NOTICE
ANSM - Updated on : 11/10/2013
Product name
VITAMIN B12 HORUS PHARMA 0.5 PER THOUSAND, eye drops solution
Cyanocobalamin
Box
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 further information or advice, ask your pharmacist.
- If symptoms worsen or persist, consult a doctor.
- If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist.
Leaflet contents
In this leaflet :
1. WHAT IS VITAMIN B12 HORUS PHARMA 0.5 PER THOUSAND, eye drops solution AND WHAT IS IT USED FOR?
2. WHAT DO YOU NEED TO KNOW BEFORE USING VITAMIN B12 HORUS PHARMA 0.5 PER THOUSAND, eye drops solution?
3. HOW DO I USE VITAMIN B12 HORUS PHARMA 0.5 PER THOUSAND, eye drops solution?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE VITAMIN B12 HORUS PHARMA 0.5 PER THOUSAND, eye drops solution?
6. ADDITIONAL INFORMATION
1. WHAT IS VITAMIN B12 HORUS PHARMA 0.5 PER THOUSAND, eye drops solution AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
This medicine is an ocular healing agent.
Therapeutic indications
This drug is recommended as an adjunctive treatment for corneal scarring disorders.
2. WHAT DO I HAVE TO KNOW BEFORE USING VITAMIN B12 HORUS PHARMA 0.5 PER THOUSAND, eye drops solution?
List of information required before taking the medicine
Not applicable.
Contraindications
Never use VITAMIN B12 HORUS PHARMA 0.5 PER THOUSAND, eye drops solution:
if you are allergic (hypersensitive) to the active substance or to any of the other ingredients contained in VITAMIN B12 HORUS PHARMA 0.5 PER THOUSAND, eye drops solution.
Precautions for use; special warnings
Take special care with VITAMIN B12 HORUS PHARMA 0.5 PER THOUSAND, eye drops solution:
Avoid touching the eye or any other surface with the tip of the bottle.
If you wear contact lenses, they should not be worn for the duration of treatment, as VITAMIN B12 HORUS PHARMA 0.5 PER THOUSAND, eye drops will discolour.
Interactions with other drugs
Taking or using other medicines
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
If you need to use another eye drop, space out the 2 administrations by 15 minutes.
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
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
Temporary visual discomfort may generally be experienced after using eye drops in the eye.
You should wait until your vision returns to normal before driving a vehicle or operating machinery.
List of excipients
Not applicable.
3. HOW TO USE VITAMIN B12 HORUS PHARMA 0.5 PER THOUSAND, eye drops solution?
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.
Directions for use
For use in the eyes only.
To ensure proper use of eye drops, certain precautions must be taken:
Wash hands thoroughly before use,
Do not touch your eye, eyelids or other surfaces with the tip of the bottle,
Do not use if the cap appears broken before use,
Stand in front of a mirror.
1. Tilt your head back slightly and look up.
2. With a clean finger, gently pull the lower eyelid until a small pocket appears.
3. Turn the bottle upside down and press to release 1 drop into the eye to be treated.
4. Release the lower eyelid and close your eye. Wipe away any excess.
If a drop falls next to your eye, start again.
If you need to treat both eyes, repeat these steps for the other eye.
Replace the cap and close the bottle immediately after use.
Frequency of administration
Distribute 3 or 4 instillations throughout the day, as needed.
Duration of treatment
If symptoms persist or worsen, consult your doctor to adjust your treatment.
Symptoms and instructions in case of overdose
If you have used more VITAMIN B12 HORUS PHARMA 0.5 PER THOUSAND, eye drops solution than you should have, contact your doctor or pharmacist:
Consult your doctor or pharmacist.
Instructions in case of missed dose(s)
If you forget to use VITAMIN B12 HORUS PHARMA 0.5 PER THOUSAND, eye drops solution:
Do not use a double dose to make up for the one you have forgotten, but simply continue your treatment.
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 side effects
Like all medicines, VITAMIN B12 HORUS PHARMA 0.5 PER THOUSAND, eye drops solution is likely to have undesirable effects, although not everyone is subject to them.
The following adverse reactions have been reported with undetermined frequency (cannot be estimated on the basis of available data):
Immune system disorders
Allergic reaction.
Eye disorders
Transient irritation (stinging, burning).
If you notice any undesirable effects not mentioned in this leaflet, or if any undesirable effects become serious, please inform your doctor or pharmacist.
5. HOW TO USE VITAMIN B12 HORUS PHARMA 0.5 PER THOUSAND, eye drops solution?
Keep out of the reach and sight of children.
Expiration date
Do not use VITAMIN B12 HORUS PHARMA 0.5 PER THOUSAND, eye drops after the expiration date stated on the box or bottle after EXP. The expiry date refers to the last day of the month.
Storage conditions
Store at a temperature not exceeding 25°C.
Any opened bottle must be used within 30 days.
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 HORUS PHARMA 0.5 PER THOUSAND, eye drops solution contain?
The active substance is: cyanocobalamin (vitamin B12).
The other components are: sodium chloride, benzododecinium bromide, sodium edetate, sodium hydroxide or hydrochloric acid (for pH adjustment), purified water.
Pharmaceutical form and contents
What is VITAMIN B12 HORUS PHARMA 0.5 PER THOUSAND, eye drops solution and what does it contain?
It is a clear, pink eye drop solution.
Each box contains 1 plastic bottle of 5 ml.
Name and address of marketing authorization holder and manufacturing authorization holder responsible for batch release, if different
Holder
horus pharma
148 avenue Georges Guynemer
cap vAr
06700 saint-laurent-du-var
Operator
HORUS PHARMA
148 avenue Georges Guynemer
Cap Var
06700 SAINT-LAURENT-DU-VAR
Manufacturer
ALLERGAN PHARMACEUTICALS IRELAND
WESTPORT
CO. MAYO
IRELAND
Drug 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.