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OPTICROM AQUEOUS 2% W/V EYE DROPS SOLUTION

Active substance(s): SODIUM CROMOGLICATE

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Packaging Administration
Sanofi Winthrop Industrie - Le Trait - France
Brand name
Dosage
Quantity
Manuf. site
Country

Opticrom Aqueous
20 mg/ml
13,5 ml
Le Trait
UK (Sale)

Article
Leaflet
Item code 520487
Based on 519127
GMID code 537868

This artwork proof indicates colour position only.
Please refer to Pantone Colour Formula Guide 1000 for exact references

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Is this leaflet hard to see or read?
Phone 0845 372 7101 for help
Read all of this leaflet carefully before you start using this
medicine
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or
pharmacist.
• This medicine has been prescribed for you. Do not pass it on
to others. It may harm them, even if their symptoms are the
same as yours.
• If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1. What Opticrom Aqueous is and what it is used for
2. Before you use Opticrom Aqueous
3. How to use Opticrom Aqueous
4. Possible side effects
5. How to store Opticrom Aqueous
6. Further information
1. What Opticrom Aqueous is and what it is used for
Opticrom Aqueous 2% Eye Drops, Solution (called Opticrom
Aqueous in this leaflet) contains a medicine called sodium
cromoglicate. This belongs to a group of medicines called antiallergics.

Date of creation
03/12/2013
By
J Suc
Date of modification By
Proof n°
1
Pantone
Colours
used: 1
Reflex Blue

PAD
Tech. specif.
Tech. area
Size (mm)

2183
TRA-P040209b
TRA-P040209-1b
230x125 flat
22,5x125 folded

It works by stopping the release of the natural substances in
your eyes that can lead to an allergic reaction. Signs of an
allergic reaction include itchy, watery, red or inflamed eyes and
puffy eyelids.
Opticrom Aqueous is used for the prevention, relief and
treatment of eye allergies. This includes:
• Short and long term allergic conjunctivitis (inflammation of
parts of the eye)
• More severe cases of conjunctivitis (‘vernal kerato
conjunctivitis’). Signs include bumps inside the upper eyelid,
sensitivity to light and severe itching
2. Before you use Opticrom Aqueous
Do not use this medicine and tell your doctor if:
You are allergic (hypersensitive) to sodium cromoglicate, or
any of the other ingredients of Opticrom Aqueous (listed in
Section 6: Further information).
Signs of an allergic reaction include: a rash, swallowing or
breathing problems, swelling of your lips, face, throat, tongue
and worsening of redness, itching or swelling of the eye or
eyelid
Do not use this medicine if the above applies to you. If you
are not sure, talk to your doctor or pharmacist before using
Opticrom Aqueous.
Take special care with Opticrom Aqueous if:
You wear soft contact lenses. You should not wear contact
lenses while using these drops
If you are not sure if the above applies to you, talk to your doctor
or pharmacist before using Opticrom Aqueous.
Pregnancy and breast-feeding
Talk to your doctor before using this medicine if you are pregnant,
might become pregnant or think you may be pregnant.
If you are breast-feeding or planning to breast-feed, talk to your
doctor or pharmacist before taking or using any medicine.

Pharmacode
Brandmark/name
Country example
Font size

52
A1 - 25.09.2006
CRGB - V1 - 05/2012
8 pt
Plan

Driving and using machines
You may have blurred eyesight straight after using this medicine.
If this happens, do not drive or use any tools or machines until
you can see clearly.
Important information about some of the ingredients of
Opticrom Aqueous
Opticrom Aqueous contains benzalkonium chloride. This may
cause your eyes to become irritated. It may also change the
colour of your contact lenses.
3. How to use Opticrom Aqueous
Always use Opticrom Aqueous exactly as your doctor has told
you. You should check with your doctor or pharmacist if you
are not sure.
How to use this medicine
• Wash your hands
• Remove the cap from the bottle
• Tilt your head back
• Squeeze one or two drops inside
the lower lid without touching your
eye
• Close your eye
• Wipe away any excess liquid from
the eyes with a clean tissue
• Always put the cap back on the
bottle as soon as you have used it
• Repeat in the other eye if needed
How much to use (adults, elderly and children)
• One or two drops in each eye four times a day, or as directed
by your doctor
• If you feel the effect of your medicine is too weak or too
strong, do not change the dose yourself, but ask your doctor
If you use more Opticrom than you should
Talk to your doctor or go to a hospital straight away.
Remember to take any medicine that is left with you so the
doctor knows what you have taken.

