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

Active substance(s): LATANOPROST / TIMOLOL MALEATE

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Package leaflet: Information for the user

777245/C

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, please tell your doctor or
pharmacist. 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
medicines: 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
these conditions are linked to an
increase in the pressure within your
eye, eventually affecting your eyesight.
Your doctor will usually prescribe you
Latanoprost+Timolol when other
medicines have not worked adequately.

• Prostaglandins, prostaglandin
analogues or prostaglandin derivates
• Epinephrine
• Drugs used to treat high blood
pressure such as calcium channel
blockers, guanethidine,
beta-blockers
• Antiarrhythmics (medications that
normalise the heart rhythm)
• Digitalis glycosides (used to treat
heart failure)
• Parasympathomimetic agents (e.g.
for the treatment of high blood
pressure)
• Quinidine (used to treat heart
conditions and some types of malaria)
• Antidepressants known as
fluoxetine and paroxetine.
Latanoprost+Timolol with food and
drink
Normal meals, food or drink have no
effect on when or how you should use
Latanoprost+Timolol.
Pregnancy, breast-feeding and fertility
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
become pregnant.
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 breastfeeding.
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
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

2. What you need to know
before you use Latanoprost+
Timolol

Always use Latanoprost+Timolol
exactly as your doctor has told you.
Check with your doctor or pharmacist if
you are not sure.

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.

Dosage
The recommended dose for adults
(including the elderly) is one drop once
a day in the affected eye(s).

Do not use Latanoprost+Timolol
• if you are allergic to latanoprost or
timolol, beta-blockers, or any of the
other ingredients of Latanoprost+
Timolol (listed in section 6)
• if you have now or have had in 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)
• if you have serious heart problems
or heart rhythm disorders
• if you are pregnant (or trying to
become pregnant)
• if you are breast feeding.

Use in children and adolescents
Latanoprost+Timolol is not
recommended for children or
adolescents.

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 or tightness,
breathlessness or choking), heart
failure, low blood pressure
(hypotension)
• disturbances of heart rate such as
slow heart beat (bradycardia)
• 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
• you are about to have any kind of
eye surgery (including cataract
surgery) or have had any kind of eye
surgery in the past
• you suffer from eye problems (such
as eye pain, eye irritation, eye
inflammation or blurred vision)
• you know that you suffer from dry
eyes
• you wear contact lenses. You can
still use Latanoprost+Timolol but
follow the instructions for contact
lens wearers in Section 3
• you know that you suffer from
angina (particularly a type known as
Prinzmetal angina)
• you know that you suffer from
severe allergic reactions that would
usually require hospital treatment
• you have suffered or are currently
suffering from a viral infection of the
eye caused by the herpes simplex
virus (HSV).
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 using or intend to use
medicines to lower blood pressure,
heart medicine or medicines to treat
diabetes.
Please tell your doctor or pharmacist if
you are taking, have recently taken or
might take any other medicines.
Talk to your doctor or pharmacist if you
know that you are taking any of the
following types of medicine:

FRONT

Do not use Latanoprost+Timolol more
than once a day.
Contact lens wearers
If you wear contact lenses, you should
remove them before using Latanoprost+
Timolol. After using this product you
should wait 15 minutes before putting
your contact lenses back in.
Instructions for use
Always wash your hands before
applying eye drops.
Apply your eye drops in the
following way:
1. Remove protective cap.
2. Tilt your head back and look at the
ceiling.
3. Gently pull the lower eyelid down
until there is a small pocket, as
illustrated in figure 1.

Figure 1

4. Squeeze the upturned dropper
bottle to release a drop into your eye.
5. Whilst keeping the affected eye
closed, press your finger against the
corner of the closed eye (the side
where the eye meets the nose) as
illustrated in figure 2 and hold for 2
minutes. This helps to stop
Latanoprost+Timolol getting into the
rest of the body.

Figure 2

Avoid touching the dropper tip against
your eye or anything else.
Replace and tighten the cap straight
after use.
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 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.
If you forget to use Latanoprost+
Timolol
Carry on with the usual dosage at the
usual time. Do not take a double dose

FRONT

to make up to the dose you have
forgotten. If you are unsure about
anything talk to 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
Latanoprost+Timolol without speaking
to your doctor.



