Sodium Cromoglicate 2% W/V Eye Drops Solution
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.
• Ifyou have any further questions, askyour doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others.
It may harm them, even iftheir symptoms are the same asyours.
• 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. Howto 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 WHATIT 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 ifthe above appliestoyou. Ifyou are not sure, talkto 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
Talkto your doctor before using this medicine ifyou are pregnant, might become pregnant orthinkyou maybe 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 abilityto 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. HOWTO USE SODIUM CROMOGLICATE EYE DROPS
Always use Sodium Cromoglicate Eye Drops exactly asyour doctor hastold you. Adults and Children over 6 years:
One or two dropsto be administered into each eye fourtimes 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, askyour doctor or pharmacist.
4. POSSIBLE SIDEEFFECTS
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. HOWTO 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. Askyour 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.
Aspire
1010215-P3.1