French pharmacy
OPHTACALM 2 CENT SINGLE DOSE EYE DROPS 0.35 ML: Eye drops indicated for the eye disease of allergic origin (allergic conjunctivitis).
Conjunctivitis is an inflammation or irritation of the conjunctiva of the eye, the membrane that covers the white of the eye and the underside of the eyelids. It can be of viral, bacterial, allergic or irritative origin. It is manifested by redness of one or both eyes associated with itching, tingling, a clear or purulent discharge and possibly swelling of the eyelids.
Eye drops indicated in case of allergic eye disease (allergic conjunctivitis).
BAUSCH & LOMB Ophtacalm 2%, eye drops in solution in 10 single-dose low density polyethylene (LDPE) containers of 0.35 ml
Wash your hands thoroughly before instilling.
Per 100 ml : Sodium cromoglicate 2 g. List of excipients: Purified water.
Take special care with OPHTACALM 2%, eye drops in solution in a single-dose container:
IF IN DOUBT DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR DOCTOR OR PHARMACIST.
Box of 10 single doses of 0.35 ml.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Last updated: 23/09/2016
OPHTACALM 2%, eye drops in solution in single-dose containers
Sodium Cromoglicate
You should always use this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information
· If you experience any of the side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel better or feel less well.
Do not use this medication for children.
2. What should be known before using OPHTACALM 2%, eye drops in solution in single-dose containers?
3. How to use OPHTACALM 2%, eye drops in solution in single dose containers?
4. What are the possible side effects?
5. How to store OPHTACALM 2%, eye drops in solution in single dose containers?
6. Package contents and other information.
1. WHAT OPHTACALM 2%, eye drops in solution in single-dose containers AND IN WHAT CASES IS IT USED?
Pharmacotherapeutic group: LOCAL ANTI-ALLERGIC (S = sensory organ) - ATC code: S01GX01
This eye drops is indicated in case of allergic eye disease (allergic conjunctivitis).
You should talk to your doctor if you do not feel better or feel less well.
2. BEFORE YOU USE OPHTACALM 2%, eye drops in solution in single dose containers?
Never use OPHTACALM 2%, eye drops in solution in single-dose containers:
· if you are allergic (hypersensitive) to sodium cromoglicate or any of the other ingredients of this medication mentioned in section 6.
Warnings and Precautions
Talk to your doctor or pharmacist before using OPHTACALM 2%, eye drops in solution in single-dose containers .
Wash your hands thoroughly before proceeding with instillation.
NEVER LEAVE TO CHILDREN.
DO NOT INJECT, DO NOT SWALLOW.
Do not exceed recommended dosage.
If there is no improvement as in the case of persistent symptoms, take a medical opinion.
children
In children, medical advice is required.
Other medicines and OPHTACALM 2%, eye drops in solution in single-dose containers
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
OPHTACALM 2%, eye drops solution in single-dose containers with food and beverages
Not applicable.
Pregnancy, breast-feeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
Sport
Not applicable.
Driving and using machines
Transient visual discomfort may be experienced after instillation of eye drops. In this case wait for the end of symptoms to drive a vehicle or use a machine.
OPHTACALM 2%, eye drops in solution in single-dose containers
Not applicable.
3. HOW TO USE OPHTACALM 2%, eye drops in solution in single dose containers?
Dosage
Depending on the severity of the symptoms, instill 1 drops in each eye, 2 to 6 times a day, at regular intervals.
Do not exceed recommended dosage.
Administration mode
Ophthalmic pathway.
Each unidose contains a sufficient amount of eye drops to treat both eyes.
Wash your hands thoroughly before proceeding with instillation.
Avoid contact of the tip with the eye or eyelids.
Instil 1 drop of eye drops into the conjunctival sac of the diseased eye, looking up, and pulling the lower eyelid down slightly.
Discard the unidose after instillation. Do not store for future use.
In case of concomitant treatment with another eye drops, wait 15 minutes between each instillation
If you feel that the effect of OPHTACALM 2%, eye drops in solution in single-dose containers is too strong or too weak, talk to your doctor or pharmacist.
Use in children
In children a medical opinion is necessary.
If you used more than 2% OPHTACALM, eye drops solution in a one-dose container you should not have:
Immediately consult your doctor or pharmacist.
If you forget to use OPHTACALM 2%, eye drops in solution in single-dose containers:
Do not take a double dose to make up for the single dose that you have forgotten to take.
If you stop using OPHTACALM 2%, eye drops in solution in single-dose containers:
Not applicable.
If you have any further questions on the use of this medication, ask your doctor or pharmacist.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
Possibility of occurrence:
· allergic reaction to the components of the product,
· of temporary visual discomfort after instillation of the eye drops.
Declaration of side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned 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 OPHTACALM 2%, eye drops in solution in single dose containers?
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month .
Discard the unidose container after use.
Do not reuse a single dose container.
Do not use this medication if you notice any signs of deterioration.
Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What OPHTACALM 2% contains, eye drops in solution in single-dose containers
· The active substance is:
Sodium Cromoglicate ............................................... .................................................. ............... 2g
For 100 ml.
· The other component is: purified water.
What is OPHTACALM 2%, eye drops in solution in single-dose containers and contents of the pack
Not all pack sizes may be marketed.
Marketing Authorization Holder
416 RUE SAMUEL MORSE - CS99535
34961 MONTPELLIER CEDEX 2
Marketing Authorization Operator
416 RUE SAMUEL MORSE - CS99535
34961 MONTPELLIER CEDEX 2
ZI RIPOTIER HAUT
07200 AUBENAS
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is:
[to be completed later by the holder]
{MM / YYYY}
Detailed information on this medicine is available on the ANSM website (France).
Anti-allergic eye drops
sodium cromoglicate
. Presentations . Composition . Indications . Warning . Drug Interactions . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon
OPHTACALM%: eye drops; box of 10 units of 0.35 ml.
-
Laboratory Chauvin Bausch & Lomb
| p 100 ml | |
| Sodium Cromoglicate | 2 g |
Usual dosage:
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