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AZYTER 15 MG/G EYE DROPS SOLUTION IN SINGLE-DOSE CONTAINER

Active substance(s): AZITHROMYCIN DIHYDRATE

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Package Leaflet: Information for the patient

Azyter 15 mg/g, eye drops, solution in single-dose container
Azithromycin dihydrate

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 the doctor treating your child, or
pharmacist or nurse.
- This medicine has been prescribed for you
or for your child 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, pharmacist or nurse. This includes
any possible side effects not listed in this
leaflet.

Other medicines and Azyter
If you are using any other eye medicine, you
should:
 use the other eye medicine first,
 wait for 15 minutes,
 then use Azyter last.
Tell your doctor, or the doctor treating your
child, or pharmacist if you are using or
have recently used or might use any other
medicines.
Pregnancy
If you are pregnant, tell your doctor before
using Azyter. If he or she considers it to
be necessary; he or she may still give this
medicine to you.
Breast feeding
You can use these drops if you are breastfeeding.
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.
Driving and using machines
You may have blurred vision for a short time
after using your drops. Wait until your vision is
normal before driving or using any machine.

If you forget to use Azyter
Do not use a double dose to make up for a
forgotten dose.
If you stop using Azyter
Always tell your doctor if you want to stop the
treatment.
If you have any further questions on the use of
this medicine, ask your doctor, pharmacist or
nurse.

By reporting side effects you can help
provide more information on the safety of this
medicine.

XXXXXXXXX
N1225U6L02/0513

5. How to store AZYTER
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 outer carton and singledose container. The expiry date refers to the
4. Possible side effects
last day of that month.
Like all medicines, this medicine can cause
• Do not store above 25ºC.
side effects, although not everybody gets them. • Keep the single-dose containers in the
The following side effects affecting the eye
sachet to protect them from light.
have been observed upon using these eye
Throw away the opened single-dose
drops:
container immediately after you have
Very common: may affect more than 1 in 10
used it, even if it has some solution
What is in this leaflet:
people:
left. Do not keep it to use again.
1. What AZYTER is and what it is used for
- itching, burning or stinging when you use
Do not throw away any medicines via
2. What you need to know before you use
the drops. This will soon pass.
wastewater or household waste. Ask your
AZYTER
pharmacist how to throw away medicines you
Common: may affect up to 1 in 10 people:
3. How to use AZYTER
no longer use. These measures will help protect
- blurred vision,
4. Possible side effects
the environment.
- a feeling of sticky eye,
5. How to store AZYTER
- a feeling there is something in your eye.
6. Contents of the pack and other information
6. Contents of the pack and other
Uncommon: may affect up to 1 in 100 people:
information
- serious allergic reaction which
1. What AZYTER is and what it is
What
Azyter contains
causes swelling of the face or throat
used for
The
active substance is azithromycin
3. How to use AZYTER
(angioedema),
Azyter contains azithromycin, which is an
dihydrate.
Each gram of solution contains
This medicine is only to be used in the eye
- allergic reaction (hypersensitivity),
antibiotic (macrolide class).
15
mg
of
azithromycin
dihydrate
(ocular use).
- inflammation of the conjunctiva (could be
Azyter is used to treat some eye infections that
equivalent
to
14.3
mg
of
azithromycin.
Always use this medicine exactly as your
due to infection or allergy) (conjunctivitis),
are caused by bacteria in adults (including the
Each single-dose container of 250 mg
doctor, or the doctor treating your child has
- allergic inflammation of the conjunctiva
elderly) and in children from birth to 17 years
solution contains 3.75 mg of azithromycin
told you. Check with your doctor, or the doctor
(allergic conjunctivitis),
of age.
dihydrate.
treating your child, or pharmacist if you are
- inflammation of the cornea (keratitis),
• purulent bacterial conjunctivitis,
The other ingredient is triglycerides,
not sure.
- itchy skin on the eyelids (eczema eyelids),
• trachoma conjunctivitis (a particular
medium-chain.
- dry, red, swelling of the eyelids (eyelid
Dosage
infection of the eye caused by bacteria
What Azyter looks like and contents
oedema),
The
recommended
dose
for
adults
(including
called Chlamydia trachomatis, which is
of the pack
the elderly) and children from birth to 17 years - eye allergy,
usually found in developing countries).
Azyter is an eye drops solution supplied in
of age is one drop twice a day in the eye(s) to - eye watering,
single-dose containers, each containing 0.25
redness
of
the
eyelids
(erythema
of
eyelids),
be treated: one drop in the morning and one
2. What you need to know before
g of the product. It is a clear, colourless to
redness
of
the
conjunctiva
(conjunctival
drop in the evening.
you use AZYTER
slightly yellow, oily liquid.
hyperaemia).
The course of treatment is three days.
Do not use Azyter:
The pack contains six single-dose containers
Azyter eye drops have a prolonged
Reporting of side effects
- If you are allergic to azithromycin, to any
in a sachet, which are for one course of
action and will continue to work
If you get any side effects, talk to your doctor
other antibiotic from the macrolide class or
treatment.
after the three day course. Do not
or the doctor treating your child, pharmacist
to medium-chain triglycerides.
use your drops for more than three
or nurse. This includes any possible side effects Marketing Authorisation Holder
Warnings and precautions
LABORATOIRES THEA
days even if you still have some
not listed in this leaflet. You can also report
Talk to your doctor, or the doctor treating your residual signs of your eye infection.
12, rue Louis Blériot
side effects directly via the national reporting
child, or your pharmacist or nurse before
63017 CLERMONT-FERRAND CEDEX 2
system:
How to use Azyter
using Azyter.
FRANCE
For a proper administration of Azyter:
United Kingdom
- If you or your child have an allergic
Manufacturer
- wash your hands well before and after
Yellow Card Scheme
reaction, stop the treatment and tell your
LABORATOIRES THEA
using your drops,
Website: www.mhra.gov.uk/yellowcard.
doctor or the doctor treating your child.
12, rue Louis Blériot
- look up and pull down the lower eyelid,
Ireland
- If your or your child’s eye infection does not
63017 CLERMONT-FERRAND CEDEX 2
- apply one drop into each affected eye,
FREEPOST
get better after three days using the drops,
FRANCE
- take care not to touch the eye and eyelids
Pharmacovigilance Section
or if you notice anything unusual, tell your
with the dropper tip of the single-dose
Irish Medicines Board
doctor or the doctor treating your child.
container,
Kevin O’Malley House
- Do not wear contact lenses when you or
- throw away the single-dose
This leaflet was last revised in
Earlsfort Centre
your child have an eye infection.
container after use. Do not keep it Earlsfort Terrace
08/2013.
Use your drops only in your eyes.
to use again.
IRL - Dublin 2
Do not inject or swallow your drops.
Tel: +353 1 6764971
DO NOT INJECT, DO NOT SWALLOW
Fax: +353 1 6762517
Website: www.imb.ie
e-mail: imbpharmacovigilance@imb.ie

