NOTICE
ANSM - Updated on: 12/13/2016
Description of the Medicine
VITAMIN B12 CHAUVIN 0.2 mg / 0.4 ml, eye drops in solution in single-dose receptacle
cyanocobalamin
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Please read this leaflet carefully before you start using this medication as it contains important information for you.
You should always use this medication carefully following the information provided in this leaflet or by your doctor, or your pharmacist.
AT· Keep this leaflet. You might need to read it again.
AT· Contact your pharmacist for advice or information.
AT· If you experience any of the side effects, talk to your doctor, or your pharmacist. This also applies to any undesirable effects not mentioned in this leaflet. See section 4.
AT· You should talk to your doctor if you feel uncomfortable or feel uncomfortable.
Do not allow this medication to reach children.
What is in this leaflet?
1. What is VITAMIN B12 CHAUVIN 0.2 mg / 0.4 ml, eye drops in solution in single-dose recipients and in which cases is it used?
2. What should be known before using VITAMINE B12 CHAUVIN 0.2 mg / 0.4 ml, eye drops in solution in single-dose recipients?
3. How to use VITAMINE B12 CHAUVIN 0.2 mg / 0.4 ml, eye drops in solution in single-dose recipients?
4. What are the possible undesirable effects?
5. How to store VITAMINE B12 CHAUVIN 0.2 mg / 0.4 ml, eye drops in solution in single-dose recipients?
6. Contents of the package and other information.
1. WHAT VITAMIN B12 CHAUVIN 0.2 mg / 0.4 ml, eye drops in solution in single-dose containers AND WHAT IT IS USED FOR?
Pharmacotherapeutic group OTHER OPHTHALMOLOGICAL MEDICINAL PRODUCTS. - ATC code: S01XA
This medication is indicated in the adjunctive treatment of ocular healing disorders.
2. BEFORE YOU BEGIN TO USE VITAMIN B12 CHAUVIN 0.2 mg / 0.4 ml, eye drops in solution in single dose container?
Never use VITAMINE B12 CHAUVIN 0.2 mg / 0.4 ml, eye drops in solution in single dose:
AT· if you are allergic (hypersensitive) to Cyanocobalamin or to any of the other ingredients of this medication mentioned in section 6.
Warnings and Precautions
Talk to your doctor or pharmacist before using VITAMINE B12 CHAUVIN 0.2 mg / 0.4 ml, eye drops in solution in single dose .
DO NOT INJECT. DO NOT SWALLOW.
Contact lens wear: Because of the staining of eye drops with vitamin B12, wearing contact lenses is not advisable during the treatment period.
If symptoms persist, take a medical opinion.
In case of concomitant treatment with another eye drops, wait 15 minutes between each instillation.
Children and Youth
Not applicable.
Other medicines and VITAMIN B12 CHAUVIN 0.2 mg / 0.4 ml, eye drops in solution in single-dose recipients
The effectiveness of eye drops may be affected by the simultaneous use of another eye drops.
Inform your doctor or pharmacist if you are taking, have recently taken or may be taking any other medicines.
VITAMIN B12 CHAUVIN 0.2 mg / 0.4 ml, eye drops solution in single dose with food, drink and alcohol
Not applicable.
Pregnancy, breast-feeding and fertility
If you are pregnant or nursing, planning to become pregnant or planning a pregnancy, ask your doctor for advice or pharmacist before taking this medication.
Sport
Not applicable.
Driving and using machines
A temporary visual gene may be felt after instillation of eye drops. It is therefore recommended not to drive or use machines until the vision is clear enough.
VITAMIN B12 CHAUVIN 0.2 mg / 0.4 ml, eye drops in solution in unidose container contains
Not applicable.
3. HOW TO USE VITAMIN B12 CHAUVIN 0.2 mg / 0.4 ml, eye drops in solution in single-dose recipients?
Always use this medication exactly as prescribed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are unsure.
Dosage
AT· 1 drop 3 to 4 times a day.
AT· Each unidose contains a sufficient amount of eye drops to treat both eyes.
AT· Do not exceed the recommended dose.
