Sigida crystal (Drops) Instructions for Use

Marketing Authorization Holder

Grotex, LLC (Russia)

ATC Code

S01GA51 (Naphazoline in combination with other drugs)

Active Substance

Naphazoline (Rec.INN registered by WHO)

Dosage Form

Sigida crystal

Eye drops 0.05%: 10 ml bottle 1 pc.; 0.4 ml single-dose container 10, 20, or 30 pcs.

Dosage Form, Packaging, and Composition

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

Excipients: boric acid – 18.7 mg, macrogol 300 – 1.125 mg, sodium hyaluronate – 1 mg, disodium edetate dihydrate – 0.5 mg, sodium hydroxide solution 1M or nitric acid 0.1M solution – to pH 4.0-7.0, water for injections – to 1 ml.

0.4 ml – single-dose containers (5) – foil film bags (2) – cardboard packs.
0.4 ml – single-dose containers (5) – foil film bags (4) – cardboard packs.
0.4 ml – single-dose containers (5) – foil film bags (6) – cardboard packs.
0.4 ml – single-dose containers (10) – foil film bags (1) – cardboard packs.
0.4 ml – single-dose containers (10) – foil film bags (2) – cardboard packs.
0.4 ml – single-dose containers (10) – foil film bags (3) – cardboard packs.
10 ml – low-density polyethylene bottles (1) with a dropper dispenser – cardboard packs.

Clinical-Pharmacological Group

Drug with vasoconstrictive action for topical use in ophthalmology

Pharmacotherapeutic Group

Agents used in ophthalmology. Decongestants and antiallergic agents. Other antiallergic agents

Pharmacological Action

Alpha-adrenomimetic. When applied to the mucous membranes, it has a rapid, pronounced and prolonged vasoconstrictive effect.

Pharmacokinetics

With topical application, systemic absorption is low.

Indications

For intranasal use: acute rhinitis, allergic rhinitis, sinusitis, eustachitis, laryngitis, laryngeal edema of allergic origin, laryngeal edema due to irradiation, hyperemia of the mucous membrane after operations on the upper respiratory tract, to facilitate rhinoscopy, to stop nosebleeds, to prolong the action of local anesthetics used for superficial anesthesia.

For use in ophthalmology: symptomatic temporary relief of secondary eye hyperemia due to moderate irritant exposure and allergic conjunctivitis.

ICD codes

Dosage Regimen

For ophthalmic use only. Instill one to two drops into the conjunctival sac of the affected eye(s).

Repeat administration every three to four hours as needed for symptomatic relief of eye redness.

Limit use to a maximum of four consecutive days. Discontinue use and consult a physician if symptoms persist or worsen.

Prior to instillation, remove contact lenses. Wait at least 15 minutes after instillation before reinserting lenses.

Avoid allowing the dropper tip to contact any surface, including the eye, to prevent contamination of the solution.

For single-dose containers: use the entire contents of one container immediately after opening. Discard any unused solution. Do not store partially used containers.

For multi-dose bottles: securely close the bottle after each use. Do not use the solution if it changes color or becomes cloudy.

Adverse Reactions

Local reactions: when used in ophthalmology – burning, itching, pain in the eye area; reactive conjunctival hyperemia, visual disturbance, dryness of the nasal mucosa, mydriasis, increased intraocular pressure; with intranasal use – reactive hyperemia, swelling of the nasal mucosa, irritation of the nasal mucosa, with use for more than 1 week – swelling of the nasal mucosa, atrophic rhinitis.

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

Contraindications

Hypersensitivity to naphazoline, arterial hypertension, severe atherosclerosis, thyrotoxicosis, chronic rhinitis, atrophic rhinitis, severe eye diseases, angle-closure glaucoma, diabetes mellitus, tachycardia, simultaneous use of MAO inhibitors and the period up to 14 days after their discontinuation; children’s age – depending on the dosage form.

With caution coronary artery disease, prostatic hyperplasia; pheochromocytoma; pregnancy, breastfeeding period; hyperthyroidism, diabetes mellitus, porphyria, dry rhinitis, dry keratoconjunctivitis, glaucoma; use of other drugs that increase blood pressure.

Use in Pregnancy and Lactation

The use of naphazoline during pregnancy and lactation (breastfeeding) is possible only for strict indications in cases where the expected therapeutic effect for the mother outweighs the potential risk of side effects in the fetus or child.

Pediatric Use

Use in children is possible according to indications, in age-appropriate recommended doses and dosage forms. It is necessary to strictly follow the instructions in the drug labels for naphazoline regarding contraindications for the use of specific naphazoline dosage forms in children of different ages. In children, especially young children, the likelihood of developing systemic adverse reactions to naphazoline increases.

Geriatric Use

In elderly patients, the likelihood of developing systemic adverse reactions to naphazoline increases.

Special Precautions

Naphazoline may have a resorptive effect.

With long-term intranasal use, the severity of the vasoconstrictive effect of naphazoline gradually decreases (tachyphylaxis phenomenon), in connection with which it is recommended to take a break for several days after 5-7 days of use. Prolonged use of the product should be avoided.

If no improvement is observed within 72 hours of using the eye drops, or if irritation or hyperemia increases, or eye pain or visual disturbances appear, the use of the product should be discontinued and a doctor should be consulted. Direct contact of the product with contact lenses should be avoided. It is recommended to remove contact lenses before using the eye drops.

Drug Interactions

Should not be used simultaneously with MAO inhibitors or within 14 days after their discontinuation.

Naphazoline slows down the absorption of local anesthetics (prolongs their action during superficial anesthesia).

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.