Uniclofen

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT UNICLOPHEN® (UNICLOPHEN®)

Composition:

Active substance: diclofenac sodium;

1 ml of solution contains 1 mg of diclofenac sodium;

1 ml contains 30 drops;

Excipients: boric acid, sodium tetraborate, propylene glycol, hydroxypropylbetadex, disodium edetate, benzalkonium chloride, water for injections.

Pharmaceutical form. Eye drops, solution.

Main physicochemical properties: clear, colorless or slightly yellowish solution, free from visible particulate matter.

Pharmacotherapeutic group. Medicinal products used in ophthalmology. Anti-inflammatory agents. Diclofenac. ATC code S01BC03.

Pharmacological Properties

Pharmacodynamics

The medicinal product Uniclophen contains sodium diclofenac—a nonsteroidal compound with pronounced anti-inflammatory and analgesic effects. Inhibition of prostaglandin biosynthesis, which has been demonstrated experimentally, is considered a key factor in the drug's mechanism of action. Prostaglandins play an important role in the etiology of inflammation and pain.

It has been established that the medicinal product Uniclophen:

• inhibits pupil constriction during cataract surgery;
• reduces inflammation following surgical intervention;
• decreases the severity of pain and discomfort in ophthalmology associated with corneal epithelial damage after excimer photorefractive keratectomy (PRK) or minor trauma;
• reduces the incidence of angiographically diagnosed cystoid macular edema following cataract surgery, although the clinical significance of this effect requires further investigation;
• reduces the intensity of postoperative inflammation and discomfort more effectively than topical corticosteroids, without causing adverse effects typical of corticosteroids, such as delayed healing of conjunctival wounds or increased intraocular pressure;
• reduces the intensity of ocular inflammation, pain, and discomfort (photophobia, burning/stinging, foreign body sensation, severe headache-like eye pain, and itching) more effectively than placebo eye drops following corneal surgery, such as radial keratotomy.

The effective daily dose achieved after administration of the medicinal product Uniclophen (approximately 0.25–0.5 mg of sodium diclofenac) corresponds to less than 1% of the recommended daily dose of the drug used for rheumatic symptoms.

The medicinal product Uniclophen contains cyclodextrin—hydroxypropyl-γ-cyclodextrin (HP-γ-CD). Cyclodextrins enhance the water solubility of certain lipophilic, water-insoluble medicinal substances. Cyclodextrins are believed to act as true carriers, maintaining hydrophobic drug molecules in solution and delivering them to the surface of biological membranes.

Pharmacokinetics

Penetration of diclofenac into the anterior chamber of the eye has been confirmed in humans. After instillation of sodium diclofenac as eye drops, detectable systemic levels of diclofenac were not found in humans.

Clinical characteristics.

Indications.

Inhibition of intraoperative miosis during cataract surgery (the medicinal product Uniclophen does not possess characteristic mydriatic properties and does not replace standard medicinal products causing pupil dilation).

Treatment of postoperative inflammation following cataract removal and other surgical procedures.

Management of pain and discomfort in ophthalmology associated with corneal epithelial damage after excimer photorefractive keratectomy (PRK) or minor non-penetrating trauma.

Control of inflammation following argon laser trabeculoplasty (ALT).

Reduction of signs and symptoms of seasonal allergic conjunctivitis (SAC) in ophthalmology.

Treatment of inflammation and discomfort following surgical correction of strabismus.

Treatment of pain and discomfort in ophthalmology following radial keratotomy.

Contraindications.

Hypersensitivity to the active substance or to any of the excipients of the medicinal product.

Like other nonsteroidal anti-inflammatory drugs (NSAIDs), the medicinal product Uniclophen is contraindicated in patients who have experienced asthma attacks, urticaria, or acute rhinitis associated with administration of acetylsalicylic acid or other drugs inhibiting prostaglandin synthetase activity. Cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs is possible.

Intraocular administration of the drug during a surgical procedure.

Interaction with other medicinal products and other forms of interaction.

If more than one type of eye drops is prescribed, they should be administered with an interval of at least 5 minutes.

Concomitant use of topically applied NSAIDs, such as diclofenac, and topical corticosteroids in patients with pronounced pre-existing corneal inflammation may increase the risk of corneal complications and delay corneal healing; therefore, the drug should be used with caution.

Concomitant use of the medicinal product Uniclophen with drugs that prolong bleeding time may increase the risk of hemorrhage.

Eye drops containing 0.1% diclofenac solution have been successfully used in clinical studies in combination with antibiotics and topical beta-blockers.

Special precautions for use.

This medicinal product contains benzalkonium chloride as a preservative, which may cause eye irritation and may form deposits on the surface of soft contact lenses. Therefore, the product should not be used while wearing soft contact lenses. Contact lenses should be removed prior to instillation of the drops and should not be reinserted earlier than 15 minutes after administration.

It is recommended to avoid wearing contact lenses during treatment of inflammatory eye diseases.

