Oftalmol (Drops) Instructions for Use

Marketing Authorization Holder

Firn M, CJSC (Russia)

ATC Code

S01XA (Other preparations for the treatment of eye diseases)

Active Substances

Boric acid (Ph.Eur. European Pharmacopoeia)

Zinc sulfate (BP British Pharmacopoeia)

Diphenhydramine (Rec.INN WHO registered)

Dosage Form

Oftalmol

Eye drops 5 mg+1 mg+2.5 mg/1 ml: dropper bottles 5 ml or 10 ml

Dosage Form, Packaging, and Composition

Excipients: hypromellose, macrogol, sodium citrate, water for injections.

5 ml – polyethylene dropper bottles (1) – cardboard boxes.
10 ml – polyethylene dropper bottles (1) – cardboard boxes.

Clinical-Pharmacological Group

Drug with antimicrobial and antiallergic action for topical use in ophthalmology

Pharmacotherapeutic Group

Antiseptic

Pharmacological Action

Antiseptic preparation for intraconjunctival use. The Zinc sulfate and Boric acid included in the preparation exert an antiseptic and astringent action.

Diphenhydramine is an antihistamine drug; it blocks the release of permeability mediators (bradykinin, serotonin, kallikrein and its derivatives), providing a pronounced antiallergic and anti-inflammatory action. In addition, Diphenhydramine exerts a local anesthetic effect.

Hypromellose (the main component of “artificial tears”) is a protector of the corneal epithelium; it exerts a lubricating and emollient action, possesses high viscosity, which increases the duration of the solution’s contact with the cornea. The refractive index of the solution is similar to natural tears. It promotes the restoration, stability and reproduction of the optical characteristics of the tear film.

Polyethylene oxide 4000 increases the residence time of the active components of the drug in the conjunctival cavity and improves the tolerability of the drug.

Indications

• Acute conjunctivitis;
• Blepharoconjunctivitis (as part of combination therapy);
• Prevention of bacterial infection when a foreign body enters the conjunctival cavity;
• Treatment of allergic conjunctivitis.

ICD codes

Dosage Regimen

Instill 1-2 drops into the conjunctival sac of the affected eye(s) 2-4 times daily.

The standard treatment course is 10-14 days. Do not exceed the recommended frequency of administration or duration of therapy.

Administer for the full prescribed duration, even if symptoms improve. Consult a physician if no improvement is observed within a few days.

Adverse Reactions

Transient eye irritation, burning, or stinging immediately upon instillation is the most commonly reported reaction. This typically resolves spontaneously within a few minutes.

Rarely, allergic reactions such as itching, redness, or eyelid swelling may occur. Discontinue use and seek medical attention if severe or persistent irritation, pain, or signs of an allergic reaction develop.

Contraindications

• Hypersensitivity to boric acid, diphenhydramine, zinc sulfate, or any of the excipients.
• Closed-angle glaucoma.
• Do not use in the presence of a known corneal epithelial defect or ulceration without direct medical supervision.

Use in Pregnancy and Lactation

The safety and efficacy of the drug during pregnancy and breastfeeding have not been studied.

Special Precautions

A short-term decrease in vision may occur after instillation of the drug.

Storage Conditions

The drug should be stored out of the reach of children, protected from light, at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life is 2 years.

Dispensing Status

The drug is dispensed by prescription.

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.