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

Active substance(s): AZITHROMYCIN DIHYDRATE / AZITHROMYCIN DIHYDRATE / AZITHROMYCIN DIHYDRATE

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Leaflet code
Package Leaflet: Information for the patient

Azyter® 15 mg/g, eye drops, solution in single-dose container
Azithromycin dihydrate 15 mg/g, eye drops, solution in single-dose container
(azithromycin)
The name of your medicine is Azyter 15 mg/g, eye drops, solution in single-dose container or Azithromycin dihydrate 15 mg/g, eye drops, solution in single-dose container.
It will be referred to as Azyter throughout the remainder of this leaflet.

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.

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

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
Do not use Azyter:
- If you are allergic to azithromycin, to
any other antibiotic from the macrolide
class or to medium-chain triglycerides.

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.

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.

Do not use a double dose to make up for
a forgotten dose.

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.

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
Like all medicines, this medicine can cause
side effects, although not everybody gets
them.
The following side effects affecting the eye
have been observed upon using these eye
drops:

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.

Very common: may affect more than 1 in
10 people:
 itching, burning or stinging when you
use the drops. This will soon pass.

3. How to use Azyter

Common: may affect up to 1 in 10
people:
 blurred vision,
 a feeling of sticky eye,
 a feeling there is something in your
eye.

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.
How to use Azyter
For a proper administration of Azyter:
 wash your hands well before and after
using your drops,
 look up and pull down the lower
eyelid,
 apply one drop into each affected eye,
 take care not to touch the eye and
eyelids with the dropper tip of the
single-dose container,



throw away the single-dose
container after use. Do not
keep it to use again.

DO NOT INJECT, DO NOT SWALLOW

5. How to store Azyter
Keep this medicine out of the sight and
reach of children.

If you stop using Azyter

Breast-feeding

Warnings and precautions
Talk to your doctor, or the doctor treating
your child, or your pharmacist or nurse
before using Azyter.
 If you or your child have an allergic
reaction, stop the treatment and tell
your doctor or the doctor treating your
child.
 If your or your child’s eye infection
does not get better after three days
using the drops, or if you notice
anything unusual, tell your doctor or
the doctor treating your child.
 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.

If you forget to use Azyter

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 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.

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.

Throw away the opened singledose container immediately after
you have used it, even if it has
some solution left. Do not keep it
to use again.
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 notice any signs of discolouration or
deterioration of your medicine, please tell
your pharmacist immediately.

6. Contents of the pack and other
information
What Azyter contains




The active substance is azithromycin
dihydrate. Each 1 g 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.

Manufacturer
Laboratoire UNITHER, ZI de la Guérie,
50200 COUTANCES, FRANCE
Procured from within the EU.
Repackaged by:
Dr. Fisher Farma B.V., Vijzelweg 32,
8243 PM, Lelystad, The Netherlands
Product Licence Holder:
Medixl Ltd., Maple House, High Street,
Potters Bar, EN6 5BS, UK.
PL 46245/0016
POM
Azyter 15 mg/g, eye drops, solution in
single-dose container
Azithromycin dihydrate 15 mg/g, eye drops,
solution in single-dose container
This leaflet was last updated on 26/09/2016
Azyter® is a trademark of Laboratoires Théa
(société par actions simplifiée).
Leaflet code

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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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