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TIDOMAT 20MG/ML + 5 MG/ML EYE DROPS SOLUTION

Active substance(s): DORZOLAMIDE HYDROCHLORIDE / TIMOLOL MALEATE

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PACKAGE LEAFLET: INFORMATION FOR THE
USER
Tidomat 20 mg/ml + 5 mg/ml eye drops,
solution
Dorzolamide / Timolol
Read all of this leaflet carefully before you start
using this medicine.
- 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.
Do not pass it on to others. It may harm
them, even if their symptoms are the same as
yours.
- If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Tidomat is and what it is used for
2. Before you use Tidomat
3. How to use Tidomat
4. Possible side effects
5. How to store Tidomat
6. Further information
1. WHAT TIDOMAT IS AND WHAT IT IS USED
FOR
Tidomat is a combination of two medicines:
dorzolamide and timolol.
• Dorzolamide belongs to a group of medicines
called “carbonic anhydrase inhibitors”.
• Timolol belongs to a group of medicines called
“beta-blockers”.
Tidomat is prescribed to lower raised pressure
within the eye in the treatment of glaucoma
when beta-blocker eye drops used alone are not
adequate.
2. BEFORE YOU USE TIDOMAT
Do not use Tidomat
 if you are allergic (hypersensitive) to Tidomat,
beta-blockers or any of the ingredients.
 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 severe kidney problems, or a prior
history of kidney stones,
 if you have a disturbance in the pH (acid/alkali
balance) of your blood,
 if you have certain heart problems, including
certain heart rhythm disturbances producing
an abnormally slow heart rate or severe heart
failure.
If you think any of these apply to you, do not use
Tidomat until you have consulted your doctor.
Take special care with Tidomat
If you have a history of heart disease your
doctor may wish to monitor your pulse rate and
other signs of this disease while you are using
Tidomat.
Tell your doctor if you now have or have had liver
problems, if you have muscle weakness or have
been diagnosed as having myasthenia gravis.
You should also tell your doctor if you now have,
or have had in the past, breathing problems,
asthma or chronic obstructive pulmonary disease,
Prinzmetal’s angina (chest pains while resting),
other heart problems (including disturbances of
heart rate such as slow heart beat or severe heart
failure), coronary heart disease (symptoms can
include chest pain or tightness, breathlessness
or choking), poor blood circulation disease (such
as Raynaud’s disease or Raynaud’s syndrome),
low blood pressure, diabetes as timolol may
mask signs and symptoms of low blood sugar,
overactivity of the thyroid gland as timolol may
mask signs and symptoms and about any allergies
to a medicine you have taken.
If you develop conjunctivitis (redness and irritation
of the eye[s]), swelling of the eye or eyelids, skin
rash, or itching in and around the eye contact your
doctor immediately. Such symptoms may be due
to an allergic reaction or may be a side-effect of
Tidomat (See ‘Possible Side Effects’).
Tell your doctor if you develop an eye infection,
receive an eye injury, have eye surgery, develop
other reactions or worsening of symptoms.
If you wear soft contact lenses, it is important
that your lenses are removed before using your
eye drops and not put back into your eyes until
15 minutes after using your eye drops as the
preservative benzalkonium chloride may possibly
discolour the contact lenses.
Before you have an operation and anaesthesia
(even at the dentist), tell your doctor or dentist
that you are taking Tidomat, as there may be a
sudden fall in blood-pressure associated with the
anaesthetic.
Use in children
There is limited experience with Tidomat in infants
and children.
Use in elderly
In studies with Dorzolamide/Timolol eye drops
solution, the effects of Dorzolamide/Timolol eye
drops solution were similar in both elderly and
younger patients.
Using other medicines
Please tell your doctor or pharmacist if you
are taking or have recently taken any other

