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Sodium Cromoglicate 2% W/V Eye Drops

Document: leaflet MAH GENERIC_PL 10622-0231 change

PATIENT INFORMATION LEAFLET

Sodium Cromoglicate 2% w/v Eye Drops

Please read all of this leaflet carefully before you used Sodium Cromoglicate Eye Drops.

Product Name

Sodium Cromoglicate 2% w/v Eye Drops What is in your drops?

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

The other ingredients are disodium edetate, benzalkonium chloride and water. It comes in packs containing 5ml or 10ml of drops.

How do your drops work?

The active ingredient of Sodium Cromoglicate Eye Drops has an antiinflammatory action in eyes affected by allergic conditions like hayfever. This means it reduces redness, soreness and itching when used regularly.

Who provides the drops?

Sodium Cromoglycate Eye Drops are made by Alcon Cusi SA, 08320 El Masnou, Barcelona, Spain. The product licence holder is: PLIVA Pharma Ltd., Vision House, Bedford Road, Petersfield, Hampshire, GU32 3QB.

What are Sodium Cromoglicate Drops for?

Sodium Cromoglicate Eye Drops are for the treatment and relief of soreness, redness and itching of the eyes due to seasonal allergies such as hayfever.

Before you use Sodium Cromoglicate Eye Drops

Ask yourself the following questions:

•    Do you wear soft contact lenses?

•    Are you sensitive to eye drops containing sodium cromoglicate, benzalkonium chloride or any of the ingredients listed above?

•    Are you pregnant or breast feeding?

If the answer to any of these questions is yes, do not use the drops until you have discussed it with your doctor or pharmacist.

This product contains benzalkonium chloride. This may cause eye irritation. Avoid contact with soft contact lenses. Remove contact lenses prior to application and wait at least 15 minutes before reinsertation. Benzalkonium chloride is known to discolour soft contact lenses.

If you have any questions concerning the use of these eye drops in a child, or are unsure whether the child has allergic eyes, you should seek advice from you doctor or pharmacist.

•    Sodium Cromoglicate Eye Drops can cause blurred vision for a few

minutes after use. If this happens, do not operate machinery until the blurring stops.

How do I use Sodium Cromoglicate Eye Drops?

For external use only.

Adults (including the elderly) and children: Place one or two drops into each eye 4 times daily, or as directed by your doctor.

Wash your hands before using the drops. Tilt your head back and carefully pull down your lower eyelid. Without touching the eyelid with the tip of the dropper, put 1 or 2 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 on the bottle.

It is important to use Sodium Cromoglicate Eye Drops regularly every day to keep your eye condition controlled.

If you forget to use the drops, use them as soon as you remember.

What might happen when I use Sodium Cromoglicate Eye Drops?

Your eyes might sting a little just after you use the drops. If they sting badly, or if your eyes get worse, stop using the drops and tell your doctor or pharmacist.

If anything else happens, tell your doctor or pharmacist.

Looking after your Sodium Cromoglicate Eye Drops

Do not use the eye drops after the expiry date printed on the label.

Do not use the eye drops more than four weeks after first opening the bottle.

Do not store the eye drops above 25°C. Keep them in the original container and out of direct sunlight.

Remember:    Keep all medicines out of the reach and sight of children.

Date of last revision: May 2005

!£) PLIVA