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LATANOPROST/TIMOLOL MALEATE 0.005%/0.5% W/V EYE DROPS SOLUTION

Active substance(s): LATANOPROST / TIMOLOL MALEATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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Latanoprost/Timolol maleate 0.005%/0.5% w/v
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

Do not use Latanoprost/Timolol if you are
breast-feeding. The active substances of
this medicine may get into your milk. Ask
your doctor for advice before taking any
medicine during breast-feeding.

What Latanoprost/Timolol is
and what it is used for

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 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 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.

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.

2

3

What you need to know
before you use
Latanoprost/Timolol

Always use this medicine 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.

If this is the first time that you have used
this bottle, write the date in the space
provided on the carton so that you will know
when they should no longer be used
because they are out of date.

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

Dosage
The recommended dose is
One drop in the affected eye(s) once daily.
The dose should not exceed one drop in
the affected eye(s) daily.
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.

Warnings and precautions
Talk to your doctor or pharmacist before taking
Latanoprost/Timolol if you have now or
have had in the past any of the following:
• you are about to have any kind of eye
surgery (including cataract surgery) or have
had any kind of eye surgery in the past
• eye problems (such as eye pain, eye
irritation, eye inflammation or blurred vision)
• dry eyes
• you wear contact lenses. You can still
use Latanoprost/Timolol but follow the
instructions for contact lens wearers in
Section 3
• breathing problems, asthma or chronic
obstructive pulmonary disease
• poor blood circulation disease (such as
Raynaud’s disease or Raynaud’s
syndrome)
• diabetes as Latanoprost/Timolol may mask
signs and symptoms of low blood sugar
• overactivity of the thyroid gland as
Latanoprost/Timolol may mask signs and
symptoms
• disturbances of the heart rate such as
slow heart beat
• heart failure
• coronary heart disease (symptoms can
include chest pain or tightness,
breathlessness or choking)
• angina (particularly a type known as
Prinzmetal angina)
• low blood pressure
• severe allergic reactions that would
usually require hospital treatment
• 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
this medicine 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 or pharmacist if you are
taking, have recently taken or might take
any other medicines.

In particular, tell your doctor if you are using
or intend to use any of the following medicines:
• Prostaglandins, prostaglandin analogues
or prostaglandin derivates
• Medicines to lower blood pressure
(e.g. beta-blockers)
• Heart medicine
• Medicines to treat diabetes
• Quinidine (used to treat heart conditions
and some types of malaria)
• Antidepressants known as fluoxetine and
paroxetine
• Medicines to prevent allergic
anaphylactic shock (adrenalin/epinephrine)

Instructions for Use
Please follow these instructions carefully
when using Latanoprost/Timolol eye drops
solution. It is recommended that you wash
your hands before putting in your eye drops.
Do not allow the tip of the container to
touch your eye or areas around your
eye. It 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 container, keep
the tip of the container away from
contact with any surface.

1. You must not use the bottle if the
tamper-proof seal on the bottle neck is
broken before you first use it.

2. To open the bottle, unscrew the cap by
turning it until the tamper-proof seal breaks.
3. Tilt your head back
and pull your lower
eyelid down slightly
to form a pocket
between your eyelid
and your eye (Fig. 1).

4. Invert the bottle, and
press gently as
shown (Fig. 2 and 3)
until a single drop
as instructed by your
doctor is dispensed
into your eye.
DO NOT TOUCH
YOUR EYE OR
EYELID WITH THE
TIP OF THE
CONTAINER.

Fig. 2

Fig. 3

5. Repeat steps 3 and 4 with the other
eye if instructed to do so by your doctor.

6. After using Latanoprost/Timolol, slowly
close your eye(s) and press a finger into
the inner corner of your eye, by the nose
for 2 minutes. This helps to stop
Latanoprost/Timolol getting into the rest
of the body.

8. The dispenser tip is designed to provide
a pre-measured drop; therefore, do not
enlarge the hole of the dispenser tip.

Using Latanoprost/Timolol with other eye drops:
If you are using Latanoprost/Timolol as well
as other eye drops, the different drops
should be instilled at least 5 minutes apart.
If you use more Latanoprost/Timolol
than you should
It is important to keep to the dose your
doctor has prescribed. If you put too many
drops in your eye or swallow any of the
contents of the bottle, you may feel unwell,
for example you may become light-headed,
have difficulty breathing, feel tired, flushed,
have stomach pains or start to sweat. If you
feel any of the above effects, you should
seek medical attention immediately.

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 become pregnant.

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Fig. 1

7. Reclose the bottle by turning the cap
firmly immediately after use and return
the bottle to the original outer carton.

Latanoprost/Timolol with food and drink
Normal meals, food or drink have no effect
on when or how you should use
Latanoprost/Timolol.

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How to use
Latanoprost/Timolol

Date prepared:
01/10/2014

Colours:
Black
Black 20%
Dimensions: 120 x 500 mm

Font size:
8pt
Fonts:
Helvetica

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
for a forgotten dose. The dose should not
exceed one drop in the affected eye(s) daily.

reactions seen within the class of
beta-blockers when used for treating eye
conditions.

• 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.

