Sigida duo (Drops) Instructions for Use

Marketing Authorization Holder

Grotex, LLC (Russia)

ATC Code

S01GA51 (Naphazoline in combination with other drugs)

Active Substances

Diphenhydramine (Rec.INN registered by WHO)

Naphazoline (Rec.INN registered by WHO)

Dosage Form

Sigida duo

Eye drops 1 mg+0.33 mg/1 ml: 10 ml bottle 1 pc.

Dosage Form, Packaging, and Composition

Eye drops as a transparent, colorless or slightly yellowish solution.

Excipients: boric acid – 16 mg, macrogol 300 – 1.125 mg, sodium hyaluronate – 1 mg, disodium edetate dihydrate (Trilon B) – 0.5 mg, 1M sodium hydroxide solution or 0.1M nitric acid solution – to pH 4.0-7.0, water for injections – to 1 ml.

10 ml – plastic bottles (1) with a dropper dispenser – cardboard packs.

Clinical-Pharmacological Group

Drug with antiallergic and vasoconstrictive action for topical use in ophthalmology

Pharmacotherapeutic Group

Agents used in ophthalmology; decongestants and antiallergic agents; sympathomimetics used as decongestants

Pharmacological Action

A combined medicinal product for topical use in ophthalmology.

Diphenhydramine is a histamine H₁-receptor blocker and has an antiallergic effect. It reduces swelling, itching, and lacrimation.

Naphazoline is an alpha-adrenergic agonist that causes prolonged constriction of peripheral vessels. Due to its vasoconstrictive effect during topical application, it has a decongestant effect.

Indications

Acute allergic conjunctivitis (including hay fever conjunctivitis); drug-induced conjunctivitis; infectious eye diseases with an acute allergic component (as an additional agent).

ICD codes

Dosage Regimen

Adults for acute symptoms – 1 drop into the conjunctival sac every 3 hours until the eye swelling and irritation decrease, then – 1 drop 2-3 times/day until clinical symptoms disappear.

Children over 2 years – 1-2 drops/day.

The duration of treatment is no more than 5 days. The necessity for longer use is decided by the doctor individually.

If conjunctival irritation symptoms persist for more than 72 hours, the use of this combination should be discontinued.

Adverse Reactions

Local reactions: symptoms of conjunctival irritation (burning in the eye area, conjunctival hyperemia, itching), as well as visual impairment, increased intraocular pressure, mydriasis, eye pain, dryness of the nasal mucosa. These reactions disappear after discontinuation of the drug. A single case of corneal opacity (with use for 7 days at least 10 times/day) has been described, which disappeared after stopping treatment with the drug.

Systemic reactions are rare (especially in children and elderly patients) – pallor of the skin, tachycardia, heart pain, increased blood pressure, increased sweating, tremor, headache, agitation, nausea, drowsiness, dizziness.

Contraindications

Conjunctival xerosis (dry keratoconjunctivitis, Sjögren’s syndrome); simultaneous use with MAO inhibitors and the period within 10 days after their discontinuation; angle-closure glaucoma; pregnancy, lactation (breastfeeding); children under 2 years of age; hypersensitivity to the active substances.

With caution

Thyrotoxicosis, arterial hypertension, atherosclerosis, arrhythmia, chronic rhinitis, bronchial asthma, adrenal adenoma, in elderly patients, benign prostatic hyperplasia with residual urine.

Use in Pregnancy and Lactation

Use during pregnancy and lactation (breastfeeding) is contraindicated.

Pediatric Use

The drug is contraindicated for use in children and adolescents under 18 years of age.

Special Precautions

Should not be used more often than every 3 hours (for 5 days).

If symptoms indicating systemic absorption appear, use should be discontinued.

Effect on the ability to drive vehicles and mechanisms

Since clarity of vision is temporarily impaired after instillation, patients should refrain from driving vehicles and engaging in activities requiring visual acuity immediately after using the medicinal product.

Drug Interactions

With simultaneous use with tricyclic antidepressants, an enhancement of the vasoconstrictive effect of naphazoline is possible.

Use of MAO inhibitors simultaneously with naphazoline or within 10 days after their discontinuation may lead to a hypertensive crisis.

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

Rx Only

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.