The eye drop vitamin B12 Chauvin is indicated for the adjunct therapy for ocular healing. It is available without a prescription and is presented as unidoses.
The active substance of this Healing eye drops is, as its name suggests, vitamin B12 or cyanocobalamin (0.2 mg per 0.4 ml of eye drops or a dosette). The excipients are simply sodium chloride and purified water.
How to use the healing vitamin B12 eye drops
You can do 3 or 4 instils over the day.
Each single dose should be discarded systematically after use even if vitamin B12 eye drops in it. You should not keep it for future use.
Before using this Healing eye drops, wash your hands and then break the tip of the pod, taking care that it does not come into contact with either your fingers or the eye.
Pull the eyelid down and look at the ceiling, leaning your head back. Put 1 to 2 drops in the hollow formed.
Close the eye for a few seconds and wipe the surplus with a gauze.
Precautions for use of vitamin B12 Chauvin eye drops
If you need to use more eye drops, leave at least 15 minutes between each injection.
Cyanocobalamin or vitamin B12 is a coloured eye drops: the wearing of contact lenses is therefore not recommended during the use of this eye drops.
Medical advice is required prior to use during pregnancy and/or breast-feeding.
If symptoms persist or get worse: blurred vision, irritation, pain, redness, it is important to seek medical advice promptly.
After instillation of the Eye drops Vitamine B12 Chauvin, a slight disturbance in vision may occur. Wait until it disappears before you get behind the wheel of your vehicle or drive a machine.
Do not use in case of known allergy to cyanocobalamin.
Read the package leaflet carefully before use.
Packaging : pack of 10 single-dose containers
SUMMARY OF PRODUCT FEATURES
ANSM - Updated on: 02/20/2023
1. NAME OF THE MEDICINE
CHAUVIN VITAMIN B12 0.2 mg/0.4 mL, eye drops solution in single-dose container
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Cyanocobalamin........................................................................................................................ 0.2 mg
For 0.4 mL
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Eye drops in solution in single-dose container.
4. CLINICAL DATA
4.1. Therapeutic indications
Adjunctive treatment of corneal healing disorders.
4.2. Dosage and method of administration
Ophthalmic route.
Wash your hands thoroughly before instilling.
Avoid contact of the tip with the eye or eyelids.
Dosage
Instill 1 drop of eye drops 3 to 4 times a day, depending on the eye problems, into the conjunctival sac of the affected eye, looking upwards and pulling the eyelid slightly downwards.
Each single-dose container contains enough eye drops to treat both eyes
Mode of administration
Discard the unit-dose container after use; do not store it for later instillation.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
DO NOT INJECT, DO NOT SWALLOW.
Due to the coloring of vitamin B 12 eye drops, wearing contact lenses is not recommended for the duration of treatment.
In case of concomitant treatment with another eye drop, wait 15 minutes between each instillation.
4.5. Interactions with other medicinal products and other forms of interaction
The effectiveness of one eye drop may be affected by the simultaneous instillation of another eye drop.
4.6. Fertility, pregnancy and breastfeeding
Not applicable.
4.7. Effects on ability to drive and use machines
Not applicable.
4.8. Adverse effects
• Possibility of allergic reactions as with all other eye drops.
• Temporary discomfort (tingling, burning eyes) may be felt after instilling the eye drops.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after drug authorization is important. It allows for continued monitoring of the drug's benefit/risk balance. Healthcare professionals report any suspected adverse reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: https://signalement.social-sante.gouv.fr/ .
4.9. Overdose
Not applicable.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
Pharmacotherapeutic group: OTHER OPHTHALMOLOGICAL MEDICINES,
ATC code: S01XA.
Eye drops for healing purposes.
5.2. Pharmacokinetic properties
Not applicable.
5.3. Preclinical safety data
Not applicable.
6. PHARMACEUTICAL DATA
6.1. List of excipients
Sodium chloride, purified water.
6.2. Incompatibilities
Not applicable.
6.3. Retention period
2 years
After opening the single-dose container: the product must be used immediately.
Discard the single-dose container after use.
Do not store for later use.
