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OPTILAST

Active substance(s): AZELASTINE HYDROCHLORIDE

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Optilast

doctor may increase your dose to one
drop in each eye, up to four times a
day.
Relief of symptoms of allergic
conjunctivitis should be noticed after
15-30 minutes.

777134VI21/7J

Package Leaflet: Information for the patient

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 Optilast 0.5 mg/ml Eye
Drops, Solution is called Optilast.
What is in this leaflet
1.What Optilast is and what it is used for
2.What you need to know before you
use Optilast
3.How to use Optilast
4.Possible side effects
5.How to store Optilast
6.Contents of the pack and other
information.
1. What Optilast is and what it is
used for
Optilast 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.
Optilast 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.
Optilast 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.
Optilast is not suitable for treating
eye infections.

Putting in your Optilast 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.

- 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.

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.

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 Optilast
Although Optilast 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.

Do not use Optilast:
• 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 Optilast
- 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 Optilast.

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
provide more information on the safety
of this medicine
5. How to store Optilast
Keep this medicine out of the sight and
reach of children.
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.
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.
6. Contents of the pack and other
information

Diagram 1

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

Diagram 2

Diagram 3

Diagram 4

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

Optilast contains benzalkonium
chloride
Optilast 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 use more Optilast than you
should
If you put too much Optilast into your
eyes you are unlikely to have any
problems. If you are worried, contact
your doctor. If you accidentally swallow
Optilast, contact your doctor or nearest
hospital casualty department as soon
as possible.

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

If you forget to use Optilast
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.

3. How to use Optilast
Always use this medicine exactly as
your doctor or pharmacist has told you.
Check with your doctor or pharmacist if
you are not sure.

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

Remember:
• Optilast should only be applied to the
eyes.

2. What you need to know before
you use Optilast

people): An allergic reaction (such as
rash and itching).

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

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.

Like all medicines this medicine can
cause side effects, although
noteverybody gets them.
These effects include:
• Common (may affect up to 1 in 10
people): Slight irritation (burning,
itching, watering) in the eyes after
putting in Optilast. 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

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

FRONT

What Optilast looks like and contents
of the pack
Optilast is a clear, colourless solution.
Optilast 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 Ltd
Skyway House
Takeley
Bishops Stortford
CM22 6PU
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
This medicinal product is authorised
in the Member States of the EEA
under the following names:

4. Possible side effects

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

What Optilast 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.

Germany:
Allergodil Augentropfen
Austria, Denmark,
Italy,
The Netherlands: Allergodil
Finland, Sweden: Lastin
Portugal:
Allergodil
Spain:
Afluon
United Kingdom,
Ireland:
Optilast
This leaflet was last revised in June
2015.

BACK

CODE: 777134VI21/7J

DRAFT: 03

DATE: 18/06/2015

CLIENT: TUBILUX (76)

PRODUCT: Insert Optilast (UK)
MEASURE: 120 x 285 mm (120 x 25 mm)
COLOURS:

Black

EXTRA: Deca code XIXIX

P. 072
Approval

TEXT SIZE: 8 pt / Helvetica Family
NOTE:
www.effe5grafica.it
Tel. (+39) 06 9326.0017
postmaster@effe5grafica.it

Visual code 7-8-9

Packaging development

Techical Direction

Regulatory

Marketing

56UK21995050-02
777134VI21/7J

Package Leaflet: Information for the patient

Optilast

doctor may increase your dose to one
drop in each eye, up to four times a
day.
Relief of symptoms of allergic
conjunctivitis should be noticed after
15-30 minutes.

777134VI21/7J

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 Optilast 0.5 mg/ml Eye
Drops, Solution is called Optilast.
What is in this leaflet
1.What Optilast is and what it is used for
2.What you need to know before you
use Optilast
3.How to use Optilast
4.Possible side effects
5.How to store Optilast
6.Contents of the pack and other
information.
1. What Optilast is and what it is
used for
Optilast 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.
Optilast 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.
Optilast 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.
Optilast is not suitable for treating
eye infections.

Putting in your Optilast 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.

- 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.

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.

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 Optilast
Although Optilast 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.

Do not use Optilast:
• 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 Optilast
- 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 Optilast.

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
provide more information on the safety
of this medicine
5. How to store Optilast
Keep this medicine out of the sight and
reach of children.
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.
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.
6. Contents of the pack and other
information

Diagram 1

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

Diagram 2

Diagram 3

Diagram 4

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

Optilast contains benzalkonium
chloride
Optilast 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 use more Optilast than you
should
If you put too much Optilast into your
eyes you are unlikely to have any
problems. If you are worried, contact
your doctor. If you accidentally swallow
Optilast, contact your doctor or nearest
hospital casualty department as soon
as possible.

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

If you forget to use Optilast
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.

3. How to use Optilast
Always use this medicine exactly as
your doctor or pharmacist has told you.
Check with your doctor or pharmacist if
you are not sure.

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

Remember:
• Optilast should only be applied to the
eyes.

2. What you need to know before
you use Optilast

people): An allergic reaction (such as
rash and itching).

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

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.

Like all medicines this medicine can
cause side effects, although
noteverybody gets them.
These effects include:
• Common (may affect up to 1 in 10
people): Slight irritation (burning,
itching, watering) in the eyes after
putting in Optilast. 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

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

FRONT

What Optilast looks like and contents
of the pack
Optilast is a clear, colourless solution.
Optilast 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 Ltd
Skyway House
Takeley
Bishops Stortford
CM22 6PU
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
This medicinal product is authorised
in the Member States of the EEA
under the following names:

4. Possible side effects

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

What Optilast 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.

Germany:
Allergodil Augentropfen
Austria, Denmark,
Italy,
The Netherlands: Allergodil
Finland, Sweden: Lastin
Portugal:
Allergodil
Spain:
Afluon
United Kingdom,
Ireland:
Optilast
This leaflet was last revised in June
2015.

BACK

CODE: 777134VI21/7J

DRAFT: 03

DATE: 18/06/2015

CLIENT: TUBILUX (76)

PRODUCT: Insert Optilast (UK)
MEASURE: 120 x 285 mm (120 x 25 mm)
COLOURS:

Black

EXTRA: Deca code XIXIX

P. 072
Approval

TEXT SIZE: 8 pt / Helvetica Family
NOTE:
www.effe5grafica.it
Tel. (+39) 06 9326.0017
postmaster@effe5grafica.it

Visual code 7-8-9

Packaging development

Techical Direction

Regulatory

Marketing

56UK21995050-02
777134VI21/7J

This medicinal product is authorised
in the Member States of the EEA
under the following names:
Germany:
Allergodil Augentropfen
Austria, Denmark,
Italy,
The Netherlands: Allergodil
Finland, Sweden: Lastin
Portugal:
Allergodil
Spain:
Afluon
United Kingdom,
Ireland:
Optilast

FRONT

BACK

CODE: 777134VI21/7J

DRAFT: 03

DATE: 18/06/2015

CLIENT: TUBILUX (76)

PRODUCT: Insert Optilast (UK)
MEASURE: 120 x 285 mm (120 x 25 mm)
COLOURS:

Black

EXTRA: Deca code XIXIX

P. 072
Approval

TEXT SIZE: 8 pt / Helvetica Family
NOTE:
www.effe5grafica.it
Tel. (+39) 06 9326.0017
postmaster@effe5grafica.it

Visual code 7-8-9

Packaging development

Techical Direction

Regulatory

Marketing

Expand view ⇕

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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