Package leaflet: Information for the user

HAY-CROM 2% w/v AQUEOUS 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 Hay-Crom Aqueous Eye Drops are and what they are used for

2.    What you need to know before you use Hay-Crom Aqueous Eye Drops

3.    How to use Hay-Crom Aqueous Eye Drops

4.    Possible side effects

5.    How to store Hay-Crom Aqueous Eye Drops

6.    Contents of the pack and other information

1.    What Hay-Crom Aqueous Eye Drops are and what they are used for

Your eye drops are called Hay-Crom 2% w/v Aqueous Eye Drops Solution. The common name for your eye drops is sodium cromoglicate, which is part of a group of drugs known as anti-allergics.

Hay-Crom is used to prevent and treat allergic conjunctivitis of the eye including hay fever.

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

2.    What you need to know before you use Hay-Crom Aqueous Eye Drops

Do not use Hay-Crom Aqueous Eye Drops Solution:

•    If you are allergic (hypersensitive) to sodium cromoglicate or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before using Hay-Crom Hayfever Eye Drops.

Other medicines and Hay-Crom Aqueous 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 any medicine.

Driving and using machines

•    Hay-Crom 2% w/v Aqueous Eye Drops Solution may cause blurring of vision for a period of time after you have put them into your eye. If you are affected, DO NOT drive or operate machinery until your vision is clear again.

Hay-Crom Aqueous Eye Drops contain benzalkonium chloride

•    Benzalkonium chloride is known to discolour soft contact lenses; it is therefore advisable to avoid contact of the solution with soft contact lenses.

•    Benzalkonium chloride may cause eye irritation.

3. How to use Hay-Crom Aqueous Eye Drops

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

These eye drops are sterile while the bottle is sealed. DO NOT use them if:

•    the bottle seal is broken when you get them

•    the bottle has been open for more than 28 days

•    the drops have become cloudy or discoloured.

You should get a new bottle.

The recommended dose is as follows.

Adults, Children and Older people:

•    One or two drops into each affected eye up to four times daily, or as instructed by your doctor.

To break the seal and prepare your eye drops for use, follow the instructions below:

1.    Place the large WHITE cap on the nozzle of the bottle. <<Insert Picture>>

2.    Screw down the large WHITE cap as far as it will go in a clockwise direction. This will break the seal. <<Insert Picture>>

3.    To use your eye drops only remove the small BLUE cap. This will reveal a white nozzle. <<Insert Picture>>

4.    Do not remove the white cap during use. The usual treatment is one or two drops up to four times a day.

The correct way to put eye drops into your eye is as follows:

•    First, wash your hands.

Take off the blue cap. <<Insert Picture>>

•    Tilt your head backwards. <<Insert Picture>>

•    Pull your bottom eyelid downwards to make a pocket. <<Insert Picture>>

•    Hold the bottle in your other hand between your thumb and first finger, with the tip close to your bottom eyelid. <<Insert Picture>>

•    Squeeze the bottle gently until one drop of the solution falls into your eye. Blink a few times to spread the eye drop.

•    Repeat the process with your other eye if you need to treat both eyes.

•    Do not breathe on or touch the dropper nozzle and do not let the dropper nozzle touch the eye.

•    Put the cap back on the bottle.

•    Wash your hands again.

•    Close the bottle tightly after you have used your eye drops.

If you wear contact lenses

•    The eye drops should not be used whilst wearing soft contact lenses.

•    You can put your contact lenses back in 15 minutes after using your eye drops.

•    Make sure you take your lenses out before you put the next dose of eye drops in your eyes.

If you use more Hay-Crom Eye Drops than you should

If you use too many eye drops, rinse your eyes immediately with clean water.

If you swallow Hay-Crom Eye Drops Solution

If you (or someone else) accidentally swallow the solution, or if you think a child has swallowed any of the solution, it is not likely to cause any harm

However, if you are worried contact your doctor or pharmacist for advice. Please take this leaflet, any remaining solution and the container with you to the doctor or pharmacist so that they know which solution has been consumed.

If you forget to use Hay-Crom Eye Drops Solution

If you forget to use your eye drops, use them as soon as you remember, unless it is nearly time for your next use. Do not take a double dose to make up for a forgotten dose.

If you stop using Hay-Crom Eye Drops Solution

Use your eye drops for as long as your doctor has told you to. DO NOT stop using them as soon as you feel better - if you stop using the drops too soon, your allergy may recur.

Complete the course of treatment, or talk to your doctor first before you stop.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop using the solution and tell your doctor immediately or go to the casualty department at your nearest hospital if the following happens:

•    an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or hives).

This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation.

The following side effects have been reported:

Not known (frequency cannot be estimated from the available data):

•    blurred vision

•    mild stinging

•    burning

These side effects only usually last for a short while and happen immediately after putting in the drops.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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 Hay-Crom Aqueous Eye Drops

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

Do not store above 30°C. Keep the bottle in the outer carton to protect from light.

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Do not use this medicine after the bottle has been open for 28 days, or if the drops have become cloudy or discoloured. Get a new 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 Hay-Crom Eye Drops Solution contains

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

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

What Hay-Crom Eye Drops Solution looks like and contents of the pack

•    Hay-Crom Eye Drops Solution is a clear, pale yellow solution.

•    The solution is contained in a sterile eye dropper bottle consisting of a white or translucent main body and white nozzle together with a blue nozzle cap. Each bottle contains 13.5 ml of the solution

Marketing Authorisation Holder and Manufacturer

Your eye drops are manufactured by IVAX Pharmaceuticals UK, Runcorn, Cheshire, WA7 3FA, England.

Marketing Authorisation Holder: Teva UK Limited, Eastbourne, BN22 9AG.

This leaflet was last revised in December 2014

PL 00289/1546