NOTICE
ANSM - Last updated: 27/08/2012
Name of the medicinal product
CRODOGLICATE OF SODIUM BIOGARAN 2%, eye drops in solution
Sodium Cromoglicate
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, seek medical attention.
· 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 SODIUM BIOGARAN CROMOGLICATE 2%, eye drops in solution AND WHAT CASES IS IT USED FOR?
2. BEFORE YOU USE SODIUM BIOGARAN CROMOGLICATE 2%, eye drops in solution?
3. HOW TO USE SODIUM BIOGARAN CROMOGLICATE 2%, eye drops in solution?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE SODIUM BIOGARAN CROMOGLICATE 2%, eye drops in solution?
6. ADDITIONAL INFORMATION
1. WHAT IS SODIUM BIOGARAN CROMOGLICATE 2%, eye drops in solution AND WHAT CASES IS IT USED FOR?
Pharmacotherapeutic group
HYPO-ALLERGENIC
(S = sensory organ)
Therapeutic indications
This eye drops is indicated in case of allergic eye disease (allergic conjunctivitis).
2. BEFORE YOU USE SODIUM BIOGARAN CROMOGLICATE 2%, eye drops in solution?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never use SODIUM BIOGARAN 2%, eye drops solution:
· If you are allergic (hypersensitive) to sodium cromoglicate or to any of the other ingredients of SODIUM BIOGARAN 2%, eye drops solution ( see composition ).
Precautions for use; special warnings
Take special care with SODIUM BIOGARAN 2% CROMOGLICATE, eye drops solution:
Do not exceed recommended dosage.
If there is no improvement as in the case of persistent symptoms, take a medical opinion.
In case of concomitant treatment with another eye drops, wait 15 minutes between each instillation.
Due to the presence of benzalkonium chloride, this drug may cause eye irritation.
Avoid contact with soft contact lenses. Remove contact lenses before application and wait at least 15 minutes before replenishing.
Benzalkonium chloride can discolour soft contact lenses.
Wash your hands thoroughly before proceeding with instillation.
Carefully close the bottle after use.
IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
Interaction with other medicines
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 treatment with another eye drops, wait 15 minutes between each instillation.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy / Breastfeeding
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 discomfort may be experienced after instillation of eye drops.
List of excipients with known effect
Important information about some of the ingredients of CROMOGLICATE DE SODIUM BIOGARAN 2%, eye drops in solution:
This medicine contains benzalkonium chloride.
3. HOW TO USE SODIUM BIOGARAN CROMOGLICATE 2%, eye drops in solution?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
Adult and child: depending on the severity of the symptoms, instill 1 drop into each eye, 2 to 6 times a day, at regular intervals.
In children a medical opinion is necessary.
Do not exceed recommended dosage.
IN ALL CASES CONFORM TO THE ORDER OF YOUR DOCTOR STRICTLY.
Administration mode
Ophthalmic pathway.
IN EYE INSULATION.
Wash your hands thoroughly before proceeding with instillation.
Insert 1 drop of eye drops into the conjunctival sac of the diseased eye, looking up, and pulling the eyelid down slightly and avoiding contact of the tip with the eye or eyelids.
Replace the bottle after use.
Frequency of Administration
In case of concomitant treatment with another eye drops, wait 15 minutes between each instillation.
Duration of the treatment
Do not prolong treatment without medical advice.
If there is no improvement as in the case of persistent symptoms, take a medical opinion.
Symptoms and Instructions for Overdose
Not applicable.
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 drugs, SODIUM CROMOGLICATE BIOGARAN 2%, eye drops in solution is likely to have undesirable effects, although not everyone is subject to it.
Possibility of an allergic reaction to the components of the product.
If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.
5. HOW TO STORE SODIUM BIOGARAN CROMOGLICATE 2%, eye drops in solution?
Keep out of the reach and sight of children.
Expiration date
Do not use after the expiry date stated on the vial. The expiry date refers to the last day of the month.
Storage conditions
No special storage conditions.
After opening , the eye drops are kept for a maximum of 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 SODIUM BIOGARAN 2% CROMOGLICATE contains, eye drops in solution?
The active substance is:
Sodium Cromoglicate ............................................... .................................................. ......................... 2 g
For 100 ml of eye drops in solution.
The other components are:
Benzalkonium chloride, edetate disodium, purified water.
Pharmaceutical form and content
What is SODIUM BIOGARAN 2% CROMOGLICATE, eye drops solution and contents of the pack?
This medication is in the form of eye drops in solution.
5 ml bottle.
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
BIOGARAN LABORATORIES
15 BOULEVARD CHARLES DE GAULLE
92707 COLOMBES CEDEX
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BIOGARAN LABORATORIES
15 BOULEVARD CHARLES DE GAULLE
92707 COLOMBES CEDEX
Maker
LAPHAL INDUSTRIES
AVENUE DE PROVENCE
13190 ALLAUCH
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.