Package Leaflet: Information for the patient

Azyter 15 mg/g, eye drops,
solution in single-dose container
Azithromycin dihydrate
Tell your doctor, or the doctor treating
your child, or pharmacist if you are using
or have recently used or might use any
other medicines.

What is in this leaflet:
1. What AZYTER is and what it is used
for
2. What you need to know before you
use AZYTER
3. How to use AZYTER
4. Possible side effects
5. How to store AZYTER
6. Contents of the pack and other
information

Driving and using machines
You may have blurred vision for a short
time after using your drops. Wait until
your vision is normal before driving or
using any machine.

1. What AZYTER is and what it is
used for
Azyter contains azithromycin, which is an
antibiotic (macrolide class).
Azyter is used to treat some eye infections
that are caused by bacteria in adults
(including the elderly) and in children
from birth to 17 years of age.
• purulent bacterial conjunctivitis,
• trachoma conjunctivitis (a particular
infection of the eye caused by bacteria
called Chlamydia trachomatis, which is
usually found in developing countries).
2. What you need to know
before you use AZYTER

Pregnancy
If you are pregnant, tell your doctor
before using Azyter. If he or she considers
it to be necessary; he or she may still give
this medicine to you.
Breast feeding
You can use these drops if you are breastfeeding.
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.

3. How to use AZYTER
This medicine is only to be used in the eye
(ocular use).
Always use this medicine exactly as your
doctor, or the doctor treating your child
has told you. Check with your doctor,
or the doctor treating your child, or
pharmacist if you are not sure.
Dosage
The recommended dose for adults
(including the elderly) and children from
birth to 17 years of age is one drop twice
a day in the eye(s) to be treated: one
drop in the morning and one drop in the
evening.
The course of treatment is three days.
Azyter eye drops have a
prolonged action and will
continue to work after the
three day course. Do not use
your drops for more than three
days even if you still have
some residual signs of your eye
infection.

