Page 127 - MEMENTO THERAPEUTIQUE RCP 2024
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SUMMARY OF PRODUCT CHARACTERISTICS

             1.   NAME OF THE MEDICINAL PRODUCT

            NAABAK 4.9 PERCENT, eye drops, solution


            2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

            N-Acetyl Aspartyl Glutamic Acid, sodium salt………………………………………………………..4.9g
                                                    For 100 ml of solution

            For the full list of excipients, see section 6.1.


             3.   PHARMACEUTICAL FORM

            Eye drops.


            4.    CLINICAL PARTICULARS

            4.1  Therapeutic indications

            Treatment of moderate symptoms of conjunctivitis and blepharoconjunctivitis of allergic origin.

            4.2  Posology and method of administration

            Ocular use.

            1 drop, 2 to 6 times daily in both adults and children.

            Instil one drop of the solution into the conjunctival sac, while pulling the lower eyelid slightly
            downwards and looking up.

            After improvement of symptoms, the treatment should be continued throughout the whole period of
            risk of allergy.

            4.3  Contraindications

                •  Hypersensitivity to the active substance or to any of the excipients

            4.4  Special warnings and precautions for use

                •  Do not inject, do not swallow.
                •  Do not touch the eye with the bottle tip.
                •  Children: no studies have been performed in children under the age of four years.
                •  In cases of severe conjunctival allergy, anti-allergic N-Acetyl Aspartyl Glutamic Acid-based
                  eye drops can be used to replace the initial corticoid treatment.
                •  The absence of preservative allows these eye drops to be used while wearing soft contact
                  lenses.

            4.5  Interaction with other medicinal products and other forms of interaction

            Based on currently available data, no clinically significant interactions are expected.

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