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EYOPTO 5 MG/ML EYE DROPS SOLUTION

Active substance(s): TIMOLOL MALEATE

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Package leaflet: Information for
the user

• Parasympathomimetic medicine,
which may have been prescribed to
help you pass urine.
Parasympathomimetics are also a
particular type of medicine which is
sometimes used to help restore
normal movements through the
bowel
• Digoxin, a medicine used to relieve
2.5mg/ml Eye Drops, Solution
heart failure or treat abnormal
5mg/ml Eye Drops, Solution
heartbeat
• Quinidine, used to treat heart
timolol
conditions and some types of
malaria
Read all of this leaflet carefully
• Antidepressants known as
before you start using this
fluoxetine and paroxetine
medicine because it contains
important information for you.
• Antiarrhythmics (including
amiodarone)
- Keep this leaflet. You may need to
• Clonidine, a medicine used to treat
read it again.
high blood pressure
- If you have any further questions,
• Other beta-blockers taken by
ask your doctor, pharmacist or
mouth or used as eye drops,
nurse.
because they belong to the same
- This medicine has been prescribed
group of medicines as Eyopto and
for you only. Do not pass it on to
could have an additive effect
others. It may harm them, even if

Insulin and other oral anti-diabetic
their signs of illness are the same
drugs
as yours.
Pregnancy and breast-feeding
- If you get any side effects, talk to
your doctor, pharmacist or nurse.
If you are pregnant or breast-feeding,
This includes any possible side
think you may be pregnant or are
effects not listed in this leaflet.
planning to have a baby, ask your
See section 4.
doctor for advice before taking this
medicine.
What is in this leaflet
Use in pregnancy
1. What Eyopto is and what it is
Do not use Eyopto if you are
used for
2. What you need to know before you pregnant unless your doctor considers
it necessary.
use Eyopto
3. How to use Eyopto
Use in breast-feeding
4. Possible side effects
Do not use Eyopto if you are
5. How to store Eyopto
6. Contents of the pack and other breast-feeding. Timolol may get into
your milk.
information

1. What Eyopto is and what
it is used for
Eyopto contains a substance called
timolol which belongs to a group of
medicines called beta-blockers.
Timolol lowers the pressure in your
eye(s). It is used to treat chronic
open-angle and secondary glaucoma,
when the pressure in the eye is
raised, in adults.
Eyopto eye drops solution is a sterile
solution that does not contain a
preservative.

