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

Active substance: TIMOLOL MALEATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Dorzolamide/Timolol 20/5 mg/ml
Eye Drops, Solution

SZ07101LT03A

Active substances: Dorzolamide and 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 Dorzolamide/Timolol Eye Drops
are and what they are used for
2. Before you use Dorzolamide/Timolol
Eye Drops
3. How to use Dorzolamide/Timolol
Eye Drops
4. Possible side effects
5. How to store Dorzolamide/Timolol
Eye Drops
6. Further information

1

What Dorzolamide/Timolol
Eye Drops are and what
they are used for

Dorzolamide/Timolol Eye Drops are a
combination of dorzolamide
hydrochloride, an ophthalmic carbonic
anhydrase inhibiting active substance
and timolol maleate, an ophthalmic
beta-blocking active substance, both of
which lower raised pressure in the eye in
different ways.

Dorzolamide/Timolol Eye Drops are
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 Eye
Drops

Do not use Dorzolamide/Timolol Eye
Drops
• if you are allergic (hypersensitive) to
dorzolamide hydrochloride, timolol
maleate, beta-blockers or any of the
other ingredients
• 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 heartbeat, heart
failure or disorders of the heart
rhythm (irregular heart beats)
• if you have severe kidney problems,
or a disturbance in the pH (acid/alkali
balance) of your blood.
If you think any of these apply to you, do
not use Dorzolamide/Timolol Eye Drops
until you have consulted your doctor.

Take special care with Dorzolamide/
Timolol Eye Drops
Before treatment with Dorzolamide/
Timolol Eye Drops, tell your doctor or
pharmacist 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. Your
doctor may wish to monitor your pulse
rate and other signs of this disease
while you are using Dorzolamide/
Timolol Eye Drops.
• disturbances of heart rate such as
slow heartbeat.
• liver problems.
• muscle weakness or myasthenia
gravis.
• breathing problems, asthma or
chronic obstructive pulmonary disease.
• Prinzmetalʼs angina (chest pains while
resting).
• diabetes as timolol may mask signs
and symptoms of low blood sugar.
• overactivity of the thyroid gland as
timolol may mask signs and symptoms.
• poor blood circulation disease
(such as Raynaudʼs disease or
Raynaudʼs syndrome).
• allergies to a medicine you have taken.
• you wear contact lenses (see the
section “Important information about
some of the ingredients of
Dorzolamide/Timolol Eye Drops”).
Contact your doctor immediately if:
• you develop an eye infection, receive
an eye injury, have eye surgery,
develop other reactions or worsening
of symptoms.
• 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.
Such symptoms may be due to an
allergic reaction or may be a
side-effect of Dorzolamide/Timolol
Eye Drops (see section 4. “Possible
side effects”).
Before an operation, tell your doctor or
dentist that you are taking Dorzolamide/
Timolol Eye Drops, as timolol may
change effects of some medicines used
during anaesthesia.
Use in children
There is limited experience with
Dorzolamide/Timolol Eye Drops in
infants and children.

Using other medicines
Dorzolamide/Timolol Eye Drops can
affect or be affected by other medicines
you are using, including other eye drops
for the treatment of glaucoma.

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,
catecholamine-depleting substances,
beta-blockers, clonidine or digoxin
• you are taking medicines to treat a
disturbed or uneven heartbeat
such as amiodarone, quinidine (used
to treat heart conditions and some
types of malaria) or digoxin

• you are using another eye drop that
contains a beta-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) 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 (acetylsalicylic acid).
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.

Pregnancy and breast-feeding
Pregnancy
Tell your doctor if you are pregnant, think
you could be pregnant, or are planning
to become pregnant. You should not use
Dorzolamide/Timolol Eye Drops during
pregnancy.
Breast-feeding
Tell your doctor if you are breast-feeding
or intend to breast-feed. Do not use
Dorzolamide/Timolol Eye Drops if you
are breast-feeding. Timolol and
Dorzolamide may get into your milk.
Ask your doctor or pharmacist for advice
before taking any medicine.
Driving and using machines
Possible side effects such as blurred
vision may affect your ability to drive
and/or use machinery. If you experience
any problems talk to your doctor, who
will advise you (see the section 4.
“Possible side effects”).

Important information about some of
the ingredients of Dorzolamide/
Timolol Eye Drops
Dorzolamide/Timolol Eye Drops contain
the preservative benzalkonium chloride,
which may cause eye irritation and is
known to discolour soft contact lenses.
• If you wear soft contact lenses, you
should consult your doctor before
using Dorzolamide/Timolol Eye Drops.
• Avoid contact with soft contact lenses.
• Remove contact lenses prior to
application and wait at least
15 minutes before reinsertion.
Your doctor can explain this to you.

