NAAXIA 38 mg/ml EYE DROPS SOLUTION

Introduction

Package Leaflet: Information for the User

Naaxia 38 mg/ml eye drops in solution

Sodium Espaglucide

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Naaxia and what is it used for
2. What you need to know before you use Naaxia
3. How to use Naaxia
4. Possible side effects
5. Storing Naaxia
6. Contents of the pack and other information

1. What is Naaxia and what is it used for

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

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

2. What you need to know before you use Naaxia

Do not use Naaxia

• if you are allergic to sodium espaglucide or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before you start using Naaxia.

Naaxia is presented as eye drops and should be used via the ophthalmic route.

Do not inject or ingest.

Using Naaxia with other medicines

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

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, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

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

Breastfeeding

The use of Naaxia is not recommended during breastfeeding.

Driving and using machines

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

3. How to use Naaxia

Follow exactly the administration instructions of Naaxia given by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

The recommended dose is:

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

The Naaxia packaging incorporates a new technology for the sterile supply of the product, called the ABAK system.

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

Check that the packaging seal is intact.

Open the packaging, making sure that the cap and dropper do not touch any surface.

With your head tilted back, pull down the lower eyelid and instill 1 drop into the conjunctival sac (space between the eye and the eyelid) of each eye while looking up.

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

Replace the cap on the bottle after each use.

Before using other ophthalmic medications, wait at least 10 minutes.

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

- Each patient will use their own packaging.

- After finishing the treatment, the medication should be discarded even if it has not been fully consumed.

If you use more Naaxia than you should

No cases of topical overdose have been reported.

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

If you forget to use Naaxia

At the moment you realize you have forgotten, apply one drop to each eye and continue with the normal treatment frequency.

Do not use a double dose to make up for forgotten doses.

If you stop using Naaxia

In order to optimize the success of the treatment, it is important to continue it for the time indicated by the doctor, even if the symptoms disappear.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Naaxia

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month shown.

Discard 3 months after first opening the packaging.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Naaxia

• The active substance is sodium espaglucide. Each ml of solution contains 38 mg of sodium espaglucide.

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

Appearance and packaging of the product

Naaxia is presented as a solution packaged in 10 ml plastic bottles.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Laboratorios Thea S.A, C/ Enric Granados nº 86-88, 2ª planta, 08008 - Barcelona

Manufacturer

EXCELVISION, Rue de la Lombardière, BP 131 - 07100 Annonay - France

Or

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

This leaflet was last revised in March 2016

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/