NAAXIA 49 mg /Ml Krople Do Oczu, Roztwór
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Treść ulotki
Naaxia 49 mg/ml eye drops, solution
spaglumic acid
Read this leaflet carefully before you start using this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- If you want more information or advice, ask your pharmacist.
- If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist.
- See your doctor if you do not feel better or if your symptoms get worse after 15 days.
Contents of this leaflet:
- 1. What NAAXIA is and what it is used for
- 2. What you need to know before you use 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 is NAAXIA and what is it used for
NAAXIA is an ophthalmic solution containing spaglumic acid, used for the treatment of mild
manifestations of eye inflammation (conjunctivitis and keratoconjunctivitis) of allergic origin, acute and
chronic. Springtime eye inflammations (conjunctivitis).
See a doctor if you do not feel better or if you feel worse after 15 days.
2. What you need to know before you use 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
Consult your doctor or pharmacist before using Naaxia.
If you wear contact lenses, you should 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 undergoing simultaneous treatment with other eye drops, wait 15 minutes between instillations.
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Effects on ability to drive and operate machinery
After instillation of Naaxia you may experience transient blurred vision, do not drive or operate
machinery until this sensation has ceased.
3. How to use NAAXIA
Use this medicine exactly as your doctor has instructed. If you have any doubts, consult your doctor or
pharmacist.
Adults and children
The recommended dose is 1 drop, to be instilled 4 times a day into the conjunctival sac of each eye.
Continue therapy throughout the period of allergy risk, even after improvement of
symptoms.
This medicine must be administered into the eye (ophthalmic use).
- Wash your hands thoroughly before using the product.
- Tilt your head slightly backwards and look upwards.
- Lower the lower eyelid with the index finger of your free hand.
- Carefully instill one drop into the lower conjunctival sac.
- Avoid contact of the container tip with the eye or eyelids.
To reduce the possibility of systemic reactions and to allow optimal penetration of the medicine into the eye, immediately
after instillation, apply brief pressure to the tear duct.
Dispose of the single-dose container after use. Do not keep the container for further use.
If you use more Naaxia than you should
In case of ingestion/accidental intake of an excessive dose of Naaxia, immediately inform your
doctor or go to the nearest hospital.
An excessive dosage in the eye is unlikely because any excess of solution would be rapidly
expelled from the conjunctival sac.
There are no risks of adverse effects due to accidental oral ingestion of Naaxia, as even
taking the contents of an entire package (0.4 ml x 30) contains an amount of active ingredient
largely below the doses capable of producing toxic effects.
If you forget to use Naaxia
Do not use a double dose to make up for a missed dose.
If you stop using Naaxia
If you have any doubts about the use of 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.
Immune system disorders:
- occasionally hypersensitivity reactions (allergic reactions).
Eye disorders:
- transient mild burning sensation following instillation;
- stinging sensation after instillation.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through 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 which is stated on the pack after Exp.. The expiry
date refers to the last day of that month.
Store at a temperature not exceeding 25°C.
After first opening of the container, the remaining product should not be reused.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Naaxia contains
- The active ingredient is spaGlumic acid, 49 mg in 1 ml of eye drops solution.
- The other components are hydrochloric acid or soda q.s. to pH 7.2; water for injections q.s. to 1 ml.
Description of the appearance of Naaxia and contents of the pack
Naaxia is an eye drop, solution available in a pack of 30 single-dose containers of 0.4 ml.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
LABORATOIRES THEA
12, rue Louis Blériot
63017 CLERMONT-FERRAND CEDEX 2
FRANCE
Sales representative
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
Naaxia 49 mg/ml eye drops, solution
spaglumic acid
Read this leaflet carefully before using this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- If you want more information or advice, ask your pharmacist.
- If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist.
- See a doctor if you do not feel better 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 is NAAXIA and what is it used for
NAAXIA is an eye drop solution containing spaaglumic acid, used for the treatment of mild
manifestations of eye inflammation (conjunctivitis and keratoconjunctivitis) of allergic nature, acute and
chronic. Springtime eye inflammations (conjunctivitis).
