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

Active substance(s): DORZOLAMIDE HYDROCHLORIDE / TIMOLOL MALEATE / DORZOLAMIDE HYDROCHLORIDE / TIMOLOL MALEATE / DORZOLAMIDE HYDROCHLORIDE / TIMOLOL MALEATE

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PACKAGE LEAFLET

Package leaflet: Information for the patient
Tidomat 20 mg/ml + 5 mg/ml eye drops, solution
Dorzolamide / 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 Tidomat is and what it is used for
2.
What you need to know before you use Tidomat
3.
How to use Tidomat
4.
Possible side effects
5.
How to store Tidomat
6.
Contents of the pack and other information

1.

What Tidomat is and what it is used forTidomat

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”.
These medicines lower the pressure in the eye in different ways
Tidomat is prescribed to lower raised pressure within the eye in the treatment of glaucoma when betablocker eye drop medicine used alone is not adequate.

2.

What you need to know before you useTidomat

Do not use Tidomat
 if you are allergic to dorzolamide hydrochloride, timolol maleate or any of the other ingredients of this
medicine (listed in section 6).
 if you have now or had in the past respiratory problems such as asthma or severe chronic obstructive
bronchitis (severe lung disease which may cause wheeziness, difficulty in breathing and/or longstanding cough),
 if you have a slow heart beat, heart failure or disorders of heart rhythm (irregular heart beats).
 if you have severe kidney disease or problems, or a prior history of kidney stones,
 if you have excess acidity of the blood caused by a build up of chloride blood (hyperchloraemic
acidosis).
If you are not sure whether you should use Tidomatthis medicine, contact your doctor or pharmacist.
Warnings and precautionsTidomat
Talk to your doctor before taking Tidomat.
Tell your doctor about any medical or eye problems you have now or have had in the past:
 coronary heart disease (symptoms can include chest pain or tightness, breathlessness, or choking), heart
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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.

Tell your doctor before you have an operation that you are using Tidomat as timolol may change effects of
some medicines used during anaesthesia.
Also tell your doctor about any allergies or allergic reactions including hives, swelling of the face, lips,
tongue, and/or throat which may cause difficulty in breathing or swallowing.
Tell your doctor if you have muscle weakness or have been diagnosed as having myasthenia gravis.
If you develop any eye irritation or any new eye problems such as redness of the eye or swelling of the
eyelids, contact your doctor immediately.
If you suspect that Tidomat is causing an allergic reaction or hypersensitivity (for example, skin rash, severe
skin reaction, or redness and itching of the eye), stop using this medicine and contact your doctor
immediately.
Tell your doctor if you develop an eye infection, receive an eye injury, have eye surgery, or develop a
reaction including new or worsening symptoms.
When Tidomat is instilled into the eye it may affect the entire body.
If you wear soft contact lenses, you should consult your doctor before using this medicine.
TidomatTidomatTidomat
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.
Use in patients with liver impairment
Tell your doctor about any liver problems you now have or have suffered from in the past.
Other medicines and Tidomat
Tidomat 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. This
is particularly important if you are:







taking medicine to lower blood pressure or to treat heart disease (such as calcium channel blockers,
beta-blockers or digoxin).
taking medicines to treat a disturbed or irregular heartbeat such as calcium channel blockers, betablockers or digoxin.
using another eyedrop that contains a beta-blocker.
taking another carbonic anhydrase inhibitor such as acetazolamide.
taking monoamine oxidase inhibitors (MAOIs) which are used to treat depression.
taking a parasympathomimetic medicine which may have been prescribed to help you pass urine.
Parasympathomimetics are also a particular type of medicine which is sometimes used to help restore
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normal movements through the bowel.
taking narcotics such as morphine used to treat moderate to severe pain.
taking medicines to treat diabetes.
taking antidepressants known as fluoxetine and paroxetine.
taking a sulfa medicine.
taking quinidine (used to treat heart conditions and some types of malaria).

