Ophtholique^® (Drops) Instructions for Use

ATC Code

S01XA (Other preparations for the treatment of eye diseases)

Active Substances

Povidone (Rec.INN registered by WHO)

Polyvinyl alcohol (USP United States Pharmacopeia)

Clinical-Pharmacological Group

Drug for moisturizing and protecting the cornea

Pharmacotherapeutic Group

Keratoprotector

Pharmacological Action

A combined medicinal product for topical use in ophthalmology, a keratoprotector. It has a protective effect on the cornea in cases of decreased tear fluid secretion or increased tear film evaporation.

Polyvinyl alcohol and povidone have lubricant properties, which reduce eye irritation and redness. By coating the eye surface, these substances reduce surface tension and prevent the occurrence of tear film ruptures.

Polyvinyl alcohol has properties similar to those of mucin produced by the conjunctival glands. It helps to soften and lubricate (moisturize) the eye surface and increases the stability of the tear film.

Pharmacokinetics

The systemic absorption of the active substances from the eye surface is minimal. After instillation into each eye, the concentration of the drug’s active substances in plasma after 4 hours remains below the possible limit of quantitation (10 ng/ml).

Indications

Use for the relief of symptoms associated with ocular surface dryness.

• Sensation of burning, irritation, and discomfort caused by dry eye.
• As tear substitutes in conditions of decreased tear fluid secretion.
• Dry eye syndrome.
• Other conditions requiring softening and/or moisturizing of the cornea.

Apply as a protective and lubricating agent for the ocular surface.

ICD codes

Dosage Regimen

Instill one drop into the conjunctival sac of each eye, three to four times daily.

Adjust the frequency of administration based on the severity of symptoms and individual patient needs.

Ensure the dropper tip does not contact the eye or any other surface to prevent contamination.

Adverse Reactions

Adverse reactions are typically mild and transient.

Discontinue use immediately and consult a healthcare professional if signs of an allergic reaction occur, such as ocular or eyelid redness, itching, swelling, or rash.

Temporary blurred vision or eye discomfort may occur immediately after instillation.

Contraindications

Do not use in patients with a known hypersensitivity to any component of the formulation.

• Hypersensitivity to povidone.
• Hypersensitivity to polyvinyl alcohol.
• Hypersensitivity to any of the excipients.

Avoid use if there is a history of severe allergic reactions to the product.

Use in Pregnancy and Lactation

There is insufficient experience with the use of this combination during pregnancy and lactation.

Use during pregnancy and lactation (breastfeeding) is possible only if the intended benefit to the mother outweighs the potential risk to the fetus.

Special Precautions

The patient should discontinue use and consult a doctor if, during use, the pain intensifies; vision deteriorates; symptoms persist for more than 72 hours; redness and irritation of the eyes persist.

Drug Interactions

Apply other ophthalmic medications at least 15 minutes before instilling these drops to avoid dilution and potential interaction.

Polyvinyl alcohol is incompatible with inorganic salts, particularly phosphates and sulfates, which may cause precipitation.

Povidone may form complexes and reduce the effectiveness of certain preservatives, such as thimerosal.

Overdose

Ocular overdose is unlikely due to the topical administration and minimal systemic absorption.

In case of accidental ingestion, symptomatic and supportive measures are recommended.

Excessive topical application may lead to temporary visual blurring or eye discomfort; rinse the eye with clean water if this occurs.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.