INDOCOLLYRE

Ophthalmic route. inhibition of intraoperative miosis: 4 drops the day before the procedure, 4 drops in the 3 hours preceding the procedure. prevention of inflammatory manifestations linked to surgical interventions for cataracts and the anterior segment of the eye: 1 drop, 4-6 times a day until the symptoms completely disappear, starting treatment 24 hours before the procedure. treatment of ocular pain associated with photorefractive keratectomy during the first post-operative days: 1 drop, 4 times a day, during the first post-operative days.

No specific studies have been carried out in children.

For proper use of eye drops, certain precautions must be taken: Wash your hands thoroughly before instilling.

Avoid contact of the tip with the eye or eyelids.

Instill a drop of eye drops into the conjunctival sac of the eye to be treated, looking upwards and pulling the lower eyelid slightly downwards.

Recap the bottle after use.

Systemic passage can be reduced by nasolacrimal occlusion or by closing the eyelids for 2 minutes.

This method can help reduce systemic adverse effects and increase local effectiveness.

If concomitant treatment with another eye drop, instill the eye drops 15 minutes apart.

This medicine contains an organomercurial compound which may cause allergic reactions.

An NSAID may cause an increased tendency to bleed from ocular tissues during surgery, particularly in patients with a known tendency to bleed or who are receiving other treatments that may prolong bleeding.

Use of topical

NSAIDs may cause keratitis.

In some predisposed patients, continued use of topical NSAIDs may result in epithelial loss, corneal thinning, corneal erosion, corneal ulceration, or corneal perforation.

These effects can threaten the visual prognosis.

Patients with corneal epithelial loss should immediately discontinue use of INDOCOLLYRE eye drops solution and the condition of their cornea should be carefully monitored.

NSAIDs may slow or delay healing.

Topical corticosteroids are also known to slow or delay healing.

Concomitant use of topical

NSAIDs and topical steroids may therefore increase these risks.

Therefore, caution is recommended if INDOCOLLYRE, eye drops, solution is administered concurrently with corticosteroids, particularly in patients at high risk of corneal adverse reactions described below.

Data obtained following the marketing of topical NSAIDs suggest that patients with complicated ophthalmologic procedures, corneal denervation, corneal epithelial losses, diabetes mellitus, ocular surface diseases (e.g. dry eye syndrome), rheumatoid arthritis, or repeated ophthalmologic procedures over a short period of time may have an increased risk of corneal adverse effects that may threaten visual prognosis.

NSAIDs should be administered with caution in these patients.

Prolonged use of topical

NSAIDs may increase the frequency and severity of corneal adverse reactions.

The eye drops should not be used as a peri.

• or intraocular injection, nor swallowed.

In case of hypersensitivity, interrupt treatment.

In the event of a risk of ocular infection, appropriate treatment must be prescribed.

Wearing contact lenses is not recommended during treatment.

If necessary, indomethacin ocularly can be combined with corticosteroid eye drops.

Although the quantities of indomethacin passing into the systemic circulation are very low after ocular instillation, the risk of drug interactions exists.

It is therefore appropriate to take into account the interactions observed with NSAIDs administered systemically. + Other NSAIDs (including high-dose salicylates, from 3 g/day in adults) Increased ulcerogenic and digestive hemorrhagic risk (additive synergy). + Oral anticoagulants Increased risk of bleeding from oral anticoagulants (inhibition of platelet function and attack on the gastroduodenal mucosa by NSAIDs).

If the association cannot be avoided, close clinical and biological monitoring. + Heparins (parenteral) Increased risk of bleeding (inhibition of platelet function and attack on the gastroduodenal mucosa by NSAIDs).

If the association cannot be avoided, close clinical monitoring (and biological monitoring for unfractionated heparins). + Lithium Described for diclofenac, ketoprofen, indomethacin, phenylbutazone, piroxicam.

Increase in lithium levels which can reach toxic values ​​(decrease in renal excretion of lithium).

If the combination cannot be avoided, monitor serum lithium levels closely and adjust the lithium dosage during the combination and after stopping the nonsteroidal anti-inflammatory drug. + Methotrexate used at doses greater than or equal to 15 mg/week Increased hematological toxicity of methotrexate (decreased renal clearance of methotrexate by anti-inflammatories). + Ticlopidine Increased hemorrhagic risk (synergy of antiplatelet aggregation activities).

