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

Active substance: TIMOLOL MALEATE

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Front of leaflet

DORZOLAMIDE/TIMOLOL 20 mg/ml If you wear soft contact lenses, you should
+ 5 mg/ml EYE DROPS, SOLUTION consult your doctor before using this medicine
Dorzolamide/Timolol

PACKAGE LEAFLET: INFORMATION FOR THE USER

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 get 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 is and
what it is 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 IS AND WHAT IT IS USED FOR

Dorzolamide/Timolol contains 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.
Dorzolamide/Timolol is prescribed to lower
raised pressure in the eye in the treatment of
glaucoma when beta-blocker eye drop
medicine used alone is 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
of this medicine (see section 6. Further
information below)
• 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 heart rhythm (irregular heart
beats)
• If you have severe kidney problems, or a
prior history of kidney stones
• If you have excess acidity of the blood
caused by a build up of chloride in the blood
(hyperchloraemic acidosis).
If you are not sure whether you should use
Dorzolamide/Timolol, contact your doctor or
pharmacist.
Take special care with Dorzolamide/Timolol
Before you use this medicine, tell your doctor
about any medical or eye problems you have
now or have had in the past, especially:
• 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 (lung disease
which may cause wheeziness, difficulty in
breathing and/or long-standing cough)
• Poor blood circulation disease (such as
Raynaud’s disease or Raynaud’s syndrome)
• Diabetes as timolol may mask the signs and
symptoms of low blood sugar (hypoglycaemia)
• Overactivity of the thyroid gland as timolol
may mask signs and symptoms.
You should 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.
Tell your doctor before you have an operation
that you are using Dorzolamide/Timolol as
timolol may change effects of some medicines
used during anaesthesia.
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 Dorzolamide/Timolol is
causing an allergic reaction or hypersensitivity
(for example, skin rash, or redness and itching
of the eye), stop using it 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 Dorzolamide/Timolol is instilled into
the eye it may affect the entire body.

(see ‘Important information about some of the
ingredients of Dorzolamide/Timolol’ below).
Use in children
There is limited experience with this medicine
in infants and children.
Use in the elderly
In studies with dorzolamide/timolol, its effects
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.
Using other medicines
Dorzolamide/Timolol 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.
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including other eye drops or
medicines obtained without a prescription.
This is particularly important if you are:
• taking medicine to lower blood pressure or
to treat heart disease (such as calcium
channel blockers, ß-blockers or digoxin)
• taking medicines to treat a disturbed or
irregular heartbeat such as calcium channel
blockers, ß-blockers, quinidine (which may
also be used to treat some types of malaria)
or digoxin
• using another eyedrop that contains a
ß-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 are
sometimes used to help restore normal
movements through the bowel
• taking narcotics such as morphine used to
treat moderate to severe pain
• taking medicines to treat diabetes
• taking medicines to treat depression such
as fluoxetine or paroxetine.
Pregnancy and breast-feeding
Use in pregnancy
Do not use Dorzolamide/Timolol if you are
pregnant unless your doctor considers it
necessary. Tell your doctor if you are pregnant
or intend to become pregnant.
Use in breast-feeding
Do not use Dorzolamide/Timolol if you are
breast-feeding. Timolol may get into your
milk. Tell your doctor if you are breast-feeding
or intend to breast-feed.
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 Dorzolamide/
Timolol, 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.
Important information about some of the
ingredients of Dorzolamide/Timolol
This medicinal product contains the
preservative benzalkonium chloride and may
cause eye irritation. Avoid contact with 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. Your doctor can
explain this to you. Benzalkonium chloride is
known to discolour soft contact lenses.

3

HOW TO USE
DORZOLAMIDE/TIMOLOL EYE DROPS

Always use this medicine 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) in the morning and in the evening.
If you are using this medicine with another
eye drop, the drops should be put in at least
10 minutes apart.
Do not change the dose of your 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, wash
your hands before using this medicine and
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.
Instructions for use
You may find it easier to apply your drops in
front of a mirror.
1. Before using the medication for the first
time, be sure the tamper seal is unbroken.
2. To open the bottle, unscrew the cap.

