Europe — EMA
Dicloftil
Dicloftil is an EU‑marketed ocular diclofenac sodium eye drop for inflammation and pain after eye surgery. Learn uses, effects, precautions.
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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?+
For which ocular conditions is Dicloftil commonly prescribed?+
How does diclofenac sodium work in the eye?+
Can Dicloftil be used together with other eye drops?+
What are the most common side effects of Dicloftil?+
What serious adverse reactions should prompt discontinuation of Dicloftil?+
Are there any patient groups that require special caution when using Dicloftil?+
Does Dicloftil interact with systemic medications?+
How should Dicloftil be stored to maintain its stability?+
What follow‑up is recommended after starting Dicloftil therapy?+
Product details
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