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LATANOPROST + TIMOLOL 50 MCG/ML + 5 MG/ML EYE DROPS SOLUTION

Active substance(s): LATANOPROST / TIMOLOL MALEATE

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Package leaflet: Information for the patient

Latanoprost / Timolol
50 micrograms/ml +
5 mg/ml
Eye Drops, solution
latanoprost / timolol
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 pharmacist.
- This medicine has been prescribed for
you 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 or pharmacist. This includes any
possible side effects not listed in this
leaflet. See section 4.
What is in this leaflet
1. What Latanoprost / Timolol is and what
it is used for
2. What you need to know before you use
Latanoprost / Timolol
3. How to use Latanoprost / Timolol
4. Possible side effects
5. How to store Latanoprost / Timolol
6. Contents of the pack and
other information
1. What Latanoprost / Timolol is and
what it is used for
Latanoprost / Timolol contains two
active substances: latanoprost and
timolol. Latanoprost belongs to a group
of medicines known as prostaglandin
analogues. Timolol belongs to a group
of medicines known as beta-blockers.
Latanoprost works by increasing the
natural outflow of fluid from the eye
into the bloodstream. Timolol works by
slowing the formation of fluid in the eye.
Latanoprost / Timolol is used to reduce the
pressure in your eye if you have conditions
known as open angle glaucoma or ocular
hypertension. Both of these conditions are
linked to an increase in the pressure within
your eye, which may eventually affect your
eyesight. Your doctor will usually prescribe
you Latanoprost / Timolol when other
medicines have not worked adequately.
2. What you need to know before you
use Latanoprost / Timolol
Latanoprost / Timolol can be used in adult
men and women (including the elderly).
Children and adolescents
Latanoprost/Timolol is not recommended
for children or adolescents less than
18 years of age.
Do not use Latanoprost / Timolol:
- if you are allergic to latanoprost or
timolol, beta-blockers, or any of the
other ingredients of this medicine
(listed in section 6).
- if you have now or have had in the past
respiratory problems such as asthma or
severe chronic obstructive bronchitis
(severe lung disease which may cause
wheeziness, difficulty in breathing and/
or long standing cough)
- if you have a slow heart rate, serious
heart problems or heart rhythm
disorders (irregular heart beats) and do
not have a pacemaker fitted
Warnings and precautions
Talk to your doctor or pharmacist before
using Latanoprost / Timolol if you have
now or have had in the past:
- coronary heart disease (symptoms can
include chest pain, including angina
(particularly a type known as Prinzmetal
angina), or tightness, breathlessness
or choking), heart failure, low
blood pressure
- other disturbances of heart rate or heart
rhythm such as slow heart beat
- breathing problems or chronic
obstructive pulmonary disease
- poor circulation disease (such as
Raynaud’s disease or Raynaud’s
syndrome)
- diabetes, or episodes of low blood
sugar, as timolol may mask signs and
symptoms of low blood sugar
- overactivity of the thyroid gland as
timolol may mask signs and symptoms
Also talk to your pharmacist or doctor:
- if you are about to have any kind of eye
surgery (including cataract surgery) or
have had any kind of eye surgery in
the past
- if you suffer from eye problems (such as
eye pain, eye irritation, eye inflammation,
swelling at the back of the eye, problems
with the front of the eyeball (cornea) or
the lens of the eye, or blurred vision)
- if you know that you suffer from dry eyes
- if you wear contact lenses. You can still
use Latanoprost / Timolol but follow the
instructions for contact lens wearers in
Section 3 
- if you know that you suffer from severe
allergic reactions that would usually
require hospital treatment as timolol
may increase the liklehood or severity of
allergic reactions occuring, or reduce the
effectiveness of medicines used to treat
allergic reactions (such as epinephrine
(adrenaline))
- if you have suffered or are currently
suffering from a viral infection of the
eye caused by the herpes simplex virus
(HSV), especially if this was caused by use
of prostagladin analogues.
Tell your doctor before you have an
operation that you are using Latanoprost /
Timolol, as timolol may change effects of
some medicines used during anaesthesia.
Other medicines and
Latanoprost / Timolol
Latanoprost / Timolol 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 taking or intend to take medicines
to lower blood pressure, heart medicines
or medicines to treat diabetes. Tell your
doctor or pharmacist if you are taking,
have recently taken or might take any
other medicines (including using eye
drops), including those obtained without
a prescription.