If you stop using Latanoprost/Timolol
If you must stop or want to stop treatment,
contact your doctor immediately.
If you have any further questions on the
use of this medicine, ask your doctor or
pharmacist.

4

• Low blood glucose levels.

• Difficulty sleeping (insomnia),
depression, nightmares, memory loss.

Possible side effects

• 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.

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.

• 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.

The frequency of possible side effects listed
below is defined using the following
convention:
Very common (may affect more than 1 in 10
people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1000 people)
Not known (frequency cannot be estimated
from the available data)

• 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.

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. It is also possible that
Latanoprost/Timolol might cause serious
changes in the way your heart works. If you
notice changes in your heart rate or heart
function you should speak to a doctor and
tell them you have been using
Latanoprost/Timolol.

• 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.

The following have been seen with
Latanoprost/Timolol:

• Taste disturbances, nausea, indigestion,
diarrhoea, dry mouth, abdominal pain,
vomiting.

Very common
• 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.

• 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 or pharmacist. This includes any
possible side effects not listed in this leaflet.
You can also report side effects directly via
the national reporting system listed in the
Yellow Card Scheme:
www.mhra.gov.uk/yellowcard. By reporting
side effects you can help provide more
information on the safety of this medicine.

Common
• eye irritation (including stinging, burning,
itching, sensation of a foreign body in the
eye)
• eye pain
Uncommon
• headache
• pink/redness of the eye
• blurred vision
• watering eyes
• inflammation of the eyelids
• corneal disorders
• skin rashes/itching
• eye infection (conjunctivitis)
• irritation or disruption of the surface of
the eye

5

How to store
Latanoprost/Timolol

Keep this medicine out of the sight and
reach of children.

There are possible side effects of the
components of Latanoprost/Timolol,
which may also be potential side effects
of Latanoprost/Timolol in some patients.
These include:

Do not use this medicine after the expiry
date which is stated on the label and
carton. The expiry date refers to the last
day of that month.

Before Latanoprost/Timolol is first opened,
it should be stored at 2-8 °C (in a refrigerator).

For Latanoprost these are:
Infections and Infestations:
• Developing a viral infection of the eye
caused by the herpes simplex virus (HSV).

Keep the bottle in the outer carton, in order
to protect from light.

Immune System Disorders:
• Symptoms of allergic reaction (swelling
and redness of the skin and rash).

After first opening: use within 28 days; do
not store the bottle above 25 °C.

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.

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).

6

Contents of the pack and
other information

What Latanoprost/Timolol contains
The active substances are:
latanoprost and timolol.

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), inflammation, swelling
and erosion of the cornea (damage to
the front layer of the eyeball), darkening
of the skin of the eyelids.

One ml contains 50 micrograms latanoprost
and 5 mg timolol (as maleate).

The other ingredients are:
benzalkonium chloride (preservative),
sodium dihydrogen phosphate dihydrate,
disodium phosphate anhydrous, sodium
chloride, sodium hydroxide/hydrochloride
acid (for pH-adjustment), water for injection.
What Latanoprost/Timolol looks like and
contents of the pack
Eye drops, solution
Colourless solution.

Ear Disorders:
• Whistling/ringing in the ears (tinnitus).

This medicinal product is available in
transparent plastic bottles with a white
screw cap.

Breathing (Respiratory) Disorders:
• Asthma, worsening of asthma, shortness
of breath.

Pack sizes
1 x 2,5 ml, 2 x 2,5 ml, 3 x 2,5 ml, 4 x 2,5 ml,
5 x 2,5 ml, 6 x 2,5 ml, 7 x 2,5 ml, 8 x 2,5 ml,
9 x 2,5 ml, 10 x 2,5 ml and 12 x 2,5 ml
Not all pack sizes will be marketed.

Heart (Cardiac) Disorders:
• Worsening of angina, awareness of heart
rhythm (palpitations).

Marketing Authorisation Holder
Sandoz Limited, Frimley Business Park,
Frimley, Camberley, Surrey, GU16 7SR, UK

Skin Disorders:
• Darkening of the skin around the eyes.
Muscle and Skeletal Disorders:
• Joint pain, muscle pain.

Manufacturer
Aeropharm GmbH,
François-Mitterrand-Allee 1, 07407
Rudolstadt, Germany or Lek
Pharmaceuticals d.d, Verovškova 57, 1526
Ljubljana, Slovenia or Salutas Pharma
GmbH, Otto-von-Guericke-Allee 1, 39179
Barleben, Germany.

General Disorders:
• Chest pain.

For timolol these are:
Like other medicines applied into eyes,
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
application into the eyes is lower than when
medicines are, for example, taken by mouth
or injected. Listed side effects include

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Each bottle contains 2.5 ml eye drops.

This leaflet was last revised in 09/2014.

00000000
SZ00000LT000
000000SNZ00/0H

Artwork Proof Box
Ref: V006 - Brand alignment & QRD update + day 30 responses
Proof no.
003.1

Date prepared:
01/10/2014

Colours:
Black
Black 20%
Dimensions: 120 x 500 mm

Font size:
8pt
Fonts:
Helvetica

Expand view ⇕

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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