2. What you need to know
before you use Eyopto
Do not use Eyopto if:
• you are allergic to timolol,
beta-blockers or any of the other
ingredients of this medicine
(listed in section 6).
• you have now or have had in the
past respiratory problems such as
asthma, severe chronic obstructive
bronchitis (severe lung disease
which may cause wheeziness,
difficulty in breathing and/or
long-standing cough).
• you have a slow heartbeat, heart
failure or disorders of heart rhythm
(irregular heartbeats).
• you have “cardiogenic shock” – a
serious heart condition caused by
very low blood pressure, which may
result in the following symptoms:
dizziness and lightheadedness, fast
pulse rate, white skin, sweating,
restlessness, loss of consciousness.
If you are not sure whether you
should use Eyopto talk to your doctor
or pharmacist.
Warnings and precautions
Talk to your doctor before using
Eyopto if you have now or have had
in the past:
• coronary heart disease (symptoms
can include chest pain or tightness,
breathlessness or choking), heart
failure.
• closed-angle glaucoma, a condition
in which the pressure inside your
eye becomes too high.
• low blood pressure.
• disturbances of heart rate such as
slow heartbeat.
• breathing problems, asthma or
chronic obstructive pulmonary
disease.
• poor blood circulation disease (such
as Raynaud’s disease or Raynaud’s
syndrome).
• diabetes as timolol may mask signs
and symptoms of low blood sugar.
• overactivity of the thyroid gland as
timolol may mask signs and
symptoms.
• muscle weakness.
• tumor of the adrenal gland
(pheochromocytoma).
• blood and body fluid abnormality
(metabolic acidosis).
• pain in the legs when walking due
to poor circulation in the legs
(claudication).
• reduced kidney function.
• you wear soft contact lenses.
Eyopto has not been studied in
patients wearing contact lenses.
If you wear contact lenses, you
should consult your doctor before
using Eyopto.
If you have a history of contact
hypersensitivity to silver, you should
not use this product.
Tell your doctor before you have an
operation that you are using Eyopto
as timolol may change effects of
some medicines used during
anaesthesia.
If you suspect that Eyopto is causing
an allergic reaction or hypersensitivity
(for example, skin rash or redness
and itching of the eye) contact your
doctor immediately.
Children and adolescents
Eyopto should generally be used with
caution in young patients. In
newborns, infants and younger
children Eyopto should be used with
extreme caution. If coughing,
wheezing, abnormal breathing or
abnormal pauses in breathing
(apnoea) occur, the use of the
medicine should be stopped
immediately. Contact your doctor as
soon as possible. A portable apnoea
monitor may also be helpful.
Other medicines and Eyopto
Tell your doctor or pharmacist if you
are taking, have recently taken or
might take any other medicines.
Eyopto can affect or be affected by
other medicines you are using,
including other eye drops for the
treatment of glaucoma.
Tell your doctor if you are using or
intend to use medicines to lower
blood pressure, heart medicine
or medicines to treat diabetes.
It is important to tell your doctor
before using Eyopto if you are taking
one or more of the following
medicines:
• Eye drops containing adrenaline
• A calcium antagonist, such as
nifedipine, verapamil or diltiazem,
often used to treat high blood
pressure, angina, an abnormal
heartbeat or Raynaud’s syndrome
• Guanethidine, a medicine often
used to treat high blood pressure

Driving and using machines
There are possible side effects
associated with Eyopto, such as
dizziness, tiredness and changes in
your eyesight, such as blurred vision,
drooping of the upper eyelid (making
the eye stay half closed), double
vision which may affect your ability
to drive and/or operate machinery.
Do not drive and/or operate
machinery until you feel well and
your vision is clear.

3. How to use Eyopto
Always use this medicine exactly as
your doctor has told you. Check with
your doctor or pharmacist if you are
not sure. The doctor will decide how
many drops you should take each day
and how long you should use them.
The recommended dose is one drop
in the affected eye(s) once or twice
(one in the morning and one in the
evening) each day.
Do not change your recommended
dose without talking to your doctor.
Do not allow the tip of the multi-dose
container to touch the eye or areas
around the eye. It could cause injury
to your eye. The eye drops solution
may become contaminated with
bacteria that can cause eye infections
leading to serious damage of the eye,
even loss of vision.
To avoid possible contamination of
the multi-dose container, keep the tip
of the multi-dose container away
from contact with any surface.
Instructions for use
Before instillation of the eye drops:
- Wash your hands before opening
the bottle.
- Do not use this medicine if you
notice that the tamper-proof seal
on the bottle neck is broken before
you first use it.
- At the first use, after cap removal,
without positioning the eyedropper
above the eye, slowly squeeze the
bottle to deliver one drop in the air
to get use to the pressure and time
required to deliver one drop. In
case of difficulties of delivering one
drop at a time, this step might be
repeated.
- Choose the position that you find
most comfortable for the instillation
of the drops (you can sit down, lie
on your back, or stand in front of a
mirror).
Instillation:
1. Hold the bottle directly below the
cap and turn the cap to open the
bottle. Do not touch anything with
the tip of the bottle to avoid
contamination of the solution.

2. Tilt your head backwards and hold
the bottle above your eye.

3. Pull the lower eyelid down and look
up. Squeeze the bottle gently in the
middle and let a drop fall into your
eye. Please note that there might
be a few seconds delay between
squeezing and the drop coming
out. Do not squeeze too hard.
If you are not sure how to
administer your medicine, ask your
doctor, pharmacist or nurse.
4. Blink a few times so that the
drop spreads over the eye.

5. After using Eyopto, press a finger
into the corner of your eye, by the
nose for 2 minutes. This helps to
stop timolol getting into the rest of
your body.

