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AZELASTINE EYE DROPS

Active substance(s): AZELASTINE HYDROCHLORIDE

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777134VI90/R

Package Leaflet: Information for the patient

Azelastine 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.
• In this leaflet Azelastine 0.5 mg/ml
Eye Drops, Solution is called Azelastine.
What is in this leaflet
1. What Azelastine is and what it is
used for
2. What you need to know before you
use Azelastine
3. How to use Azelastine
4. Possible side effects
5. How to store Azelastine
6. Contents of the pack and other
information.
1. What Azelastine is and what it is
used for
Azelastine contains the active
substance azelastine hydrochloride,
which belongs to a group of medicines
called antiallergics (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
aged 4 years and above.

- if you wear contact lenses.
Children and adolescents
For the treatment of eye disorders
caused by hayfever (seasonal allergic
conjunctivitis):
Do not give this medicine to children
below 4 years of age, because safety
and efficacy have not been established.
For the treatment of eye disorders
caused by an allergy (non-seasonal
(perennial) allergic conjunctivitis):
Do not give this medicine to children
below 12 years of age, because safety
and efficacy have not been established.
Other medicines and Azelastine
Although Azelastine is not known to be
affected by other medicines, 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 this medicine.

You must talk to a doctor if you do not
feel better or if you feel worse after 2
days.
Azelastine is not suitable for treating
eye infections.

2. What you need to know before
you use Azelastine
Do not use Azelastine:
• if you are allergic to azelastine
hydrochloride or any of the other
ingredients of this medicine (listed in
section 6).
Warnings and precautions
Talk to your doctor or pharmacist
before using Azelastine:
- 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

provide more information on the safety
of this medicine.

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.

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

Diagram 1

Diagram 2

Diagram 3

Diagram 4

Duration of treatment
If possible, you should use Azelastine
regularly until your symptoms have
disappeared.
Do not take Azelastine for more than 6
weeks.

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.

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.

Azelastine contains benzalkonium
chloride
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.

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.

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

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
aged 12 years and above.

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.

Always use this medicine exactly as
your doctor has told you. Check with
your doctor if you are not sure.
Remember:
• Azelastine should only be applied to
the eyes.
The recommended dose is:
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.

6. Contents of the pack and other
information
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, disodium edetate,
hypromellose, liquid sorbitol
(crystallising) (E420i), sodium hydroxide
(E524) and water for injections.
What Azelastine looks like and
contents of the pack
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 eye drops,
solution. Not all pack sizes may be
marketed.
Marketing Authorisation Holder
Meda Pharmaceuticals Limited
Skyway House
Parsonage Road
Takeley
Bishop’s Stortford
CM22 6PU

4. Possible side effects

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

These effects include:
• Common (may affect up to 1 in 10
people): Slight irritation (burning,
itching, watering) in the eyes after
putting in Azelastine. This should not
last long.
• Uncommon (may affect up to 1 in 100
people): A bitter taste in your mouth.
This should quickly disappear
especially if you have a soft drink.
• Very rare (may affect up to 1 in
10,000 people): An allergic reaction
(such as rash and itching).

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.

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.

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

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

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

Do not use this medicine after the expiry
date which is stated on the bottle label
and the outer carton. The expiry date
refers to the last day of that month.
Once opened: Do not use this
medicine if the bottle has been open
for longer than 4 weeks.
This medicine does not require any
special storage conditions.

Manufacturer
MEDA Pharma GmbH & Co. KG
Benzstrasse 1
61352 Bad Homburg
Germany
Tel: +49 (0) 6172 888 - 01
fax: +49 (0) 6172 888 - 2740
e-mail: medinfo@medapharma.de

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

3. How to use Azelastine

5. How to store Azelastine

United Kingdom:
Ireland:
Italy:
Austria, Denmark,
Finland, Portugal,
Sweden,
The Netherlands:
Spain:
Germany:

Relief of symptoms of allergic
conjunctivitis should be noticed after
15-30 minutes.

FRONT

BACK

CODE: 777134VI90/R

DRAFT: 04

DATE: 17/07/2015

CLIENT: TUBILUX

PRODUCT: Insert Azelastine (UK)
MEASURE: 120 x 295 mm (120 x 25 mm)
COLOURS:

Black

EXTRA: Deca code

NOTE:
www.effe5grafica.it
Tel. (+39) 06 9326.0017
postmaster@effe5grafica.it

Visual code

P. 072
Approval

TEXT SIZE: 8 pt / Helvetica Family

Oculastin
Corifina
Allergodil akut
Augentropfen
Allergodil
Augentropfen

This leaflet was last revised in June
2015.

Reporting of side effects
If you get any side effects, talk to your
doctor, pharmacist or nurse. 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

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

Azelastine
Azelastine Eye Drops
Lasticom

Packaging development

Techical Direction

Regulatory

Marketing

777134VI90/R
56UK21052015-00-R

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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