Page 147 - MEMENTO THERAPEUTIQUE RCP 2024

Approved SPC FR/H/296/01/II/18

Not known (cannot be estimated from the available data)
Cough

Skin and subcutaneous tissue disorders
Rare (≥1/10,000, <1/1,000)
Pruritus, erythema, photosensitivity reaction

Not known (cannot be estimated from the available data)
Urticaria, rash, contact eczema

Corneal thinning and corneal ulcerations have been reported, in rare cases, especially in patients at risk when
using corticosteroids or when presenting a concomitant rheumatoid arthritis. Most of the patients had been
treated during an extended period of time (see section 4.4).

Due to the presence of macrogolglycerol ricinoleate, risk of contact eczema.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows
continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked
to report any suspected adverse reactions via the national reporting system listed in Appendix V.

4.9 Overdose

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: non steroidal anti-inflammatory agents at topical use, ATC code: S01BC03.

Diclofenac sodium is an inhibitor of the prostaglandin synthetase. It has an anti-inflammatory and analgesic
properties.

This eye drops, solution is preservative-free. It is supplied in a multidose bottle equipped with a system
containing a filtering membrane (0.2 microns) in order to protect the eye drops, solution from microbial
contamination during the period of use.

The efficacy and safety of diclofenac eye drops in glaucoma filtration surgery is supported by limited data.

5.2 Pharmacokinetic properties

In rabbits, peak concentrations of labelled diclofenac are demonstrated in the cornea and conjunctiva 30
minutes after application; elimination is fast and almost complete after 6 hours.

Penetration of diclofenac into the anterior chamber has been demonstrated in humans.

No measurable plasmatic levels of diclofenac could be found after ocular application.

5.3 Preclinical safety data

In repeat-dose toxicity, the principal adverse effect of diclofenac is on the gastrointestinal tract with
ulcerations occurring - dependent on the species - at oral doses of more than 0.5 to 2.0 mg/kg (approximately
300 to 1200 times the human topical ophthalmic daily dose).
Reproduction toxicity studies in animals showed embryo-foetotoxicity, prolonged gestation time and dystocia.
Foetal deaths and growth retardation were observed at maternal toxic doses.