medicines, including medicines obtained without
a prescription. This is particularly important if any
of the following apply to you:
 You are taking antihypertensive medicines
which are used to lower high blood pressure
or medicines to treat heart disease such as
calcium channel blockers and ß-blockers or
digoxin
 You are taking quinidine (used to treat heart
conditions and some types of malaria) or
digoxin
 You are using another eyedrop that contains a
ß-blocker
 You are taking another carbonic anhydrase
inhibitor such as acetazolamide. You may be
taking this type of medicine by mouth, as eye
drops, or by some other method
 You are taking monoamine oxidase inhibitors
(MAOIs) or selective serotonin reuptake
inhibitors (SSRIs) both of which are used to
treat depression or another illness
 You are taking a parasympathomimetic
medicine which may have been prescribed to
help you pass urine. Parasympathomimetics
are also a particular type of medicine which
are sometimes used to help restore normal
movements through the bowel
 You are taking narcotics such as morphine
used to treat moderate to severe pain or if you
are taking large doses of aspirin. Although there
is no evidence that dorzolamide hydrochloride
interacts with aspirin, some other medicines
which are related to dorzolamide hydrochloride
and which are taken by mouth, have been
known to interact with aspirin
 You are taking medicines to treat diabetes or
high blood sugar
 You are taking epinephrine (adrenaline).
 You are taking antidepressants known as
fluoxetine and paroxetine.
 Tidomat can affect or be affected by other
medicines you are using, including other eye
drops for the treatment of glaucoma.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before
taking any medicine.
Do not use Tidomat if you are pregnant unless
your doctor considers it necessary. Tell your
doctor if you are pregnant or planning to become
pregnant.
Do not use Tidomat if you are breast-feeding.
Tidomat may get into your milk. Ask your doctor
for advice before taking any medicine during
breast-feeding.
Driving and using machines
Tidomat may cause side effects such as blurred
vision in some patients. Do not drive or use
any tools or machines until the symptoms have
cleared.
Important information about some of the
ingredients of Tidomat
Tidomat contains the preservative benzalkonium
chloride.
• Benzalkonium chloride may cause eye
irritation
• Benzalkonium chloride is known to discolour
soft contact lenses. Avoid contact with soft
contact lenses. Remove contact lenses prior
to application and wait until 15 minutes before
re-insertion.
3. HOW TO USE TIDOMAT
Always use Tidomat exactly as your doctor has
told you. You should check with your doctor or
pharmacist if you are not sure.
The appropriate dosage and duration of treatment
will be established by your doctor.
The usual dose is one drop in the affected eye(s)
two times a day, for example in the morning and
in the evening.
If you use Tidomat with another eye drop, leave at
least 10 minutes between putting in Tidomat and
the other medicine.
Do not change the dosage of the drug without
consulting your doctor. If you must stop
treatment, contact your doctor immediately.
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.
In order to secure correct dosage - the dropper tip
should not be enlarged.
Instructions for use:
It is recommended that you wash your hands
before putting in your eye drops.
It may be easier to apply your eye drops in front
of a mirror.

1. Before using the medication for the first time,
be sure that the tamper-proof seal on the
bottle neck is unbroken. A gap between the
bottle and the cap is normal for an unopened
bottle.

2. Take off the cap of the bottle.
3. Tilt your head back and gently pull your lower
eyelid down to form a small pocket between
your eyelid and your eye.
4. Invert the bottle, and squeeze it until a single
drop is dispensed into the eye as directed by
your doctor. DO NOT TOUCH YOUR EYE OR
EYELID WITH THE DROPPER TIP.
5. Repeat steps 3 & 4 with the other eye if
instructed to do so by your doctor.
6. Put the cap back on and close the bottle straight
after you have used it.
After using Tidomat, press a finger into the corner
of your eye, by the nose for 2 minutes. This helps
to stop dorzolamide/timolol getting into the rest of
the body.

If you use more Tidomat 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, or feel that
your heart rate has slowed. If you feel any of the
above effects you should seek medical attention
immediately.
If you forget to use Tidomat
It is important to use Tidomat as prescribed by
your doctor.
If you miss a dose, apply it as soon as possible.
However, if it is almost time for the next dose,
skip the missed dose and go back to your regular
dosing schedule.
Do not use a double dose to make up for forgotten
individual doses.
If you stop taking Tidomat
If you want to stop using this medicine talk to your
doctor first.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Tidomat 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 Tidomat
without speaking to your doctor.
Like other medicines applied into eyes,
dorzolamide/timolol is absorbed into the blood.
This may cause similar side effects as seen with
‘intravenous’ and/or ‘oral’ as applicable betablocking 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.
If you develop generalized allergic reactions
including hives (or itchy rash), localized and
generalized rash, itchiness, severe sudden lifethreatening allergic reaction, swelling beneath
the skin (that can occur in areas such as the face
and limbs, and can obstruct the airway which
may cause difficulty breathing or swallowing),
you should stop Tidomat and talk to your doctor
immediately.
The following side effects may be seen with
Tidomat:
Very Common (affects more than 1 user in 10):
Burning and stinging of the eyes, taste
disturbances.
Common (affects 1 to 10 users in 100):
Redness in and around the eye(s), watering or
itching of the eye(s), and effects on the surface of
the eye(s), swelling and/or irritation in and around
the eye(s), feeling of having something in the eye
(corneal erosion), decreased corneal sensitivity
(not realising of getting something in the eye and
not feeling pain), eye pain, dry eyes, blurred vision,
headache, sinusitis (feeling of tension or fullness
in the nose), feeling sick, also called nausea, and
fatigue.
Uncommon (affects 1 to 10 users in 1,000):
Dizziness, depression, inflammation of the iris,
blurred vision (in some cases due to withdrawal
of medication to treat excessive contraction of
the pupil of the eye), slow heart beat, fainting,
indigestion, and kidney stones (often marked by
a sudden onset of excruciating, cramping pain in
their low back and/or side, groin, or abdomen).
Rare (affects 1 to 10 users in 10,000):
Systemic lupus erythematosus (an immune disease
which may cause an inflammation of internal
organs), tingling or numbness of hands and feet,
(Raynnaud’s phenomenon), unusual sensations
(like pins and needles), difficulty sleeping
(insomnia), nightmares, memory loss, weakening
of the muscles, sexual dysfunction, decreased
libido, stroke, temporary shortsightedness
which may resolve when treatment is stopped,
detachment of the layer below the retina that
contains blood vessels following filtration surgery
which may cause visual disturbances, drooping of
the upper eyelid (making the eye stay half closed),
double vision, eyelid crusting, swelling of the
cornea (with symptoms of visual disturbances),
low pressure in the eye, ringing noises in your ear,
low blood pressure, irregular heartbeat, chest pain,

