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TRAVOPROST/TIMOLOL MYLAN 40 MICROGRAMS/ML + 5 MG/ML EYE DROPS SOLUTION

Active substance(s): TIMOLOL MALEATE / TRAVOPROST

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Package leaflet: Information for the user
Travoprost/Timolol 40 micrograms/mL+ 5 mg/mL eye drops, solution
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 Travoprost/Timolol is and what it is used for
2.
What you need to know before you use Travoprost/Timolol
3.
How to use Travoprost/Timolol
4.
Possible side effects
5.
How to store Travoprost/Timolol
6.
Contents of the pack and other information

1.

What Travoprost/Timolol is and what it is used for

Travoprost/Timolol eye drops solution is a combination of two active substances (travoprost
and timolol). Travoprost is a prostaglandin analogue which works by increasing the outflow
of liquid of the eye, which lowers its pressure. Timolol is a beta blocker which works by
reducing the production of fluid within the eye. The two substances work together to reduce
pressure within the eye.
Travoprost/Timolol eye drops are used to treat high pressure in the eye in adults, including
the elderly. This pressure can lead to an illness called glaucoma.
2.

What you need to know before you use Travoprost/Timolol

Do not use Travoprost/Timolol:

if you are allergic to travoprost, timolol, or any of the other ingredients of this medicine
(listed in section 6)

if you are allergic to any prostaglandins or beta-blockers

if you 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), or other types of breathing
problems

if you have severe hayfever

if you have a slow heartbeat, heart failure or disorders of heart rhythm (irregular
heartbeats)

if the surface of your eye is cloudy.
Ask your doctor for advice if any of these apply to you.
Warnings and precautions
Talk to your doctor or pharmacist before using Travoprost/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
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 of thyroid
disease
myasthenia gravis (chronic neuromuscular weakness)
any severe allergic reaction (skin rash, redness and itching of the eye) while using
Travoprost/Timolol, whatever the cause, adrenaline treatment may not be as effective.
So when receiving any other treatment please tell the doctor that you are using
Travoprost/Timolol
a cataract surgery
an eye inflammation.

Tell your doctor before you have an operation that you are using Travoprost/Timolol as
timolol may change effects of some medicines used during anaesthesia.
Travoprost/Timolol may change the colour of your iris (the coloured part of your eye). This
change may be permanent.
Travoprost/Timolol may increase the length, thickness, colour and/or number of your
eyelashes and may cause unusual hair growth on your eyelids.
Travoprost may be absorbed through the skin and therefore should not be used by women
who are pregnant or are attempting to become pregnant. If any of the medicine comes into
contact with the skin then it should be washed off straight away.
Children
Travoprost/Timolol is not to be used by children and adolescents under 18 years of age.
Other medicines and Travoprost/Timolol
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Travoprost/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 including quinidine (used to treat heart conditions and some types of
malaria)
 medicines to treat diabetes or antidepressants known as fluoxetine and paroxetine.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a
baby, ask your doctor for advice before taking this medicine.
Do not use Travoprost/Timolol if you are pregnant unless your doctor considers it necessary.
If you could get pregnant you must use adequate contraception whilst you use the medicine.
Do not use Travoprost/Timolol if you are breast-feeding. This medicine may get into your
milk.
Driving and using machines

You may find that your vision is blurred for a time just after you use Travoprost/Timolol. Do
not drive or use machines until this has worn off.
Travoprost/Timolol contains benzalkonium chloride and macrogolglycerol
hydroxystearate 40
This medicine contains benzalkonium chloride, which may cause eye irritation and is known
to discolour soft contact lenses.
Avoid contact with soft contact lenses.
Remove contact lenses prior to application and wait at least 15 minutes before reinsertion.
This medicine contains macrogolglycerol hydroxystearate 40, which may cause skin reactions.
3.

How to use Travoprost/Timolol

Always use this medicine exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure.
The recommended dose is:
One drop in the affected eye or eyes, once a day-in the morning or in the evening. Use at the
same time each day.
Only use Travoprost/Timolol in both eyes if your doctor told you to do so. Use it for as long
as your doctor told you to.
Only use Travoprost/Timolol for dropping in your eyes.
Instructions for use
 Immediately before using a bottle for the first time, tear-off the
sachet (picture 1). Take out the bottle and write the date of
opening on the label in the space provided.
 Get the medicine bottle and a mirror.
 Wash your hands.
 Twist off the cap.
1
 Hold the bottle, pointing down, between your thumb and fingers.
 Tilt your head back. Pull down your eyelid with a clean finger,
until there is a ‘pocket’ between the eyelid and your eye. The drop
will go in here (picture 2).
 Bring the bottle tip close to the eye. Use the mirror if it helps.
2
 Do not touch your eye or eyelid, surrounding areas or other
surfaces with the dropper. It could infect the drops.
 Gently squeeze the bottle to release one drop of medicine at a time
(picture 3).

3
 After using the medicine, press a finger into the corner of your eye,
by the nose for 2 minutes (picture 4). This helps to stop the
medicine getting into the rest of the body.

4

 If you use drops in both eyes, repeat these same steps for your
other eye.
 Close the bottle cap firmly immediately after use.
 Only use one bottle of medicine at a time. Do not open the sachet
until you need to use the bottle.
 You must throw away the bottle 4 weeks after you first opened
it, to prevent infections, and use a new bottle.