3

How to use Dorzolamide/
Timolol Eye Drops

Always use Dorzolamide/Timolol Eye
Drops exactly as your doctor has told
you. You should check with your doctor
or pharmacist if you are not sure.
Dosage

The usual dose is:
One drop in the affected eye(s) two
times a day, for example in the morning
and in the evening.
Using Dorzolamide/Timolol Eye Drops
with another eye drop:
If you are using Dorzolamide/Timolol
Eye Drops as well as other eye drops,
the different drops should be used at
least ten minutes apart.

Do not change the dose of the medicinal
product without consulting your doctor. If
you must stop treatment, contact your
doctor immediately.

Instructions for use:
Please follow these instructions carefully
when using Dorzolamide/Timolol Eye Drops.
It is recommended that you wash your
hands before putting in your eye drops.
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.
1. You must not use the bottle if the
tamper-proof seal on the bottle neck
is broken before you first use it.
2. To open the bottle, unscrew the
cap by turning it until the
tamper-proof seal breaks.
3. Tilt your head back and pull your
lower eyelid down slightly to form a
pocket between your eyelid and
your eye (Fig. 1).

Continued on the next page >>

4.

Invert the bottle, and press gently as
shown (Fig. 2 and 3) until a single
drop as instructed by your doctor is
dispensed into your eye. DO NOT
TOUCH YOUR EYE OR EYELID
WITH THE TIP OF THE CONTAINER.

5.

Repeat steps 3 and 4 with the other eye
if instructed to do so by your doctor.
Reclose the bottle by turning the cap
firmly immediately after use and return
the bottle to the original outer carton.
The dispenser tip is designed to
provide a pre-measured drop;
therefore, do not enlarge the hole of
the dispenser tip.

6.

7.

After using Dorzolamide/Timolol Eye
Drops press a finger into the corner of
your eye, by the nose for 2 minutes. This
helps to stop timolol getting into the rest
of the body.

If you use more Dorzolamide/
Timolol Eye Drops 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,
nausea, headache, fatigue or feel that
your heartbeat is slower than usual. If you
feel any of the above effects you should
seek medical attention immediately.
If you forget to use Dorzolamide/
Timolol Eye Drops
If you miss a dose, use 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
a forgotten dose.

If you stop using Dorzolamide/Timolol
Eye Drops
If you must stop or want to stop treatment,
contact your doctor immediately.
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
Eye Drops 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
Dorzolamide/Timolol Eye Drops without
speaking to your doctor.

The frequency of possible side effects
listed below is defined using the
following convention:
Very common (affects more than 1 user
in 10)
Common (affects 1 to 10 users in 100)
Uncommon (affects 1 to 10 users in
1,000)
Rare (affects 1 to 10 users in 10,000)
Not known (frequency cannot be
estimated from the available data)

The following side effects have been
seen with the fixed combination of
dorzolamide and timolol or one of its
components:
Very common side effects (more than 1
of 10 patients)
• burning and stinging in the eye(s)
• bitter taste after putting in the eye drops
Common side effects (1 to 10 patients of
100)
• headache
• redness in and around the eye(s),
blurred vision,
• watering or itching of the eye(s) and
effects on the surface of the eye
• eyelid inflammation, irritation of the
eye(s), e.g. dry eyes
• sinusitis
• feeling sick
• weakness/tiredness
• corneal erosion (damage to the front
layer of the eyeball)

Uncommon side effects (1 to 10 patients
of 1,000)
• dizziness
• depression
• inflammation of the iris and the ciliary
body
• visual disturbances including blurred
vision (in some cases due to withdrawal
of medication to treat excessive
contraction of the pupil of the eye)
• slowing of your heart rate
• fainting
• sudden loss of consciousness
• changes in the rhythm or speed of the
heartbeat
• dyspnoea (shortness of breath)
• indigestion
• development of kidney stones