palpitations (a quicker and/or irregular heartbeat),
heart attack, reduced blood supply to the brain,
congestive heart failure (heart disease with shortness
of breath and swelling of the feet and legs due to
fluid build up), coldness of hands and feet, reduced
circulation in your arms and legs, leg cramps and/
or leg pain when walking (claudication), shortness
of breath, feeling out of breath, runny or stuffed
nose, nose bleed, difficulty breathing, cough, throat
irritation, dry mouth, diarrhoea, contact dermatitis,
hair loss, psoriasis or worsening of psoriasis,
Peyronie’s disease (which may cause a curvature
of the penis), muscle weakness/tiredness, allergic
type reactions such as skin rash, hives, itchiness,
in rare cases possible swelling of the lips, eyes and
mouth, wheezing.
Not known (frequency cannot be estimated from
the available data):
Low blood glucose levels, oedema (fluid build up),
severe sudden life-threatening allergic reaction,
increases in signs and symptoms of myasthenia
gravis (muscle disorder), constriction of the
airways in the lungs (predominantly in patients
with pre-existing disease), muscle pain not caused
by exercise, skin rash with white silvery coloured
appearance (psoriasiform rash), heart failure,
abdominal pain, vomiting.
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist, particularly
if you experience any changes/visual disturbance
when using Tidomat after eye surgery.
5. HOW TO STORE TIDOMAT
Keep out of the reach and sight of children.
Do not use Tidomat after the expiry date which
is stated on the bottle label and the carton after
EXP. The expiry date refers to the last day of that
month.
This medicinal product does not require any
special temperature storage conditions.
Tidomat should be used within 28 days after the
bottle is first opened. Therefore, you must throw
away the bottle 4 weeks after you first opened it,
even if some solution is left. To help you remember,
write down the date that you opened it in the space
on the carton.
Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protect the environment.
6. FURTHER INFORMATION
What Tidomat contains
- The active substances are Dorzolamide and
Timolol. Each ml contains 20 mg dorzolamide
(as 22.26 mg of dorzolamide hydrochloride)
and 5 mg timolol (as 6.83 mg of timolol
maleate).
- The other ingredients are Mannitol (E421),
Hydroxy Ethyl Cellulose, Benzalkonium Chloride
(as a preservative), Sodium Citrate (E331),
Sodium Hydroxide (E524) for pH adjustment
and Water for injection.
What Tidomat looks like and contents of the
pack
Your medicine is in the form of a sterile, clear,
slightly viscous, colourless aqueous eye drop
solution.
Tidomat is presented in a white opaque medium
density polyethylene bottle with a sealed low
density polyethylene dropper tip and a high
density polyethylene cap with tamper proof seal,
containing 5 mL of the ophthalmic solution.
Pack size: 1, 3 or 6 bottles of 5ml each.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Pharmathen S.A.
6 Dervenakion str., 153 51 Pallini, Attiki,
Greece
Manufacturer
Pharmathen S.A.,
6 Dervenakion str., 153 51 Pallini, Attiki,
Greece
and
Famar S.A.,
Plant A, 63 Agiou Dimitriou Street, 174 56
Alimos,
Greece
Distributed by
Lupin (Europe) Limited
Victoria Court,
Bexton Road,
Knutsford,
Cheshire WA16 0PF
United Kingdom
This leaflet was last revised in 09/2013.
ID#: xxxxxx

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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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