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 taking this medicine.
TidomatDo not use Tidomat if you are breast-feeding. Ask your doctor for advice before taking any medicine
during breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
No studies on the effects on the ability to drive or use machines have been performed. There are side effects
associated with Tidomat, 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 or your vision is clear.Tidomat
TidomatTidomat 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 this medicineTidomat exactly as your doctor has told you. 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 recommended 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 dose of the medicine without consulting your doctor.
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. If you think your medication may be contaminated, or if you develop an eye infection,
contact your doctor immediately concerning continued use of this bottle.
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.

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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
If you put too many drops in your eye or swallow any of the contents of the container, among other effects,
you may become light-headed, have difficulty breathing, or feel that your heart rate has slowed. Contact
your doctor 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 the forgotten dose.
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, this medicineTidomat 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.
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, localised and generalised rash, itchiness, severe sudden life-threatening allergic reaction.
5

The following side effects have been reported with Tidomat or one of its components either during clinical
trials or during post-marketing experience:Tidomat
Very Common (may affect more than 1 in 10 people)
Burning and stinging of the eyes, unusual taste.
Common (may affect up to 1 in 10 people)
Redness in and around the eye(s), watering or itching of the eye(s), corneal erosion (damage to the front
layer of the eyeball), swelling and/or irritation in and around the eye(s), feeling of having something in the
eye, 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, weakness/tiredness and fatigue.
Uncommon (may affect up to 1 to 100 people)
Dizziness, depression, inflammation of the iris, visual disturbances (in some cases due to withdrawal of
medication to treat excessive contraction of the pupil of the eye) , slow heart beat, fainting, difficulty
breathing (dyspnoea), 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 (may affect up to 1 in 1,000 people)
Systemic lupus erythematosus (an immune disease which may cause an inflammation of internal organs),
tingling or numbness of the hands or feet trouble sleeping, nightmares, memory loss, an increase in signs
and symptoms of myasthenia gravis (muscle disorder), decreased sex drive, stroke, temporary short
sightedness which may resolve when treatment is stopped, detachment of the layer below the retina that
contains blood vessels following from filtration surgery which may cause visual disturbances, drooping of
the eyelids (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,
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), oedema (fluid build up), cerebral ischaemia
(reduced blood supply to the brain), chest pain, palpitations (a quicker and/or irregular heartbeat), heart attack,
Raynaud's phenomenon, swelling or coldness of your hands and feet and 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, constriction of the airways in the lungs causing difficulty in breathing,
cough, throat irritation, dry mouth, diarrhoea, contact dermatitis, hair loss, skin rash with white silvery
coloured appearance (psoriasiform rash) Peyronie’s disease (which may cause a curvature of the penis),
allergic type reactions such as rash, hives, itching, in rare cases possible swelling of the lips, eyes and
mouth, wheezing or severe skin reactions (Stevens Johnson syndrome, toxic epidermal necrolysis).
Like other medicines applied into your eyes, timolol is absorbed into the blood. This may cause similar side
effects as seen with oral 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 additional
side effects include reactions seen within the class of beta-blockers when used for treating eye conditions.
Not known (frequency cannot be estimated from the available data):
Low blood glucose levels heart failure, a type of heart rhythm disorder, abdominal pain, vomiting, muscle
pain not caused by exercise, sexual dysfunction.
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 listed in
Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Tidomat
5.

How to store Tidomat

Keep out of the sight and reach of children.
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Do not use this medicineTidomat 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.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose
of medicines you no longer use. These measures will help to protect the environment.

6.

Contents of the pack and other 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
Pharmathen S.A.
6, Dervenakion str.,
153 51 Pallini, Attiki,
Greece
Manufacturer
Pharmathen S.A.
6, Dervenakion str.,
153 51 Pallini, Attiki,
Greece
Or
Famar S.A.
63 Agiou Dimitriou Street,
174 56 Alimos
Greece

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This leaflet was last revised in {MM/YYYY}.
<[To be completed nationally]>

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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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