NOTICE
ANSM - Updated on : 04/06/2018
Product name
VITAMIN B12 THEA 0.05 PER CENT (0.2 mg/0.4 ml), eye drops in single-dose container
Cyanocobalamin
Cover
Please read this leaflet carefully before using this medicine. It contains important information for your treatment.
If you have any further questions, please ask your doctor or pharmacist.
- Keep this leaflet as you may need to read it again.
- If you need more information or advice, ask your pharmacist.
- If symptoms worsen or persist, consult a doctor.
- If you notice any side effects not mentioned in this leaflet, or if you experience any of the effects mentioned as serious, please tell your doctor or pharmacist.
Contents
In this leaflet :
1. WHAT IS VITAMIN B12 THEA 0.05 PER CENT (0.2 mg/0.4 ml), eye drops in single-dose containers AND WHAT IS IT USED FOR?
2. WHAT DO I HAVE TO KNOW BEFORE USING VITAMIN B12 THEA 0.05 PER CENT (0.2 mg/0.4 ml), eye drops in single-dose containers?
3. HOW TO USE VITAMIN B12 THEA 0.05 PER CENT (0.2 mg/0.4 ml), eye drops in single-dose containers?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE VITAMIN B12 THEA 0.05 PER CENT (0.2 mg/0.4 ml), eye drops in single-dose container?
6. ADDITIONAL INFORMATION
1. WHAT IS VITAMIN B12 THEA 0.05 PER CENT (0.2 mg/0.4 ml), eye drops in single-dose containers AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
OPHTHALMIC/HEALING DRUG
(S: sensory organ)
Therapeutic indications
This drug is recommended as an adjunctive treatment for ocular scarring disorders.
2. WHAT DO I HAVE TO KNOW BEFORE USING VITAMIN B12 THEA 0.05 PER CENT (0.2 mg/0.4 ml), eye drops in single-dose containers?
What you should know before taking this medicine
Not applicable.
Contraindications
Never use VITAMIN B12 THEA 0.05 PER CENT (0.2 mg/0.4 ml), eye drops in single-dose containers in the following cases:
- if you are allergic (hypersensitive) to cyanocobalamin or any of the other ingredients of VITAMIN B12 THEA 0.05 per cent (0.2 mg/0.4 ml), eye drops in single-dose containers.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Precautions for use; special warnings
Take special care with VITAMIN B12 THEA 0.05 PER CENT (0.2 mg/0.4 ml), eye drops in single-dose containers:
Special warnings
Due to the coloration of vitamin B12 eye drops, contact lenses should not be worn for the duration of treatment.
Precautions for use
In the event of persistent or worsening symptoms: CONSULT YOUR DOCTOR so that he/she can adapt your treatment.
To avoid contamination, do not touch the eye, eyelids or any other surface with the single-dose tip.
In the event of concomitant treatment with another eye drop, wait 15 minutes between instillations.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Interactions with other drugs
Taking or using other medications:
If you are currently using (or plan to use) another eye drop, wait 15 minutes between instillations.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medication, even if obtained without a prescription.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and breast-feeding
Pregnancy and breast-feeding
Under normal conditions of use, this medicine may be used during pregnancy and while breast-feeding.
As a general rule, ask your doctor or pharmacist for advice before taking any medication.
Sportsmen
Not applicable.
Effects on ability to drive and use machines
Driving vehicles and using machines:
A brief visual disturbance may occur after instillation of the product. Wait until normal vision is restored before driving a vehicle or operating machinery.
List of excipients
Not applicable.
3. HOW TO USE VITAMIN B12 THEA 0.05 PER CENT (0.2 mg/0.4 ml), eye drops in single-dose containers?
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage
Always follow the dosage instructions given by your doctor. If in doubt, consult your doctor or pharmacist.
The usual dose is 1 drop in the eye(s) to be treated, 3 to 4 times a day if necessary.
Method and route of administration
DO NOT INJECT, DO NOT SWALLOW.
This drug is intended for instillation into the eye (ophthalmic route).
Wash your hands thoroughly before instilling,
Avoid contact of the unit-dose tip with the eye, eyelids or any other surface.
Instill 1 drop into the eye, looking upwards and pulling the lower eyelid slightly downwards,
Dispose of the single-dose container after use. Do not keep the single-dose container for future use.
Symptoms and instructions in case of overdose
If you have used more VITAMIN B12 THEA 0.05 PER CENT (0.2 mg/0.4 ml), eye drops in single-dose containers than you should have, contact your doctor or pharmacist:
In case of overdose, rinse with sterile saline solution.
Instructions in case of missed dose(s)
If you forget to take VITAMIN B12 THEA 0.05 PER CENT (0.2 mg/0.4 ml), eye drops in unidose container:
Do not take a double dose to make up for the one you forgot to take.
Risk of withdrawal syndrome
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?
Description of undesirable effects
As with all medicines, this drug may cause undesirable effects, but they do not occur systematically in everyone.
- Allergic reactions may occur.
Reporting side effects
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.ansm.sante.fr.
By reporting adverse reactions, you contribute to providing more information on drug safety.
5. HOW TO USE VITAMIN B12 THEA 0.05 PER CENT (0.2 mg/0.4 ml), eye drops in single-dose container?
Keep out of the reach and sight of children.
Expiration date
Do not use VITAMIN B12 THEA 0.05 PER CENT (0.2 mg/0.4 ml), eye drops in single-dose containers after the expiration date stated on the outer packaging.
Storage conditions
Discard single-dose container after use.
Do not store for future use.
If necessary, warnings against certain visible signs of deterioration
Medicines must not be disposed of down the drain or with household waste. Ask your pharmacist what to do with unused medicines. These measures will help protect the environment.
6. FURTHER INFORMATION
Complete list of active ingredients and excipients
What does VITAMIN B12 THEA 0.05 PER CENT (0.2 mg/0.4 ml), eye drops in single-dose containers contain?
The active substance is:
Cyanocobalamin ............................................................................................................................ 0.2 mg
For one single-dose container.
The other components are:
Sodium chloride, purified water.
Pharmaceutical form and contents
What is VITAMIN B12 THEA 0.05 PER CENT (0.2 mg/0.4 ml), eye drops in a single-dose container and what does it contain?
This medicine comes in the form of 0.04 ml single-dose eye drops.
Boxes of 5, 10, 20 and 30 single-dose containers.
Name and address of the marketing authorization holder and of the manufacturing authorization holder responsible for batch release, if different
Holder
LABORATOIRES THEA
12, RUE LOUIS BLERIOT
63017 CLERMONT-FERRAND CEDEX 2
Operator
THEA PHARMA
12 RUE LOUIS BLERIOT
ZI DU BREZET
63100 CLERMONT FERRAND
Manufacturer
LABORATOIRES UNITHER
ZI LONGPRE
10 RUE ANDRE DUROUCHEZ
80084 AMIENS CEDEX 02
Product names in member states of the European Economic Area
Not applicable.
Date of approval of the package leaflet
This leaflet was last approved on {date}.
MA under exceptional circumstances
Not applicable.
Internet information
Detailed information on this product is available on the Afssaps (France) website.
Information reserved for healthcare professionals
Not applicable.
Other
Not applicable.