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TAPTIQOM 15 MICROGRAMS/ML + 5 MG/ML EYE DROPS SOLUTION IN SINGLE-DOSE CONTAINER

Active substance(s): TAFLUPROST / TIMOLOL MALEATE

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Package leaflet: Information for the
patient
Taptiqom® 15 micrograms/ml + 5 mg/ml
Eye drops, solution in single-dose
container

Tafluprost/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, pharmacist or nurse.
• 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,
pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.
See section 4.
What is in this leaflet

1. What Taptiqom is and what it is used for
2. What you need to know before you use
Taptiqom
3. How to use Taptiqom
4. Possible side effects
5. How to store Taptiqom
6. Contents of the pack and other information
1.What Taptiqom is and what it is used for
What kind of medicine is it and how does
it work?

Taptiqom eye drops contain tafluprost and
timolol. Tafluprost belongs to a group of
medicines called prostaglandin analogues and
timolol belongs to a group of medicines called
beta blockers. Tafluprost and timolol work
together and lower the pressure in the eye.
Taptiqom is used when the pressure in the eye
is too high.
What is your medicine for?

Taptiqom is used to treat a type of glaucoma
called open angle glaucoma and also a condition
known as ocular hypertension in adults. Both of
these conditions are linked with an increase in
the pressure within your eye and eventually they
may affect your eyesight.
2.What you need to know before you use
Taptiqom

Do not use Taptiqom:
• if you are allergic to tafluprost, timolol, beta
blockers or any of the other ingredients of this
medicine (listed in section 6.)
• 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)
• if you have a slow heart beat, heart failure or
disorders of the heart rhythm (irregular heart
beats).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before
using Taptiqom.
Before you use this medicine, tell your doctor
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
• any allergies or anaphylactic reactions
• myasthenia gravis (a rare disease causing
muscle weakness)
• other eye diseases; for example, disease of
the cornea (the transparent tissue that covers
the front of the eye) or a disease requiring
eye surgery.
Tell your doctor if you have
• kidney problems
• liver problems.
Please note that Taptiqom may have the
following effects and that some of them may be
permanent:
• Taptiqom may increase the length, thickness,
colour and/or number of your eyelashes
and may cause unusual hair growth on your
eyelids.
• Taptiqom may cause darkening of the colour
of the skin around the eyes. Wipe off any
excess solution from the skin. This will reduce
the risk of skin darkening.
• Taptiqom may change the colour of your iris
(the coloured part of your eye). If Taptiqom is
used in one eye only, the colour of the treated
eye may permanently become different from
the colour of the other eye.
Tell your doctor before you have an operation
that you are using Taptiqom as timolol may
change effects of some medicines used during
anaesthesia.
Children and adolescents
Taptiqom is not recommended for children and
adolescents below 18 years due to a lack of data
on safety and efficacy in this age group.
Other medicines and Taptiqom
Tell your doctor or pharmacist if you are
taking, have recently taken or might take other
medicines.
Taptiqom may affect or be affected by other
medicines you are using.
In particular, tell your doctor if you are using or
intend to use:
• other eye drops for the treatment of glaucoma
• medicines to lower blood pressure
• heart medicine
• medicines to treat diabetes
• quinidine (used to treat heart conditions and
some types of malaria)
• antidepressants known as fluoxetine and
paroxetine.
If you use other medicines in the eye, leave at
least 5 minutes between putting in Taptiqom and
the other medication.
Contact lenses
Remove contact lenses before putting in the
drops and wait at least 15 minutes before putting
the lenses back.
Pregnancy, breast-feeding and fertility
If you may become pregnant, you must use
an effective method of birth control during
Taptiqom therapy. Do not use Taptiqom if you are
pregnant. You should not use Taptiqom if you are
breast-feeding. Ask your doctor for advice.
Driving and using machines
There are side effects associated with Taptiqom,
such as blurred vision, which may affect your
ability to drive and/or operate machinery. Do not
drive or operate machinery until you feel well and
your vision is clear.

