DORZOLAMIDE / TIMOLOL 20MG/ML + 5MG/ML EYE DROPS SOLUTION

Active substance: TIMOLOL MALEATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Dorzolamide/Timolol 20mg/ml + 5mg/ml eye drops, solution
Dorzolamide / Timolol
(referred to as Dorzolamide/Timolol throughout this leaflet)
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 Dorzolamide/Timolol is and what it is used for
2. Before you use Dorzolamide/Timolol
3. How to use Dorzolamide/Timolol
4. Possible side effects
5. How to store Dorzolamide/Timolol
6. Further information
1. WHAT DORZOLAMIDE/TIMOLOL IS AND
WHAT IT IS USED FOR
Dorzolamide/Timolol 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’.
Dorzolamide/Timolol 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 DORZOLAMIDE/TIMOLOL
Do not use Dorzolamide/Timolol
• if you are allergic (hypersensitive) to any of the ingredients
of this solution,
• if you have respiratory problems such as asthma, have a
history of asthma or have, or have had in the past 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
Dorzolamide/Timolol until you have consulted your doctor.
Take special care with Dorzolamide/Timolol
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 Dorzolamide/Timolol.
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 Dorzolamide/Timolol (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 using
Dorzolamide/Timolol, as there may be a sudden fall in
blood-pressure associated with the anaesthetic.
Use in children
There is limited experience with Dorzolamide/Timolol 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
• Dorzolamide/Timolol 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 Dorzolamide/Timolol 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 Dorzolamide/Timolol if you are breast- feeding.
Dorzolamide/Timolol may get into your milk. Ask your doctor
for advice before taking any medicine during breast-feeding.
Driving and using machines
Dorzolamide/Timolol 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
Dorzolamide/Timolol
Dorzolamide/Timolol 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 DORZOLAMIDE/TIMOLOL
Always use Dorzolamide/Timolol 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) twice a day,
for example in the morning and in the evening.
If you use Dorzolamide/Timolol with another eye drop, leave
at least 10 minutes between putting in Dorzolamide/Timolol
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. Turn the bottle upside down, 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 Dorzolamide/Timolol, 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 Dorzolamide/Timolol 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 Dorzolamide/Timolol
It is important to use Dorzolamide/Timolol 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 Dorzolamide/Timolol
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, Dorzolamide/Timolol can cause side
effects, although not everybody gets them.
You can usually carry on using the drops, unless the effects
are serious. If you're worried, talk to a doctor or pharmacist.
Do not stop using Dorzolamide/Timolol without speaking to
your doctor.
like other medicines applied into the eyes, dorzolamide/
timolol is absorbed into the blood. 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. This may
cause similar side effects as seen with intravenous and oral
beta-blocking agents.
If you develop generalised allergic reactions including hives
(or itchy rash), localised and generalised rash, itchiness,
severe sudden life-threatening 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 in breathing or swallowing), you should stop using
Dorzolamide /Timolol and talk to your doctor immediately.
The following side effects may be seen with
Dorzolamide/Timolol:
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 that something has gotten into 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 tiredness (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
heartbeat, fainting, indigestion, and kidney stones (often
marked by a sudden onset of excruciating, cramping pain in
the lower 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 (Raynaud’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 Dorzolamide/Timolol after
eye surgery.
5. HOW TO STORE DORZOLAMIDE/TIMOLOL
Keep out of the reach and sight of children.
Do not use Dorzolamide/Timolol 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.
Dorzolamide/Timolol 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 Dorzolamide/Timolol contains
- The active substances are Dorzolamide and Timolol.
each ml contains 20mg dorzolamide (as 22.26mg of
dorzolamide hydrochloride) and 5mg timolol (as 6.83mg
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 injections.
What Dorzolamide/Timolol looks like and
contents of the pack
Your medicine is in the form of a sterile, clear, slightly viscous,
colourless aqueous eye drop solution.
Dorzolamide/Timolol 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
5ml of the ophthalmic solution.
Pack sizes: 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
Distributor
Aspire Pharma ltd
Bellamy House, Winton Road
Petersfield, Hampshire, GU32 3HA
United Kingdom
Manufacturer
Pharmathen S.A.
or Famar S.A.
6 Dervenakion str.
63 Agiou Dimitriou Street
153 51 Pallini Attiki
174 56 Alimos
Greece
Greece
This leaflet was last approved in 09/2013
1010077/P3.1

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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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