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LATANOPROST + TIMOLOL 0.05 MG/ML AND 5 MG/ML EYE DROPS

Active substance(s): LATANOPROST / TIMOLOL MALEATE / TIMOLOL MALEATE / LATANOPROST / TIMOLOL MALEATE

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BLACK

CUTTER

PANTONE® GREEN C

17 October 2016

2

Package leaflet: Information for the
patient

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231-30-11202-G LEA LATANOPROST + TIMOLOL 0.05mg/ml + 5mg/ml SOL 5mg/ml TUK FrULM
TEVA UK Ref:

Latanoprost + Timolol
0.05mg/ml + 5 mg/ml
Eye Drops

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 is a medicine for
the treatment of increased intraocular
pressure (pressure inside the eye).
Latanoprost + Timolol is a drug
combination containing two active
substances: latanoprost (a
prostaglandin derivative) and timolol
maleate (a beta-blocker).
Fluid known as aqueous humour is
produced inside the eye. This fluid is
then drained back into the
bloodstream, thereby maintaining
the required pressure within the eye.
If this outflow is obstructed, pressure
within the eye increases.
Among other things, beta-blockers
reduce pressure inside the eye, by
reducing the production of aqueous
humour. Prostaglandins promote the
outflow of aqueous humour.
Latanoprost + Timolol is used:
• to reduce inner eye pressure in
patients with open-angle
glaucoma (damage to the optic
nerve, caused by excessive
pressure within the eye).
• to reduce inner eye pressure in
patients for whom the effect of
beta-blockers or prostaglandin
derivatives alone is not sufficient.

2 What you need to know

before you use
LATANOPROST + TIMOLOL

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
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 a slow heart beat,
heart failure or disorders of heart
rhythm (irregular heartbeats).
Warnings and precautions
Talk to your doctor or pharmacist
before using Latanoprost + Timolol,
especially 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;
• disturbances of heart rate such as
slow heart beat;
• breathing problems, asthma or
chronic obstructive pulmonary
disease;
• 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;
• any kind of eye surgery (including
cataract surgery);
• eye problems (such as eye pain,
eye irritation, eye inflammation or
blurred vision);
• dry eyes;
• wear contact lenses. You can still
use Latanoprost + Timolol but
follow the instructions for contact
lens wearers in section “Important
information about some of the
ingredients of Latanoprost +
Timolol”;
• angina (particularly a type known
as Prinzmetal angina);
• 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).
Childrens and adolescents
Latanoprost + Timolol is not
recommended for children or
adolescents.
Elderly patients
Latanoprost + Timolol is also suitable
for the treatment of elderly patients.
Tell your doctor before you have an
operation that you are using
Latanoprost + Timolol as Latanoprost
+ 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.
Tell your doctor or pharmacist if you
are taking, have recently taken or
might take any other medicines.
Medicines can affect each other and
interactions may occur. You must
bear this in mind if you are taking or
using any of the following types of
medicine:
„Calcium antagonists (e.g. in
coronary heart disease or for high
blood pressure);