3.How to use Taptiqom

Always use this medicine exactly as your doctor
or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
The recommended dose is 1 drop of Taptiqom
in the eye or eyes, once daily. Do not instil more
drops or use more often than as instructed
by your doctor. This may make Taptiqom less
effective.
Only use Taptiqom in both eyes if your doctor
told you to. Discard the opened container with
any remaining contents immediately after use.
For use as eye drops only. Do not swallow.
Do not allow the single-dose container to
touch the eye or areas around the eye. It could
cause injury to your eye. It may also 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 single dose container, keep
the tip of the single dose container away from
contact with any surface.
Instructions for use:
When you start a new pouch:
Do not use the single-dose containers if the
pouch is broken. Open the pouch along the
dashed line. Write down the date you opened
the pouch in the space reserved for the date on
the pouch.
Every time you use Taptiqom:
Max. 5 mm {

1.
2.
3.
4.
5.
6.

7.

8.

9.

A.

B.

C.

D.

Wash your hands.
Take the strip of containers from the pouch.
Detach one single-dose container from the strip.
Put the remaining strip back in the pouch and fold
the edge to close the pouch.
To open the container, twist off the tab. (Picture A)
Hold the container between your thumb and index
finger. Note that the tip of the container must not
show more than 5 mm above the edge of your
index finger. (Picture B)
Tilt your head backwards or lie down. Place your
hand on your forehead. Your index finger should
be aligned with your eyebrow or resting on the
bridge of the nose. Look up. Pull the lower eyelid
downwards with the other hand. Do not allow any
part of the container to touch your eye or any area
around your eye. Gently squeeze the container to
let one drop fall into the space between the lid and
the eye. (Picture C)
Close your eye and press the inner corner of the
eye with your finger for about two minutes. This
helps prevent the eye drop from draining down the
tear duct. (Picture D)
Wipe off any excess solution from the skin around
the eye.

If a drop misses your eye, try again.
If your doctor has told you to use drops in
both eyes, repeat steps 7 to 9 for your other
eye.
The contents of one single-dose container
are sufficient for both eyes. Discard the
opened container with any remaining contents
immediately after use.
If you use other medicines in the eye, leave at
least 5 minutes between putting in Taptiqom and
the other medication.

If you use more Taptiqom than you should,
you may feel dizzy or have headache, heart
symptoms or breathing problems. If necessary,
contact a doctor for advice.
If the medicine is accidentally swallowed,
contact a doctor for advice.
If you forget to use Taptiqom, use a single
drop as soon as you remember, and then go
back to your regular routine. However, if it is
nearly time for the next dose, skip the missed
dose. Do not use a double dose to make up for a
forgotten dose.
Do not stop using Taptiqom without asking
your doctor. If you stop using Taptiqom, the
pressure in the eye will increase again. This may
cause a permanent injury to your eye.
If you have any further questions on the use of
this medicine, ask your doctor, pharmacist or
nurse.
4.Possible side effects

Like all medicines, this medicine can cause side
effects, although not everybody gets them. Most
side effects are not serious.
You can usually carry on using the drops, unless
the effects are serious. If you are worried, talk to
a doctor or pharmacist.
The following are known side effects of using
Taptiqom:
Common side effects
The following may affect up to 1 in 10 people:
Eye disorders
Itching of the eye. Irritation in the eye. Eye pain.
Redness of the eye. Changes in the length,
thickness and number of eyelashes. Foreign
body sensation in the eye. Discolouration of
eyelashes. Sensitivity to light. Blurred vision.
Uncommon side effects
The following may affect up to 1 in 100 people:
Nervous system disorders
Headache.
Eye disorders
Dry eye. Redness of the eyelids. Small spotlike
areas of inflammation on the surface of the
eye. Watery eyes. Puffy eyelids. Tired eyes.
Inflammation of the eyelids. Inflammation inside
the eye. Discomfort in the eye. Eye allergy.
Inflammation of the eye. Abnormal sensation in
the eye.
The following additional side effects have
been seen with the medicines in Taptiqom
(tafluprost and timolol) and therefore might
occur when you use Taptiqom:
The following side effects have been seen
with tafluprost:
Eye disorders
Reduction in the eye’s ability to see details.
Change of colour of the iris (may be permanent).
Change of colour of the skin around the eyes.
Swelling of the eye’s surface membranes.
Eye discharge. Pigmentation of the eye’s
surface membranes. Follicles in the surface
membranes of the eye. Sunken eye. Iritis/uveitis
(inflammation of the coloured part of the eye).
Skin disorders
Unusual hair growth on eyelids.
Effects on the respiratory system
Worsening of asthma, shortness of breath.
The following side effects have been seen
with timolol:
Immune system disorders
Allergic reactions, including swelling beneath the
skin, hives, rash. Severe sudden life-threatening
allergic reaction. Itching.
Metabolism and nutrition disorders
Low blood sugar.
Psychiatric disorders
Depression. Difficulty sleeping. Nightmares.
Memory loss.

