Skip to Content



View full screen / Print PDF » Download PDF ⇩

PDF Transcript

• 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
• Digoxin, a medicine used to relieve
2.5mg/ml Eye Drops, Solution
heart failure or treat abnormal
5mg/ml Eye Drops, Solution
• Quinidine, used to treat heart
conditions and some types of
• Antidepressants known as
before you start using this
and paroxetine.
medicine because it contains
important information for you.
• Antiarrhythmics (including
You may need to
- Keep this
• 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,
because they belong to the same
- This medicine has been prescribed
group of medicines as Eysano and
for you only. Do not pass it on to
could have an additive effect.
others. It may harm them, even if

and other oral anti-diabetic
their signs of illness are the same
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
planning to have a baby, ask your
See section 4.
doctor for advice before taking this
Information for the user

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

1. What Eysano is and what
it is used for
Eysano 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.
Eysano eye drops solution is a sterile
solution that does not contain a

Use in pregnancy
Do not use Eysano if you are
pregnant unless your doctor considers
it necessary.
Use in breast-feeding
Do not use Eysano if you are
breast-feeding. Timolol may get into
your milk.
Driving and using machines
There are possible side effects
associated with Eysano, 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 Eysano

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
Do not use Eysano if:
many drops you should take each day
and how long you should use them.
• you are allergic to timolol,
beta-blockers or any of the other
The recommended dose is one drop
ingredients of this medicine
in the affected eye(s) once or twice
(listed in section 6).
(one in the morning and one in the
evening) each day.
• you have now or have had in the
past respiratory problems such as
Do not change your recommended
asthma, severe chronic obstructive
dose without talking to your doctor.
bronchitis (severe lung disease
Do not allow the tip of the multi-dose
which may cause wheeziness,
container to touch the eye or areas
in breathing and/or
around the eye. It could cause injury
long-standing cough).
to your eye. The eye drops solution
• you have a slow heartbeat, heart
may become contaminated with
failure or disorders of heart rhythm bacteria that can cause eye infections
(irregular heartbeats).
leading to serious damage of the eye,
• you have “cardiogenic shock” – a
even loss of vision.
serious heart condition caused by
very low blood pressure, which may To avoid possible contamination of
the multi-dose container, keep the tip
result in the following symptoms:
the multi-dose container away
dizziness and lightheadedness, fast
from contact with any surface.
pulse rate, white skin, sweating,
restlessness, loss of consciousness. Instructions for use
If you are not sure whether you
Before instillation of the eye drops:
should use Eysano talk to your doctor
- Wash your hands before opening
or pharmacist.
the bottle.
Warnings and precautions
- Do not use this medicine if you
notice that the tamper-proof seal
Talk to your doctor before using
on the bottle neck is broken before
Eysano if you have now or have had
use it.
in the past:
use, after cap removal,
• coronary heart disease (symptoms
without positioning the eyedropper
can include chest pain or tightness,
above the eye, slowly squeeze the
breathlessness or choking), heart
bottle to deliver one drop in the air
to get use to the pressure and time
• closed-angle glaucoma, a condition
required to deliver one drop. In
in which the pressure inside your
of delivering one
eye becomes too high.
drop at a time, this step might be
• low blood pressure.
• disturbances of heart rate such as
- Choose the position that you
slow heartbeat.
most comfortable for the instillation
• breathing problems, asthma or
of the drops (you can sit down, lie
chronic obstructive pulmonary
on your back, or stand in front of a
• poor blood circulation disease (such Instillation:
as Raynaud’s disease or Raynaud’s
1. Hold the bottle directly below the
cap and turn the cap to open the
• diabetes as timolol may mask signs
bottle. Do not touch anything with
and symptoms of low blood sugar.
the tip of the bottle to avoid
• overactivity of the thyroid gland as
contamination of the solution.
timolol may mask signs and
• muscle weakness.
• tumor of the adrenal gland
• blood and body
(metabolic acidosis).
• pain in the legs when walking due
2. Tilt your head backwards and hold
to poor circulation in the legs
the bottle above your eye.
• reduced kidney function.
• you wear soft contact lenses.
Eysano has not been studied in
patients wearing contact lenses.
If you wear contact lenses, you
should consult your doctor before
using Eysano.
3. Pull the lower eyelid down and look
If you have a history of contact
up. Squeeze the bottle gently in the
hypersensitivity to silver, you should
middle and let a drop fall into your
not use this product.
eye. Please note that there might
Tell your doctor before you have an
be a few seconds delay between
operation that you are using Eysano
squeezing and the drop coming
as timolol may change effects of
out. Do not squeeze too hard.
some medicines used during
If you are not sure how to
administer your medicine, ask your
If you suspect that Eysano is causing
doctor, pharmacist or nurse.
an allergic reaction or hypersensitivity 4. Blink a few times so that the
(for example, skin rash or redness
drop spreads over the eye.
and itching of the eye) contact your
doctor immediately.

