Azelastine-COMOD® 0.5 mg/ml

What is Azelastin COMOD® and what is it used for?
Azelastin COMOD® contains the active ingredient azelastine hydrochloride. This belongs to a group of medicines called anti-allergics (antihistamines). Antihistamines work by protecting against the effects of substances such as histamine, which the body produces as part of an allergic reaction. Azelastine has also proven effective against eye inflammation.

Azelastin COMOD® can be used for the treatment and prevention of eye conditions associated with hay fever (seasonal allergic conjunctivitis) in adults and children aged 4 years and older. Azelastin COMOD® can be used for the treatment of eye conditions caused by an allergy to substances such as house dust mites or animal dander (non-seasonal, perennial allergic conjunctivitis) in adults or children aged 12 years and older.

How to use Azelastin COMOD®?
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Please remember:
Azelastin COMOD® should only be instilled into the eyes.

The recommended dose is:
Eye conditions caused by hay fever (seasonal allergic conjunctivitis):

• Use in adults and children from 4 years: The usual dose is one drop in each eye morning and evening.
  

If you expect contact with flower pollen, you can apply the usual Azelastin COMOD® dose preventively before leaving the house. Eye disease caused by allergies (non-seasonal (perennial)
allergic conjunctivitis):

• Use in adults and children from 12 years: The usual dose is one drop in each eye morning and evening.
  

If you have severe symptoms, your doctor may increase the dose to up to one drop in each eye four times daily. An improvement in symptoms of allergic conjunctivitis should be noticed after 15-30 minutes.

How to apply Azelastin COMOD®?
Wash your hands.
Take a clean paper tissue and gently remove lacrimal fluid from the lower eyelid margin.

Image 1:
Remove the cap before each use. Before first use of Azelastin COMOD®, hold the bottle with the dropper tip vertically downwards and press the bottom of the bottle until the first
drop appears at the tip of the bottle. After that, the bottle is ready for subsequent uses.

Image 2:
Hold the bottle with the dropper tip pointing downwards, placing your thumb on the bottle shoulder and your other fingers on the bottom of the bottle.

Image 3:
Support the hand holding the COMOD® bottle with your free hand as shown.

Image 4:
Tilt your head back slightly, gently pull the lower eyelid away from the eye with your free hand and press quickly and firmly in the middle of the bottle bottom. This activates the mechanism for dispensing a
drop. Due to the special valve technology of the COMOD® system, the size and speed of the drop are always the same, even with very strong pressure on the bottle bottom. Avoid contact of the dropper tip with the eye or facial skin during dripping. Close your eyes slowly,
so that the liquid can spread evenly over the surface of the eye.

Image 5:
After instillation of Azelastin COMOD®, release the lower eyelid and gently press against the bridge of the nose from the corner of the eye. While holding your finger against your nose, blink slowly several times to distribute the drop over the eye surface. Remove excess
eyetrops.

Image 6:
After use, immediately close the dropper tip carefully with the cap. Please ensure that the dropper tip is dry.

Duration of application
If possible, you should use Azelastin COMOD® regularly until your symptoms have disappeared.

Do not use Azelastin COMOD® for longer than 6 weeks.

If you have used more Azelastin COMOD® than you should
It is unlikely that problems will arise from instilling too much Azelastin COMOD® into the eye. If you are concerned, contact your doctor.

If you have accidentally swallowed Azelastin COMOD®, contact your doctor or the nearest hospital emergency department as soon as possible.

If you forget to use Azelastin COMOD®
Take your eye drops as soon as you remember and continue with the next application at the usual time. Do not use a double dose if you have forgotten the previous application.

If you stop using Azelastin COMOD®
If you interrupt the use of Azelastin COMOD®, your symptoms may reappear.

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

Contents of the pack and other information
What Azelastin COMOD® contains
The active ingredient is azelastine hydrochloride 0.05% (0.50 mg/ml).
Each drop of approx. 30 microliters contains 0.015 mg azelastine hydrochloride.
The other ingredients are:
Sodium edetate, hypromellose, sorbitol, sodium hydroxide (for pH adjustment) and water for injections.