Nervous system disorders
Dizziness. Fainting. Unusual sensations (like
pins and needles). Increases in signs and
symptoms of myasthenia gravis (muscle
disorder). Stroke. Reduced blood supply to the
brain. Nervousness.
Eye disorders
Inflammation of the cornea. Decreased corneal
sensitivity. Visual disturbances including
refractive changes (sometimes due to withdrawal
of miotic therapy). Drooping of the upper eyelid.
Double vision. Blurred vision and detachment of
the layer below the retina that contains bloodvessels following filtration surgery which may
cause visual disturbances. Corneal erosion.
Ear disorders
Tinnitus (ringing in the ears).
Heart 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. Heart
attack. Heart failure.
Vascular disorders
Low blood pressure. Limping. Raynaud’s
phenomenon, cold hands and feet.
Breathing disorders
Constriction of the airways in the lungs
(predominantly in patients with pre-existing
disease). Difficulty breathing. Cough.
Gastrointestinal disorders
Nausea. Indigestion. Diarrhoea. Dry mouth.
Taste disturbances. 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. Joint pain.
Reproductive system and breast disorders
Peyronie’s disease (which may cause a
curvature of the penis). Sexual dysfunction.
Decreased libido.
General disorders
Muscle weakness/tiredness. Thirst.
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 via the national
reporting system, (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.
Ireland: HPRSS Pharmacovigilance, Earlsfort
Terrace, IRL - Dublin 2, Tel: +353 1 6764971,
Fax: +353 1 6762517, Website: www.hpra.ie ,
e-mail: medsafety@hpra.ie.
Malta: ADR Reporting, The Medicines Authority,
Post-Licensing Directorate, 203 Level 3, Rue
D’Argens, GŻR-1368 Gżira, Website: www.
medicinesauthority.gov.mt , e-mail: postlicensing.
medicinesauthority@gov.mt
5.How to store Taptiqom

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 single-dose container,
pouch and the carton after ‘Exp’. The expiry date
refers to the last day of that month.
Store the unopened foil pouches in a refrigerator
(2°C - 8°C). Do not open the pouch until you

are about to start using the eye drops as unused
containers in an open pouch must be discarded
28 days after first opening the pouch.
After opening the foil pouch:
• Keep the single-dose containers in the
original foil pouch in order to protect from
light.
• Do not store above 25°C
• Discard unused single-dose containers after
28 days from date of first opening of the foil
pouch
• Discard an opened single-dose container with
any remaining solution immediately after use.
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 Taptiqom contains
• The active substances are tafluprost
and timolol. 1 ml of solution contains 15
micrograms of tafluprost and 5 mg of timolol.
• The other ingredients are glycerol, disodium
phosphate dodecahydrate, disodium edetate,
polysorbate 80, hydrochloric acid and/or
sodium hydroxide (to adjust pH), and water
for injections.
What Taptiqom looks like and contents of the
pack
Taptiqom is a clear, colourless liquid (solution)
supplied in single-dose plastic containers, each
containing 0.3 ml of solution. Ten single-dose
containers are provided in one pouch. Taptiqom
is supplied in packs containing 30 or 90 singledose containers.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Santen Oy, Niittyhaankatu 20,
33720 Tampere, Finland
Manufacturer
Laboratoire Unither, ZI La Guerie,
F-50211 Coutances Cedex, France
This medicinal product is authorised in the
following Member States of the EEA under
the name Taptiqom:
Austria, Belgium, Bulgaria, Croatia, Cyprus,
Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland,
Ireland, Latvia, Lithuania, Luxembourg, Malta,
The Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden,
United Kingdom
Loyada: Italy
This leaflet was last revised in
IE, MT: 10/2014
UK: 08/2015

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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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