6.4. Special storage precautions
This medicine does not require any special storage precautions.
For storage conditions of the medicinal product after first opening, see section 6.3.
6.5. Nature and contents of outer packaging
Single-dose containers (LDPE) of 0.4 mL in sachets (Polyethylene/aluminum). Box of 5, 10, 20 or 30 single-dose containers.
Not all presentations may be marketed.
6.6. Special precautions for disposal and handling
No special requirements.
Any unused medicine or waste material should be disposed of in accordance with local regulations.
7. MARKETING AUTHORISATION HOLDER
CHAUVIN LABORATORY
416 RUE SAMUEL MORSE - CS 99535
34961 MONTPELLIER
8. MARKETING AUTHORISATION NUMBER(S)
· CIP 34009 367 300 1 4: 0.4 mL in single-dose container (LDPE); box of 5.
· CIP 34009 367 301 8 2: 0.4 mL in single-dose container (LDPE); box of 10.
· CIP 34009 367 302 4 3: 0.4 mL in single-dose container (LDPE); box of 20.
· CIP 34009 367 303 0 4: 0.4 mL in single-dose container (LDPE); box of 30.
9. DATE OF FIRST AUTHORIZATION/RENEWAL OF AUTHORIZATION
[to be completed later by the holder]
Date of first authorization: {DD month YYYY}
Last renewal date: {DD month YYYY}
10. DATE OF TEXT UPDATE
[to be completed later by the holder]
{DD month YYYY}
11. DOSIMETRY
Not applicable.
12. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS
Not applicable.
CONDITIONS OF PRESCRIPTION AND DELIVERY
Drug not subject to medical prescription.
NOTICE
ANSM - Updated on: 02/20/2023
Name of the drug
CHAUVIN VITAMIN B12 0.2 mg/0.4 mL, eye drops solution in single-dose container
Cyanocobalamin
Boxed
Please 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 directed in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You may need to read it again.
· Contact your pharmacist for any 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 should contact your doctor if you do not feel any improvement or if you feel worse.
What does this leaflet contain?
1. What is CHAUVIN VITAMIN B12 0.2 mg/0.4 mL, eye drops, solution in single-dose container and what is it used for?
2. What information should you know before using VITAMIN B12 CHAUVIN 0.2 mg/0.4 mL, eye drops, solution in single-dose container?
3. How to use CHAUVIN VITAMIN B12 0.2 mg/0.4 mL, eye drops solution in single-dose container?
4. What are the possible side effects?
5. How to store CHAUVIN VITAMIN B12 0.2 mg/0.4 mL, eye drops solution in single-dose container?
6. Package contents and other information.
1. WHAT IS CHAUVIN VITAMIN B12 0.2 mg/0.4 mL, eye drops, solution in single-dose container AND WHAT IS IT USED FOR?
Pharmacotherapeutic group OTHER OPHTHALMOLOGICAL MEDICINES. - ATC code: S01XA
This medication is indicated in the adjunctive treatment of eye healing disorders.
2. WHAT YOU NEED TO KNOW BEFORE USING CHAUVIN VITAMIN B12 0.2 mg/0.4 mL, eye drops, solution in single-dose container?
Never use CHAUVIN VITAMIN B12 0.2 mg/0.4 mL, eye drops solution in single-dose container:
· if you are allergic to Cyanocobalamin or any of the other ingredients of this medicine, listed in section 6.
Warnings and Precautions
Talk to your doctor or pharmacist before using VITAMIN B12 CHAUVIN 0.2 mg/0.4 mL, eye drops, solution in single-dose container .
DO NOT INJECT. DO NOT SWALLOW.
Contact lens wear : Due to the coloring of vitamin B12 eye drops, wearing contact lenses is not recommended during treatment.
If symptoms persist, seek medical advice.
In case of concomitant treatment with another eye drop, wait 15 minutes between each instillation.
Children and adolescents
Not applicable.
Other medicines and VITAMIN B12 CHAUVIN 0.2 mg/0.4 mL, eye drops, solution in single-dose container
The effectiveness of one eye drop may be affected by the simultaneous use of another eye drop.
