PACKAGE
LEAFLET
EMADINE
0.05% eye drops, solution.
Emedastine
Read all of this leaflet carefully
before you start using this medicine.
This medicine has been prescribed for
you personally. You must not pass it on to other
people. It may harm them even if they have the same
illness as you.
Keep this leaflet. You may
need to read it again. If you still have questions after
reading it, please ask your doctor or your pharmacist.
The active substance is
emedastine 0.05% (0.5 mg/ml) as difumarate.
Other ingredients:
benzalkonium chloride, trometamol; sodium chloride;
hypromellose; purified water.
Tiny amounts
of hydrochloric acid or sodium hydroxide are sometimes
added to keep acidity levels (pH levels) normal.
1. WHAT
EMADINE DOES
EMADINE is used to treat seasonal
allergic conjunctivitis in the eye.
Allergic conjunctivitis. Some
materials (allergens) like pollens, house dust or animal
fur may cause allergic reactions resulting in itching,
redness as well as swelling of the surface of your eye.
EMADINE is a medicine for the
treatment of allergic conditions of the eye. It works by
reducing the intensity of the allergic reaction.
EMADINE is a liquid (a
solution) supplied in a 5 ml or 10 ml plastic (DROP-TAINER)
bottle with a screw cap. Not all pack sizes may be
marketed.
2.
BEFORE YOU USE EMADINE
Do
not use EMADINE...
-
if you are allergic to
emedastine or any of the other ingredients.
Ask your
doctor for advice.
Take special care using EMADINE
...
-
Do not use EMADINE in
children under the age of 3 years.
-
If you are pregnant, or might
get pregnant, if you are breast-feeding.
Ask your doctor for advice.
-
If you wear contact lenses.
Do not use the drops while your contact lenses
are in your eyes. Wait at least 15 minutes after
using the eye drops before putting your lenses
back into your eyes. A preservative in EMADINE (benzalkonium
chloride) may cause eye irritation and is known
to discolour soft contact lenses.
-
EMADINE is not recommended
for use in patients over 65 years of age, as it
has not been studied in clinical trials in this
age group. It is not recommended for use in
patients with kidney or liver problems.
Driving or using machines
You may
find that your vision is blurred for a time just
after you use EMADINE. Do not drive or use machines
until your vision is clear.
EMADINE and other medicines.
Tell your doctor or pharmacist if
you are taking (or have recently taken) any other
medicines. Don’t forget to mention any other
medicines that you have bought yourself without
prescription.
If you
are using other eye drops at the same time as
EMADINE , follow the advice at the end of section 3.
3. HOW
TO USE EMADINE
How
much to use
Adults
and children over 3 years: One
drop in the eye, twice a day – morning and
night.
Use this
much unless your doctor tells you something
differently. Use it for as long as your doctor tells
you to. Only use drops in both eyes if your doctor
tells you to.
Only use the drops in your
eyes.
Turn the
page for more advice
Now turn
over>
3. HOW TO USE EMADINE
(continued)
How much
to use
< see
side 1
-
Get the EMADINE bottle and a mirror.
-
Wash your hands.
-
Take the bottle and twist off the cap.
-
Hold the bottle, pointing down, between your
thumb and middle finger.
-
Tilt your head back. Pull down your eyelid with
a clean finger, until there is a ‘pocket’
between the eyelid and your eye. The drop will
go in here (picture 1).
-
Bring the bottle tip close to the eye. Use the
mirror if it helps.
-
Don’t touch your eye or
eyelid, surrounding areas or other surfaces with
the dropper. It could infect the drops
left in the bottle.
-
Gently press on the base
of the bottle to release one drop of EMADINE at
a time.
-
Don’t squeeze the bottle,
it is designed so that just a gentle press on
the bottom is needed(picture 2).
-
If you use drops in both eyes, repeat the steps
for your other eye.
-
Put the bottle cap back on firmly immediately
after use.
If you accidentally swallow
EMADINE or inject it contact a doctor immediately.
It may affect your heart rhythm.
If a drop misses your eye,
try again.
If you get too much in your eyes,
rinse it all out preferably with sterile saline or,
if not available, with warm water. Don’t put in any
more drops until it’s time for your next regular
dose.
If you forget to use EMADINE,
use one drop as soon as you remember, and then go
back to your normal routine. Do
not use a double dose to make up for the one
missed.
If you are using other eye drops,
leave at least 10 minutes between using EMADINE and
the other drops.
Don’t forget to tell your doctor
or pharmacist about any other medicines you
are taking or have recently taken – including any
you have bought yourself.
4.
POSSIBLE SIDE EFFECTS
Like all medicines EMADINE eye drops
can have side effects. These can be unpleasant, but most
of them disappear quickly.
In clinical
studies up to 10 in 100 patients experienced some type
of side effect.
The most common side effect
(affecting about 5 in every 100 people) was temporary
mild irritation, (burning or stinging) in the eye.
Less common side effects
(affecting less than 5 in every 100 people) were:
Effects in the eye: itching,
redness, dryness, tired or watery eyes, a feeling of
something in the eye, blurred vision.
Effects in the body: headache,
rash , altered sense of taste, allergy.
You can usually continue using the
drops, unless the effects are serious. If you're
worried, talk to a doctor or pharmacist.
If you find that your vision is
blurred for a time just after you use EMADINE do
not drive or use machines until your vision is clear.
If you notice
any other side effects not listed here,
tell your doctor or pharmacist.
5.
STORING EMADINE
You must throw away the bottle four
weeks after you first opened it, to guard against
infections.Write down the date you opened it in the
space on each bottle label and box and in the space
below.
Opened:
Keep the drops in a safe place
where children can’t see or reach them.
Do not use
the drops after the expiry date (marked ‘Exp’) on the
bottle and the box.
Do not store
above 25°C.
If you have any other questions about
your medicines you should ask your doctor or pharmacist.
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