Naaxia 38 mg/ml eye drops solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Naaxia 38 mg/ml eye drops, solution
Epsaglumic acid
Read the entire 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, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents:
- What Naaxia is and what it is used for
- What you need to know before using Naaxia
- How to use Naaxia
- Possible adverse effects
- How to store Naaxia
- Contents of the pack and other information
1. What Naaxia is and what it is used for
Naaxia is an ophthalmic solution eye drop that has broad-spectrum antiallergic activity and allows 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) of allergic origin.
2. What you need to know before using Naaxia
Do not use Naaxia
- if you are allergic to spaglumic acid and isospaglumic acid or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before starting to use Naaxia.
Naaxia is presented as eye drops and must be used by ophthalmic route.
Do not inject or ingest.
Use of Naaxia with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
The effectiveness of the eye drops may be altered by simultaneous instillation with another eye drop. In such case, wait 10 minutes before administering the second drop.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist 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 experience blurred vision immediately after applying Naaxia. Do not drive or operate machinery until this effect has disappeared.
3. How to use Naaxia
Follow exactly the administration instructions for Naaxia provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The recommended dose is:
Adults and children: 1 drop 4 times a day into the conjunctival sac of each eye.
The Naaxia container incorporates a new technology for sterile delivery of the product, known as the ABAK® system.
Wash your hands thoroughly before administering the drops, and avoid any contact between the dropper tip and your fingers, the surface of the eye, or any other surface.
Check that the container's seal is intact.
Open the container carefully, ensuring that the cap and dropper do not touch any surface.
Tilt your head backward, pull down the lower eyelid, and instill 1 drop into the conjunctival sac (the space between the eye and the eyelid) of each eye while looking upward.
Gently close your eyes and keep them closed for a few moments.
Replace the cap on the bottle after each use.
Wait at least 10 minutes before using any other eye medications.
Since these are sterile preparations, it is recommended to follow these instructions:
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Each patient should use their own container.
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After completion of treatment, any remaining medication should be discarded, even if not completely used.
If you use more Naaxia than you should
No cases of toxic topical overdose have been reported.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medication and the amount ingested.
If you forget to use Naaxia
As soon as you remember, apply one drop to each eye and then continue with the normal dosing schedule.
Do not use a double dose to make up for a missed dose.
If you stop using Naaxia
To optimize treatment success, it is important to continue treatment for the duration prescribed by your doctor, even if symptoms disappear.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.
At the time of instillation, a momentary stinging sensation may occur.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Naaxia
Keep out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Discard 3 months after first opening the container.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Naaxia
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The active substance is espaglumic and isoespaglumic acid (sodium salt). Each ml of solution contains 38 mg of espaglumic and isoespaglumic acid (sodium salt).
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The other components are: sodium hydroxide or hydrochloric acid (for pH adjustment) and water for injections.
Presentation of the product and contents of the pack
Naaxia is presented as a solution packed in plastic vials containing 10 ml.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Laboratorios Thea S.A., C/ Enric Granados nº 86-88, 2nd floor, 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 reviewed in March 2016
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.es/