PACKAGE LEAFLET: INFORMATION FOR THE USER
Azelastine OmniVision 0.5 mg/ml eye drops, solution
Azelastine hydrochloride
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 Azelastine OmniVision is and what it is used for
2. What you need to know before you use Azelastine OmniVision
3. How to use Azelastine OmniVision
4. Possible side effects
5. How to store Azelastine OmniVision
6. Contents of the pack and other information
1. What Azelastine OmniVision is and what it is used for
Azelastine OmniVision 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 OmniVision is used to treat and prevent the ocular symptoms of hayfever
(seasonal allergic conjunctivitis), in adults and children age 4 years and above.
Azelastine OmniVision is used to treat and prevent the ocular symptoms of allergy due
to, for example house dust mite or dog and cat hairs (perennial allergic conjunctivitis),
in adults and children age 12 years and above.
2. What you need to know before you use Azelastine OmniVision
Do not use Azelastine OmniVision
- If you are allergic (hypersensitive) to Azelastine hydrochloride or any of the
ingredients of Azelastine OmniVision.
Warnings and precautions
Talk to your doctor or pharmacist before using Azelastine OmniVision:
- If you are not sure whether your eye symptoms are caused by an allergy. In particular,
if only one eye is affected, 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 symptoms worsen or last longer than 48 hours without remarkable improvement
despite the use of Azelastine OmniVision.
Azelastine OmniVision is not suitable for treating eye infections.
Other medicines and Azelastine OmniVision
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
It is not known if Azelastine OmniVision reacts with 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 before using this medicine.
Driving and using machines
If you have a transient blurring of vision after using Azelastine OmniVision, you should
wait until your sight clears before driving or operating machinery.
3. How to use Azelastine OmniVision
Always use Azelastine OmniVision exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.
Ocular symptoms of hayfever (seasonal allergic conjunctivitis)
The usual dose for seasonal allergic conjunctivitis in adults and children aged 4 years
and above is one drop in each eye in the morning and the evening.
If you anticipate contact with pollen, the usual dose of Azelastine OmniVision may be
taken as a preventive measure before going outside.
Ocular symptoms of allergy due to, for example house dust mite or dog and cat hairs
(perennial allergic conjunctivitis)
The usual dose for non-seasonal allergic conjunctivitis in adults and children aged 12
years and above is one drop in each eye in the morning and evening.
Use in children
The safety and efficacy of Azelastine OmniVision in children aged less than 4 years has
not been established.
Do not take Azelastine OmniVision for more than 6 weeks. Azelastine OmniVision
should only be applied to the eyes.
If your symptoms are severe, your doctor may increase your dose to one drop in each
eye, up to four times a day.
Do not allow the tip of bottle touch your eye or areas around your eye. It may become
contaminated with bacteria that can cause eye infections leading to serious damage of
the eye, even loss of vision. To avoid possible contamination of the bottle, keep its tip
away from contact with any surface.
How to use Azelastine OmniVision
1. Wash your hands before using the drops.
2. Remove the top from the bottle (figure 1). Make sure that the tip of the bottle does
not touch anything.
Figure 1
3. If you pump the bottle for the first time, you will have to press up to 10 times before
the first drop appears. Hold the bottle as it is shown in figure 2. Please avoid any
contact of the tip with any surface.
Figure 2
4. Hold the bottle as shown in figure 3. Put your thumb on the broad circular plate.
Figure 3
5. In order to apply the drops, tilt your head back, and use your other forefinger to pull
down the lower eyelid. Put the bottle in position with the dropper pointing
downwards (figure 4). Place the dropper tip close to your eye, but not touching the
eye or lid. Gently press on the circular plate to bring a drop in your eye.
Figure 4
6. Close your eyelid and gently press the corner of your eye with your forefinger for
one minute.
7. After instillation, close the bottle.
Figure 5
8. Once the bottle has been opened it can be stored only 12 weeks. After that time you
must discard the bottle even if there is solution remaining.
Follow these instructions carefully. Consult your doctor or pharmacist if there is
anything you do not understand.
If you use more Azelastine OmniVision than you should
If you put too much Azelastine OmniVision into your eyes you are unlikely to have any
problems. If you are worried, contact your doctor. If you accidentally swallow
Azelastine OmniVision, contact your doctor as soon as possible.
If you forget to use Azelastine OmniVision
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 stop using Azelastine OmniVision
If you interrupt the use of Azelastine OmniVision your symptoms are likely to return.
If you have any further questions on the use of this product, ask your doctor or
pharmacist.
4. Possible side effects
Like all medicines, Azelastine OmniVision can cause side effects, although not
everybody gets them.
• Common: affects 1 to 10 users in 100. Slight irritation (burning, itching, watering) in
the eyes after putting in Azelastine OmniVision. This should not last long.
• Uncommon: affects 1 to 10 users in 1,000. Bitter taste in your mouth.
• Very rare: affects less than 1 user in 10,000. Allergic reaction (such as rash and
itching).
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 (see details
below). By reporting side effects you can help provide more information on the safety
of this medicine.
[To be completed nationally]
5.
How to store Azelastine OmniVision
Keep this medicine out of the sight and reach of children.
Do not use the medicine if the tamper-proof seal on the bottle is broken before first use.
Do not use Azelastine OmniVision after the expiry date which is stated on the carton
and bottle after “EXP” MM/YYY. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage condition.
You can use Azelastine OmniVision 12 weeks after first opening of the bottle. Discard
the bottle 12 weeks after opening, even if there is solution remaining.
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
to protect the environment.
6. Contents of the pack and other information
What Azelastine OmniVision contains
- The active substance is Azelastine hydrochloride.
- The other ingredients are: sorbitol liquid hypromellose, disodium edeate, sodium
hydroxide and Purified Water.
What Azelastine OmniVision looks like and contents of the pack
Azelastine OmniVision is a clear, colourless and slightly viscous solution supplied in 6
ml white high density polyethylene bottles.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
OmniVision GmbH. Lindberghstrasse 7, D-82178 Puchheim, Germany.
Tel. +49 89 840 792 30
Fax. +49 89 840 792 40
E-mail: info@omnivision.de
Manufacturer
Novocat Farma, S.A. Av. De las Flores, 29 L7, 08191 Rubí, Barcelona, Spain.
Tel. +34 93 588 60 80
Fax. +34 93. 588 60 80
E-mail:info@novocatfarma.com
Farma Mediterrània S.L Av Sebastià s/n. 08960, Sant Just Desvern. Barcelona, Spain
Telephone: +34 93 371 94 53
Telefax: +34 93 371 38 57
E-Mail: farmamed@farmamed.com
This medicinal product is authorised in the Member States of the EEA under the
following names:
Germany: Azela-Vision MD sine 0,5 mg/ml Augentropfen
Austria: Azela-Vision MD sine 0,5 mg/ml Augentropfen
Sweden: Azelastine OmniVision
This leaflet was last revised in 2015-11-27