Rescula (Drops) Instructions for Use

Marketing Authorization Holder

CIBA VISION, AG (Switzerland)

ATC Code

S01E (Antiglaucoma drugs and miotic agents)

Active Substance

Unoprostone (Rec.INN registered by WHO)

Dosage Form

Rescula

Eye drops solution 1.2 mg/1 ml: 5 ml dropper bottle

Dosage Form, Packaging, and Composition

5 ml – plastic dropper bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Antiglaucoma drug

Pharmacotherapeutic Group

Antiglaucoma agent – prostaglandin

Pharmacological Action

Antiglaucoma agent, a synthetic analogue of dinoprost. It improves uveoscleral outflow of intraocular fluid and does not affect its production.

It does not cause mydriasis, does not affect accommodation, and does not reduce the blood supply to the tissues of the eyeball.

Indications

• For the reduction of elevated intraocular pressure in patients with open-angle glaucoma.
• For the management of ocular hypertension.

Apply one drop into the affected eye(s) two times daily, approximately every twelve hours. Do not exceed the recommended dosage.

If using other topical ophthalmic medications, administer them at least five minutes apart. To prevent contamination, avoid touching the dropper tip to any surface.

ICD codes

Dosage Regimen

For topical ophthalmic use only.

Instill one drop into the affected eye(s) twice daily, approximately every twelve hours.

Do not exceed the recommended dosage.

If using other topical ophthalmic medications, administer them at least five minutes apart.

To prevent contamination of the solution, avoid touching the dropper tip to the eye, eyelids, or any other surface.

Wash hands before use.

Remove contact lenses prior to application; lenses may be reinserted after 15 minutes.

Close the bottle tightly immediately after use.

Discard the container 4 weeks after first opening.

Adverse Reactions

From the organ of vision: conjunctival hyperemia, keratitis, corneal erosion, eye pain; rarely – punctate corneal opacities, conjunctival chemosis, conjunctival discharge, blepharitis, burning, foreign body sensation, and blurred vision.

With prolonged use, increased pigmentation in the tissues of the eyeball or surrounding structures is possible.

Systemic reactions: headache, increased blood pressure, nasal congestion, dry mouth, decreased sensitivity of the tongue tip, nausea, vomiting, increased heart rate are possible.

Contraindications

• Hypersensitivity to unoprostone or any component of the formulation.
• Do not use in patients with active or suspected inflammatory ocular conditions.
• Contraindicated in patients with a ruptured ocular barrier or in the postoperative period following ocular surgery where the integrity of the posterior lens capsule is compromised.

Use in Pregnancy and Lactation

During pregnancy, use is possible only in cases where the intended therapeutic benefit for the mother outweighs the potential risk to the fetus.

If use during lactation is necessary, the issue of discontinuing breastfeeding should be considered.

Experimental studies have shown that Unoprostone is excreted in breast milk.

Pediatric Use

The safety of use in children under 12 years of age has not been established.

Special Precautions

Use with caution in severe systemic diseases.

Intraocular pressure should be monitored regularly during treatment.

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.