NOTICE
ANSM - Last updated: 30/11/2015
Name of the medicinal product
VITABACT 0.05 PERCENT, eye drops
Picloxydine hydrochloride
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 VITABACT 0.05 PERCENT, eye drops AND IN WHAT CASES IS IT USED?
2. BEFORE YOU USE VITABACT 0.05 PERCENT, eye drops?
3. HOW TO USE VITABACT 0.05 PERCENT, eye drops?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE VITABACT 0.05 PERCENT, eye drops?
6. ADDITIONAL INFORMATION
1. WHAT VITABACT 0.05 PERCENT, eye drops AND IN WHAT CASES IS IT USED?
Pharmacotherapeutic group
ANTISEPTIC FOR OPHTHALMIC USE
(S: sensory organs)
Therapeutic indications
This medication is an antiseptic eye drops.
This drug is recommended in the treatment of certain superficial infections of the eye.
2. BEFORE YOU USE VITABACT 0.05 PERCENT, eye drops?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never use VITABACT 0.05 PERCENT, eye drops in the following cases:
· Allergy known to one of the constituents of eye drops.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Precautions for use; special warnings
Take special care with VITABACT 0.05 PERCENT, eye drops:
Precautions for use
· Do not swallow. Do not inject.
· Wash hands before instillation.
· Do not touch the eye with the tip of the vial.
· Re-close this one carefully after use.
· In case of infection of the eye, contact lenses should not be worn during the treatment.
IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
NEVER LEAVE TO CHILDREN.
Interaction with other medicines
Taking other medicines
If you are currently using (or plan to use) another eye drops, wait 15 minutes between instillations.
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
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
This medication should be used with caution during pregnancy and lactation.
In general, you should seek advice from your doctor or pharmacist before taking any medication.
Sport
Not applicable.
Effects on ability to drive or use machines
Driving and using machines
Short visual disturbance may occur after instillation of the product. Wait for restoration of normal vision before driving or using machines.
List of excipients with known effect
Not applicable.
3. HOW TO USE VITABACT 0.05 PERCENT, eye drops?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
1 drop, 2 to 6 times a day.
IN ALL CASES COMPLY WITH THE ORDER OF YOUR DOCTOR STRICTLY
Method and route of administration
When first used, screw the cap thoroughly into the bottle cap.
When looking up and pulling the lower eyelid down slightly, instill 1 drop into the eye to be treated.
Duration of treatment
The duration of the treatment will be specified by your doctor. The usual treatment will not exceed 10 days.
Symptoms and Instructions for Overdose
If you used more VITABACT 0.05 PERCENT, eye drops than you should:
In case of overdosage, rinse with sterile saline solution.
Instructions for omission of one or more doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, this medicine may cause side effects, although not everybody gets them.
Reactions of local intolerance (transient irritation, possibility of allergic reactions necessitating cessation of treatment).
Declaration of side effects
If you notice any side effects, talk to your doctor or pharmacist. This also applies to any side effects not listed in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (Ansm) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr .
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE VITABACT 0.05 PERCENT, eye drops?
Keep out of the reach and sight of children.
Expiration date
Do not use VITABACT 0.05 PERCENT, eye drops after the expiry date which is stated on the outer packaging.
Storage conditions
Store at a temperature not exceeding 25 ° C.
This medication should not be stored more than 1 month after first use. Note the opening date in plain text on the packaging.
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 VITABACT contain 0.05 PERCENT, eye drops?
The active substance is:
Picloxydine hydrochloride ............................................... .................................................. ............ 0.0500 g
Corresponding amount of PICLOXYDINE BASE at ............................................ ................................ 0.0434 g
For 100 ml of eye drops.
The other components are:
Polysorbate 80, anhydrous glucose, purified water.
Pharmaceutical form and content
What is VITABACT 0.05 PERCENT, eye drops and contents of the pack?
This medication is in the form of eye drops. Box of 1 bottle of 10 ml.
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
THEA LABORATORIES
12 RUE LOUIS BLERIOT
63017 CLERMONT-FERRAND CEDEX 2
exploiting
THEA LABORATORIES
12 RUE LOUIS BLERIOT
63100 CLERMONT FERRAND
Maker
EXCELVISION
RUE DE LA LOMBARDIERE
07100 ANNONAY
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.