SODIUM CROMOGLICATE EYE DROPS 2% W/V

PACKAGE LEAFLET: INFORMATION FOR THE USER

The name of your medicine is Sodium Cromoglicate Eye Drops, which will be referred to as 'Sodium Cromoglicate Drops' throughout this leaflet.

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.

WHAT IS IN THIS LEAFLET:

1.    What Sodium Cromoglicate Drops are and what they are used for

2.    What you need to know before you use Sodium Cromoglicate Drops

3.    How to use Sodium Cromoglicate Drops

4.    Possible side effects

5.    How to store Sodium Cromoglicate Drops

6.    Contents of the pack and other information

OWHAT SODIUM

CROMOGLICATE DROPS ARE AND WHAT THEY ARE USED FOR

Sodium Cromoglicate Eye Drops contain the active ingredient sodium cromoglicate, which belongs to a group of medicines known as anti-allergics.They work 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 Drops are used for the relief and treatment of:

• acute allergic conjunctivitis

(inflammation of the eye) caused by conditions such as hay fever

•    chronic (long-term) allergic conjunctivitis

•    vernal kerato conjunctivitis (red eye). Signs include bumps inside the upper eyelid, sensitivity to light and severe itching.

©WHAT YOU NEED TO KNOW BEFORE YOU USE SODIUM CROMOGLICATE DROPS

Do not use Sodium Cromoglicate Drops if you:

• are allergic (hypersensitive) to sodium cromoglicate or any of the other ingredients of Sodium Cromoglicate Drops (see list of ingredients in Section 6). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue.

Warnings and precautions:

• Your eye drops also contain benzalkonium chloride, which may cause eye irritation in a few people.

• Avoid contact with soft contact lenses. Remove contact lenses prior to application and wait at least 15 minutes before reinsertion. Benzalkonium chloride is known to discolour soft contact lenses.

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

This medicine can cause blurred vision for a few minutes after use. If this happens, do not drive or operate machinery until you can see normally again.

©HOW TO USE SODIUM CROMOGLICATE DROPS

Dosage

Always use Sodium Cromoglicate Drops exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Adults (including the elderly) and

children:

•    Place one or two drops into each eye four times daily.

•    Wash your hands before using the drops.

•    Tilt your head back and carefully pull down your lower

•    Without touching the eyelid with the tip of the dropper, put one or two drops into your lower lid and then blink a few times to make sure your whole eye is covered by the liquid.

•    Replace the cap securely on the bottle.

If you have any questions concerning the use of these drops in a child, you should seek advice from your doctor or pharmacist.

If you use more Sodium Cromoglicate Drops than you should

Talk to your doctor or a pharmacist if you use more of the eye drops than you should, or if anyone accidentally swallows any of the medicine.

If you forget to use Sodium Cromoglicate Drops If you miss a dose, use the drops as directed, and then continue your normal course of treatment. Do not use a double dose to make up for a forgotten dose.

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

POSSIBLE SIDE EFFECTS

Like all medicines, Sodium Cromoglicate Drops can cause side effects, although not everybody gets them.

All medicines can cause allergic reactions, although serious allergic reactions are very rare.

Tell your doctor straight away if you get any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body).

The following side effects have been reported:

•    temporary stinging and blurring of vision

•    other symptoms of eye irritation (rare).

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

©HOW TO STORE SODIUM CROMOGLICATE DROPS

Keep out of the reach and sight of children.

Store below 25°C. Keep the bottle in

the outer carton to protect from light.

Do not use Sodium Cromoglicate Drops after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. Do not use your eye drops more than 4 weeks after first 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| FURTHER INFORMATION

What Sodium Cromoglicate Drops contain:

The active substance is sodium cromoglicate 2% w/v.

The other ingredients are: disodium edetate, benzalkonium chloride and water.

What Sodium Cromoglicate Drops look like and contents of the pack

White plastic bottles fitted with a dropper and closed with a screw cap. The bottle contains 13.5 ml of Eye Drops Solution.

Marketing Authorisation Holder:

PLIVA Pharma Ltd, Ridings Point, Whistler Drive, Castleford,

WF10 5HX, UK.

Manufacturer:

Alcon Cusi SA, C/Camil Fabra, 58 El Masnou, Barcelona, Spain.

This leaflet was last revised:

November 2011

PL 10622/0016

87477-B