NOTICE
ANSM - Updated on : 19/03/2024
Product name
NAABAK 19.6 mg/0.4 ml, eye drops in single-dose container
N-acetyl aspartyl glutamic acid (sodium salt)
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Please read this leaflet carefully before using this medicine, as it contains important information for you.
Always use this medicine exactly as it is described in this leaflet or by your doctor or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for any advice or information you may need.
- If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should contact your doctor if you do not feel any improvement or if you feel less well.
What does this leaflet contain?
1. What is NAABAK 19.6 mg/0.4 ml, eye drops in single-dose containers and what is it used for?
2. What do I need to know before using NAABAK 19.6 mg/0.4 ml, eye drops in single-dose containers?
3. How do I use NAABAK 19.6 mg/0.4 ml, eye drops in single-dose containers?
4. What are the possible side effects?
5. How should NAABAK 19.6 mg/0.4 ml be stored?
6. Package contents and other information.
1. WHAT IS NAABAK 19.6 mg/0.4 ml, eye drops in single-dose containers AND WHAT IS IT USED FOR?
Pharmacotherapeutic class ANTI ALLERGICS - ATC code: S01GX03.
This medicine is an anti-allergic eye drop. It contains no preservatives.
It is recommended for the treatment of certain allergic ocular disorders (conjunctivitis, blepharoconjunctivitis).
2. WHAT DO I HAVE TO KNOW BEFORE USING NAABAK 19.6 mg/0.4 ml, eye drops in single-dose containers?
Never use NAABAK 19.6 mg/0.4 ml, eye drops in single-dose containers:
- if you are allergic (hypersensitive) to N-acetyl-aspartyl-glutamic acid or to any of the other ingredients of NAABAK eye drops.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Warnings and Precautions
Talk to your doctor or pharmacist before using NAABAK 19.6 mg/0.4 ml, eye drops in single-dose containers.
Do not exceed the prescribed dosage.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST.
KEEP OUT OFTHE REACH OF CHILDREN.
Children
Not applicable.
Other medicines and NAABAK 19.6 mg/0.4 ml, eye drops in single-dose containers
If you are currently using (or plan to use) another eye drop, wait 15 minutes between instillations.
Talk to your doctor or pharmacist if you are taking or have recently taken any other medication, including over-the-counter medicines.
NAABAK 19.6 mg/0.4 ml, eye drops in single-dose containers with food and drink
Not applicable.
Pregnancy and breast-feeding
Under normal conditions of use, this medicine may be used during pregnancy and breast-feeding.
As a general rule, ask your doctor or pharmacist for advice before taking any medication.
Driving vehicles and operating machinery
A brief visual disturbance may occur after instillation of the product. Wait until normal vision is restored before driving or operating machinery.
NAABAK 19.6 mg/0.4 ml, eye drops in single-dose containers contains {name excipient(s)}.
Not applicable.
3. HOW TO USE NAABAK 19.6 mg/0.4 ml, eye drops in single-dose containers?
Follow prescription: usually 2 to 6 instillations per day.
NAABAK 19.6 mg/0.4 ml, eye drops in single-dose containers comes in single-dose vials, each containing a minimum of 4 drops, enough for both eyes.
How to use the single-dose bottle
- When using for the first time, tear off the envelope containing a pack of 5 single-dose vials;
- Remove the blister from its protective cover and detach a single dose;
- To open the unit-dose, vigorously rotate the flat part of the blister to break the seal;
- Invert the single-dose container to lower the contents towards the end;
- Instill 1 to 2 drops into the eye(s) to be treated, squeezing lightly;
- To ensure that the solution is always sterile, we recommend using a new single-dose container for each application.
IN ALL CASES, STRICTLY COMPLY WITH YOUR DOCTOR'S INSTRUCTIONS.
If you have used more NAABAK 19.6 mg/0.4 ml, eye drops in single-dose containers than you should have
In case of overdose, rinse with sterile saline solution.
If you forget to use NAABAK 19.6 mg/0.4 ml, eye drops in single-dose containers
Do not take a double dose to make up for the single dose you forgot to take.
If you stop taking NAABAK 19.6 mg/0.4 ml, eye drops in single-dose containers
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this drug may cause undesirable effects, but they do not occur systematically in everyone.
- Brief burning or tingling sensations may sometimes occur on instillation.
If you notice any side effects not mentioned in this leaflet, or if any side effects become serious, please inform your doctor or pharmacist.
Reporting side effects
If you experience any side effects, please tell your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr/
By reporting adverse reactions, you contribute to providing more information on drug safety.
5. HOW TO CONSERVE NAABAK 19.6 mg/0.4 ml, eye drops in single-dose containers?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the outer packaging after EXP. The expiration date refers to the last day of this month. Store at a temperature not exceeding 25°C.
Do not dispose of any medicine in the drain or with the household waste. Ask your pharmacist to dispose of any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What NAABAK 19.6 mg/0.4 ml eye drops in single-dose containers contain
- The active substance is :
N-acetyl aspartyl glutamic acid (sodium salt)........................................................ 19.6 mg
For one single-dose container
- The other components are :
Sodium hydroxide or hydrochloric acid, purified water.
What is NAABAK 19.6 mg/0.4 ml, eye drops in a single-dose container and what does it contain?
NAABAK is an eye drop solution in a 0.4 ml single-dose container, packaged in boxes of 5, 10, 20, 30, 36 and 60 single-doses.
Marketing authorization holder
LABORATOIRES THEA
12, RUE LOUIS BLERIOT
63017 CLERMONT-FERRAND CEDEX 2
Marketing authorization holder
THEA PHARMA
37 RUE GEORGES BESSE
63100 CLERMONT-FERRAND
Manufacturer
LABORATOIRE UNITHER
ESPACE INDUSTRIEL NORD
151 RUE ANDRE DUROUCHEZ
CS28028
80084 AMIENS CEDEX 2
or
EXCELVISION
RUE DE LA LOMBARDIERE
ZI DE LA LOMBARDIERE
07100 ANNONAY
or
LABORATOIRE UNITHER
1 RUE DE LARQUERIE
50200 COUTANCES
Drug names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder]
{MM/YYYY}
Other
Detailed information on this drug is available on the ANSM (France) website.