Guanethidine (for high blood
pressure);
Beta-blockers (for high blood
pressure);
Antiarrhythmics (medications that
normalise the heart rhythm);
Digitalis glycosides (for heart failure);
Parasympathomimetic agents (e.g.
for the treatment of glaucoma);
Taking/using Latanoprost + Timolol
together with the above medicines
can cause low blood pressure
and/or slow down the heart rate.
„Medicines that act in a similar way
to Latanoprost + Timolol
If used at the same time as
Latanoprost + Timolol, the effect of
other medicines with a similar
action to Latanoprost + Timolol may
be increased. For this reason,
ophthalmic use (i.e. in the eye) of
two beta-blockers or two
prostaglandin derivatives is not
recommended.
„Clonidine
If you are using the active
substance clonidine to reduce
blood pressure together with
Latanoprost + Timolol and you
suddenly stop using clonidine, your
blood pressure may rise. If you are
also using beta-blockers at the
same time to lower your blood
pressure, your blood pressure may
- due to this reverse effect - rise
even further.
„Quinidine (used to treat heart
conditions and some types of
malaria).
„Antidepressants known as
fluoxetine and paroxetine.
„Prostaglandins, prostaglandin
analogues or additional
prostaglandin derivates (used to
lower inner eye pressure, to treat
circulatory disorders or pain, to
prevent blood clotting)
Your inner eye pressure could be
increased further.
„Adrenaline (Epinephrine) (used to
increase or lower blood pressure;
emergency treatment in case of
circulatory shock, heart failure or
allergic reactions)
Your pupils may be dilated.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding,
think you may be pregnant or are
planning to have a baby, ask your
doctor or pharmacist for advice
before using this medicine.
Pregnancy
Do not use Latanoprost + Timolol if
you are pregnant unless your doctor
considers it necessary.
Breast-feeding
Do not use Latanoprost + Timolol if
you are breast-feeding. Timolol and
latanoprost may get into your milk.
Driving and using machines
After putting in Latanoprost + Timolol
eye drops, your vision may become
temporarily impaired.
If you should experience blurred
vision – particularly after just putting
in Latanoprost + Timolol eye drops –
you should
• not drive any vehicles;
• not use any tools or machines.
Latanoprost + Timolol contains
benzalkonium chloride
Benzalkonium chloride may cause
eye irritation. Avoid contact with soft
contact lenses. Remove contact
lenses prior to application and wait at
least 15 minutes before putting them
back in. Benzalkonium chloride is
known to discolour soft contact
lenses.

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.
Unless otherwise prescribed by the
doctor, the recommended dose is:
Adults, including elderly patients:
insert one drop once a day into each
affected eye.
If you are using other eye drops in
addition to Latanoprost + Timolol,
these should be used at least 5
minutes apart.
Directions for use
1. Wash your hands and sit or stand in
a comfortable position.
2.Remove the outer protective cap
from the bottle.
3.Use your fingertip to gently pull
down the lower lid of the affected
eye.
4.Place the tip of the bottle close to,
but not touching the eye. Carefully
squeeze the bottle until one drop
falls into your eye. Please make
sure that you do not squeeze the
bottle too hard, so that no more than
one drop falls into the affected eye.
5.Let go of your eyelid.
6.After using Latanoprost + Timolol
press a finger into the corner of
your eye, by the nose for 2 minutes.
This helps to stop Latanoprost +
Timolol getting into the rest of the
body.
If prescribed by your doctor, repeat
the procedure in your other eye. If
the drop should miss your eye,
apply another drop.
7. Close the bottle.
If you use more Latanoprost +
Timolol than you should
If too many drops have gone into
your eye, irritation and redness may
occur.
Tell a doctor immediately if you or
anyone else has swallowed the eye
drops by mistake, or if you have been
using the drops more often than
prescribed.
Keep the pack of this medicine ready,
so that the doctor can find out more
about the medication. He/she will
then decide what to do next.
If you forget to use Latanoprost +
Timolol
If you have forgotten to use your eye
drops, continue your treatment as
normal at the next dose. The daily
dose of one drop into the affected
eye should not be exceeded.
Do not use a double dose to make up
for a forgotten dose.
If you stop using Latanoprost +
Timolol
Do not interrupt or stop your
treatment with Latanoprost + Timolol
without talking to your doctor first.
If you do not use Latanoprost +
Timolol regularly or if you frequently
forget to use it, the success of your
treatment may be at risk.