If the combination cannot be avoided, close clinical and biological monitoring (including bleeding time). + Diflunisal Fatal digestive hemorrhages with increased plasma concentrations of indomethacin (enzymatic competition at the glucuronidation level). + Diuretics, ACE inhibitors, angiotensin II inhibitors Acute renal failure in dehydrated patients (decrease in glomerular filtration by inhibition of vasodilator prostaglandins, due to NSAIDs).

Furthermore, reduction in the antihypertensive effect for ACE inhibitors and angiotensin II inhibitors.

Hydrate the patient; monitor renal function at the start of treatment. + Methotrexate used at doses less than 15 mg/week Increased hematological toxicity of methotrexate (decreased renal clearance of methotrexate by anti-inflammatories).

Weekly blood count monitoring in the first weeks of the association.

Increased monitoring in the event of impairment (even slight) of renal function, as well as in the elderly. + Pentoxifylline Increased risk of bleeding.

Strengthen clinical monitoring and check bleeding time more frequently. + Zidovudine Risk of increased toxicity on the red lineage (action on reticulocytes) with severe anemia occurring 8 days after the introduction of the NSAID.

Control of blood count and reticulocyte count 8-15 days after the start of NSAID treatment. + Beta-blockers By extrapolation, from indomethacin.

Reduction of the antihypertensive effect (inhibition of vasodilator prostaglandins by NSAIDs). + Cyclosporin Risk of additional nephrotoxic effects, particularly in the elderly. + Desmopressin Potentiation of antidiuretic activity. + Intrauterine device Risk (controversial) of reduced effectiveness of the intrauterine device. + Thrombolytics Increased risk of bleeding.

Store at a temperature below 25°C. For storage conditions of the medicinal product after first opening.

Inhibition of intraoperative miosis

Prevention of inflammatory manifestations linked to surgical procedures for cataracts and the anterior segment of the eye.

Treatment of ocular pain associated with photorefractive keratectomy during the first post-operative days.

Pharmacotherapeutic group

NON-STEROID ANTI-INFLAMMATORY/ANTALGIC for local use. (S: sensory organ), ATC code: S01BC01.

Indomethacin is a prostaglandin synthetase inhibitor; it belongs to the indolic group.

Adverse reactions from clinical trials and post-marketing data are categorized by frequency according to the following convention: very common (≥ 1/10), common (between ≥ 1/100 and < 1/10), uncommon (between ≥ 1/1,000 and < 1/100), rare (between ≥ 1/10,000 and < 1/1,000), very rare (< 1/10,000) or frequency not known (frequency cannot be estimated based on available data).

System organ class Frequency Adverse reactions Eye disorders Uncommon eye pain eye irritation Rare punctate keratitis photosensitivity Not known frequency increased tear secretion visual defects keratitis conjunctival hyperemia ocular hyperemia corneal edema eyelid edema corneal perforation corneal ulcer* Immune system disorders Rare hypersensitivity reactions with pruritus and redness Corneal complications such as keratitis or corneal ulcers which can lead to perforation have been reported, particularly in at-risk patients treated with corticosteroids administered topically to the eye and/or in those whose cornea was already damaged.

Reporting suspected adverse reactions after authorization of the medicinal product is important.

It allows continuous monitoring of the benefit/risk ratio of the drug.

Healthcare professionals report any suspected adverse reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Pharmacovigilance Centers.

This medication is contraindicated in the following situations: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. proven allergy to indomethacin and substances of similar activity such as other non-steroidal anti-inflammatory drugs (NSAIDs including aspirin) pregnancy, from the beginning of the 6th month (beyond 24 weeks of amenorrhea) history of asthma attack linked to taking aspirin or other NSAIDs, by analogy with NSAIDs administered systemically and although the risk is low after ocular instillation: developing peptic ulcer severe hepatocellular insufficiency, severe renal failure.

This medicine should generally not be used in combination with: oral anticoagulants other NSAIDs (including salicylates in high doses, from 3 g/day in adults) heparin, lithium, methotrexate in high doses (≥ 15 mg per week) ticlopidine, diflunisal.