Leaflet: information for the user

Naaxia 38 mg/ml eye drops solution

Espaglumic acid

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

-Keep this leaflet, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Naaxia is an eye drop solution for ophthalmic use, which has a broad-spectrum antiallergic activity and allows for the treatment of allergic eye conditions without the risks associated with corticosteroid therapy.

It is used for the treatment of allergic conjunctivitis and blepharoconjunctivitis (inflammation of the conjunctiva and eyelids).

Do not use Naaxia

• if you are allergic to pepsin and isopepsin or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Naaxia.

Naaxia is presented in the form of eye drops and must be used by ocular instillation.

Do not inject or ingest.

Use of Naaxia with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may have to use any other medication.

The efficacy of the eye drops may be altered by simultaneous instillation with another eye drop. In this case, wait 10 minutes before performing the second instillation.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

As a general rule, Naaxia is not recommended for use in the first three months of pregnancy.

Breastfeeding

Naaxia is not recommended for use during breastfeeding.

Driving and operating machines

You may experience blurred vision immediately after applying Naaxia. Do not drive or operate machines until this effect has disappeared.

Follow exactly the administration instructions for Naaxia indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults and children:1 drop 4 times a dayin the conjunctival sac of each eye.

The Naaxia packaging includes a new technology for the sterile supply of the product, which is called the ABAK^® system.

Wash your hands carefully before proceeding with the application and avoid any contact of the dropper with your fingers and the surface of the eye or any other.

Verify that the packaging seal is intact.

Open the packaging while ensuring that the stopper and dropper do not touch any surface.

With your head tilted back, separate the lower eyelid downwards and instill 1 drop in the conjunctival sac (space between the eye and the eyelid) of each eye while directing your gaze upwards.

Closely close your eyes and keep them closed for a few moments.

Close the bottle after each use.

Wait at least 10 minutes before using other eye medications.

As these are sterile specialties, it is recommended to follow the following instructions:

-Each patient will use their own packaging.

-After completing the treatment, the medication should be discarded, even if it has not been consumed in its entirety.

If you use more Naaxia than you should

No cases of topical overdosing have been described.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Naaxia

When you become aware of the omission, apply 1 drop to each eye and continue with the normal frequency of treatment.

Do not use a double dose to compensate for the missed doses.

If you interrupt the treatment with Naaxia

To optimize the success of the treatment, it is essential to continue it for the time indicated by your doctor, even if the symptoms disappear.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them

At the time of instillation, a temporary stinging sensation may occur.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https//: notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Dispose of after 3 months after the first opening of the packaging.

Medicines should not be thrown down the drain or in the trash.Deposit the packaging and medicines that you do not need at the SIGRE collection pointof the pharmacy.Ask your pharmacist how to dispose of the packaging and medicines that you do not need. This way, you will help protect the environment.

Composition of Naaxia

• The active principle is esomeprazole and omeprazole sodium. Each ml of solution contains 38 mg of esomeprazole and omeprazole sodium.

• The other components are: sodium hydroxide or hydrochloric acid (pH adjustment) and water for injectable preparations.

Appearance of the product and contents of the packaging

Naaxia is presented as a solutionpacked in plastic vials with 10 ml.

Holder of the marketing authorization and manufacturer responsible

Holder of the marketing authorization

Thea Laboratories S.A, Enric Granados St. nº 86-88, 2nd floor, 08008 - Barcelona

Manufacturer responsible

EXCELVISION, Rue dela Lombardière, BP 131 - 07100 Annonay - France

Or

FARMILA Thea Farmaceutici S.p.A, Via E. Fermi, 50- 20019 Sttimo Milanese (MI)- Italy

This leaflet was revised in March 2016

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/