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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 because it contains important information for you.

•    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 only. Do not pass it on to others.

It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Sodium Cromoglicate Eye Drops is and what it is used for

2.    What you need to know 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.    Contents of the pack and other information

1. WHAT SODIUM CROMOGLICATE EYE DROPS IS AND WHAT IT IS USED FOR

Sodium Cromoglicate 2% w/v Eye Drops, solution contains 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 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 keratoconjunctivitis’). Signs include bumps inside the upper eyelid, sensitivity to light and severe itching.

2. WHAT YOU NEED TO KNOW 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 this medicine (listed in Section 6)

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.

Warnings and Precautions

Talk to your doctor or pharmacist before using this medicine if you wear soft contact lenses. You should not wear contact lenses while using these drops.

Other medicines and Sodium Cromoglicate Eye Drops

Tell your doctor or pharmacist if you are taking, have recently taken or might take

any other medicines.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this 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 or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.

How to use this medicine

•    Wash your hands

•    Before using the medication for the first time, be sure that the tamper-proof seal on the bottle neck is unbroken. A gap between the bottle and the cap is normal for an unopened bottle

•    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 Sodium Cromoglicate Eye Drops than you should

Talk to your doctor or pharmacist or go to the hospital straight away. Remember to take any medicine that is left with you so the doctor knows what you have used.

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

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.

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 get 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.

5. HOW TO STORE SODIUM CROMOGLICATE EYE DROPS

Keep this medicine out of the sight and reach of children.

Do not use this medicine 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.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION What Sodium Cromoglicate Eye Drops contain

•    The active substance is sodium cromoglicate. Each 1ml of eye drops contains 20mg 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, 10ml or 13.5ml plastic dropper bottle with a tamper-proof cap.

Marketing Authorisation Holder

Aspire Pharma Limited Unit 4, Rotherbrook Court Bedford Road, Petersfield Hampshire, GU32 3QG United Kingdom

Manufacturer

Rafarm S.A.

Agiou Louka str.

19002 Paiania

Attiki

Greece

This leaflet was last revised in 09/2016.

Aspire

Pharma