Increased intraocular pressure
(pressure within the eye) can damage
the optic nerve and worsen your
eyesight. Blindness may occur.
Normally, you can barely feel
increased intraocular pressure. The
disorder can only be diagnosed via
an examination by an eye specialist.
If you suffer from increased
intraocular pressure, regular eye
tests are necessary, together with
measurements of inner eye pressure.
Pressure within the eye should be
measured at least every 3 months.
Visual field measurements and optic
nerve examinations should be
performed at least once a year.
If 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.
Listed below are the known side
effects of using eye drops containing
the active substances latanoprost and
timolol. The most important side
effect is the possibility of a gradual,
permanent change in your eye
colour. It is also possible that eye
drops containing the active
substances latanoprost and 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.
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 frequency of possible side effects
listed below is defined using the
following convention
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.
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
The following side effects have been
seen with latanoprost:
Not known (cannot be estimated
from the available data):
Infections and Infestations:
• Developing a viral infection of the
eye caused by the herpes simplex
virus (HSV).
Nervous System Disorders:
• Dizziness.
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, irritation or
disruption to the surface of the eye,
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, swelling and damage of the
front layer of the eyeball (corneal
oedema and erosion), fluid filled
cyst within the coloured part of the
eye (iris cyst), light sensitivity
(photophobia), sunken eye
appearance (deepening of the eye
sulcus).
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.
The following side effects have been
seen with timolol:
Like other medicines applied into
eyes, timolol is absorbed into the
blood. This may cause similar side
effects as seen with 'intraveneous'
and/or 'oral' as applicable
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.
Not known (cannot be estimated
from the available data):
Immune System Disorders:
• Generalised 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.
Metabolism and nutrition disorders:
• Low blood glucose levels.

Psychiatric Disorders:
• Difficulty sleeping (insomnia),
depression, nightmares, memory
loss.
Nervous System Disorders:
• 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, headache.
Eye Disorders:
• 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, damage to the
front layer of the eyeball (corneal
erosion), drooping of the upper
eyelid (making the eye stay half
closed), double vision.
Ear Disorders:
• Whistling/ringing in the ears
(tinnitus).
Heart (Cardiac) Disorders:
• 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
(atrioventricular block), heart attack,
heart failure.
Bloodflow (Vascular) Disorders:
• Low blood pressure,
discolouration/coldness of the
fingers and toes (Raynaud's
phenomenon), cold hands and feet.
Breathing (Respiratory) Disorders:
• Constriction of the airways in the
lungs (predominantly in patients
with pre-existing disease), difficulty
breathing, cough.
Digestive System (Gastrointestinal)
Disorders:
• Taste disturbances, nausea,
indigestion, diarrhoea, dry mouth,
abdominal pain, vomiting.
Skin Disorders:
• Hair loss, skin rash with white
silvery coloured appearance
(psoriasiform rash) or worsening of
psoriasis, skin rash.
Muscle and Skeletal Disorders:
• Muscle pain not caused by
exercise.
Reproductive system:
• Sexual dysfunction, decreased
libido.
General Disorders:
• Muscle weakness/tiredness.
Latanoprost + Timolol contains
phosphates. 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 this medicine after the
expiry date which is stated on the
bottle label and carton after “EXP”.
The expiry date refers to the last day
of that month.
Please note the following storage
instructions:
Unopened bottles: Store in a
refrigerator at 2°C - 8°C.
After the first opening of the bottle:
Do not store above 25°C.
Once opened, you must discard the
bottle - with any remaining contents after 4 weeks. Otherwise, there is a
risk of eye infection.
Do not throw away any medicines via
wastewater. 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
1 ml eye drops contains 50
micrograms of latanoprost and
6.8 mg of timolol maleate, equivalent
to 5.0 mg timolol.
The other ingredients are:
Sodium chloride, benzalkonium
chloride, sodium dihydrogen
phosphate dihydrate, disodium
hydrogen phosphate dodecahydrate‚
purified water, sodium hydroxide for
pH adjustment and hydrochloric acid
for pH adjustment.
What Latanoprost + Timolol looks
like and contents of the pack
Latanoprost + Timolol is a clear,
colourless liquid packed in a
transparent dropper bottle with a
screw cap.
Latanoprost + Timolol is available in
the following pack sizes:
1 dropper bottle containing 2.5 ml
eye drops,
3 dropper bottles, each containing
2.5 ml eye drops,
6 dropper bottles, each containing
2.5 ml eye drops.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Teva UK Limited
Brampton Road,
Hampden Park,
Eastbourne,
East Sussex BN22 9AG
UNITED KINGDOM
Manufacturer
S.C. Rompharm Company S.R.L.
Erolior Street, no 1A,
Otopeni 075100,
Ilfov district,
ROMANIA
This leaflet was last revised in
November 2015.
PL 00289/1525
11202-G
193043.06-GB

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.

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