The anti-inflammatory effect of ophthalmic NSAIDs, including diclofenac, may mask the onset and/or progression of ocular infections. In the presence of infection or when there is a risk of developing infection, appropriate therapy (e.g. antibiotic treatment) should be administered concurrently with the use of this medicinal product.

There is a theoretical possibility that patients receiving other medicinal products that prolong bleeding time or who have hemostatic disorders may experience exacerbation of their condition during treatment with this product, although reports of adverse effects are lacking.

It is known that topically applied NSAIDs may slow down or delay healing. Topically applied corticosteroids may also delay corneal healing. Caution should be exercised when using topical NSAIDs such as diclofenac together with steroid agents (see section "Interaction with other medicinal products and other forms of interaction").

Do not use for subconjunctival injections; do not inject into the anterior chamber of the eye.

Treatment with Uniclofen should be discontinued immediately in patients who develop symptoms indicating corneal integrity impairment.

After instillation of eye drops, nasolacrimal occlusion for 3 minutes may reduce systemic absorption. This, in turn, may lead to a reduction in systemic adverse effects and an increase in local drug activity.

Use during pregnancy or breastfeeding.

Pregnancy.

There are no clinical data on the use of Uniclofen during pregnancy. Even though systemic effects are lower compared to oral administration, it is unknown whether the systemic exposure to Uniclofen achieved after topical application could be harmful to the embryo/fetus. Uniclofen should not be used during the first and second trimesters of pregnancy unless clearly necessary. If used, the dose should be as low as possible and the duration of treatment as short as possible.

During the third trimester of pregnancy, systemic use of inhibitors of prostaglandin synthesis, to which Uniclofen belongs, may cause cardiovascular and renal toxicity in the fetus. At late stages of pregnancy, prolonged bleeding may occur in both mother and child, and labor may be delayed. Therefore, Uniclofen is not recommended during the last trimester of pregnancy.

Breastfeeding period.

Diclofenac is excreted in breast milk. However, no effect of Uniclofen on the breastfed infant is expected at therapeutic doses. The use of diclofenac in ophthalmology is not recommended during breastfeeding, except when the expected benefit of treatment outweighs the potential risk.

Ability to affect reaction speed when driving or operating machinery.

Patients experiencing blurred vision should refrain from driving or operating machinery.

Administration and dosage.

The Uniclophen medicinal product is intended only for instillation into the conjunctival sac of the eye. It must under no circumstances be administered subconjunctivally, nor should it be injected directly into the anterior chamber of the eye.

Adults

Children.

The drug should not be administered to children. Experience with the use of the drug in this age group is limited to several published clinical studies conducted in the field of surgical treatment of strabismus.

Overdose.

The risk of developing adverse effects following accidental oral ingestion of the drug is practically negligible, since a 5 ml bottle of eye drops contains only 5 mg of diclofenac sodium, corresponding to approximately 3% of the recommended maximum daily dose of the medicinal product Uniclophen for adults when taken orally.

Adverse Reactions

Adverse reactions observed during clinical trials of the active substance can be categorized by frequency of occurrence: very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10000 to <1/1000), and very rare (<1/10000).

Eye disorders

Common: punctate keratitis, eye pain, ocular mucosal irritation, itching, conjunctival hyperemia.

Uncommon: keratitis, increased intraocular pressure, corneal edema, conjunctival edema, corneal deposits, conjunctival follicles, eye discomfort, eye discharge, crusting on eyelid margins, increased lacrimation, eyelid irritation, eye redness.

Not known: corneal perforation, ulcerative keratitis, corneal epithelial defects, corneal clouding, corneal thinning, allergic conjunctivitis and other allergic eye disorders, eyelid erythema, eyelid swelling and itching, blurred vision.

Immune system disorders

Uncommon: hypersensitivity reactions.

General disorders and administration site conditions

Uncommon: impaired healing.

Infections and infestations

Not known: rhinitis.

Respiratory, thoracic and mediastinal disorders

Not known: exacerbation of bronchial asthma, dyspnea, cough.

Skin and subcutaneous tissue disorders

Not known: urticaria, rash, eczema, erythema, pruritus.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after marketing authorization is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals and pharmacists, as well as patients or their legal representatives, should report any suspected adverse reactions and lack of efficacy through the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life. 2 years.

After first opening, store for no more than 28 days.

Storage conditions.

Keep out of reach of children. Store at a temperature not exceeding 25°C in the original packaging. Do not freeze.

Packaging.

5 ml or 10 ml in a dropper container closed with a cap featuring a first-opening control.

One dropper container with the instruction for medical use is placed in a cardboard box.

Prescription category. Prescription only.

Manufacturer.

TOV "UNIMED PHARMA"/"UNIMED PHARMA Ltd".

Manufacturer's address and location of its business operations.

Orieskova 11, 821 05, Bratislava, Slovak Republic /
Orieskova 11, 821 05 Bratislava, Slovak Republic.