Tell your doctor or pharmacist if you have
recently taken or used, or might take or
use any of the following medicines:
- Prostaglandins, prostaglandin analogues
or prostaglandin derivates (taken by
mouth, applied into the vagina, or in
other eye drops)
- Beta-blockers (taken by mouth or given
by injection, or in other eye drops)
- Epinephrine (also known as adrenaline)
- Drugs used to treat high blood pressure
such as oral calcium channel blockers,
guanethidine, antiarrythmics (like
amiodarone), digitalis glycosides
(like digoxin) or parasympathomimetics
(like bethanechol (used for urinary
problems) or nicotine (used to help
people stop smoking)
- Quinidine (used to treat heart conditions
and some types of malaria)
- Clonidine (used to treat high blood
pressure, or to help with flushing)
- Medicines for diabetes
- Antidepressants known as fluoxetine
and paroxetine
Pregnancy and breast-feeding
Do not use Latanoprost / Timolol if you are
pregnant unless your doctor considers it
necessary. Tell your doctor immediately if
you are pregnant, think you are pregnant
or are planning to have a baby.
Do not use Latanoprost / Timolol if you
are breast-feeding. Latanoprost / Timolol
may get into your milk. Ask your doctor for
advice before taking any medicine during
breast-feeding.
Driving and using machines
When you use Latanoprost / Timolol your
vision may become blurred for a short
time. If this happens to you, do not drive
or use any tools or machines until your
vision becomes clear again.
Latanoprost / Timolol contains
benzalkonium chloride
Latanoprost / Timolol contains a
preservative called benzalkonium
chloride. This preservative may cause eye
irritation or disruption to the surface of
the eye. It can be absorbed by contact
lenses and is known to discolour soft
contact lenses. Therefore, avoid contact
with soft contact lenses. See the
instructions for contact lens wearers in
Section 3.
3. How to use Latanoprost / Timolol
Always use this medicine exactly as your
doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are
not sure.
The recommended dose for adults
(including the elderly) is one drop once
a day in the affected eye(s). It is normally
recommended to use the eye drops in the
evening, however, if this is not convenient
for you, your doctor or pharmacist may
recommended that you use the eye drops
in the morning.
Meals, food or drink have no effect on
when or how you should use
Latanoprost / Timolol.
Do not use Latanoprost / Timolol more
than once a day, because the effectiveness
of the treatment can be reduced if you
administer it more often.
Use Latanoprost / Timolol as instructed
by your doctor until your doctor tells you
to stop.
Your doctor may want you to have extra
checks on your heart and circulation if you
use Latanoprost / Timolol.
Contact lens wearers
If you wear contact lenses, you should
remove them before using Latanoprost /
Timolol. After using Latanoprost / Timolol
you should wait 15 minutes before putting
your contact lenses back in.
Instructions for use
1. Wash your hands and sit or
stand comfortably.
2. Unscrew and remove the outer
protective cap from the bottle
3. Use your finger to gently pull down the
lower eyelid of your affected eye.
4. Place the tip of the bottle close to, but
not touching your eye.
5. Squeeze the bottle gently so that only
one drop goes into your eye, then
release the lower eyelid.
6. After using Latanoprost / Timolol
press a finger into the corner of your
eye (see figure 4 below), by the nose
for 2 minutes. This helps to stop
Latanoprost / Timolol getting into the
rest of the body.

7. Repeat in your other eye if your doctor
has told you to do this.
8. Close the bottle.
If you use Latanoprost / Timolol with
other eye drops
Wait at least 5 minutes between using
Latanoprost / Timolol and using other
eye drops.
If you use more Latanoprost / Timolol
than you should
If you put too many drops in your eye you
may experience some minor irritation in
your eye and your eyes may water and
turn red. This should pass but if you are
worried contact your doctor for advice.
If you swallow Latanoprost / Timolol
If you swallow Latanoprost / Timolol
accidentally you should contact your
doctor for advice. If you swallow a lot of
Latanoprost / Timolol you may feel sick,
have stomach pains, feel tired, flushed
and dizzy and start to sweat. You may also
notice a slow heart rate, feel faint or dizzy
(due to a reduction in blood pressure),
have difficulty breathing or wheeziness, or
a serious problem with your heart could
develop which could lead to heart attack
(cardiac arrest).

