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PACKAGE LEAFLET: INFORMATION FOR THE USER

VANTAGE ALLERGY 2% EYE DROPS Sodium Cromoglicate

The name of your medicine is Vantage Allergy 2% 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.

Always use this medicine exactly as described in this leaflet or as your pharmacist has told you.

•    Keep this leaflet. You may need to read it again.

•    Ask your pharmacist if you need more information or advice.

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

•    You must talk to a doctor if you do not feel better or if you feel worse within a few days.

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

1.    WHAT SODIUM CROMOGLICATE DROPS ARE AND WHAT THEY ARE USED FOR

Sodium Cromoglicate Drops contain the active ingredient Sodium Cromoglicate.

Sodium Cromoglicate belongs to a group of medicines called anti-allergics.

Sodium Cromoglicate Eye Drops are used for the relief and treatment of the eye symptoms of hayfever. They work by reducing the body's response to the allergy when used regularly during the course of treatment.

These symptoms occur usually in the late spring or early summer when pollen from grasses or trees comes into contact with the eyes of people who are sensitive to them. This condition is sometimes called 'hayfever eyes' or by its medical term, seasonal allergic conjunctivitis.

If you suffer from hayfever, you can also help control your symptoms by trying to ensure low exposure to pollen when hayfever symptoms are expected. For example, keep windows closed, do not cut grass, stay indoors as much as possible.

2.    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.

You must be confident that you or your child's eye symptoms are caused by hayfever, or have been previously diagnosed by your doctor to suffer from hayfever:

You can be sure allergic eyes are caused by hayfever if:

•    Both eyes are affected

•    You also have a runny or blocked nose

•    Your eyesight is not affected

•    You know you suffer from hayfever and your symptoms coincide with the times of year when grass or tree pollen is high.

But if you or your child have:

•    No nose symptoms

•    Only one eye is affected

•    Your sight is affected

Or if the eye symptoms:

•    Occur at the wrong time of year for hayfever

•    Are likely to be caused by another allergy, e.g. a pet or dust mite allergy

then you cannot be sure that the condition is due to hayfever and you should see your doctor or pharmacist before you use these drops.

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 breastfeeding

If you are pregnant or breastfeeding, 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.

3. HOW TO USE SODIUM CROMOGLICATE DROPS Dosage

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 eyelid

•    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, or are unsure if the child has eye symptoms of hayfever, 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.

4.    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 pharmacist. This includes any side effects not listed in this leaflet.

5.    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 28 days after first opening the bottle. Discard any unused medicine after this time.

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 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

The medicine is a clear liquid in white plastic tamper-evident bottles fitted with a dropper and closed with a screw cap. The bottle contains 5ml or 10ml of Eye Drops Solution.

Not all pack sizes may be marketed.

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