6. Follow the instructions 2-5 for
dropping also into the other eye.
7. After use and prior to recapping,
the bottle should be shaken once in
a downwards direction, without
touching the dropper tip, in order
to remove any residual liquid on
the tip. This is necessary in order
to ensure delivery of subsequent
drops.

T
 here might remain a small amount
of solution in the bottle at the end.
This is accounted for by an overfill
of all bottles ensuring that 5ml
solution can always be dispensed.

Do not use the eye drops for longer
than 28 days after first opening the
bottle.

Like other medicines applied into
eyes, timolol is absorbed into the
blood. This may cause similar side
effects as seen with intravenous
Use in children and adolescents
and/or oral beta-blocking agents.
Before your child starts to use Eyopto, Incidence of side effects after topical
ophthalmic administration is lower
your child’s doctor will have carried
than when medicines are, for
out a detailed medical examination
example taken by mouth or injected.
and decided whether or not this
The following additional side effects
medicine is suitable. Your child,
were seen within the class of
especially a newborn, should be
beta-blockers when used for treating
closely monitored for one to two
eye conditions:
hours after the first dose and
carefully monitored for any signs of
• Low blood glucose levels
side effects.
• Corneal erosion (damage to the
front layer of the eyeball), tearing
Method of administration for use
and redness in the eyes
in children:
• Heart failure
One drop only of Eyopto should be
instilled into the affected eye(s) each • Severe allergic reactions with
swelling and difficulty breathing
time. Follow the “Instructions for Use”

Skin rash and itching
above when administering the eye
• Taste disturbances, abdominal pain,
drops.
vomiting
Duration of treatment for use in
• Muscle pain not caused by exercise
children
• Sexual dysfunction
Your child’s doctor will decide for how
Reporting of side effects
long the eye drops will be needed.
If you get any side effects, talk to
If you use more Eyopto than
your doctor or pharmacist or nurse.
you should
This includes any possible side effects
If you put too many drops in your eye not listed in this leaflet. You can also
or swallow any of the drops, you may: report side effects directly via the
Yellow Card Scheme (website:
• have a headache.
www.mhra.gov.uk/yellowcard).
• feel dizzy or light-headed.
By reporting side effects you can help
• have difficulty breathing.
provide more information on the
• chest pain.
safety of this medicine.
• feel that your heart rate has
slowed down.
5. How to store Eyopto
If this happens, contact your
Keep this medicine out of the sight
doctor immediately.
and reach of children.
If you forget to use Eyopto
This medicinal product does not
It is important to take Eyopto as
require any special storage conditions.
prescribed by your doctor.
You can use Eyopto for 28 days after
• If you miss a dose, use the drops
first opening the bottle.
as soon as possible.
Do not use Eyopto after the expiry
• If it is almost time for the next
date which is stated on the carton
dose, skip the missed dose and
and the bottle after EXP. The expiry
take the next dose at the
date refers to the last day of that
usual time.
month. Make sure the container is
• Do not take a double dose to make properly closed.
up for the forgotten dose.
Do not throw away any medicines via
wastewater or household waste. Ask
If you stop using Eyopto
your pharmacist how to throw away
If you want to stop using this
medicines you no longer use. These
medicine talk to your doctor first. If
measures will help protect the
you have any further questions on the environment.
use of this medicine, ask your doctor
or pharmacist.

