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Vantage Allergy 2% Eye Drops

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Document: leaflet ALMUS PHARMACEUTICALS_PL 10622-0016 change

SODIUM CROMOGLICATE EYE DROPS 2% W/V

sodium cromoglicate


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.

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

OWHAT 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 hay fever. 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 'hay fever eyes' or by its medical term, seasonal allergic conjunctivitis.


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

©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 hay fever, or have been previously diagnosed by your doctor to suffer from hay fever: You can be sure allergic eyes are caused by hay fever if:

• both eyes are affected • you also have a runny or blocked nose

• your eyesight is not affected • you know you suffer from hay fever 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 hay fever

• 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 hay fever 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 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

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 hay fever, 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.

©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.

©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 5 ml or 10 ml 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 in:

November 2011


PL 10622/0016


87477-B