Packaging Administration
Sanofi Winthrop Industrie - Le Trait - France
Brand name
Dosage
Quantity
Manuf. site
Country

Opticrom Aqueous
20 mg/ml
13,5 ml
Le Trait
UK (Sale)

Article
Leaflet
Item code 520487
Based on 519127
GMID code 537868

This artwork proof indicates colour position only.
Please refer to Pantone Colour Formula Guide 1000 for exact references

If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4. Possible side effects

2183
TRA-P040209b
TRA-P040209-1b
230x125 flat
22,5x125 folded

By reporting side effects you can help provide more information
on the safety of this medicine.
5. How to store Opticrom Aqueous
Keep this medicine in a safe place where children cannot see
or reach it.
Do not use Opticrom Aqueous after the expiry date which is
stated on the bottle label and carton. The expiry date refers to
the last day of that month.
Store below 30°C. Keep the bottle in the outer carton in order
to protect from light.
Opticrom Aqueous is sterile when you buy it, so you must not
keep it for more than four weeks after opening the bottle.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.
6. Further information

Pharmacode
Brandmark/name
Country example
Font size

52
A1 - 25.09.2006
CRGB - V1 - 05/2012
8 pt
Plan

Manufacturer
Sanofi Winthrop Industrie, Boulevard Industriel, 76580 Le Trait,
France
This leaflet does not contain all the information about your
medicine. If you have any questions or are not sure about
anything, ask your doctor or pharmacist.
This leaflet was last revised in 11/2013
© Sanofi, 2001 – 2013

What Opticrom Aqueous contains
• The solution contains 2% w/v of the active substance, sodium
cromoglicate
• The other ingredients are disodium edetate, benzalkonium
chloride and purified water
What Opticrom Aqueous looks like and contents of the
pack
Opticrom Aqueous is a clear colourless to pale yellow solution
supplied in a 13.5 ml plastic dropper bottle with a tamper-proof
cap
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
Tel: 0845 372 7101
email: uk-medicalinformation@sanofi.com

Opticrom Aqueous

Like all medicines, Opticrom Aqueous can cause side effects,
although not everybody gets them.
Stop using Opticrom Aqueous and see a doctor as soon as
possible if:
• The itching, redness or swelling gets worse. You may be
allergic to these drops.
Talk to your doctor or pharmacist if any of the side effects
gets serious or lasts longer than a few days, or if you notice
any side effects not listed in this leaflet:
• Stinging or burning in your eyes or blurring of eyesight. This
should only last for a short time and occurs immediately after
using the eye drops
• Mild eye irritation
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet.
United Kingdom
You can also report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard
Malta
ADR Reporting, The Medicines Authority, Post-Licensing
Directorate, 203 Level 3, Rue D'Argens, GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt

PAD
Tech. specif.
Tech. area
Size (mm)

520487 / 537868

If you forget to use Opticrom Aqueous
If you forget a dose, use your drops as soon as you remember.
However, if it is nearly time for your next dose, skip the missed
dose. Do not use a double dose to make up for a forgotten dose.
If you stop using Opticrom Aqueous
Keep using the eye drops until your doctor tells you to stop. Do
not stop using the eye drops just because your eyes feel better.

Date of creation
03/12/2013
By
J Suc
Date of modification By
Proof n°
1
Pantone
Colours
used: 1
Reflex Blue

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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