AT· If the condition persists or worsens, consult an ophthalmologist to adjust your treatment.
Method and route of administration
Ophthalmic pathway.
Instill a drop of eye drops into the conjunctival cul-de-sac of the sick eye, looking up, and gently pulling the lower eyelid down.
For proper use of this eye drops, some precautions should be taken:
AT· Wash your hands thoroughly before proceeding with instillation.
AT· Avoid contact with the eye or eyelids.
AT· Discard the unidose container immediately after use. Do not store for future use.
Frequency of administration
Repeat the 3 or 4 instillations during the day, depending on the needs.
If you have the impression that the effect of VITAMIN B12 CHAUVIN 0.2 mg / 0.4 ml, eye drops in solution in a single dose is too high or too low, talk to your doctor or pharmacist.
If you used more than VITAMIN B12 CHAUVIN 0.2 mg / 0.4 ml, eye drops in solution in a single dose you should not have:
Immediately consult your doctor or pharmacist.
If you forget to use VITAMINE B12 CHAUVIN 0.2 mg / 0.4 ml, eye drops in solution in single dose:
Do not take a double dose to make up for the single dose that you forgot to take.
If you stop using VITAMINE B12 CHAUVIN 0.2 mg / 0.4 ml, eye drops in solution in single dose:
Not applicable.
If you have any further questions about the use of this medication, ask your doctor or pharmacist for more information.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medication can cause side effects, although not everybody gets them.
AT· Possibility of local reactions: irritation (tingling, burning) transient, allergic reactions.
Declaration of side effects
If you experience any undesirable effects, talk to your doctor or pharmacist. This also applies to any undesirable effects not mentioned in this leaflet. You can also report undesirable effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (NSAH) and network of Pharmacovigilance Regional Centers - Website: www.ansm.sante.fr
By reporting adverse effects, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE VITAMIN B12 CHAUVIN 0.2 mg / 0.4 ml, eye drops in solution in single-dose recipients?
Keep this medication out of the reach and sight of children.
Do not use this medication after the expiration date stated on the package and single dose after EXP. The redemption date refers to the last day of that month.
Before opening the single-dose container : This medicinal product does not require any special storage precautions.
After opening the single-dose container : The product must be used immediately. Discard the unidose container after use. Do not store for future use.
Do not use this medication if you notice any visible signs of deterioration.
Do not throw any medicines into the sewer or with the household garbage. Ask your pharmacist to discontinue the medications you are no longer using. These measures will help to protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What VITAMINE B12 CHAUVIN contains 0.2 mg / 0.4 ml, eye drops in solution in single-dose recipients
AT· The active substance is:
Cyanocobalamin ................................................. .................................................. ................ 0.2 mg
For 0.4 ml of eye drops
AT· The other components are: Sodium chloride, purified water
What is VITAMINE B12 CHAUVIN 0.2 mg / 0.4 ml, eye drops in solution in single-dose container and contents of the outer packaging
This medication is in the form of an eye drops solution in a 0.4 ml single-dose container. Boxes of 5, 10, 20, 30 single dose containers.
Not all presentations may be marketed.
Holder of the marketing authorization
CHAUVIN LABORATORY
416 RUE SAMUEL MORSE Â- CS 99535
34961 MONTPELLIER CEDEX 2 Â- FRANCE
Operator of the marketing authorization
CHAUVIN LABORATORY
416 RUE SAMUEL MORSE Â- CS 99535
34961 MONTPELLIER CEDEX 2 Â- FRANCE
Maker
LABORATOIRE CHAUVIN SA
ZI RIPOTIER HAUT
07200 AUBENAS Â- FRANCE
OR
UNITHER LABORATORY
NORTHERN INDUSTRIAL SPACE
151 RUE ANDRE DUROUCHEZ Â- CS 28028
80084 AMIENS CEDEX 2
Names of medicines in the Member States of the European Economic Area
Not applicable.
The last date on which this notice was revised is as follows:
[To be subsequently completed by the Contractor]
{month YYYY}.
Other
Detailed information on this medicinal product is available on the website of the ANSM (France).