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
CHAUVIN VITAMIN B12 0.2 mg/0.4 mL, eye drops, solution in single-dose container with food, drinks and alcohol
Not applicable.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, 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 operating machinery
Temporary visual discomfort may be experienced after instilling the eye drops. It is therefore recommended not to drive or operate machinery until vision is sufficiently clear.
CHAUVIN VITAMIN B12 0.2 mg/0.4 mL, eye drops solution in single-dose container contains
Not applicable.
3. HOW TO USE CHAUVIN VITAMIN B12 0.2 mg/0.4 mL, eye drops solution in single-dose container?
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are unsure.
Dosage
· The recommended dose is 1 drop 3 to 4 times a day.
· Each single-dose unit contains enough eye drops to treat both eyes.
· Do not exceed the recommended dose.
· If the problems persist or worsen, consult an ophthalmologist so that your treatment can be adjusted.
Method and route of administration
Ophthalmic route.
Instill one drop of eye drops into the conjunctival sac of the affected eye, looking upwards and pulling the lower eyelid slightly downwards.
For proper use of this eye drop, certain precautions must be taken:
· Wash your hands thoroughly before instilling.
· Avoid contact of the tip of the bottle with the eye or eyelids.
· Discard the single-dose container immediately after use. Do not store it for future use.
Frequency of administration
Spread the 3 or 4 instillations throughout the day, depending on your needs.
If you have the impression that the effect of VITAMIN B12 CHAUVIN 0.2 mg/0.4 mL, eye drops, solution in single-dose container is too strong or too weak, consult your doctor or pharmacist.
If you use more CHAUVIN VITAMIN B12 0.2 mg/0.4 mL, eye drops, solution in single-dose container than you should
Consult your doctor or pharmacist immediately.
If you forget to use CHAUVIN VITAMIN B12 0.2 mg/0.4 mL, eye drops, solution in single-dose container
Do not take a double dose to make up for a forgotten single dose.
If you stop using CHAUVIN VITAMIN B12 0.2 mg/0.4 mL, eye drops, solution in single-dose container
Not applicable.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
· Possibility of local reactions: transient irritation (tingling, burning), allergic reactions.
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: https://signalement.social-sante.gouv.fr/
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE CHAUVIN VITAMIN B12 0.2 mg/0.4 mL, eye drops solution 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 and single-dose container after EXP. The expiry date refers to the last day of that month.
Before opening the single-dose container : This medicine does not require any special storage precautions.
After opening the single-dose container : The product must be used immediately. Discard the single-dose container after use. Do not store it for later use.
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 you no longer use. These measures will help to protect the environment.
6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION
What VITAMIN B12 CHAUVIN 0.2 mg/0.4 mL, eye drops solution in single-dose container contains
· The active substance is:
Cyanocobalamin............................................................................................................ 0.2 mg
For 0.4 mL of eye drops
· Other ingredients are: Sodium chloride, purified water.
What is VITAMIN B12 CHAUVIN 0.2 mg/0.4 mL, eye drops, solution in single-dose container and contents of the outer packaging?
This medicine comes in the form of eye drops in solution in a 0.4 mL single-dose container. Boxes of 5, 10, 20, 30 single-dose containers.
Not all presentations may be marketed.
Marketing Authorisation Holder
CHAUVIN LABORATORY
416 RUE SAMUEL MORSE – CS 99535
34961 MONTPELLIER
Marketing Authorization Operator
CHAUVIN LABORATORY
416 RUE SAMUEL MORSE – CS 99535
34961 MONTPELLIER
Manufacturer
CHAUVIN LABORATORY
RIPOTIER INDUSTRIAL ZONE
50 AVENUE JEAN MONNET
07200 AUBENAS
OR
UNITHER LABORATORY
NORTH INDUSTRIAL SPACE
151 RUE ANDRE DUROUCHEZ – CS 28028
80084 AMIENS CEDEX 2
Names of the medicine in the member states of the European Economic Area
Not applicable.
The last date this notice was revised is:
[to be completed later by the holder]
{month YYYY}.