If you forget to use Latanoprost / Timolol
Carry on with the usual dosage at the
usual time. Do not take a double dose to
make up to the dose you have forgotten. If
you are unsure about anything talk to your
doctor or pharmacist.
If you stop using Latanoprost / Timolol
Talk to your doctor or pharmacist before
you stop using Latanoprost / Timolol
eye drops.
4. Possible side effects
Like all medicines, this medicine can cause
side effects, although not everybody
gets them.
You can usually carry on using the drops,
unless the effects are serious. If you're
worried, talk to a doctor or pharmacist.
Do not stop using Latanoprost / Timolol
without speaking to your doctor.
Listed below are the known side effects
of latanoprost or timolol, the active
ingredients (which make the medicine
work) in this medicine. The most important
side effect is the possibility of a gradual,
permanent change in your eye colour.
It is also possible that this medicine might
cause serious changes in the way your
heart works or allergic reactions in the
body, even though this medicine is used
in the eyes. This medicine may also cause
some other eye problems.
If you notice any of the following you
should speak to a doctor straight away
and tell them you have been using
Latanoprost / Timolol:
- Changes in your heart rate or heart
function.
- A generalised allergic reaction including
swelling beneath the skin that can occur
in areas such as the face and limbs, and
can obstruct the airway causing difficulty
swallowing or breathing, hives or itchy
rash.
- Swelling of the coloured part of the eye
(iritis/uveitis), sudden eye pain or blurred
vision.
The following are other known side effects
of this medicine:
Very common (may affect more than 1 in
10 people):
- A gradual change in your eye colour by
increasing the amount of brown pigment
in the coloured part of the eye known
as the iris. If you have mixed-colour eyes
(blue-brown, grey-brown, yellow-brown
or green-brown) you are more likely to
see this change than if you have eyes of
one colour (blue, grey, green or brown
eyes). Any changes in your eye colour
may take years to develop. The colour
change may be permanent and may be
more noticeable if you use Latanoprost
/ Timolol in only one eye. There appears
to be no problems associated with
the change in eye colour. The eye
colour change does not continue after
Latanoprost / Timolol treatment is
stopped. You may have eye examinations
to see if there is any colour change.
Common (may affect up to 1 in
10 people):
- Eye irritation (a feeling of burning,
grittiness, itching, stinging or the
sensation of a foreign body in the eye)
and eye pain.
Uncommon (may affect up to 1 in
100 people):
- Headache.
- Redness of the eye, eye infection
(conjunctivitis), blurred vision, watery
eyes, inflammation of the eyelids,
irritation or disruption of the surface of
the eye.
- Skin rashes or itching (pruritus).
Other side effects
Although not seen with this medicine,
the following additional side effects have
been seen with the individual active
ingredients in Latanoprost / Timolol
(latanoprost and timolol) and therefore
might occur when you use
Latanoprost / Timolol:
The following side effects have been seen
with latanoprost:
- Developing a viral infection of the eye
caused by the herpes simplex virus
(HSV).
- Dizziness.
- Changes to the eyelashes and fine hairs
around the eye (increased number,
length, thickness and darkening),
damage to, or erosion of, the front layer
of the eyeball (cornea), swelling of the
cornea (corneal oedema), changes to
the direction of eyelash growth, swelling
around the eye, swelling at the back of
the eye (macular oedema) in people
where the lens of the eye is absent or
does not work properly, inflammation/
irritation of the surface of the eye
(keratitis), dry eyes, fluid filled cyst within
the coloured part of the eye (iris cyst),
light sensitivity (photophobia), sunken
eye appearance (deepening of the eye
sulcus).
- Worsening of angina, awareness of heart
rhythm (palpitations).
- Asthma, worsening of asthma, shortness
of breath.
- Darkening of the skin around the eyes.
- Joint pain, muscle pain.
- Generalised chest pain.

