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OPTICROM HAYFEVER 2% W/V EYE DROPS

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
2%
5/10 ml
Le Trait
UK (Sale)

Article
Leaflet
Item code 520488
Based on 519550
GMID code 537869

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

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Date of creation
04/12/2013
By
J Suc
Date of modification By
Proof n°
1
Pantone
Colours
used: 1
Reflex Blue

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

2184/2185
TRA - P040210b
TRA - P040210-1b
270x125 flat
22,5x125 mm 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.
These symptoms occur usually in the late spring or early summer when
pollen from grasses or trees comes into contact with the eyes of people
who are sensitive to them. This condition is sometimes called ‘hayfever
eyes’ or by its medical term: seasonal allergic conjunctivitis.
2. Before you use Opticrom Hayfever

Is this leaflet hard to see or read?
Phone 0845 372 7101 for help
Read all of this leaflet carefully because it contains important
information for you.
This medicine is available without prescription. However, you still need to
use Opticrom Hayfever carefully to get the best results from it.
• Keep this leaflet. You may need to read it again
• Ask your pharmacist if you need more information or advice
• You must contact a doctor if your symptoms worsen or do not improve
after 14 days
• 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 Hayfever is and what it is used for
2. Before you use Opticrom Hayfever
3. How to use Opticrom Hayfever
4. Possible side effects
5. How to store Opticrom Hayfever
6. Further information
1. What Opticrom Hayfever is and what it is used for
Opticrom Hayfever 2% w/v Eye Drops (called Opticrom Hayfever in this
leaflet) contain a medicine called sodium cromoglicate. This belongs to a
group of medicines called anti-allergics.

Do not use this medicine:
× If you or your child are allergic (hypersensitive) to sodium cromoglicate,
or any of the other ingredients of Opticrom Hayfever (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
× If your child is under 6 years of age
× For other allergic eye symptoms (not caused by hayfever). Other things in
everyday life can start allergies causing eye symptoms in certain people.
For example contact with animals including pets, house dust mites,
other particles and chemicals. Talk to your pharmacist or doctor.
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 Hayfever.
Take special care with Opticrom Hayfever:
must be confident that you or your child’s irritated eyes are
caused by hayfever, or have been previously diagnosed by your
doctor to suffer from hayfever: You can be sure allergic eyes are
caused by hayfever if:
• Both eyes are affected
• You also have a runny or blocked nose
• Your eyesight is not affected
• You know you suffer from hayfever and your symptoms coincide
with the times of year when grass or tree pollen is high.

▲ You






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But if you or your child have:
• No nose symptoms
• Only one eye is affected
• Your sight is affected
Or if the eye symptoms:
• occur at the wrong time of year for hayfever
• are likely to be caused by another allergy, e.g. a pet or dust mite
allergy
then you cannot be sure that the condition is due to hayfever and you
should see your doctor or pharmacist before you use these drops.
If you are not sure if the above applies to you, talk to your doctor or
pharmacist before using Opticrom Hayfever.
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.
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
Hayfever
Opticrom Hayfever contains benzalkonium chloride. This may cause your
eyes to become irritated.
Benzalkonium chloride is known to discolour soft contact lenses. Avoid
contact with soft contact lenses.
For all other types of contact lenses:
Remove contact lenses prior to application and wait at least 15 minutes
before reinsertion.

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

Opticrom
2%
5/10 ml
Le Trait
UK (Sale)

Article
Leaflet
Item code 520488
Based on 519550
GMID code 537869

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

Date of creation
04/12/2013
By
J Suc
Date of modification By
Proof n°
1
Pantone
Colours
used: 1
Reflex Blue

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

2184/2185
TRA - P040210b
TRA - P040210-1b
270x125 flat
22,5x125 mm folded

4. Possible side effects
Like all medicines, Opticrom Hayfever can cause side effects, although not
everybody gets them.
Stop using Opticrom Hayfever 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. You can also
report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the
safety of this medicine.

6. Further information
What Opticrom Hayfever contains
• The solution contains 2.0% w/v of the active substance, sodium
cromoglicate

Plan

• The other ingredients are disodium edetate, benzalkonium chloride and
purified water
What Opticrom Hayfever looks like and contents of the pack
Opticrom Hayfever is a clear colourless to pale yellow solution supplied
in a 5 ml or 10 ml plastic dropper bottle with a tamperproof cap. Not all
pack sizes may be marketed.
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
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

Opticrom

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

5. How to store Opticrom Hayfever
Keep this medicine in a safe place where children cannot see or reach it.
Do not use Opticrom Hayfever after the expiry date which is stated on the
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 Hayfever 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.

54
A1 - 25.09.2006
CRGB - V1 - 05/2012
8 pt

520488 / 537869

3. How to use Opticrom Hayfever
How to use this medicine
Adults (including the elderly) and children over 6 years
• 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
How much to use
• One or two drops in each eye four times a day
If you have any questions concerning the use of these drops in a child, or
are unsure if the child has allergic eyes, you should seek advice from your
doctor or pharmacist.
If your eyes are no better after 2 days of using the eye drops, see
your doctor or pharmacist.
It is best to use your eye drops regularly every day while high pollen levels
are expected, to keep your eye condition controlled. If you find you need
to use them continuously for more than 14 days, then check with
your pharmacist or doctor before continuing
If you use more of this medicine than you should
Contact your doctor if you use the eye drops more frequently than the
recommended dose.
If you forget to use Opticrom Hayfever
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.

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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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