NOTICE
ANSM - Last updated: 29/02/2012
Name of the medicinal product
VITAMIN A DULCIS 25 000 IU PER 100 g, ophthalmic ointment
Vitamin A
framed
Read this leaflet carefully before you start using this medicine. It contains important information for your treatment.
If you have any further questions, ask your doctor or pharmacist.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, ask your pharmacist.
· If symptoms worsen or persist, consult a physician.
· 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.
Review summary
In this notice :
1. WHAT IS VITAMIN A DULCIS 25 000 IU PER 100 g Ophthalmic Ointment WHAT IS IT FOR?
2. BEFORE YOU USE VITAMIN A DULCIS 25 000 IU PER 100 g Ophthalmic Ointment?
3. HOW TO USE VITAMIN A DULCIS 25,000 IU PER 100 g Ophthalmic Ointment?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE VITAMIN A DULCIS 25 000 IU PER 100 g, Ophthalmic Ointment?
6. ADDITIONAL INFORMATION
1. WHAT IS VITAMIN A DULCIS 25 000 IU PER 100 g Ophthalmic Ointment WHAT IS IT FOR?
Pharmacotherapeutic group
This medication is an ocular healing.
Therapeutic indications
This medication is used:
· in case of severe dryness of the eye.
· in complementary treatment in the event of disorders of corneal healing.
2. BEFORE YOU USE VITAMIN A DULCIS 25 000 IU PER 100 g Ophthalmic Ointment?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never use VITAMINE A DULCIS 25,000 IU PER 100 g ophthalmic ointment:
· If you are allergic (hypersensitive) to the active substance or any of the other ingredients of VITAMIN A DULCIS ophthalmic ointment.
Precautions for use; special warnings
Take special care with VITAMINE A DULCIS 25 000 IU per 100 g, ophthalmic ointment:
This ointment contains wool fat (lanolin) and can cause skin reactions (eg eczema).
Interaction with other medicines
Use of 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 also need to put eye drops, wait 15 minutes to put it on.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
It is best not to use this medication during pregnancy.
Ask your doctor or pharmacist for advice before taking any medicine.
Sport
Not applicable.
Effects on ability to drive or use machines
Driving and using machines
Transient visual impairment may be experienced after use of an ointment in the eye. You must wait until your vision returns to normal before driving a vehicle or using a machine.
List of excipients with known effect
Important information about some of the ingredients of VITAMINE A DULCIS 25,000 IU PER 100 g, ophthalmic ointment
This medication contains wool fat (lanolin) and may cause skin reactions (eg, eczema).
3. HOW TO USE VITAMIN A DULCIS 25,000 IU PER 100 g Ophthalmic Ointment?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
Always take the dose recommended by your doctor. If in doubt, consult your doctor or pharmacist.
The usual dose is the equivalent of a grain of rice in the sac of conjunctival sac 2 to 3 times a day.
Administration mode
For use in the eyes only.
Wash your hands thoroughly beforehand.
Apply the ointment by pulling the eyelid downward while looking up and drop the ointment between the eyelid and the eyeball.
Replace the tube after administration.
Frequency of Administration
Distribute the 2 or 3 applications during the day, according to the needs.
Duration of treatment
If the condition persists or worsens, consult a doctor to adjust your treatment.
Symptoms and Instructions for Overdose
If you used more VITAMIN A DULCIS 25,000 IU PER 100 g ophthalmic ointment than you should:
Consult your doctor or pharmacist.
Instructions for omission of one or more doses
If you forget to use VITAMINE A DULCIS 25,000 IU PER 100 g ophthalmic ointment:
Do not use a double dose to make up for the missed dose, but simply continue with your treatment.
Risk of withdrawal syndrome
If you stop using VITAMINE A DULCIS 25,000 IU PER 100 g ophthalmic ointment:
Not applicable.
If you have any further questions about the use of this ointment, ask your doctor or pharmacist.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, VITAMIN A DULCIS 25,000 IU PER 100 g, ophthalmic ointment is likely to have undesirable effects, although not everyone is subject to it.
The following adverse reactions have been reported with an indeterminate frequency (can not be estimated from the available data):
Immune system disorders
Allergic reaction.
Eye disorders
Transient irritation (tingling, burns).
If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, please tell your doctor or pharmacist.
5. HOW TO STORE VITAMIN A DULCIS 25 000 IU PER 100 g, Ophthalmic Ointment?
Keep out of the reach and sight of children.
Expiration date
Do not use VITAMIN A DULCIS 25 000 IU PER 100 g ophthalmic ointment after the expiry date stated on the tube and carton after EXP. The expiry date refers to the last day of the month.
Storage conditions
Store at a temperature not exceeding 25 ° C.
Any open tube must be used within 28 days.
If necessary, warnings against visible signs of deterioration
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What does VITAMINE A DULCIS contain 25,000 IU PER 100 g, ophthalmic ointment?
The active substance is : synthetic vitamin A (concentrate of) in oily form.
The other components are :
Wool grease, liquid paraffin, vaseline.
Pharmaceutical form and content
What is VITAMINE A DULCIS 25,000 IU PER 100 g, ophthalmic ointment and contents of the pack?
Ophthalmic ointment.
Tube of 10 g. Box of 1.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Holder
ALLERGAN FRANCE
12 DEFENSE PLACE
92400 COURBEVOIE
exploiting
ALLERGAN FRANCE
12 DEFENSE PLACE
92400 COURBEVOIE
Maker
TUBILUX PHARMA SPA
VIA COSTARICA 20/22
00040 POMEZIA
ROME
ITALY
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the notice
The last date on which this leaflet was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the Afssaps website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.