NOTICE
ANSM - Updated on : 19/03/2024
Product name
VITABACT 0.173 mg/0.4 ml eye drops in single-dose container
Picloxydine hydrochloride
Box
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 after your treatment.
What does this leaflet contain?
1. What is VITABACT 0.173 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 VITABACT 0.173 mg/0.4 ml, eye drops in single-dose containers?
3. How do I use VITABACT 0.173 mg/0.4 ml, eye drops in a single-dose container?
4. What are the possible side effects?
5. How should VITABACT 0.173 mg/0.4 ml be stored?
6. Package contents and other information.
1. WHAT IS VITABACT 0.173 mg/0.4 ml, eye drops in single-dose containers AND WHAT IS IT USED FOR?
Pharmacotherapeutic class - ANTISEPTIC FOR OPHTHALMIC USE
(S: sense organ) ATC code: S01AX16
This medicine is an antiseptic eye drop.
It is recommended for the treatment of certain superficial eye infections.
You should consult your doctor if you do not feel any improvement or if you feel less well after treatment.
2. WHAT DO I HAVE TO KNOW BEFORE USING VITABACT 0.173 mg/0.4 ml, eye drops in single-dose containers?
Never use VITABACT 0.173 mg/0.4 ml, eye drops in single-dose containers:
- if you are allergic to picloxydine hydrochloride or any of the other ingredients listed in section 6.
Warnings and precautions
- Do not swallow. Do not inject.
- Wash hands before instillation.
- Do not touch the eye with the tip of the unit dose.
- In the event of eye infection, contact lenses should not be worn for the duration of treatment.
- This single-dose eye drop contains no preservatives. It should be used as soon as opened and discarded after use.
Ask your doctor or pharmacist before using VITABACT 0.173 mg/0.4 ml, eye drops in single-dose containers.
Children and adolescents
KEEP OUT OF THE REACH OF CHILDREN.
Other medicines and VITABACT 0.173 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.
Tell your doctor or pharmacist if you are using, have recently used or may use any other medicines.
VITABACT 0.173 mg/0.4 ml, eye drops in single-dose containers with food, drink and alcohol
Not applicable.
Pregnancy and breast-feeding
This medicine should be used with caution during pregnancy and breast-feeding.
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
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.
VITABACT 0.173 mg/0.4 ml, eye drops in single-dose containers contains
Not applicable.
3. HOW DO I USE VITABACT 0.173 mg/0.4 ml, eye drops in single-dose containers?
Always use this medicine exactly as instructed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
The recommended dose is 1 drop, 2 to 6 times a day.
Method and route of administration
- Ophthalmic route
- Looking upwards and pulling the lower eyelid slightly downwards, instill 1 drop into the eye to be treated.
- Use a new single-dose container for each instillation.
Duration of treatment
The duration of treatment will be specified by your doctor. The usual course of treatment should not exceed 10 days.
If you have used more VITABACT 0.173 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 VITABACT 0.173 mg/0.4 ml, eye drops in single-dose containers
Not applicable.
If you stop using VITABACT 0.173 mg/0.4 ml, eye drops in single-dose containers
Not applicable.
If you have any further questions about the use of this medicine, please ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this product may cause undesirable effects, but these do not always occur in everyone.
Local intolerance reactions (transient irritation, possible allergic reactions requiring discontinuation of treatment).
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: www.signalement-sante.gouv.fr
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO CONSERVE VITABACT 0.173 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 that month.
Store at a temperature not exceeding 25°C.
Do not store lunidose after opening.
Do not use if you notice any visible signs of deterioration.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to identify any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What VITABACT 0.173 mg/0.4 ml eye drops in single-dose containers contains
- The active substance is :
Picloxydine hydrochloride................................................................................................... 0.2 mg
Quantity corresponding to picloxydine base .......................................................................0.173 mg
For one single-dose container
- The other components are :
Polysorbate 80, anhydrous glucose, water for injection.
What VITABACT 0.173 mg/0.4 ml, eye drops in single-dose containers is and what it contains
This medicine is available as an eye drop in a single-dose container. Boxes of 10, 20 or 100 single-dose containers.
Marketing authorization holder
LABORATOIRES THEA
12 rue Louis Blériot
631017 CLERMONT-FERRAND cedex 2
Marketing authorization holder
THEA PHARMA
37 RUE GEORGES BESSE
63100 CLERMONT-FERRAND
Manufacturer
EXCELVISION
Rue de la Lombardière
07100 ANNONAY
Product 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.