NOTICE
ANSM - Updated: 30/06/2017
Name of the drug
HOMEOPTIC, eye drops in single-dose container
framed
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
You should always use this medicine exactly as described in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Talk to your pharmacist for any advice or information.
· If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you feel no improvement or feel worse after 2 days.
What does this booklet contain ?
1. What is HOMEOPTIC, eye drops in single-dose container and in which cases is it used?
2. What information do you need to know before using HOMEOPTIC eye drops in a single-dose container?
3. How to use HOMEOPTIC, eye drops in single-dose container?
4. What are the possible side effects?
5. How to store HOMEOPTIC, eye drops in single-dose container?
6. Contents of the package and other information.
1. WHAT IS HOMEOPTIC, eye drops in a single-dose container AND WHAT IT IS USED FOR?
Pharmacotherapeutic group: Homeopathic medicine.
HOMEOPTIC, eye drops in single-dose container is a homeopathic medicine traditionally used in adults and children from one year, in case of irritation or ocular discomfort of various origins (sustained visual effort, bath of sea or pool, eyestrain, smoky atmosphere, etc ...).
2. BEFORE YOU USE HOMEOPTIC, eye drops in a single-dose container?
NEVER use HOMEOPTIC, eye drops in single-dose container:
· if you are allergic to the active substances or to any of the other ingredients of this medicine, listed in section 6.
· in children under one year old.
Warnings and precautions
· when the irritation is accompanied by pus (eyelids stuck in the morning upon waking) or in case of pain vi
· ve, direct shock or injury: then promptly consult a doctor.
· To be reserved for minor ailments, if the symptoms increase or persist for more than two days, consult a doctor.
· Wearing contact lenses is not recommended for the duration of the treatment.
· During application, avoid contact of the tip of the container with the eyeball or eyelashes.
children
Do not use in children under 1 year.
Other medicines and HOMEOPTIC, eye drops in single-dose container
Tell your doctor or pharmacist if you use, have recently used, or may use any other medicines.
HOMEOPTIC, eye drops in single-dose container with food, drinks and alcohol
Not applicable.
Pregnancy and breast feeding
In the absence of experimental and clinical data and as a precaution, the use of this drug should be avoided during pregnancy.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Not applicable.
HOMEOPTIC, eye drops in a single-dose container contains
Not applicable.
3. HOW TO USE HOMEOPTIC, eye drops in single-dose container?
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if in doubt.
Dosage
The usual dose is 1 to 2 drops in each eye, 2 to 6 times a day.
Stop treatment as soon as the symptoms disappear.
Administration mode
Ophthalmic way.
1. Open the aluminum bag.
2. Detach a single-dose vial from the barrette.
3. Open the single dose by rotating the tip.
4. Pull the lower eyelid down while looking up and drop a drop of eyedrops between the eyelid and the eye (in the conjunctival cul-de-sac), pressing the single dose slightly.
5. Carefully close the pouch containing the other single doses by folding the open side.
In order to instill an always sterile solution, use a new single dose unit for each application.
If you have the impression that the effect of HOMEOPTIC eye drops in a single-dose container is too strong or too weak, consult your doctor or pharmacist.
Use in children
Not applicable.
If you have used more HOMEOPTIC, eye drops in a single-dose container than you should
Consult your doctor or your pharmacist.
If you forget to use HOMEOPTIC, eye drops in single-dose container
Do not take a double dose to make up for the dose you forgot to take.
If you stop using HOMEOPTIC, eye drops in single-dose container
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is not mentioned 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.ansm.sante.fr
By reporting side effects, you can help provide more information about the safety of the medicine.
5. HOW TO STORE HOMEOPTIC, 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 which is stated on the carton. The expiry date refers to the last day of the month.
Keep away from heat.
Do not dispose of any medication in the sewage system or in the household garbage. Ask your pharmacist to eliminate medications that you no longer use. These measures will help protect the environment.
6. CONTENTS OF PACKAGING AND OTHER INFORMATION
What HOMEOPTIC contains, eye drops in single-dose container
· The active substances are:
Euphrasia officinalis 3 DH .............................................. .................................................. ..... 0.004 g
Calendula officinalis 3 DH .............................................. .................................................. ..... 0.001 g
Magnesia carbonica 5 CH .............................................. .................................................. ..... 0.001 g
For a dose of 0.4 ml
· The other components are:
Sodium chloride, purified water.
What is HOMEOPTIC, eye drops in single-dose container and contents of the pack
This medicine comes in the form of eye drops in a single-dose container without preservatives. The box contains 2 or 4 sachets of 5 single doses.
Marketing Authorization Holder
Boiron
2 AVENUE OF WESTERN LYONNAIS
69510 MESSIMY
la France
Operator of the marketing authorization
Boiron
2 AVENUE OF WESTERN LYONNAIS
69510 MESSIMY
la France
Maker
Boiron
ZAC DES FRENES
1 EDOUARD BUFFARD STREET
77144 MONTEVRAIN
LA FRANCE
Names of the drug in the member states of the European Economic Area
Not applicable.
The last date this leaflet was revised is:
{month YYYY}
Other
Detailed information on this medicine is available on the ANSM website (France).