Page 128 - MEMENTO THERAPEUTIQUE RCP 2024

In case of concomitant treatment with other eye drops, instillations should be spaced out by 15
minutes.

4.6 Pregnancy and lactation

Pregnancy

Animal studies have shown no evidence of teratogenicity, consequently foetal malformations are
not expected in humans. Current data indicates that substances responsible for malformations in
humans have shown evidence of teratogenicity in animals during studies conducted on two
species.

In clinical practice, the relatively widespread use of N-Acetyl Aspartyl Glutamic Acid has not shown
any evidence of malformations or foetal toxicity thus far. However, epidemiological studies are
required to confirm the absence of risk.

Therefore, N-Acetyl Aspartyl Glutamic Acid should be used during pregnancy only if necessary.

Breastfeeding

There are no data on the excretion of the active substance into breast milk.

4.7 Effects on ability to drive and use machines

NAABAK has no influence on the ability to drive and use machines.

4.8 Undesirable effects

Possible transient burning or stinging sensations upon instillation.

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 declaration
system.

4.9 Overdose

In the event of overdose, rinse with sterile saline solution.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: OCULAR ANTIALLERGIC
(S = sensory organ)

NAABAK is supplied in a multidose bottle equipped with a system containing a filtering membrane
(0.2 micron) allowing to protect the solution against microbial contamination during its duration of
use.

Experimental animal studies have shown that:
• N-Acetyl Aspartyl Glutamic Acid:
o Inhibits degranulation of mast cells in the conjunctival mucosa that release chemical
mediators of the inflammation responsible for allergy,

2