The following are known side effects of
using Latanoprost+Timolol:



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 greenbrown) 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.
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 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 this product:
The following side effects have been
seen with latanoprost:
Infections and Infestations:
• Developing a viral infection of the
eye caused by the herpes simplex
virus (HSV).
Immune System Disorders:
• Symptoms of allergic reaction
(swelling and redness of the skin and
rash).
Psychiatric Disorders:
• Depression, memory loss, decreased
sex drive, inability to sleep,
nightmares.
Nervous System Disorders:
• Dizziness, tingling or numbness in
the skin, changes in blood flow to the
brain, worsening of symptoms of
myasthenia gravis (if you already suffer
from this condition), sudden fainting or
feeling you may faint (syncope).
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),
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).
Ear Disorders:
• Whistling/ringing in the ears (tinnitus).
Heart (Cardiac) Disorders:
• Worsening of angina, awareness of
heart rhythm (palpitations).
Breathing (Respiratory) Disorders:
• Asthma, worsening of asthma,
shortness of breath.
Skin Disorders:
• Darkening of the skin around the
eyes.
Muscle and Skeletal Disorders:
• Joint pain, muscle pain.
General Disorders:
• Chest pain.
Like other medicines applied into eyes,
Latanoprost+Timolol is absorbed into
the blood.
This may cause similar side effects as
seen with systemic beta-blocking
agents. Side effects after topical
application into the eyes are 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:
• 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 (angioedema), hives or
itchy rash, localized and generalized
rash, itchiness, severe sudden
life-threatening allergic reaction
(anaphylactic reaction).
• Low blood glucose levels
(hypoglycaemia).
• Difficulty sleeping (insomnia),
depression, nightmares, memory
loss.
• Fainting, stroke, reduced blood
supply to the brain, increases in
signs and symptoms of myasthenia
gravis (muscle disorder), dizziness,
unusual sensations like pins and
needles, and headache.
• Signs and symptoms of eye irritation
(e.g. burning, stinging, itching,
tearing, redness), inflammation of the
eyelid, inflammation in the cornea,
blurred vision and 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.
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,
heart failure.
Low blood pressure, Raynaud's
phenomenon, cold hands and feet.
Constriction of the airways in the
lungs (predominantly in patients with
pre-existing disease), difficulty
breathing, 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.

BACK

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 (see details below).
By reporting side effects you can help
provide more information on the safety
of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

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 after EXP
on the carton and bottle. The expiry
date refers to the last day of that month.
Store the unopened bottle in a
refrigerator (2°C - 8°C). After opening
the bottle it is not necessary to store it
in a refrigerator but do not store it
above 25°C. After opening do not use
this bottle for more than 4 weeks.
When you are not using Latanoprost+
Timolol, keep the bottle in the outer
carton, in order to protect from light.
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 pack and other
information
What Latanoprost+Timolol contains
- The active substances are
latanoprost and timolol maleate.
Each ml of solution contains 50
micrograms latanoprost and 6.8 mg
timolol maleate equivalent to 5 mg
timolol.
- The other ingredients are:
Sodium chloride
Benzalkonium chloride
Sodium dihydrogen phosphate
monohydrate
Disodium phosphate anhydrous
Hydrochloric acid solution (for
adjustment to pH 6.0)
Sodium hydroxide solution (for
adjustment to pH 6.0)
Water for injections.
See section 2 “Latanoprost+Timolol
contains benzalkonium chloride” for
further information.
What Latanoprost+Timolol looks
like and contents of the pack
Latanoprost+Timolol is a clear,
colourless solution contained in a
LDPE bottle and dropper applicator, PP
screw cap, tamper evident LDPE
overcap.
Pack sizes:
1 bottle x 2.5 ml
3 bottles x 2.5 ml
6 bottles x 2.5 ml
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Tubilux Pharma S.p.A
Via Costarica 20/22
00071 Pomezia (RM) - ITALY

This medicinal product is
authorised in the Member States of
the EEA under the following names
GERMANY
Latanoprost/Timolol Tubilux Pharma 50
Mikrogramm/ml + 5 mg/ml
Augentropfen
UK
Latanoprost+Timolol 50 micrograms/ml
+ 5 mg/ml eye drops, solution
SWEDEN
Latanoprost/Timolol Tubilux Pharma
50 mikrogram/ml + 5 mg/ml
ögondroppar, lösning
This leaflet was last revised in
September 2015

777245/C

BACK

CODE: 777245/C

DRAFT: 11

DATE: 16/09/2015

CLIENT: TUBILUX

PRODUCT: Leaflet Latanoprost + Timolol
MEASURE: 120 x 475 mm (120 x 27 mm)
COLOURS:

EXTRA: Deca code

Black
Approval

TEXT SIZE: 7,8 pt
NOTE: Carta da 40 g/m2
www.effe5grafica.it
Tel. (+39) 06 9326.0017
postmaster@effe5grafica.it

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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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