Uniclophen (Drops) Instructions for Use

Marketing Authorization Holder

Unimed Pharma, s.r.o. (Slovakia)

ATC Code

S01BC03 (Diclofenac)

Active Substance

Diclofenac (Rec.INN registered by WHO)

Dosage Form

Uniclophen

Ophthalmic drops 1 mg/1 ml: dropper bottle 5 ml

Dosage Form, Packaging, and Composition

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

Clinical-Pharmacological Group

NSAIDs for topical use in ophthalmology

Pharmacotherapeutic Group

NSAID

Pharmacological Action

NSAID, a phenylacetic acid derivative. It has anti-inflammatory and analgesic effects. The mechanism of action is due to non-selective inhibition of COX-1 and COX-2 activity, which leads to suppression of prostaglandin synthesis.

When used topically in ophthalmology, it reduces swelling and pain in inflammatory processes of non-infectious etiology.

The use of diclofenac does not affect the wound healing time.

Pharmacokinetics

The time to reach C_max in the cornea and conjunctiva is 30 minutes after instillation; it penetrates into the anterior chamber of the eye. It does not penetrate into the systemic circulation in therapeutically significant concentrations.

Indications

Inhibition of miosis during cataract surgery; inflammatory process after surgical intervention; prevention and treatment of cystoid macular edema after surgical removal of cataract; inflammatory processes of non-infectious origin (including conjunctivitis, keratoconjunctivitis, corneal erosion, post-traumatic inflammation of the conjunctiva and cornea); pain syndrome during excimer laser intervention; photophobia after keratotomy.

ICD codes

Dosage Regimen

The frequency and duration of use are determined individually.

For inhibition of intraoperative miosis, the drug is instilled into the conjunctival sac for 2 hours at 30-minute intervals (4 times in total) before surgery.

For prevention of cystoid macular edema, instill 1 drop 3-4 times/day for 2 weeks after surgery.

For other indications – 1 drop 3-4 times/day depending on the severity of the condition. The course of treatment can last from 1 to 2 weeks.

Adverse Reactions

Local reactions: eye burning, blurred vision (immediately after instillation), corneal opacity (leukoma), iritis.

Gastrointestinal system: nausea, vomiting.

Allergic reactions: itchy eyes, hyperemia, angioedema of the face, fever, chills, photosensitivity, skin rash (mainly erythematous, urticaria), erythema multiforme exudativum.

Contraindications

Disorders of hematopoiesis of unclear origin; erosive and ulcerative processes in the gastrointestinal tract in the acute stage; hypersensitivity to acetylsalicylic acid or other NSAIDs; hypersensitivity to diclofenac and auxiliary components of the drug used.

With caution: epithelial herpetic keratitis (including in history); bronchial asthma induced by taking acetylsalicylic acid; diseases causing blood clotting disorders (including hemophilia, prolonged bleeding time, tendency to bleed, hemorrhagic diathesis, use of anticoagulants); pregnancy; lactation period (breastfeeding); children and adolescents under 18 years of age; elderly age.

Use in Pregnancy and Lactation

Use during pregnancy and lactation (breastfeeding) is possible in cases where the potential benefit to the mother outweighs the potential risk to the fetus or newborn.

Use in Hepatic Impairment

Use with particular caution in patients with a history of liver disease.

Use in Renal Impairment

Use with particular caution in patients with a history of kidney disease.

Pediatric Use

Use with caution in children and adolescents under 18 years of age.

Geriatric Use

Use with caution in elderly patients.

Special Precautions

Intended for topical use only and is not administered subconjunctivally or into the anterior chamber of the eye.

The anti-inflammatory effect of diclofenac may mask the symptoms of infections. In the presence of an infection or threat of its development, local antibacterial treatment is prescribed simultaneously with the use of diclofenac.

In patients with bronchial asthma combined with rhinitis or chronic sinusitis, since the risk of allergic reactions when using acetylsalicylic acid or NSAIDs is increased, the use of diclofenac may cause bronchospasm.

Effect on the ability to drive vehicles and mechanisms

During treatment with the drug, caution must be exercised when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug Interactions

Instillation of NSAIDs, including Diclofenac, into the conjunctival cavity together with corticosteroids in patients with severe corneal inflammation may lead to progression of corneal damage (caution is required when used concomitantly).

If it is necessary to use simultaneously with other eye drops – antibiotics and beta-blockers – the interval between instillations should be at least 5 minutes to prevent washing out of the active substances by subsequent doses.

Theoretically, it is possible that the use of diclofenac in the form of eye drops together with drugs that reduce blood clotting, or in patients with reduced blood clotting, may increase bleeding time.

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.