Page 144 - MEMENTO THERAPEUTIQUE RCP 2024

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

- to wash carefully their hands prior to instillation,
- to avoid contact between the tip of the dispenser and the eye or eyelids,
- to close the bottle after use.

Patients should be instructed to use nasolacrimal occlusion and to close the eyelids for 2 minutes after
instillation, to reduce the systemic absorption. This may result in a decrease in systemic undesirable effects
and an increase in local activity (see section 4.4).

In order to avoid the dilution of the active substances, in case of concomitant use with another eye drops, wait
for 15 minutes between instillations. Ointment should be administrated last.

4.3 Contraindications

Hypersensitivity to the active substance (diclofenac sodium) or to any of the excipients listed in section 6.1.

History of allergy, urticaria, acute rhinitis or asthma precipitated by the intake of diclofenac sodium or drugs
with similar activity as aspirin or other non-steroidal anti-inflammatory agents (NSAIDs). (See section 4.4 for
cross-sensitivity reactions).

th
Pregnancy, from the start of the 6 month (from 24 weeks of amenorrhea) (see section 4.6).

4.4 Special warnings and precautions for use

Do not inject, do not swallow.

The eye drops should not be administered by peri- or intra-ocular injection.

Hypersensitivity
Voltarenophtabak may, as other NSAIDs, in rare cases induce allergic reactions including anaphylactic
reactions, even without prior exposure of the drug.
In case of hypersensitivity reactions such as itching and redness or suggestive signs of allergy to that
medicinal product, especially attack of asthma or sudden face and neck swelling, the treatment should be
discontinued.

Corneal disorder
NSAIDs, including topical diclofenac, delay the reepithelialisation of the cornea even if given shortly. The
consequences of this on the quality of the cornea and risk of infections due to delayed corneal wound closure
is unclear.
Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and
topical steroids may increase the potential for healing problems.
When patients are treated with high dose and during an extended period of time, use of topical NSAIDs may
result in keratitis. In some susceptible patients continued use may result in epithelial breakdown, corneal
thinning, corneal infiltrates, corneal erosion, corneal ulceration and corneal perforation. These events may be
sight threatening. Patients with evidence of corneal epithelial breakdown should immediately discontinue use
of VOLTARENOPHTABAK and should be monitored closely for corneal health

Post marketing experience suggests that patients experiencing complicated ocular surgeries, corneal epithelial
defects, diabetes mellitus, ocular surface disease (eg dry eye syndrome), rheumatoid arthritis or repeated
ocular surgeries within a short period of time may be at increased risk of corneal adverse events. Topical
NSAIDs should be used with caution in these patients. Prolonged use of topical NSAIDs may increase patient
risk for occurrence and severity of corneal adverse reactions.

Ocular infection
An acute ocular infection may be masked by the topical use of anti-inflammatory drugs. NSAIDs do not have
any antimicrobial properties. In case of ocular infection, their use with one/some anti-infectious drugs should
be done carefully.

Susceptible persons