- Increase in tears, detachment of the
layer below the retina that contains
blood vessels, following filtration surgery
which may cause visual disturbances,
decreased corneal sensitivity, dry eyes,
corneal erosion (damage to the front
layer of the eyeball), drooping of the
upper eyelid (making the eye stay half
closed), double vision.
- Whistling/ringing in the ears (tinnitus)
- Slow heart rate, chest pain, palpitations,
oedema (fluid build up), 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 (you may notice sudden chest
pain which may spread to the neck/jaw
or arm, with shortness of breath and a
clammy feeling), heart failure.
- Low blood pressure, restriction of
blood flow to fingers and toes causing
discolouration and coldness (Raynaud's
phenomenon), cold hands and feet.
- Constriction of the airways in the lungs
(predominantly in patients with preexisting disease), shortness of breath,
cough.
- Taste disturbances, nausea, indigestion,
diarrhoea, dry mouth, abdominal pain,
vomiting.
- Hair loss, skin rash with white silvery
coloured appearance (psoriasiform rash)
or worsening of psoriasis, skin rash.
- Muscle pain not caused by exercise.
- Sexual dysfunction, decreased libido.
- Muscle weakness/tiredness.
In very rare cases, some patients with
severe damage to the clear layer at
the front of the eye (the cornea) have
developed cloudy patches on the cornea
due to calcium build-up during treatment.
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
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.
5. How to store Latanoprost / Timolol
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 carton and
bottle label after EXP. The expiry date
refers to the last day of that month.
Store unopened bottles of Latanoprost
/ Timolol in a refrigerator (between
2 °C – 8 °C). After first opening the bottle
it is not necessary to store the bottle in a
refrigerator but do not store above 25°C.
Use within 4 weeks of opening. When you
are not using Latanoprost / Timolol, keep
the bottle in the outer carton, in order to
protect from light.
Do not use this medicine if you notice that
the tamper evident seal has been broken
or damaged before you first open it.
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.
6. Contents of the pack and
other information
What Latanoprost / Timolol contains
The active substances are latanoprost and
timolol maleate
Each ml of solution contains
50 micrograms of latanoprost and 6.83 mg
of timolol maleate (equivalent to 5 mg of
timolol).
The other ingredients are sodium
chloride, benzalkonium chloride, sodium
dihydrogen phosphate monohydrate,
disodium phosphate anhydrous‚ water
for injections, and sodium hydroxide and
hydrochloric acid for pH adjustment.
What Latanoprost / Timolol looks like
and contents of the pack
Latanoprost / Timolol is a clear colourless,
aqueous solution.
Latanoprost / Timolol is packaged in a
round translucent plastic dropper bottle
with translucent plastic dropper plug
and yellow plastic screw cap with tamper
evident sealing ring. Each bottle contains
2.5 ml of Latanoprost / Timolol eye
drops, solution.
Latanoprost / Timolol is available in the
following pack sizes:
1 bottle of 2.5 ml, eyes drops solution,
3 bottles of 2.5 ml, eye drops solution,
6 bottles of 2.5 ml, eye drops solution.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan
Potters Bar, Hertfordshire,
EN6 1TL, United Kingdom
Manufacturer
Mylan S.A.S (Saint Priest), 117 Allee des
Parcs, 69 800 Saint Priest, France.

Like other medicines applied into eyes,
this medicine is absorbed into the blood.
The timolol portion of this combination
may cause similar side effects as seen with
'intraveneous' 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.
Listed side effects include reactions seen
within the class of beta-blockers when
used for treating eye conditions:
- Low blood glucose levels.
- Difficulty sleeping (insomnia),
depression, nightmares, memory loss.
- Fainting, a stroke, or reduced blood
supply to the brain (you may collapse,
or notice numbness or weakness in
the arms or legs, difficulty swallowing,
slurred, mixed up or loss of speech),
increases in signs and symptoms of
myasthenia gravis (muscle disorder),
dizziness, unusual sensations like pins
and needles.

This leaflet was last revised in
August 2014.

471780

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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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