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

Active substance(s): LATANOPROST / TIMOLOL MALEATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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 uptothedose you have forgotten.
If you have any further questions on the
use of this product, ask your doctor or
pharmacist.

Latanoprost/Timolol 50 microgram/ml +
5mg/ml eye drops, solution

Read all of this leaflet carefully
before you start taking this medicine
because it contains important
information for you.
• Keep this leaflet. You may need to
read it again.
• If you any have 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 inthis 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
The name of your medicine is
Latanoprost/Timolol 50 microgram/ml +
5mg/ml Eye Drops, solution (referred to
as Latanoprost/Timolol throughout this
leaflet). Latanoprost/Timolol contains
two medicines: latanoprost and timolol.
Latanoprost belongs toagroup of
medicines known as prostaglandin
analogues. Timolol belongs to a group
ofmedicines known asbeta-blockers.
Latanoprost works by increasing the
natural outflow offluid from the eye into
thebloodstream. Timolol works by
slowing the formation of fluid inthe eye.
Latanoprost/Timolol is used to reduce
the pressure in your eye if you have
conditions known asopen angle
glaucoma or ocular hypertension. Both
these conditions are linked toan
increase inthepressure within the eye,
eventually affecting 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), but is not recommended for
use if you are less than 18 years of age.
Do not use Latanoprost/Timolol if you
• are allergic to the active substances
latanoprost or timolol, beta-blockers
or any of the other ingredients of
Latanoprost/Timolol 50 microgram/ml
+ 5mg/ml Eye Drops solution (listed
in section 6).
• have now or have had in past severe
breathing problems such as asthma,
severe chronic obstructive bronchitis
(severe lung disease which may cause
wheeziness, difficulty inbreathing
and/or long-standing cough).
• have serious heart problems or heart
rhythm disorders.
• are pregnant or trying to become
pregnant.
• are breast-feeding.
Warnings and precautions
Talk to your doctor or pharmacist
before taking Latanoprost/Timolol, if
you have now or have had inthe past:
• heart problems such as coronary heart
disease (symptoms can include chest
pain ortightness, breathlessness or
choking), heart failure, low blood
pressure, disturbances ofheart rate
such asbradycardia (slow heart rate),
Prinzmetal’s angina (chest pain occurs
atrest). If taking Latanoprost/Timolol
you should be monitored for signs of
deterioration of these illnesses.
• breathing problems, asthma or chronic
obstructive pulmonary disease.
• poor blood circulation disease such as
Raynaud’s disease or Raynaud’s
syndrome (discolouration of fingertips
in cold accompanied with pain).
• diabetes or low blood sugar levels
(hypoglycaemia) as timolol may mask
signs andsymptoms oflow blood sugar.
• overactivity of the thyroid gland as
timolol may mask signs and symptoms.
• any kind of eye surgery (including
cataract surgery).
• eye problems (such as eye pain, eye
irritation, eye inflammation or blurred
vision, dryeyes or cornea problems,
problems with choroidea).
• take beta-blocking drugs (used for
therapy of high blood pressure, rapid
heart rate etc.).
• severe allergic reactions that would
usually require hospital treatment.
• a viral infection of the eye caused by
the herpes simplex virus (HSV).
• wear contact lenses. You can still use
Latanoprost/Timolol but follow the
instructions forcontact lens wearers in
section 3.
Tell your doctor before you have an
operation that you use Latanoprost/
Timolol astimolol may change the effects
of some medicines used during anaesthesia.
Your doctor may want you to have extra
checks on your heart and circulation if
you use Latanoprost/Timolol.
Other medicines and Latanoprost/
Timolol
Latanoprost/Timolol can affect or be
affected by other medicines you are
using, including other eye drops forthe
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. Tell your doctor or pharmacist
if you are taking, have recently taken or
might take any other medicines (or eye
drops).
In particular, speak to your doctor or

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 are worried, talk toadoctor or
pharmacist. Do not stop using
Latanoprost/ Timolol without speaking
to your doctor.
Listed below are the known side effects
of using Latanoprost/Timolol.
The most important side-effect is the
possibility of a gradual, permanent
change in your eye colour.

pharmacist if you know that you are
taking any ofthefollowing types of
medicine:
• prostaglandins, prostaglandin
analogues or prostaglandin derivates.
• beta-blockers.
• epinephrine.
• drugs used to treat high blood
pressure such as oral calcium channel
blockers, guanethidine, antiarrythmics
(incl. amiodarone, quinidnine (used to
treat heart conditions and some types
ofmalaria), digitalis glycosides or
parasympathomimetics.
• quinidine (used to treat heart
conditions and some types of malaria).
• antidepressants (fluoxetine,
paroxetine).

Tell your doctor immediately that
you have been using
Latanoprost/Timolol if you notice
changes inyour heart rate or heart
function. It is also possible that
Latanoprost/Timolol might cause
serious changes in the way your heart
works.

