Optive^® (Drops) Instructions for Use

Marketing Authorization Holder

Allergan, Inc. (USA)

Manufactured By

Allergan Sales, LLC (USA)

ATC Code

S01XA20 (Artificial tears and other indifferent preparations)

Active Substances

Glycerol (Rec.INN registered by WHO)

Carmellose (Rec.INN registered by WHO)

Dosage Form

Optive®

Eye drops: dropper bottle 10 ml or 15 ml

Dosage Form, Packaging, and Composition

Eye drops transparent, colorless.

10 ml – dropper bottles (1) – cardboard packs.
15 ml – dropper bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Keratoprotector

Pharmacotherapeutic Group

Keratoprotective agent

Pharmacological Action

Carmellose sodium and Glycerol have properties of a corneal epithelium protector, improve corneal hydration with reduced tear fluid secretion, and increase the stability of the tear film.

Pharmacokinetics

Pharmacokinetic studies in humans have not been conducted.

Indications

• Symptomatic treatment of dry eye syndrome.

ICD codes

Dosage Regimen

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

Use the drops as needed to relieve symptoms of dry eye.

Administer the solution topically; it is for ophthalmic use only.

If using other topical ophthalmic medications, maintain an interval of at least 5 minutes between instillations.

Apply Optive^® after other eye drop solutions to prevent dilution or washing out.

To avoid contamination, do not let the dropper tip contact the eye, eyelids, or any other surface.

Securely close the bottle immediately after each use.

Discard the bottle 28 days after first opening, even if solution remains.

Do not use if the solution becomes cloudy or changes color.

If symptoms persist or worsen after 72 hours of use, discontinue the product and consult a physician.

Transient blurred vision may occur after instillation; wait until vision clears before driving or operating machinery.

Adverse Reactions

When using the drug, the following adverse reactions may occur with the indicated frequency – very common (≥10%), common (≥1%, <10%), uncommon (≥0.1%, <1%); rare (≥0.01%, <0.1%), very rare (<0.01%).

Eye disorders: common – conjunctival hyperemia, eyelid hyperemia, blurred vision, dry eye sensation, discomfort upon instillation, itching and irritation of the eyes, crusting on the eyelid margin.

In the post-marketing period, reports of the following adverse reactions for Optive^® have been received (frequency unknown): eye pain, eye discharge, foreign body sensation in the eye, eyelid edema, increased lacrimation, photophobia.

Contraindications

• hypersensitivity to the components of the drug;
• children under 18 years of age (no experience with use).

With caution: during pregnancy and breastfeeding (due to limited data).

Use in Pregnancy and Lactation

Strictly controlled studies in pregnant women and nursing mothers have not been conducted. Animal studies have not revealed adverse effects of the drug’s active components.

Optive^® is not absorbed from the mucosal surface, thus there are no objective prerequisites for the possible excretion of its components with breast milk.

Use of the drug during pregnancy and breastfeeding is possible with caution.

Pediatric Use

Contraindicated in children under 18 years of age.

Special Precautions

The drug is intended for topical use only. Do not use if the film covering the bottle neck is damaged, or if the solution is cloudy or has changed color.

Do not let the tip of the dropper touch any surface, including the conjunctiva, to avoid contamination of the bottle contents. Close the bottle immediately after use.

The shelf life of the drug after first opening the bottle is 28 days. Consult your doctor if you experience eye pain, impaired visual clarity, prolonged redness or irritation of the eye mucosa. Also seek consultation if there is no improvement from using the drug and/or if you experience other adverse events that worsen or do not resolve within 72 hours.

Effect on driving and operating machinery

If blurred vision occurs after instillation, refrain from driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions until vision is restored.

Overdose

Information on cases of overdose with Optive^® is not available.

Drug Interactions

There are no data on drug interactions for Optive^®.

When prescribed with other topical ophthalmic agents, the interval between instillation of Optive^® and other eye drops should be at least 5 minutes to avoid the possibility of “washing out” the drug.

Storage Conditions

Store at a temperature not exceeding 25°C (77°F). Keep out of reach of children.

Shelf Life

Shelf life – 2 years.

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.