Rare side effects (1 to 10 patients of
10,000)
• unusual sensations like pins and needles
• difficulty sleeping (insomnia)
• nightmares
• decreased sex drive
• stroke (cerebrovascular accident)
• reduced blood supply to the brain
• irritation of the eye(s) including eyelid
crusting and eye pain
• swelling and/or irritation in and around
the eye(s)
• low pressure in the eye
• detachment of the layer below the
retina that contains blood vessels
following filtration surgery which may
cause visual disturbances
• ringing noises in the ear
• low blood pressure
• chest pain
• palpitations (rapid or strong heartbeat)
• heart failure
• congestive heart failure (heart disease
with shortness of breath and swelling
of the feet and legs due to fluid build up)
• cardiac arrest
• Raynaudʼs phenomenon (bluish
hands and feet)
• swelling or coldness of your hands
and feet and reduced circulation in
your arms and legs
• oedema (fluid build up)
• rhinitis and breathing difficulties such
as shortness of breath/breathlessness
and more rarely wheezing
• coughing and nose bleed
• dry mouth






(itchy) rash
itchiness
hair loss
skin rash with white silvery coloured
appearance (psoriasiform rash) or
worsening of psoriasis
• Peyronieʼs disease (which may cause
a curvature of the penis)
• generalized allergic reactions
including swelling beneath the skin
that can occur in areas such as the
face and limbs, and can obstruct the
airways which may cause difficulty
swallowing or breathing
• severe sudden life-threatening allergic
reaction.
There are possible side effects of the
components of Dorzolamide/Timolol
Eye Drops, which may also be
potential side effects of Dorzolamide/
Timolol Eye Drops in some patients.
These include:

Common side effects (1 to 10 patients of
100)
• decreased sensitivity of the eye(s)
• inflammation in the cornea
• muscle weakness/tiredness
Uncommon side effects (1 to 10 patients
of 1,000)
• fainting

Rare side effects (1 to 10 patients of
10,000)
• facial rash, joint pain, muscle disorder,
fever (systemic lupus erythematosus)
• memory loss
• increases in signs and symptoms of
myasthenia gravis (muscle disorder)
• temporary short sightedness which may
stop when treatment is discontinued
• drooping of the upper eyelid (making
the eye stay half closed) double vision
• stroke (cerebral ischemia)
• leg cramps and/or leg pain when
walking (claudication)
• throat irritation
• diarrhoea
• constriction of the airways in the lungs
(predominantly in patients with
pre-existing disease)

Like other medicines applied into eyes,
timolol is absorbed into the blood. This
may cause similar side effects as seen
with “intravenous” or “oral” beta-blocking
agents. Incidence of side effects after
application into the eyes 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:










localized and generalized rash
low blood glucose levels
a type of heart rhythm disorder
heart attack
taste disturbances
abdominal pain
vomiting
muscle pain not caused by exercise
sexual dysfunction

If any of the side effects happen to you,
or you have any other unusual
symptoms or feelings, contact your
doctor immediately, particularly if you
experience any changes/visual
disturbance when using Dorzolamide/
Timolol Eye Drops after eye surgery.

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.

5

How to store Dorzolamide/
Timolol Eye Drops

Keep out of the reach and sight of children.

Do not use Dorzolamide/Timolol Eye Drops
after the expiry date which is stated on
the label and carton. The expiry date
refers to the last day of that month.
Keep the bottle in the outer carton, in
order to protect from light.
Do not store above 30°C.
After first opening: use within 28 days.
Discard any unused solution afterwards.

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 Eye Drops
contain
The active substances are:
dorzolamide and timolol.
1 ml solution contains 20 mg of
dorzolamide (as hydrochloride) and
5 mg of timolol (as maleate).

The other ingredients are:
hydroxyethylcellulose, mannitol (E421),
sodium citrate dihydrate, sodium
hydroxide/hydrochloric acid (for
pH-adjustment) and water for injection.
Benzalkonium chloride (0.075 mg/ml) is
added as a preservative.

What Dorzolamide/Timolol Eye Drops
look like and contents of the pack
Eye drops, solution. Colourless to
slightly yellowish, viscous solution.
Dorzolamide/Timolol Eye Drops are
available in white coloured plastic 5 ml
bottles (PE-bottles).
Pack sizes: 1 x 5 ml, 3 x 5 ml and
6 x 5 ml eye drops.
Not all pack sizes will be marketed.

Marketing authorization holder and
manufacturer
Marketing Authorization Holder:
Sandoz Ltd, Frimley Business Park,
Frimley, Camberley, Surrey, GU16 7SR.

Manufacturer:
Aeropharm GmbH, 07407 Rudolstadt,
François-Mitterrand-Allee 1, Germany or
Salutas Pharma GmbH, 39179
Barleben, Otto-von-Guericke-Allee 1,
Germany.
This leaflet was last approved in
02/2012.

46086640
SZ07101LT03A

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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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