Using Latanoprost/Timolol with food,
drink and alcohol
Normal meals, food or drink have no
effect on when or how you should use
Latanoprost/Timolol.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding,
think you may be pregnant or planning
to have a baby, ask your doctor or
pharmacist for advice before taking this
medicine.
Do not use Latanoprost/Timolol when
you are pregnant unless your doctor
considers it necessary. Do not use
Latanoprost/Timolol when you are
breast-feeding. Latanoprost/Timolol
may get into your milk.
Neither latanoprost nor timolol have
been found to have any effect on male
or female fertility in animal studies.

The following review covers side effects
reported to date in terms of their
frequency:
Very common
(may affect more than 1 in 10 people):
• A gradual change in your eye colour
byincreasing the amount of brown
pigment inthecoloured 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). Anychanges inyour 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 tobenoproblems
associated with the change in eye
colour. The eye colour change does
not continue after Latanoprost/
Timolol treatment is stopped.

Driving and using machines
When you use Latanoprost/Timolol
your vision may become blurred for a
short time. If this happens toyou, do
not drive or use any tools or machines
until your vision becomes clear again.
Latanoprost/Timolol contains a
preservative called benzalkonium
chloride
This preservative may cause eye irritation
or disruption to the surface of the eye. It
can beabsorbed by contact lenses andis
known to discolour soft contact lenses.
Therefore, avoid contact with soft
contact lenses. Seetheinstructions for
contact lens wearers in section 3.

Common
(may affect up to 1 in 10 people):
• Eye irritation (a feeling of burning,
grittiness, itching, stinging or the
sensation ofaforeign 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 oftheeyelids,
irritation or disruption of the surface
of the eye.
• Skin rashes or itching (pruritus).

3. HOW TO USE LATANOPROST/
TIMOLOL
Always use Latanoprost/Timolol exactly
as your doctor has told you. Check with
your doctor orpharmacist if you are not
sure.
The recommended dosage for adults
(including the elderly) is one drop once
a day intheaffected eye(s).
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.

Other side effects
Although not seen with Latanoprost/
Timolol, the following additional side
effects have been seen with the medicines
in Latanoprost/Timolol (latanoprost and
timolol) and therefore might occur
when you use Latanoprost/Timolol:
Like other medicines applied into eyes,
Latanoprost/Timolol 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 islower than
when medicines are, for example, taken
bymouth or injected.
Heart (cardiac) disorders:
• Worsening of angina.
• Awareness of heart rhythm
(palpitations).
• Slow heart rate, Changes in heart
rhythm.
• Chest pain.
• Swelling (oedema).
• Congestive heart failure – heart
disease with shortness of breath and
swelling of the feet and legs due to
fluid build-up), heart block, heart
attack, heartfailure.
Nervous system disorders:
• Dizziness.
• Fainting or feeling you may faint
(syncope).
• Stroke.
• Reduced blood supply to the brain.
• Worsening of symptoms of myasthenia
gravis (muscle disorder).
• Tingling or numbness in the skin.
• Headache.
Eye disorders:
• Changes to the eyelashes and fine
hairs around the eye (increased number,
length, thickness and darkening, changes
to the direction of eyelash growth).
• Swelling around the eye.
• Swelling of the coloured part of the
eye (iritis/uveitus).
• Swelling at the back of the eye
(macular oedema).
• Dry eye.
• Inflammation/irritation of the surface of
the eye (keratitis).
• Corneal erosion and swelling (damage
to the front layer of the eyeball).
• Fluid filled cyst within the coloured
part of the eye (iris cyst).
• Sensitivity to light (photophobia).
• Changes in lid and around eye
resulting in deepening oftheeyelid
groove.
• Eye burning, stinging, itching, tearing,
redness.
• Inflammation of conjunctiva and eye
lids (blepharitis).
• Injury to the lining ofthe back ofthe
eye (a condition known as retinal
detachment, butonly seen when used
following some kinds of eye surgery).
• Decreased corneal sensitivity.
• Visual changes/disturbances, double
or blurred vision.
• Drooping of the upper eyelid (making
the eye stay half closed).
Ear disorders:
• Whistling/ringing in the ears (tinnitus).
Breathing (respiratory) disorders:
• Asthma, worsening of asthma.
• Shortness of breath, difficulty breathing.

Contact lens wearers
If you wear contact lenses, you should
remove them before using Latanoprost/
Timolol. Afterusing Latanoprost/
Timolol you should wait 15 minutes
before putting your contact lenses back in.
Instructions for use
Follow the steps below to help you use
Latanoprost/Timolol properly:
1. Wash your hands and sit or stand
comfortably.
2. Unscrew the outer protective cap.
3. Use your finger to gently pull down
the lower eyelid of your affected eye
until there isa‘pocket’ between the
eyelid and your eye. The drop will go
in here.
4. Place the tip of the bottle close to
your eye. Do not touch your eye or
eyelid, surrounding areas orother
surfaces with the dropper. It could
infect the drops.

5. Squeeze the bottle gently so that only
one drop goes into your eye and then
release thelower eyelid.
6. After using Latanoprost/Timolol press
a finger against the corner of the
affected eye bythenose. Hold for 2
minutes whilst keeping the eye closed.
This helps to stop
Latanoprost/Timolol getting intothe
rest of the body.

