SODIUM CROMOGLICATE 2% W/V EYE DROPS SOLUTION

Active substance: SODIUM CROMOGLICATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Sodium Cromoglicate 2% w/v Eye Drops, solution
Sodium cromoglicate
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 Sodium Cromoglicate Eye Drops is and what it is used for
2. Before you use Sodium Cromoglicate Eye Drops
3. How to use Sodium Cromoglicate Eye Drops
4. Possible side effects
5. How to store Sodium Cromoglicate Eye Drops
6. Further information

1.WHAT SODIUM CROMOGLICATE EYE DROPS IS AND
WHAT IT IS USED FOR
Sodium Cromoglicate Eye Drops contain a medicine called sodium
cromoglicate.
This belongs to a group of medicines called anti-allergics.
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.
Sodium Cromoglicate Eye Drops is used for the relief and treatment of eye
allergies. These allergies can happen:
• At any time of the year and is called ‘perennial allergic conjunctivitis’
• In different seasons of the year caused by different pollens.
This is called ‘seasonal allergic conjunctivitis’ or hay fever

2.BEFORE YOU USE SODIUM CROMOGLICATE EYE DROPS
Do not use Sodium Cromoglicate Eye Drops
• if you are allergic (hypersensitive) to sodium cromoglicate or any of the
other ingredients of Sodium Cromoglicate Eye Drops (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 these eye drops.
Take special care with Sodium Cromoglicate Eye Drops 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 Sodium Cromoglicate Eye Drops.
Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines, including medicines obtained without a prescription.
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
Sodium cromoglicate may interfere with your ability to drive and use 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
Sodium Cromoglicate Eye Drops
Sodium Cromoglicate Eye Drops contain benzalkonium chloride. This may
cause your eyes to become irritated and may change the colour of your contact
lenses. Avoid contact with soft contact lenses. Remove contact lenses prior to
application and wait at least 15 minutes before reinsertion.

3.HOW TO USE SODIUM CROMOGLICATE EYE DROPS
Always use Sodium Cromoglicate Eye Drops exactly as your doctor has told you.
Adults and Children over 6 years:
One or two drops to be administered into each eye four times daily.
Children under 6 years
Sodium Cromoglicate Eye Drops should not be used in children under
6 years of age.
Elderly
There is no evidence to suggest that a different dose is needed for
elderly patients.
You should check with your doctor or pharmacist if you are not sure.
How to use this medicine
Using the drops for the first time:
You must not use the bottle if the tamper-proof base ring with cap is broken
before you first use it. These eye drops come in a bottle with a screw cap. The
inside of the screw cap contains a spike. The screw cap is fitted to the bottle in
such a way that there is no contact between the spike and the top of the bottle.
In order to open the bottle it is necessary to tighten the screw cap further, so
that the tamper-proof base ring will break. Remove the tamper-proof base ring.

Further, tighten the screw cap so that the edge of the screw cap and the edge of
the bottle neck are totally aligned. At this point the screw cap spike will pierce
the top of the bottle which will open the bottle. Once the bottle has been opened
in this way, unscrew the screw cap fully to remove it from the bottle and apply
the eye drops as instructed below:
• Wash your hands
• Rotate cap clockwise to pierce the container
• 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
• One or two drops in each eye four times a day, or as directed by your doctor
• If your symptoms worsen or do not improve, talk to your doctor or pharmacist
If you forget to use Sodium Cromoglicate Eye Drops
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 Sodium Cromoglicate Eye Drops
You should keep using these drops if you are still around the things that you are
allergic to. If you stop using Sodium Cromoglicate Eye Drops your allergy
symptoms may come back.
If you have any further questions on the use of this product, ask your doctor
or pharmacist.

4.POSSIBLE SIDE EFFECTS
Like all medicines, Sodium Cromoglicate Eye Drops can cause side effects,
although not everybody gets them.
Stop using Sodium Cromoglicate Eye Drops 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

5.HOW TO STORE SODIUM CROMOGLICATE EYE DROPS
Keep out of the reach and sight of children.
Do not use Sodium Cromoglicate Eye Drops after the expiry date which is
stated on the bottle label and carton after EXP. The expiry date refers to the last
day of that month.
This medicinal product does not require any special storage conditions before
opening the bottle and after opening the bottle ‘Do not store above 25°C’.
Sodium Cromoglicate Eye Drops 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
What Sodium Cromoglicate Eye Drops contain
• The active substance is sodium cromoglicate. Each 1ml of eye drops contains
20mg of sodium cromoglicate (2.0% w/v). One drop contains 0.7mg of
sodium cromoglicate.
• The other ingredients are disodium edetate, benzalkonium chloride and water
for injections.
What Sodium Cromoglicate Eye Drops look like and contents of the pack
Sodium Cromoglicate Eye Drops is a clear colourless to pale yellow solution
supplied in either a 5ml or 10ml plastic dropper bottle with a white plastic
screw cap having a tamper-proof base ring.
Marketing Authorisation Holder and Manufacturer
Brown & Burk UK Ltd
5, Marryat Close
Hounslow West
Middlesex
TW4 5DQ
UK
Distributed by:
Aspire Pharma Ltd
Antrobus House Business Centre
18 College Street
Petersfield
Hampshire
GU31 4AD
United Kingdom
This leaflet was last approved in 03/2013.

1010215-P3.1

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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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