Naaxia

PACKAGE LEAFLET

Package leaflet: Information for the user

Naaxia 49 mg/ml eye drops, solution

spaglumic acid
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist.
• Consult your doctor if you do not notice improvement or if your symptoms worsen after 15 days.

Contents of this leaflet:

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

1. What NAAXIA is and what it is used for

NAAXIA is an ophthalmic solution containing spaglumic acid, used for the treatment of mild
inflammatory eye conditions (conjunctivitis and keratoconjunctivitis) of allergic origin, both acute and
chronic. Seasonal eye inflammations (conjunctivitis).
If you do not feel better or if you feel worse after 15 days, consult your doctor.

2. What you need to know before using NAAXIA

Do not use Naaxia

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

Warnings and precautions
Talk to your doctor or pharmacist before using Naaxia.
If you wear contact lenses, you must remove them before using Naaxia.
Other medicines and Naaxia
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you are using other eye drops at the same time, wait 15 minutes between each instillation.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Effects on ability to drive and use machines
After instilling Naaxia, you may experience transient blurred vision. Do not drive or operate machinery until this effect has passed.

3. How to use NAAXIA

Use this medicine exactly as prescribed by your doctor. If you have any doubts, you should consult your doctor or pharmacist.
Adults and children
The recommended dose is 1 drop, instilled 4 times a day into the conjunctival sac of each eye.
Continue treatment throughout the entire period of allergy risk, even after improvement of symptoms.
This medicine is for ocular administration (ophthalmic use).

• Wash your hands thoroughly before using the product.
• Tilt your head slightly backward and look upward.
• Pull down the lower eyelid with the index finger of your free hand.
• Carefully instill one drop into the lower conjunctival sac.
• Avoid contact between the tip of the container and the eye or eyelids.

To reduce the possibility of systemic reactions and to ensure optimal penetration of the medicine into the eye, apply gentle pressure to the lacrimal duct immediately after instillation.
Discard the single-dose container after use. Do not store or reuse the container.
If you use more Naaxia than you should
In case of accidental ingestion/overdose, contact your doctor immediately or go to the nearest hospital.
Ocular overdose is unlikely, as any excess solution would be rapidly expelled from the conjunctival sac.
There are no risks of adverse effects from accidental oral ingestion of Naaxia, since even the ingestion of the entire contents of a package (0.4 ml x 30) contains an amount of active substance far below doses capable of producing toxic effects.
If you forget to use Naaxia
Do not use a double dose to make up for the missed dose.
If you stop treatment with Naaxia
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.

Immune system disorders:

• Occasionally, hypersensitivity reactions (allergic reactions).

Eye disorders:

• Transient mild burning sensation following instillation;
• Pricking sensation after instillation.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, please contact your doctor or pharmacist. You may also report adverse reactions directly through the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store NAAXIA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after Exp.. The expiry date refers to the
last day of that month.
Store below 25°C.
After first opening the container, any remaining product must not be reused.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Naaxia contains

• The active substance is spaglumic acid, 49 mg in 1 ml of eye drop solution.
• The other components are hydrochloric acid or sodium hydroxide q.s. to pH 7.2; water for injections q.s. to 1 ml.

Description of the appearance of Naaxia and package contents
Naaxia is an eye drop solution available in a carton containing 30 single-dose containers of 0.4 ml each.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
LABORATOIRES THEA
12, rue Louis Blériot
63017 CLERMONT-FERRAND CEDEX 2
FRANCE
Sales Licence Holder
THEA FARMA S.p.A.
Via Giotto, 36 – 20145 MILANO
Manufacturer
Excelvision
ANNONAY - FRANCE
and/or
Laboratoire UNITHER
ZI DE LA GUERIE
50200 COUTANCES
FRANCE
PACKAGE LEAFLET

Package leaflet: information for the user

Naaxia 49 mg/ml eye drops, solution

spaglumic acid
Please read this leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any of the side effects, including those not listed in this leaflet, consult your doctor or pharmacist.
• Consult your doctor if you do not notice improvement or if you notice worsening of symptoms after 15 days.

Contents of this leaflet:

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

1. What NAAXIA is and what it is used for

NAAXIA is an ophthalmic solution containing spaglumic acid, used for the treatment of mild
inflammatory conditions of the eye (conjunctivitis and keratoconjunctivitis) of allergic origin, both acute and
chronic. Springtime eye inflammations (conjunctivitis).
Consult your doctor if you do not feel better or if you feel worse after 15 days.

2. What you need to know before using NAAXIA

Do not use Naaxia

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

Warnings and precautions
Talk to your doctor or pharmacist before using Naaxia.
If you wear contact lenses, you must remove them before using Naaxia.
Naaxia is for ophthalmic use (in the eyes).
It is recommended not to inject or ingest the product.
Children and adolescents
Use Naaxia in children under 4 years of age only after careful evaluation by the doctor, since
there are no data confirming that Naaxia is safe and effective in children below 4 years of age.
Other medicines and Naaxia
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
If you are using other eye drops at the same time, wait 15 minutes between each instillation.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding,
consult your doctor or pharmacist before taking this medicine.
Effects on ability to drive vehicles and use machinery
After instillation of Naaxia, you may experience transient blurred vision. Do not drive or operate
machinery until this sensation has passed.

3. How to use NAAXIA

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Adults and children over 4 years of age
The recommended dose is 1 drop, instilled 2 to 6 times daily into the conjunctival sac by gently pulling down the lower eyelid and looking upwards.

Continue treatment throughout the entire period of allergy risk, even after symptoms have improved.

This medicine is for ophthalmic use (in the eye).

• Wash your hands thoroughly before using your eye drops solution;
• avoid contact between the tip of the container and the eye or eyelids;
• gently pull down the lower eyelid of the affected eye while looking upwards, and instill the drop into the eye;
• the drop comes out of the bottle more slowly than with a traditional eye drop bottle;
• to reduce the possibility of systemic reactions and to ensure optimal penetration of the medicine into the eye, apply brief pressure to the lacrimal duct immediately after instillation.

If you use more Naaxia than you should
In case of accidental ingestion or overdose, inform your doctor immediately or go to the nearest hospital.
In case of overdose, rinse the eye with sterile physiological saline solution.

If you forget to use Naaxia
Do not use a double dose to make up for the missed dose.

If you stop using Naaxia
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The reported side effects concern the eye and are listed below:

• transient mild burning sensation following instillation;
• pricking sensation after instillation.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store NAAXIA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.". The expiry date refers to the last day of that month.
Store below 25°C.
The shelf-life after first opening the bottle is 3 months.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Naaxia contains

• The active substance is spaglumic acid, 49 mg in 1 ml of ophthalmic solution.
  The other components are sodium hydroxide or hydrochloric acid to adjust pH to 7.2, water for injections up to 10 ml.

Description of the appearance of Naaxia and contents of the pack
Naaxia is an ophthalmic solution available in a pack containing 1 bottle of 10 ml made of low-density polyethylene, equipped with a sterile filter membrane that allows a preservative-free formulation.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
LABORATOIRES THEA
12, rue Louis Blériot
63017 CLERMONT-FERRAND CEDEX 2
FRANCE

Concessionaire for sales
THEA FARMA S.p.A.
Via Giotto, 36 – 20145 MILANO
ITALY

Manufacturer
Farmila-Thea Farmaceutici S.p.A.
Via E. Fermi, 50
20019 Settimo Milanese (MI)
and/or
Excelvision
Rue de la Lombardière
07100 Annonay
FRANCE