2. What you need to know
before you use Eysano

Children and adolescents
Eysano should generally be used with
caution in young patients. In
newborns, infants and younger
children Eysano 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 Eysano
Tell your doctor or pharmacist if you
are taking, have recently taken or
might take any other medicines.
Eysano 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 Eysano if you are taking
one or more of the following
• 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.

5. After using Eysano, press a
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


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

Do not use the eye drops for longer
than 28 days after
opening the
Use in children and adolescents
Before your child starts to use
Eysano, your child’s doctor will have
carried out a detailed medical
examination and decided whether or
not this medicine is suitable. Your
child, especially a newborn, should be
closely monitored for one to two
hours after the
dose and
carefully monitored for any signs of
side effects.
Method of administration for use
in children:
One drop only of Eysano should be
instilled into the affected eye(s) each
time. Follow the “Instructions for
Use” above when administering the
eye drops.
Duration of treatment for use in
Your child’s doctor will decide for how
long the eye drops will be needed.
If you use more Eysano than you
If you put too many drops in your eye
or swallow any of the drops, you may:
• have a headache.
• feel dizzy or light-headed.
• have
• chest pain.
• feel that your heart rate has
slowed down.
If this happens, contact your
doctor immediately.
If you forget to use Eysano
It is important to take Eysano as
prescribed by your doctor.
• If you miss a dose, use the drops
as soon as possible.
• If it is almost time for the next
dose, skip the missed dose and
take the next dose at the
usual time.
• Do not take a double dose to make
up for the forgotten dose.
If you stop using Eysano
If you want to stop using this
medicine talk to your doctor
you have any further questions on the
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 Eysano
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
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
• 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
up), a type of heart rhythm
disorder, heart attack, heart failure.
breathing, shortness of

breath, wheezing, cough.
• Very slow pulse.
• Sudden decreased vision after
surgery for glaucoma.
• Rash on the face, kidney
fever, joint and
muscle pain due to connective
tissue disease. A condition called
lupus (systemic lupus
• 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
• Raynaud’s phenomenon (White,
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.

Like other medicines applied into
eyes, timolol is absorbed into the
blood. This may cause similar side
effects as seen with intravenous
and/or oral beta-blocking agents.
Incidence of side effects after topical
ophthalmic administration is lower
than when medicines are, for
example taken by mouth or injected.
The following additional side effects
were seen within the class of
beta-blockers when used for treating
eye conditions:
• Low blood glucose levels
• Corneal erosion (damage to the
front layer of the eyeball), tearing
and redness in the eyes
• Heart failure
• Severe allergic reactions with
swelling and
• Skin rash and itching
• Taste disturbances, abdominal pain,
• Muscle pain not caused by exercise
• Sexual dysfunction
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
You can also
report side effects directly via the
Yellow Card Scheme (website:
By reporting side effects you can help
provide more information on the
safety of this medicine.

5. How to store Eysano
Keep this medicine out of the sight
and reach of children.
This medicinal product does not
require any special storage conditions.
You can use Eysano for 28 days after
opening the bottle.
Do not use Eysano after the expiry
date which is stated on the carton
and the bottle after EXP. The expiry
date refers to the last day of that
month. Make sure the container is
properly closed.
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

6. Contents of the pack and
other information
What Eysano contains
The active substance is timolol
Eysano is available in two strengths:
• Each ml of Eysano 2.5mg/ml
solution contains 3.417mg of
timolol maleate (equivalent to
2.5mg of timolol).
• Each ml of Eysano 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 Eysano looks like and
contents of the pack
Eysano 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.
Eysano 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
Pharmathen S.A.,
6 Dervenakion
15351 Pallini Attiki
27 st. La Lombardière, Zl La

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),
of the eyelid,
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,
• 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,
• 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
build up)

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
• Ringing sound in the ears
• Unusual sensations like tingling or
pins and needles
• Cold hands and feet

Artwork for:
Product name:
PL/PA no:
Artwork dimensions:
Profile supplied:
Date of first artwork:
Reason for request:
Version no:
Date of revision:
Artwork software:
BAC ref:

Aspire Pharma Limited
Eysano Timolol
630mm x 120mm
Dimensions supplied
3 June 2016
Insertion of Manufacturer codes
As swatch(es)
9pt Tahoma
InDesign CS6

Expand Transcript

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.