Bausch + Lomb Sensivision single-dose eye drops

LEAFLET
ANSM - Updated on: 11/30/2020

IN THIS ANNEX, THE TERMS "MARKETING AUTHORIZATION" ARE UNDERSTOOD AS "REGISTRATION OF A TRADITIONAL HERBAL MEDICINAL PRODUCT" AND THE TERM "AUTHORIZATION" AS "REGISTRATION"

Name of the medicinal product
SENSIVISION PLANTAIN, eye drops in single-dose container
Ribwort plantain (soft leaf extract)
Box
Please read this leaflet carefully before using this medicine because it contains important information for you.
You must always use this medicine exactly as provided in this leaflet or by your doctor or pharmacist.
Keep this leaflet. You may need to read it again.
Ask your pharmacist for advice or information. If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
You must talk to your doctor if you do not feel better or if you feel worse after 2 days.
What is in this leaflet?
1. What is SENSIVISION AU PLANTAIN, single-dose eye drops and what is it used for?
2. What you need to know before you use SENSIVISION AU PLANTAIN, single-dose eye drops?
3. How to use SENSIVISION AU PLANTAIN, single-dose eye drops?
4. Possible side effects?
5. How to store SENSIVISION AU PLANTAIN, single-dose eye drops?
6. Contents of the pack and other information.
1. WHAT IS SENSIVISION PLANTAIN, single-dose eye drops AND WHAT IS IT USED FOR?
SENSIVISION PLANTAIN, single-dose eye drops is a traditional herbal medicine used for eye irritation or discomfort due to various causes (smoky atmosphere, sustained visual effort, sea or pool bathing, etc.).
Its use is reserved for the specified indication based solely on long-standing use.
SENSIVISION PLANTAIN, single-dose eye drops is indicated for adults.
You should consult your doctor if you do not feel any improvement or if you feel worse after 2 days.
2. WHAT YOU NEED TO KNOW BEFORE USING SENSIVISION PLANTAIN, single-dose eye drops?

Never use SENSIVISION AU PLANTAIN, single-dose eye drops:
· if you are allergic to ribwort plantain or any of the other ingredients of this medicine, listed in section 6.
· when irritation is accompanied by pus (eyelids sticking together in the morning upon waking),
· in case of severe pain, direct shock, or injury.
Consult a doctor promptly.
Warnings and precautions
Talk to your doctor or pharmacist before using SENSIVISION AU PLANTAIN, single-dose eye drops.
For minor ailments only. If symptoms worsen or persist for more than two days, consult a doctor.
Wearing contact lenses is not recommended while using eye drops. Wait 30 minutes before replacing the lens.
This medicine contains methyl parahydroxybenzoate, which may cause allergic reactions (possibly delayed). Children and Adolescents
There is no relevant use of SENSIVISION AU PLANTAIN, single-dose eye drops in children and adolescents under 18 years of age.
Other medicines and SENSIVISION AU PLANTAIN, single-dose eye drops
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
SENSIVISION AU PLANTAIN, single-dose eye drops with food and drink
Not applicable.
Pregnancy and Breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist before taking this medicine.
Due to a lack of data, the use of SENSIVISION AU PLANTAIN, single-dose eye drops is not recommended during pregnancy and breastfeeding.
Driving and using machines
Not applicable.
SENSIVISION PLANTAIN eye drops in a single-dose container contain boric acid, borax, and methyl parahydroxybenzoate.
3. HOW TO USE SENSIVISION PLANTAIN eye drops in a single-dose container?
Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are unsure.
Dosage
Adults
The recommended dose is 1 to 2 drops in each eye, 2 to 4 times a day.
Use in children and adolescents
This medicine is not indicated for children and adolescents under 18 years of age.

Method of administration
For ophthalmic use.
When using this eye drop, follow these steps:
1. Wash your hands thoroughly before applying the eye drops. 2. Avoid contact with the tip of the single-dose container with your fingers or your eye.
3. Pull your lower eyelid down slightly while looking up.
4. Place a drop of eye drops into the space formed.
5. Close your eye for a few seconds.
6. With your eye closed, wipe off any excess.
7. Press a finger on the corner of your eye near your nose for 2 minutes. This will reduce the passage of the active ingredient (ribwort plantain) into the rest of your body.
8. Discard the single-dose container immediately after use.
Treatment duration
Treatment should not be extended beyond 2 days without medical advice.
If symptoms persist while using this medication, consult a doctor or qualified healthcare professional. If you use more SENSIVISION PLANTAIN eye drops in single-dose container than you should
Not applicable.
If you forget to use SENSIVISION PLANTAIN eye drops in single-dose container
Not applicable.
If you stop using SENSIVISION PLANTAIN eye drops in single-dose container
Not applicable.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Hypersensitivity reactions or local irritation such as burning, stinging, or tearing may occur after instillation.
The frequency of this type of reaction is not known. If other side effects not listed above occur, consult a doctor or a qualified healthcare professional.
Reporting of side effects
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.signalement-sante.gouv.fr
By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE SENSIVISION AU PLANTAIN, eye drops in single-dose container?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date shown on the outer packaging after EXP. The expiry date refers to the last day of that month. Store below 25°C.
Do not store after opening the single-dose container.
Do not use this medicine if you notice any visible signs of deterioration.
Do not dispose of any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What SENSIVISION PLANTAIN, eye drops in single-dose container contains
· The active ingredient is:
Ribbon plantain (soft leaf extract)............................................................................ 8 mg
Per 0.4 mL single-dose container.
· The other ingredients are:
Boric acid, borax, disodium edetate, methyl parahydroxybenzoate, purified water.
What is SENSIVISION PLANTAIN, eye drops in single-dose container and contents of the outer packaging?
This medicine is presented as eye drops in single-dose containers.
Box of 5, 10, 15, or 20 single-dose containers.
Not all pack sizes may be marketed. Marketing Authorization Holder
LABORATOIRE CHAUVIN
416 RUE SAMUEL MORSE - CS 99535
34961 MONTPELLIER
Marketing Authorization Holder
LABORATOIRE CHAUVIN
416 RUE SAMUEL MORSE - CS 99535
34961 MONTPELLIER
Manufacturer
LABORATOIRE CHAUVIN
ZONE INDUSTRIELLE DE RIPOTIER
50 AVENUE JEAN MONNET
07200 AUBENAS
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.

This leaflet was last revised:
[to be completed later by the holder]
{month YYYY}.
Other
Detailed information on this medicinal product is available on the ANSM website (France).