7. If you use drops in both eyes, repeat
the steps for your other eye.
8. If a drop misses your eye, try again.
9. Put the cap back on the bottle.
If you use Latanoprost/Timolol with
other eye drops
Wait at least 5 minutes between using
Latanoprost/Timolol and using the
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 andyour eyes may
water and turn red. This should pass but
if you are worried contact your doctor
foradvice.
If you swallow Latanoprost/Timolol
If you swallow Latanoprost/Timolol
accidentally you should contact your
doctor for advice. Ifyou swallow a lot
of Latanoprost/Timolol you may feel
sick, have stomach pains, feel tired,
flushed anddizzy and start to sweat.

FRONT
CODE: 777206WTH/2H

• Sudden difficulty to breathe
(bronchospasm).
• Cough.
Digestive system (gastrointestinal)
disorders:
• Taste disturbances.
• Feeling sick (nausea).
• Indigestion.
• Diarrhoea.
• Dry mouth.
• Stomach-ache.
• Vomiting.
Skin disorders:
• Darkening of the skin around the eyes.
• Hair loss/baldness (alopecia).
• Skin rash with white silvery coloured
appearance (psoriasiform rash) or
worsening ofpsoriasis.
• Skin rash.
Muscle and skeletal disorders:
• Joint pain.
• Muscle pain (not caused by exercise).
Metabolism and nutrition disorders:
• Low blood glucose levels.
Infections and infestations:
• Developing a viral infection of the eye
caused by the herpes simplex virus
(HSV).
Blood flow (vascular) disorders:
• Low blood pressure.
• Discolouration/coldness of the fingers
andtoes (Raynaud’s phenomenon)
and coldness ofthehands and feet.
General disorders:
• Muscle weakness/tiredness.
Immune system disorders:
• Generalized allergic reactions including
swelling beneath the skin that can occur
in areas such as the face and limbs and
can obstruct the airway which may
cause difficulty swallowing or
breathing.
• Hives or itchy rash.
• Localized and generalized rash.
• Itchiness.
• Severe sudden life-threatening allergic
reaction (anaphylactic reaction).
Reproductive system and breast disorder:
• Sexual dysfunction.
• Decreased sex drive.
Psychiatric disorders:
• Difficulty sleeping (insomnia).
• Depression.
• Nightmares.
• Memory loss.
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 or pharmacist. 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 Latanoprost/Timolol after
the expiry date which is stated on the
bottle and box after EXP. The expiry
date refers to the last day of that month.
Before Latanoprost/Timolol is first
opened, it should be stored at 2 °C – 8 °C
(in a refrigerator).
Once the bottle has been opened,
Latanoprost/Timolol can be kept at
room temperature (below25°C). You
must throw away the bottle 4 weeks
after you first opened it, to prevent
infections, and use anew bottle. Write
down the date you open it.
Keep the bottle in the outer carton in
order to protect the medicine from light.
Do not use Latanoprost/Timolol if you
notice the bottle is damaged or eye drops
don’t look right insome other way.
Do not throw away any medicines via
wastewater or household waste. Ask
your pharmacist how tothrow away
medicines you no longer use. These
measures will help protect the
environment.
6. CONTENTS OF THE PACK AND
OTHER INFORMATION
What Latanoprost/Timolol 50
microgram/ml + 5mg/ml Eye Drops,
solution contains
• The active substances are latanoprost
and timolol maleate. 1 ml of
Latanoprost/Timolol 50
microgram/ml + 5mg/ml Eye Drops,
solution contains latanoprost 50
micrograms and timolol maleate 6.83
mg equivalent to 5 mg timolol.
• The other ingredients are: sodium
chloride, sodium dihydrogen
phosphate monohydrate, disodium
phosphate anhydrous, benzalkonium
chloride, hydrochloric acid, sodium
hydroxide, water for injections.
What Latanoprost/Timolol 50
microgram/ml + 5mg/ml Eye Drops,
solution looks like and contents of the
pack
The solution is a clear colourless,
odourless liquid. Each bottle contains
2.5 ml eye drop solution.
Pack sizes:
1 × 2.5 ml
6 × 2.5ml
3 × 2.5 ml
8 × 2.5 ml
4 × 2.5 ml
12 × 2.5 ml
Not all pack sizes may be marketed.
Marketing authorisation holder
Zentiva, One Onslow Street, Guildford,
Surrey, GU1 4YS, UK
Manufacturer
Tubilux Pharma S.p.A.
Via Costarica 20/22,
00040 Pomezia (Roma), Italy
This leaflet was last revised in 05/2014.
‘Zentiva’ is a registered trademark.
© 2014 Zentiva.

BACK
DRAFT: 04

DATE: 19/05/2014

CLIENT: TUBILUX

PRODUCT: Leaflet Latanoprost/Timolol
MEASURE: 120 x 500 mm (120 x 27 mm)
COLOURS:

EXTRA: Deca code XIXI

Black
Approval

TEXT SIZE: 9 pt
NOTE: Carta da 40 g/m2
www.effe5grafica.it
Tel. (+39) 06 9326.0017
postmaster@effe5grafica.it

Visual code 3-7-11

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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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