If a drop misses your eye, try again.
If you use more Travoprost/Timolol than you should
If you use more Travoprost/Timolol than you should, rinse it all out with warm water. Do not
put in any more drops until it is time for your next regular dose.
If you forget to use Travoprost/Timolol
If you forget to use Travoprost/Timolol, continue with the next dose as planned. Do not use a
double dose to make up for a forgotten dose. The dose should not exceed one daily drop in the
affected eye(s).
If you stop using Travoprost/Timolol
If you stop using Travoprost/Timolol without speaking to your doctor the pressure in your eye
will not be controlled which could lead to loss of sight.
If you are using other eye drops, leave at least 5 minutes between putting in
Travoprost/Timolol and the other drops.
If you wear soft contact lenses do not use the drops with your lenses in. After using the drops
wait 15 minutes before putting your lenses back in.
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.
You can usually carry on taking the drops, unless the effects are serious. If you are worried,
talk to a doctor or pharmacist. Do not stop using Travoprost/Timolol without speaking to your
doctor.
Very common (may affect more than 1 in 10 people):
Effects in the eye: eye redness.
Common (may affect up to 1 in 10 people):
Effects in the eye: eye surface inflammation with surface damage, eye pain, blurred vision,
abnormal vision, dry eye, itchy eye, eye discomfort, signs and symptoms of eye irritation (e.g.
burning, stinging).
Uncommon (may affect up to 1 in 100 people):
Effects in the eye: inflammation of the eye surface, inflammation of the eyelid, swollen
conjunctiva, increased growth of eyelashes, iris inflammation, eye inflammation, sensitivity
to light, reduced vision, tired eyes, eye allergy, eye swelling, increased tear production, eyelid
redness, eyelid colour change.

General side effects: drug allergy, dizziness, headache, increased or decreased blood pressure,
shortness of breath, excessive hair growth, drip at back of throat, skin inflammation and
itching, decreased heart rate.
Rare side effects (may affect up to 1 in 1,000 people):
Effects in the eye: thinning of the eye surface, inflammation of the eyelid glands, broken
blood vessel in the eye, eyelid crusting, abnormally positioned eyelashes, abnormal growth of
lashes.
General side effects: nervousness, irregular heart rate, loss of hair, voice disorders, difficulty
breathing, cough, throat irritation, hives, abnormal liver blood tests, skin discolouration, skin
darkening, thirst, tiredness, discomfort inside of nose, coloured urine, pain in hands and feet.
Not known (frequency cannot be estimated from the available data):
Effects in the eye: droopy eyelid (making the eye stay half closed).
General side effects: rash, heart failure, chest pain, stroke, fainting, depression, asthma,
increased heart rate, numbness or tingling sensation, palpitations, swelling in the lower limbs,
bad taste.
Additionally:
Travoprost/Timolol is a combination of 2 active substances. Like other medicines applied into
eyes, travoprost and timolol (a beta-blocker) are absorbed into the blood. This may cause
similar side effects as seen with intravenous and/or oral beta-blocking medicines. The
incidence of side effects after topical ophthalmic administration is lower than when medicines
are, for example, taken by mouth or injected. Listed side effects which include reactions seen
within the class of beta-blockers when used for treating eye conditions are as follows:
Effects in the eye: inflammation of the eyelid, inflammation in the cornea, detachment of the
layer below the retina that contains blood vessels following filtration surgery which may
cause visual disturbances, decreased corneal sensitivity, corneal erosion (damage to the front
layer of the eyeball), double vision, changes in the colour of the iris.
General side effects:
 Heart and circulation: slow heart rate, 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 low blood pressure, Raynaud's phenomenon, cold hands and feet,
reduced blood supply to the brain.


Respiratory: constriction of the airways in the lungs (predominantly in patients with preexisting disease), difficulty breathing, stuffy nose.



Nervous system and general disorders: difficulty sleeping (insomnia), nightmares,
memory loss, loss of strength and energy.



Gastric: taste disturbances, nausea, indigestion, diarrhoea, dry mouth, abdominal pain,
vomiting.



Allergy: 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, localized and generalized rash, itchiness, severe
sudden life-threatening allergic reaction.



Skin: skin rash with white silvery coloured appearance (psoriasiform rash) or worsening
of psoriasis, peeling skin.



Muscular: increases in signs and symptoms of myasthenia gravis (muscle disorder),
unusual sensations like pins and needles, muscle weakness/tiredness, muscle pain not
caused by exercise.



Reproduction: sexual dysfunction, decreased libido.



Metabolism: low blood sugar levels.

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 Travoprost/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, sachet and bottle
after EXP. The expiry date refers to the last day of that month.
Before opening, this medicine does not require any special temperature storage conditions.
Keep the bottle in the sachet in order to protect from light.
After first opening, this medicine does not require any special storage conditions.
You must throw away the bottle 4 weeks after you first opened it, to prevent infections,
and use a new bottle. Write down the date you opened the bottle in the space on the bottle
label and box.
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 Travoprost/Timolol contains

The active substances are travoprost and timolol.
Each mL of solution contains 40 micrograms of travoprost and 5 mg of timolol (as
timolol maleate).

The other ingredients are benzalkonium chloride, macrogolglycerol hydroxystearate 40,
trometamol, edetate disodium, boric acid (E284), mannitol (E421), sodium hydroxide
(for pH adjustment) and water for injection.
What Travoprost/Timolol looks like and contents of the pack
Travoprost/Timolol eye drops, solution is presented as a clear, colourless, aqueous solution,
practically free from particles supplied in a 5 mL plastic bottle with colorless nozzle and
white opaque cap with tamper proof seal.
Each bottle is enclosed in a sachet. Each bottle contains 2.5 mL solution.

The product is available in the following pack sizes:
Cartons containing 1 or 3 bottles.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL. United Kingdom.
Manufacturer
BALKANPHARMA-RAZGRAD AD, 68 Aprilsko vastanie Blvd., Razgrad, 7200, Bulgaria.
Pharmathen SA, 6 Dervenakion Str, Pallini, 153 51, Greece.
This leaflet was last revised in 05/2017

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