term follow-up.
  • Obesity treatment and weight management: a medical approach to weight loss, including assessment of underlying causes, evaluation of comorbidities, development of a personalised plan (nutrition, physical activity, pharmacotherapy if needed), and ongoing progress monitoring.
  • Imaging interpretation: analysis of ultrasound, CT, MRI, and X-ray results, surgical planning based on imaging data.
  • Second opinions and medical navigation: clarifying diagnoses, reviewing current treatment plans, helping patients choose the best course of action.

Experience and qualifications:

  • 12+ years of clinical experience in university hospitals in Germany and Spain.
  • International education: Ukraine – Germany – Spain.
  • Member of the German Society of Surgeons (BDC).
  • Certified in radiological diagnostics and robotic surgery.
  • Active participant in international medical conferences and research.

Dr Yakovenko explains complex topics in a clear, accessible way. He works collaboratively with patients to analyse health issues and make evidence-based decisions. His approach is grounded in clinical excellence, scientific accuracy, and respect for each individual.

If you are unsure about a diagnosis, preparing for surgery, or want to discuss your test results – Dr Yakovenko will help you evaluate your options and move forward with confidence.

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Doctor

Joao Silva

General medicine 6 years exp.

Dr. João Silva is a physician with training and experience in the field of General and Family Medicine, dedicated to providing healthcare focused on the well-being and quality of life of his patients. Throughout his professional career, he has developed broad clinical competencies, striving to maintain a medical practice based on scientific evidence and continuous knowledge updates.

Between 2013 and 2019, he completed the Integrated Master's Degree in Medicine at the Abel Salazar Institute of Biomedical Sciences in Porto, where he acquired a solid academic and clinical education.

Subsequently, between January 2021 and December 2021, he completed the General Internship at the Entre Douro e Vouga Hospital Center in Santa Maria da Feira, where he had the opportunity to work in different hospital settings and deepen his competencies in several areas of medicine.

From January 2022 until March 2026, he works as a Resident Physician in General and Family Medicine at USF Salvador Machado in Oliveira de Azeméis, developing clinical activities in primary healthcare, follow-up of chronic patients, and health promotion in the community.

Complementing his medical training, Dr. João Silva also completed a Postgraduate Degree in Continuing and Palliative Care at CESPU, strengthening his preparation in the comprehensive approach to patient care, especially in situations requiring prolonged care and multidisciplinary support.

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€55
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Doctor

Bulat Garipov

General medicine 15 years exp.

Dr. Bulat Garipov is a radiologist with more than 15 years of experience, specializing in magnetic resonance imaging (MRI). Throughout his professional career, he has worked in leading diagnostic imaging centers, both in on-site practice and teleradiology, which has allowed him to develop a broad and versatile approach to radiology.

Over the years, he has gained solid experience in interpreting MRI studies in various areas, including:

  •  Neuroimaging
  •  Musculoskeletal system (MSK)
  •  Angiography
  •  Abdomen and pelvis
  •  Soft tissues

Additionally, Dr. Garipov is open to new collaboration opportunities in radiology and teleradiology projects. He offers his expertise in MRI, providing both first and second readings of studies, as well as advanced image interpretation, ensuring accurate and high-quality diagnostics.

You could consult Dr. Bulat Garipov in cases where accurate interpretation of MRI studies or a second expert opinion is required. His expertise is especially valuable in cases of suspected neurological conditions, back and joint pain, vascular disorders, as well as in the diagnosis of abdominal and pelvic diseases. The doctor also provides support in complex or unclear clinical situations, including the review of previously performed studies, which helps improve diagnostic accuracy and determine the optimal treatment strategy. A teleradiology format is available, allowing you to receive a professional opinion remotely.

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€60

Frequently Asked Questions

Is a prescription required for OFTASTERIL 50 mg/ml EYE DROPS SOLUTION?
OFTASTERIL 50 mg/ml EYE DROPS SOLUTION requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in OFTASTERIL 50 mg/ml EYE DROPS SOLUTION?
The active ingredient in OFTASTERIL 50 mg/ml EYE DROPS SOLUTION is povidone-iodine. This information helps identify medicines with the same composition but different brand names.
Who manufactures OFTASTERIL 50 mg/ml EYE DROPS SOLUTION?
OFTASTERIL 50 mg/ml EYE DROPS SOLUTION is manufactured by Alfa Intes Industria Terapeutica Splendore S.R.L.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of OFTASTERIL 50 mg/ml EYE DROPS SOLUTION online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether OFTASTERIL 50 mg/ml EYE DROPS SOLUTION is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to OFTASTERIL 50 mg/ml EYE DROPS SOLUTION?
Other medicines with the same active substance (povidone-iodine) include AKANTIOR 0.8 mg/ml EYE DROPS IN SINGLE-DOSE CONTAINERS, POSIFORLID 20 MG/G OPHTHALMIC OINTMENT, ABIMOX 5 mg/ml EYE DROPS SOLUTION. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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