See a doctor if you do not feel better or if you feel worse after 15 days.
2. What you need to know before you use NAAXIA
Do not use Naaxia
- if you are allergic to spaaglumic 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 should 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 a doctor, as
there is no data to confirm that Naaxia is safe and effective in children under 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 undergoing simultaneous treatment with other eye drops, wait 15 minutes between instillations.
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Effects on ability to drive and operate machinery
After instillation of Naaxia, you may experience transient blurred vision, do not drive and do not use
machinery until this sensation has ceased.
3. How to use NAAXIA
Use this medicine following exactly the instructions of your doctor. If you have any doubts, you should consult your doctor or
pharmacist.
Adults and children over 4 years of age
The recommended dose is 1 drop, to be instilled 2 to 6 times a day in the conjunctival sac, by gently pulling
the lower eyelid down and looking upwards.
Continue the therapy throughout the period of allergy risk, even after improvement of the
symptoms.
This medicine must be administered into the eye (ophthalmic use).
- Wash your hands thoroughly before using your eye drops solution;
- avoid contact of the container tip with the eye or eyelids;
- gently lower the lower eyelid of the affected eye while looking upwards, and instill the drop into the eye;
- the drop comes out of the bottle after a longer time than with a traditional eye drop bottle;
- to reduce the possibility of systemic reactions and to allow optimal penetration of the medicine into the eye, immediately after instillation, apply brief pressure to the lacrimal duct.
If you use more Naaxia than you should
In case of ingestion/accidental intake of an excessive dose of Naaxia, immediately inform your
doctor or go to the nearest hospital.
In case of overdose, rinse the eye with sterile saline solution.
If you forget to use Naaxia
Do not use a double dose to make up for a missed dose.
If you stop using Naaxia
If you have any doubts about the use of 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.
Reported side effects concern the eye and are listed below:
- transient sensation of mild burning following instillation;
- stinging sensation after instillation.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through 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 at a temperature not exceeding 25°C.
The shelf life after first opening of the bottle is 3 months.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Naaxia contains
- The active ingredient is spaGlumic acid, 49 mg in 1 ml of eye drops solution. The other components are sodium hydroxide or hydrochloric acid to pH 7.2 - water for injections q.s. to 10 ml.
Description of the appearance of Naaxia and contents of the pack
Naaxia is an eye drop, solution, available in a pack containing 1 bottle of 10 ml of low density polyethylene equipped with a sterilizing membrane which allows a preservative-free formulation.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
LABORATOIRES THEA
12, rue Louis Blériot
63017 CLERMONT-FERRAND CEDEX 2
FRANCE
Sales representative
THEA FARMA S.p.A. Via Giotto, 36 – 20145 MILANO
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
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- Kraj rejestracji
- Postać farmaceutycznaEye drops, solution, 49 MG/ML
- Kod ATCS01GX03
- Substancja czynna
- Wymaga receptyNie
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki NAAXIAPostać farmaceutyczna: Eye drops, solution, 2%Substancja czynna: cromoglicic acidProducent: BRUSCHETTINI S.R.L.Bez receptyPostać farmaceutyczna: Eye drops, solution, 250 MICROGRAMMI/MLSubstancja czynna: ketotifenProducent: BRUSCHETTINI S.R.L.Bez receptyPostać farmaceutyczna: Eye drops, solution, 1 MG/MLSubstancja czynna: olopatadineProducent: DOC GENERICI SRLBez recepty
Odpowiedniki NAAXIA w innych krajach
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Odpowiednik NAAXIA w Hiszpania
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NAAXIA nie wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w NAAXIA jest spaglumic acid. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
NAAXIA jest produkowany przez LABORATOIRES THEA. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie NAAXIA jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić NAAXIA w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (spaglumic acid) to m.in. BRUNIKROM, BRUNISTILL, KALMIRA. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