Do not use Azyter:
- If you are allergic to azithromycin, to
any other antibiotic from the macrolide
class or to medium-chain triglycerides. How to use Azyter
For a proper administration of Azyter:
Warnings and precautions
- wash your hands well before and after
Talk to your doctor, or the doctor treating
using your drops,
your child, or your pharmacist or nurse
- look up and pull down the lower
before using Azyter.
eyelid,
- If you or your child have an allergic
- apply one drop into each affected eye,
reaction, stop the treatment and tell
- take care not to touch the eye and
your doctor or the doctor treating your
eyelids with the dropper tip of the
child.
single-dose container,
- If your or your child’s eye infection
- throw away the single-dose
does not get better after three days
container after use. Do not
using the drops, or if you notice
keep it to use again.
anything unusual, tell your doctor or
the doctor treating your child.
DO NOT INJECT, DO NOT SWALLOW
- Do not wear contact lenses when you
or your child have an eye infection.
Use your drops only in your eyes.
Do not inject or swallow your drops.
Other medicines and Azyter
If you are using any other eye medicine,
you should:
 use the other eye medicine first,
 wait for 15 minutes,
 then use Azyter last.

If you forget to use Azyter
Do not use a double dose to make up for
a forgotten dose.
If you stop using Azyter
Always tell your doctor if you want to stop
the treatment.
If you have any further questions on the
use of this medicine, ask your doctor,
pharmacist or nurse.
4. Possible side effects

5. How to store AZYTER
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 outer carton
and single-dose container. The expiry date
refers to the last day of that month.
• Do not store above 25ºC.
• Keep the single-dose containers in
the sachet to protect them from light.

Like all medicines, this medicine can cause Throw away the opened singleside effects, although not everybody gets
dose container immediately after
them.
you have used it, even if it has
some solution left. Do not keep it
The following side effects affecting the eye to use again.
have been observed upon using these eye
drops:
Do not throw away any medicines via
wastewater or household waste. Ask your
Very common: may affect more than 1 in pharmacist how to throw away medicines
10 people:
you no longer use. These measures will
- itching, burning or stinging when you
help protect the environment.
use the drops. This will soon pass.
Common: may affect up to 1 in 10
people:
- blurred vision,
- a feeling of sticky eye,
- a feeling there is something in your
eye.
Uncommon: may affect up to 1 in 100
people:
- serious allergic reaction which
causes swelling of the face or throat
(angioedema),
- allergic reaction (hypersensitivity),
- inflammation of the conjunctiva
(could be due to infection or allergy)
(conjunctivitis),
- allergic inflammation of the
conjunctiva (allergic conjunctivitis),
- inflammation of the cornea (keratitis),
- itchy skin on the eyelids (eczema
eyelids),
- dry, red, swelling of the eyelids (eyelid
oedema),
- eye allergy,
- eye watering,
- redness of the eyelids (erythema of
eyelids),
- redness of the conjunctiva (conjunctival
hyperaemia).
Reporting of side effects
If you get any side effects, talk to your
doctor or the doctor treating your child,
pharmacist or nurse. This includes any
possible side effects not listed in this
leaflet. You can also report side effects
directly via the national reporting system:

6. Contents of the pack and other
information
What Azyter contains
- The active substance is azithromycin
dihydrate. Each gram of solution
contains 15 mg of azithromycin
dihydrate equivalent to 14.3 mg
of azithromycin. Each single-dose
container of 250 mg solution contains
3.75 mg of azithromycin dihydrate.
- The other ingredient is triglycerides,
medium-chain.
What Azyter looks like and
contents of the pack
Azyter is an eye drops solution supplied
in single-dose containers, each containing
0.25 g of the product. It is a clear,
colourless to slightly yellow, oily liquid.
The pack contains six single-dose
containers in a sachet, which are for one
course of treatment.
Marketing Authorisation Holder
LABORATOIRES THEA
12, rue Louis Blériot
63017 CLERMONT-FERRAND CEDEX 2
FRANCE
Manufacturer
Laboratoire UNITHER
ZI de la Guérie
50200 COUTANCES
FRANCE

United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard.
Ireland
FREEPOST
Pharmacovigilance Section
Irish Medicines Board
Kevin O’Malley House
Earlsfort Centre
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.imb.ie
e-mail: imbpharmacovigilance@imb.ie
By reporting side effects you can help
provide more information on the safety of
this medicine.

This leaflet was last revised in
08/2013

N1225U6L02/X0513

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 the doctor treating your
child, or pharmacist or nurse.
- This medicine has been prescribed for
you or for your child 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, pharmacist or nurse. This
includes any possible side effects not
listed in this leaflet.

XXETNXXXX/X

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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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