ALLERGODIL

ALLERGODIL acute eye drops

Important notes (mandatory information)

Allergodil eye drops. Active ingredient: Azelastine hydrochloride. Areas of application: can be used to treat and prevent hay fever-related eye complaints (seasonal allergic conjunctivitis) in adults and children aged 4 and over, to treat eye complaints caused by allergies to substances such as house dust mites and animal hair (non-seasonal (perennial) allergic conjunctivitis) in adults and children aged 12 and over.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER Allergodil eye drops,
0.5 mg/ml eye drops, solution
Azelastine hydrochloride 0.05% (0.5 mg/ml)
Read the entire package leaflet carefully because it contains important information for you. This medicine is available without a prescription. However, Allergodil eye drops must be used as directed in order to achieve the best possible treatment results.
o Keep the package leaflet. You may want to read it again later.
o Ask your pharmacist if you need more information or advice.
o If your symptoms worsen or do not improve after two days, you must consult a doctor.
o If any of the side effects listed become serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
o This package leaflet refers to Allergodil eye drops, 0.5 mg/ml eye drops, solution, as Allergodil.

This package leaflet contains

1. WHAT IS ALLERGODIL AND WHAT IS IT USED FOR?
2. WHAT YOU NEED TO KNOW BEFORE USING ALLERGODIL
3. HOW TO USE ALLERGODIL
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE ALLERGODIL
6. FURTHER INFORMATION

1. WHAT IS ALLERGODIL AND WHAT IS IT USED FOR?

Allergodil contains the active ingredient azelastine. This belongs to a group of medicines called antihistamines. Antihistamines prevent the effects of substances (such as histamines) that are produced by the body in connection with an allergic reaction. Azelastine has been shown to reduce inflammation in the eye. Allergodil can be used to treat and prevent hay fever-related eye complaints (seasonal allergic conjunctivitis) in adults and children aged 4 and over. Allergodil can be used to treat eye complaints caused by allergies to substances such as house dust mites and animal hair (non-seasonal (perennial) allergic conjunctivitis) in adults and children aged 12 and over. Allergodil is not suitable for treating eye infections.

2. WHAT YOU NEED TO KNOW BEFORE USING ALLERGODIL

Allergodil must not be used,
o if you are hypersensitive (allergic) to the active ingredient azelastine hydrochloride or any of the other ingredients of Allergodil (see section 6). If this applies to you, talk to your doctor or pharmacist.

Special care must be taken when using Allergodil,
- if you are not sure whether your eye problems are due to an allergy. In particular, if only one eye is affected, if your vision is impaired or if the eye is painful and you have no symptoms in your nose, it is possible that this is an inflammation rather than an allergy.
- if the symptoms worsen despite treatment with Allergodil or do not improve noticeably for more than 48 hours.

In this case, please contact your doctor or pharmacist.

Ask your doctor, pharmacist or optician before using Allergodil

o if you are taking/using other non-prescription medicines.
o if you wear contact lenses.

Warnings about other ingredients of Allergodil
Allergodil contains the preservative benzalkonium chloride, which is known to discolour soft contact lenses. Contact with soft contact lenses should be avoided. Remove contact lenses before use and do not reinsert them until at least 15 minutes after instillation. Benzalkonium chloride can cause an allergic reaction (irritation of the eye).

When using Allergodil with other medicines
Allergodil is not known to be affected by other medicines.

Pregnancy and breast-feeding
If you are pregnant, planning to become pregnant or breast-feeding, please ask your doctor or pharmacist for advice before using Allergodil.

Driving and using machines
Your vision may be impaired for a short time after using Allergodil. In this case, wait until you can see clearly again before taking an active part in road traffic or operating machinery.

3. HOW TO USE ALLERGODIL

Always use Allergodil exactly as directed by your doctor.

An important note

Please ask your doctor or pharmacist if you are not entirely sure how to use this medicine and what the correct dose is.