4. Possible side effects
Like all medicines, this medicine can
cause side effects, although not
everybody gets them.
You can usually carry on taking the
drops, unless the effects are serious.
If you’re worried, talk to a doctor or
pharmacist. Do not stop using Eyopto
without speaking to your doctor.
Serious side effects
See your doctor immediately if
you notice any of the following
side effects for which you may
need urgent medical treatment:
Rare (may affect up to
1 in 1000 people)
• Severe sudden life-threatening
allergic reaction with sudden rash,
swelling beneath the skin that can
occur in areas such as the face and
limbs, and can obstruct the airway
which may cause difficulty
breathing or swallowing, and
fainting (within minutes to hours)
due to hypersensitivity
(anaphylactic reaction).
• Paralysis, speech disorders, loss of
consciousness due to reduced
blood supply to the brain,
interference with the blood supply
to the brain which may lead to a
stroke.
• Changes in the rhythm or speed of
the heartbeat, congestive heart
failure (heart disease with
shortness of breath and swelling of
the feet and legs due to fluid build
up), a type of heart rhythm
disorder, heart attack, heart failure.
• Difficulty breathing, shortness of
breath, wheezing, cough.
• Very slow pulse.
• Sudden decreased vision after
surgery for glaucoma.
• Rash on the face, kidney
inflammation, fever, joint and
muscle pain due to connective
tissue disease. A condition called
lupus (systemic lupus
erythematosus).
• Increases in signs and symptoms of
myasthenia gravis (a muscle
disorder which causes muscle
weakness and fatigue of the eye
muscles and/or of the muscles used
in swallowing, chewing and
breathing).
• Raynaud’s phenomenon (White,
“dead” fingers and toes).
• Limping and leg pain when walking
because there is a reduced blood
supply to your legs.
• In men, a condition which affects
your penis called Peyronie’s
disease. The signs may be
abnormal curve, pain or hardening
of the tissue of your penis.

6. Contents of the pack and
other information

What Eyopto contains
The active substance is timolol
maleate.
Eyopto is available in two strengths:
• Each ml of Eyopto 2.5mg/ml
solution contains 3.417mg of
timolol maleate (equivalent to
2.5mg of timolol).
• Each ml of Eyopto 5mg/ml contains
6.834mg of timolol maleate
(equivalent to 5mg of timolol).
- The other ingredients are: sodium
dihydrogen phosphate dihydrate,
disodium phosphate dodecahydrate,
sodium hydroxide (for pH
adjustment), water for injection.
What Eyopto looks like and
contents of the pack
Eyopto 2.5mg/ml eye drops solution,
is presented as a clear, colorless
aqueous solution in a white opaque
11 ml LDPE bottle and white Novelia
nozzle (HDPE and silicone) with a
white HDPE cap.
Eyopto 5mg/ml eye drops solution, is
presented as a clear, colorless
aqueous solution in a white opaque
11 ml LDPE bottle and white Novelia
nozzle (HDPE and silicone) with a
white HDPE cap.
Pack sizes: 1 or 2 bottles in a card
box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
and Manufacturer
Marketing Authorisation Holder
Pharmathen S.A.,
6 Dervenakion
15351 Pallini Attiki
Greece
Manufacturer
Pharmathen S.A.,
6 Dervenakion
15351 Pallini Attiki
Greece
and
EXCELVISION
27 st. La Lombardière, Zl La
Lombardière,
ANNONAY 07100
France
This leaflet was last revised in:
06/2016

Other side effects
Common (may affect up to
1 in 10 people)
• Blurred vision, signs and symptoms
of eye irritation (e.g. burning,
stinging, itching, tearing, redness),
inflammation of the eyelid,
inflammation of the surface of the
eye, irritation or pain in the eye,
dry eyes, decreased corneal (layer
at the front of the eye) sensitivity,
corneal erosion (damage to the
front layer of the eyeball), feeling
of a foreign object in the eye,
secretion
• Headache, dizziness
Uncommon (may affect up to
1 in 100 people)
• Fainting, general weakness, fatigue
• Depression
• Abnormal vision
• Nausea, indigestion
Rare (may affect up to
1 in 1000 people)
• General allergic reactions including
localized and generalized rash,
itchiness
• Double vision, drooping of the
upper eyelid (making the eye stay
half closed) and separation of one
of the layers within the eyeball
after surgery to reduce the
pressure in the eye
• Low blood pressure
• Chest pain, palpitations, oedema
(fluid build up)
• Difficulty sleeping (insomnia),
nightmares, memory loss
• Decreased sex drive
• Diarrhoea, dry mouth
• Hair loss, skin rash with white
silvery coloured appearance
(psoriasiform rash) or worsening of
psoriasis
• Ringing sound in the ears
• Unusual sensations like tingling or
pins and needles
• Cold hands and feet
XXXXXXX-P1.7

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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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