GNH USA

Europe — EMA

Dicloftil

Dicloftil is an EU‑marketed ocular diclofenac sodium eye drop for inflammation and pain after eye surgery. Learn uses, effects, precautions.

Diclofenac Sodium

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What is Diclofenac Sodium?

Dicloftil is an ophthalmic preparation containing the non‑steroidal anti‑inflammatory drug (NSAID) diclofenac sodium. The product is supplied in a topical eye‑drop form, with the exact strength not disclosed in the public label. It is marketed within the European Union and is classified under ATC code S01BC02. Dicloftil is intended for use under the guidance of a qualified eye‑care professional to manage ocular inflammation and related discomfort.

What is Diclofenac Sodium used for?

Dicloftil is indicated for several ocular conditions where inflammation or pain is present.

- Inflammation of the anterior segment of the eye, such as iritis or uveitis, where reduction of prostaglandin‑mediated swelling is desired. - Post‑operative ocular inflammation after cataract extraction, intra‑ocular lens implantation, or other intra‑ocular procedures to help control swelling and discomfort. - Mild to moderate eye pain that accompanies inflammatory conditions, providing analgesic relief while the underlying inflammation resolves. - Conjunctival hyperemia and associated redness that result from inflammatory processes, helping to restore normal ocular appearance. - Adjunctive treatment for allergic conjunctivitis when inflammatory signs predominate, complementing antihistamine therapy. - Prevention of excessive inflammatory response in patients receiving topical steroids, allowing a balanced anti‑inflammatory regimen.

What are the side effects of Diclofenac Sodium?

The ocular formulation of diclofenac sodium may be associated with a range of local and systemic effects, most of which are mild and transient.

Common: - Transient eye irritation or burning sensation upon instillation. - Temporary blurred vision that resolves within minutes. - Mild conjunctival redness or tearing. - Slight headache or mild systemic discomfort. - Mild photophobia that improves with continued use. - Temporary sensation of a foreign body in the eye.

Serious: - Persistent corneal epithelial defect or ulceration. - Severe allergic reaction manifesting as eyelid swelling, rash, or angioedema. - Significant intra‑ocular pressure increase. - Development of anterior uveitis or worsening of existing intra‑ocular inflammation. - Systemic adverse events such as gastrointestinal bleeding or renal impairment, especially in patients with pre‑existing risk factors.

What precautions apply to Diclofenac Sodium?

When prescribing or dispensing Dicloftil, clinicians should consider several precautionary measures to ensure safe use in the ocular setting.

- Assess for known hypersensitivity to diclofenac, other NSAIDs, or any component of the eye‑drop formulation before initiation. - Use with caution in patients with a history of corneal disease, dry eye, or compromised ocular surface integrity. - Avoid concurrent use of multiple topical NSAIDs unless specifically directed, to reduce the risk of additive toxicity. - Monitor intra‑ocular pressure in individuals receiving long‑term therapy, particularly if they have glaucoma. - Evaluate renal or hepatic impairment in systemic NSAID users, as systemic absorption may be clinically relevant. - Counsel pregnant or breastfeeding women that safety data are limited and the product should be used only if clearly indicated.

What does Diclofenac Sodium interact with?

Dicloftil may interact with other ophthalmic or systemic medications; awareness of potential interactions helps to minimize adverse outcomes.

Avoid: - Concomitant use of other topical NSAID eye drops, which can increase the risk of corneal toxicity. - Simultaneous administration of topical corticosteroids without ophthalmologist supervision, due to possible antagonistic effects on wound healing.

Use with caution: - Systemic NSAIDs or anticoagulants, as additive systemic exposure may raise bleeding risk. - Beta‑blocker eye drops in glaucoma patients, since diclofenac may affect intra‑ocular pressure control. - Anticholinergic agents that can exacerbate dry eye symptoms when combined with diclofenac eye drops. - Contact lens wearers should be evaluated, as diclofenac may affect lens tolerance and increase irritation.

Frequently asked questions

What type of medication is Dicloftil and what is its active ingredient?+
Dicloftil is an ophthalmic eye‑drop formulation that contains the active ingredient diclofenac sodium, a non‑steroidal anti‑inflammatory drug.
For which ocular conditions is Dicloftil commonly prescribed?+
It is commonly used for anterior segment inflammation such as iritis or uveitis, postoperative eye inflammation after surgery, mild to moderate eye pain related to inflammation, conjunctival redness, and as an adjunct in allergic conjunctivitis when inflammation is prominent.
How does diclofenac sodium work in the eye?+
Diclofenac sodium inhibits cyclooxygenase (COX) enzymes, reducing prostaglandin synthesis and thereby decreasing inflammation and pain in ocular tissues.
Can Dicloftil be used together with other eye drops?+
Concurrent use of other topical NSAID eye drops should be avoided to reduce the risk of corneal toxicity. Use with other eye medications, such as corticosteroids or beta‑blockers, should be guided by an eye‑care professional.
What are the most common side effects of Dicloftil?+
Common side effects include transient eye irritation or burning, temporary blurred vision, mild conjunctival redness, tearing, slight headache, mild photophobia, and a sensation of a foreign body in the eye.
What serious adverse reactions should prompt discontinuation of Dicloftil?+
Serious reactions may include persistent corneal epithelial defects or ulceration, severe allergic responses such as eyelid swelling or angioedema, significant rises in intra‑ocular pressure, development of anterior uveitis, or systemic events like gastrointestinal bleeding.
Are there any patient groups that require special caution when using Dicloftil?+
Patients with known hypersensitivity to diclofenac or other NSAIDs, those with pre‑existing corneal disease, dry eye, glaucoma, renal or hepatic impairment, and pregnant or breastfeeding women should be evaluated carefully before use.
Does Dicloftil interact with systemic medications?+
Systemic NSAIDs or anticoagulants may increase bleeding risk when used together with Dicloftil, so clinicians should assess the overall NSAID exposure and monitor for signs of bleeding.
How should Dicloftil be stored to maintain its stability?+
The product should be kept in its original container, protected from light, and stored at room temperature away from excessive heat or moisture. Do not use if the solution appears discolored or contains particles.
What follow‑up is recommended after starting Dicloftil therapy?+
Patients should be reviewed by an eye‑care professional to assess response, monitor intra‑ocular pressure if therapy is prolonged, and check for any signs of adverse effects or interactions with other ocular medications.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Diclofenac Sodium
Route
Ocular Use
Manufacturer
Farmigea Spa
Origin
EU

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