Back of leaflet

3. Tilt your head back and
pull your lower eyelid
down slightly to form a
pocket between your
eyelid and your eye:
4. Invert the bottle, and press
lightly on the sides of the
bottle 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. Replace the cap by turning until it is firmly
touching the bottle.
7. The dispenser tip is designed to provide a
pre-measured drop; therefore, do not
enlarge the hole of the dispenser tip.
After using Dorzolamide/Timolol,
press a finger into the corner
of your eye, by the nose (as
in the picture beside) for
2 minutes. This helps to
stop timolol getting into
the rest of the body.
If you use more Dorzolamide/Timolol than
you should
If you put too many drops in your eye or
swallow any of the contents of the bottle,
among other effects, you may become
light-headed, have difficulty breathing or a
headache, feel that your heart rate has slowed,
feel sick or tired. Contact your doctor
immediately.
If you forget to use Dorzolamide/Timolol
It is important to use your medicine 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 apply a double dose to make
up for the forgotten dose.

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 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:
Side effects the frequency of which is
unknown (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.

If you stop using Dorzolamide/Timolol
If any of the side effects get serious, or if you
If you want to stop using this medicine talk to notice any side effects not listed in this
your doctor first. Never abruptly stop using
leaflet, please tell your doctor or pharmacist.
this medicine since this may worsen certain
symptoms, especially if you have coronary
HOW TO STORE
heart disease or an overactive thyroid.
DORZOLAMIDE/TIMOLOL EYE DROPS

5

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. If they do occur, you may need
medical attention.
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 without speaking
to your doctor.
If you develop allergic reactions including
hives, swelling of the face, lips, tongue, and/or
throat which may cause difficulty in breathing
or swallowing, you should stop Dorzolamide/
Timolol and talk to your doctor immediately.
The following side effects have been reported
with Dorzolamide/Timolol or one of its
components either during clinical trials or
during post-marketing experience.

• Keep out of the reach and sight of children
• Do not use this medicine after the expiry date
which is stated on the bottle and carton. The
expiry date refers to the last day of that month
• Store below 30°C
• Do not refrigerate or freeze
• Do not transfer Dorzolamide/Timolol into
another container, it might get mixed up
or contaminated
• Dorzolamide/Timolol should be used within
28 days after the bottle is first opened.
Discard the bottle with any remaining
solution after that time
• 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. One millilitre contains 20 mg
dorzolamide as dorzolamide hydrochloride
Very common side effects (affect more than 1
(22.26 mg) and 5 mg timolol as timolol
user in 10):
maleate (6.83 mg).
Burning and stinging of the eyes, unusual
• The other ingredients are
taste.
hydroxyethylcellulose, mannitol, sodium
Common side effects (affect 1 to 10 users in
citrate dihydrate, sodium hydroxide for pH
100):
adjustment, and water for injections.
Redness in and around the eye(s), watering
Benzalkonium chloride (0.075 mg/ml) is
or itching of the eye(s), corneal erosion
added as a preservative.
(damage to the front layer of the eyeball),
What Dorzolamide/Timolol looks like and
swelling and/or irritation in and around the
contents of the pack
eye(s), feeling of having something in the
• Colourless, clear, viscous solution, free from
eye, decreased corneal sensitivity (not
visible particles with a pH between 5.2-5.7,
realisation of getting something in the eye
and an osmolality of 242-323 mosmol/kg in
and not feeling pain), eye pain, dry eyes,
white bottles with white droppers and yellow,
blurred vision, headache, sinusitis (feeling of
tamper proof cap.
tension or fullness in the nose), feeling sick,
• Each bottle contains 5 ml of solution. It is
also called nausea, weakness/tiredness, and
available in pack sizes of 1 x 5 ml, 2 x 5 ml,
fatigue.
3 x 5 ml and 6 x 5 ml. Not all pack sizes may
Uncommon side effects (affect 1 to 10 users
be marketed.
in 1,000):
Dizziness, depression, inflammation of the
Marketing Authorisation Holder and
iris, visual disturbances including refractive
Manufacturer
changes (in some cases due to withdrawal of Marketing Authorisation Holder is: TEVA UK
medication to treat excessive contraction of
Limited, Eastbourne, BN22 9AG, United Kingdom.
the pupil of the eye), slow heartbeat, fainting,
Manufacturer is: TEVA Pharmaceutical Works
difficulty breathing (dyspnoea), indigestion,
and kidney stones (often marked by a sudden Private Limited Company, Táncsics Mihály út
onset of excruciating, cramping pain in their 82, H-2100 Gödöllő, Hungary.
low back and/or side, groin, or abdomen).
This leaflet was last revised in January 2013
Rare side effects (affect 1 to 10 users in 10,000):
PL 00289/1130
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
3-29122920/C
disturbances, drooping of the eyelids (making
87033-C

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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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