Read all of this leaflet carefully before

you start using this medicine.

•    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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

•    In this leaflet Azelastine 0.5 mg/ml Eye Drops, Solution is called Azelastine.

In this leaflet:

1 .What Azelastine is and what it is used for

2. Before you use Azelastine

3. How to use Azelastine

4. Possible side effects

5.    How to store Azelastine

6. Further information.

Azelastine contains azelastine which belongs to a group of medicines called antihistamines. Antihistamines work by preventing the effects of substances such as histamine that the body produces as part of an allergic reaction. Azelastine has been shown to reduce inflammation of the eye.

Azelastine can be used to treat and prevent eye disorders which you get with hayfever (seasonal allergic conjunctivitis) in adults and children age 4 years and above.

Azelastine can be used for eye disorders caused by an allergy to substances such as house dust mites or animal hair (perennial allergic conjunctivitis) in adults and children age 12 years and above.

Azelastine is not suitable for treating eye infections.

2. Before you use Azelastine

Do not use Azelastine if:

•    You are allergic to azelastine hydrochloride or any of the other ingredients of Azelastine (see section 6).

If this applies to you, talk to your doctor

or pharmacist.

Take special care with Azelastine

Please talk to your doctor or pharmacist

-    if you are not sure whether your eye disorders are caused by an allergy. In particular if only one eye is affected; if your vision is impaired; or the eye hurts and you do not have any symptoms in your nose, you may have an infection rather than an allergy

-    if the complaints worsen or last longer than 48 hours without remarkable improvement despite the use of Azelastine.

Check with your doctor, pharmacist

or optician before using Azelastine if:

•    You are taking any other medicines obtained without a prescription.

•    You wear contact lenses.

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Warnings about the ingredients in Azelastine

Azelastine contains the preservative benzalkonium chloride which is known to discolour soft contact lenses. Avoid contact with soft contact lenses.

Remove contact lenses prior to application and wait at least 15 minutes before reinsertion.

Benzalkonium chloride may cause an allergic reaction (eye irritation).

Using other medicines

Azelastine is not known to be affected by other medicines.

Pregnancy and breast-feeding

If you are pregnant, trying to become pregnant or breast-feeding ask your doctor or pharmacist for advice before using Azelastine.

Driving and using machines

Your sight may become blurred for a short time after you use Azelastine. If this happens, wait until your sight clears before you drive or use machinery.

Always use Azelastine exactly as your doctor has told you.

Important:

•    If you are not sure of the correct dose or how to use this medicine, ask your doctor or pharmacist.

Eye disorders caused by hayfever (seasonal allergic conjunctivitis)

•    Use in adults and children aged 4 years and above

•    The usual dose is one drop in each eye in the morning and evening.

If you anticipate contact with pollen, the usual dose of Azelastine may be taken as a preventive measure before going outside.

Eye disorders caused by an allergy (non-seasonal (perennial) allergic conjunctivitis)

•    Use in adults and children aged 12 years and above

•    The usual dose is one drop in each eye in the morning and evening.

If your symptoms are severe, your doctor may increase your dose to one drop in each eye, up to four times a day.

If possible, you should use Azelastine regularly until your symptoms have disappeared.

If you interrupt the use of Azelastine your symptoms are likely to return.

Remember:

•    Do not take Azelastine for more than 6 weeks

•    Azelastine should only be applied to the eyes.

Putting in your Azelastine eye drops

To help you put in your eye drops correctly, you may find it useful to sit in front of a mirror so you can see what you are doing for the first few times.

1.    Wash your hands.

2.    Gently wipe around your eyes with a tissues to remove any moisture (Diagram 1).

3.    Unscrew the top of the bottle and check that the dropper is clean.

4.    Gently pull your lower eye lid down (Diagram 2).

5.    Carefully place the drop inside the middle of your lower eyelid (Diagram 3). Take care not to let the dropper touch your eye.

6.    Release your lower eye lid and gently press on the inner corner of your eye against the bridge of your nose (Diagram 4). Keeping your finger pressed against your nose, slowly blink your eyes a few times to spread the drop across the surface of your eye.

7.    Blot away any excess medicine with a tissue.

8.    Repeat this for your other eye.

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Diagram 1 Diagram 2 Diagram 3 Diagram 4

If you use more Azelastine than you should

If you put too much Azelastine into your eyes you are unlikely to have any problems. If you are worried, contact your doctor. If you accidentally swallow Azelastine, contact your doctor or nearest hospital casualty department as soon as possible.

If you forget to use Azelastine

Use your eye drops as soon as you remember, then take the next dose at the usual time. Do not take a double dose to make up for a missed dose.

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

Like all medicines Azelastine can cause side effects. Not everybody gets them and they are not usually serious.

These effects include:

•    Common (1 to10 of 100 patients treated): Slight irritation (burning, itching, watering) in the eyes after putting in Azelastine. This should not last long.

•    Uncommon (1 to 10 of 1,000 patients treated): A bitter taste in your mouth. This should quickly disappear especially if you have a soft drink.

•    Very rare (less than 1 of 10,000 patients treated): An allergic reaction (such as rash and itching).

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

This medicinal product does not require any special storage conditions. Do not use Azelastine after the expiry date given on the bottle label and the outer carton. The expiry date refers to the last day of that month.

Once opened: Do not use Azelastine if the bottle has been open for longer than 4 weeks.

Unused medicine should not be disposed of via wastewater or household waste. Return any medicine you no longer need to your pharmacist.

What Azelastine contains

The active substance is azelastine hydrochloride 0.05% (0.5 mg/ml). Each drop contains 0.015 mg azelastine hydrochloride.

The other ingredients are benzalkonium chloride (E210), disodium edetate, hypromellose, liquid sorbitol (crystallising) (E420i), sodium hydroxide (E524) and water for injections.

What Azelastine looks like

Azelastine is a clear, colourless solution. Azelastine comes in a plastic bottle with a dropper attachment. One bottle contains either 6, 8 or 10 ml of eye drops. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Meda Pharmaceuticals Ltd, Skyway House, Takeley, Bishops' Stortford CM22 6PU

Manufacturer

MEDA Pharma Gmbh & Co. KG Benzstrasse 1 61352 Bad Homburg Germany

This leaflet was last revised in:

June 2012

This medicinal product is authorised in the Member States of the EEA under the following names:

UK/H/0256/001

Germany:    Allergodil Augentropfen

Austria, Denmark,

Italy,

The Netherlands: Allergodil Finland, Sweden: Lastin Portugal:    Allergodil

Spain:    Afluon

United Kingdom,

Ireland:    Optilast