Eye problems caused by hay fever (seasonal allergic conjunctivitis)

o Use in adults and children aged 4 and over

o The usual dose is one drop in each eye in the morning and evening.
If you expect to come into contact with flower pollen, you can use the usual dose of Allergodil as a precaution before leaving the house.

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

o Use in adults and children aged 12 and over

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

If you have severe symptoms, your doctor may increase the dose to one drop in each eye up to four times a day. If possible, you should use Allergodil regularly until your symptoms have disappeared. If you stop using Allergodil, your symptoms may recur.

Please remember

o Do not use Allergodil for more than 6 weeks.
o Allergodil should only be instilled into the eyes.

How do you instil Allergodil eye drops?
To instil the eye drops correctly, you should sit in front of a mirror the first few times so that you can better see what you are doing.
1. Wash your hands.
2. Wipe your eyes gently with a cloth to remove moisture.
3. Unscrew the bottle and check that the dropper is clean.
4. Gently pull the lower eyelid down.
5. Carefully drop the drop into the middle of the lower eyelid). Make sure that the dropper does not touch the eye.
6. Release the lower eyelid and press gently against the nose from the inner corner of the eye). Continue to press your finger against your nose and blink slowly several times to spread the drop over the eyeball.
7. Then remove any excess eye drops with a cloth.
8. Repeat the procedure for the other eye.

If you have used more Allergodil than you should
It is unlikely that instilling too much Allergodil into the eye will cause any problems. If you are concerned about this, contact your doctor. If Allergodil is accidentally swallowed, please contact your doctor or the emergency department of the nearest hospital as soon as possible.

If you forget to use Allergodil
Take your eye drops as soon as you remember and then continue with the next application at the usual time. Do not use a double dose to make up for a forgotten application. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Allergodil can have side effects, although not everybody gets them and they are usually not serious. Such side effects include

o Common (1 to 10 out of 100 people treated): Mild irritation (burning, itching, watering) of the eye after instillation of Allergodil, which usually passes quickly.
o Uncommon (1 to 10 out of 1,000 people treated): A bitter taste in the mouth, which quickly disappears when you drink a non-alcoholic beverage.
o Very rare (less than 1 in 10,000 people treated): An allergic reaction (e.g. rash and itching).

Please inform your doctor or pharmacist if any of the side effects listed become serious or if you notice any side effects not listed in this leaflet.

5. HOW TO STORE ALLERGODIL

Keep out of the reach of children.
No special storage conditions are required for this medicine. Do not use Allergodil after the expiry date which is stated on the label of the bottle and the carton. The expiry date refers to the last day of the month. After opening: Do not use Allergodil for more than 4 weeks after opening the bottle. The medicine must not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist.

6. FURTHER INFORMATION

What Allergodil contains
The active ingredient is azelastine hydrochloride 0.05% (0.5 mg/ml). Each drop contains 0.015 mg azelastine hydrochloride.
The other ingredients are benzalkonium chloride (E210), sodium edetate, hypromellose, sorbitol solution (crystallising) (E420i), sodium hydroxide (E524) and water for injections.

What Allergodil looks like and contents of the pack
Allergodil is a clear, colourless solution. It is contained in a plastic bottle with a dropper. A bottle contains either 6 ml, 8 ml or 10 ml of eye drops. Not all pack sizes may be marketed.

Pharmaceutical entrepreneur and manufacturer
MEDA Pharma GmbH & Co. KG
Benzstrasse 1
61352 Bad Homburg
Telephone: (06172) 888-01
Fax: (06172) 888-2740

This medicine is authorised in the Member States of the European Economic Area (EEA) under the following names

Austria, Denmark, Italy, Netherlands: Allergodil
Finland, Sweden: Lastin
Portugal: Allergodil
Spain: Afluon
United Kingdom, Ireland: Optilast

This leaflet was last revised in November 2011.

Source: Package leaflet information
Version: 08/2015