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

Active substance(s): DORZOLAMIDE HYDROCHLORIDE / TIMOLOL MALEATE

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Front of leaflet

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

TEVA UK Ref: 231-30-87033-D LEA DORZOLAMIDE/TIMOLOL 2/0.5 % SOL TUK
Version:

3

08 September 2015

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 (listed in section 6.)
• 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 the 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.

If you wear soft contact lenses, you should
consult your doctor before using this
medicine (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 eye drop 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
causes 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. 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.

Version:

3

08 September 2015

Back of leaflet

2. To open the bottle,
unscrew the cap
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 below) 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.
If you stop using Dorzolamide/Timolol If you
want to stop using this medicine talk to your
doctor first. Never abruptly stop using this
medicine since this may worsen certain
symptoms, especially if you have coronary
heart disease or an overactive thyroid.
If you have any further questions on the use
of this product, ask your doctor or pharmacist.

TEVA UK Ref: 231-30-87033-D LEA DORZOLAMIDE/TIMOLOL 2/0.5 % SOL TUK
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.
Very common side effects (affect more than 1
user in 10)
Burning and stinging of the eyes, unusual
taste
Common side effects (affect 1 to 10 users in
100)
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
realisation 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 side effects (affect 1 to 10 users
in 1,000)
Dizziness, depression, inflammation of the
iris, visual disturbances including refractive
changes (in some cases due to withdrawal
of medication to treat excessive contraction
of the pupil of the eye), slow heartbeat,
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 side effects (affect 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
the hands or feet (like pins and needles),
difficulty sleeping (insomnia), 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 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.
Reporting of side effects
If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide
more information on the safety of this medicine.

5

HOW TO STORE DORZOLAMIDE/
TIMOLOL EYE DROPS

• 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 substance are dorzolamide and
timolol. One millilitre contains 20 mg
dorzolamide as dorzolamide hydrochloride
(22,26 mg) and 5 mg timolol as timolol
maleate (6,83 mg).
• The other ingredients are
hydroxyethylcellulose, mannitol, sodium
citrate dihydrate, sodium hydroxide for pH
adjustment, and water for injections.
Benzalkonium chloride (0.075 mg/ml) is
added as a preservative.
What Dorzolamide/Timolol look like and
contents of the pack
• Colourless, clear, viscous solution, free
from visible particles with a pH between
5.2-5.7, and an osmolality of 242–323
mosmol/kg in white bottles with white
droppers and yellow, tamper proof cap.
• Each bottle contains 5 ml of solution. It is
available in pack sizes of 1 x 5ml, 2 x 5 ml,
3 x 5ml and 6 x 5ml. Not all pack sizes may
be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorsation Holder is: TEVA UK
Limited, Eastbourne, BN22 9AG, United
Kingdom
Manufacturer is: TEVA Pharmaceutical Works
Private Limited Company Táncsics Mihály út
82, H-2100 Gödöllő, Hungary
This leaflet was last revised in September
2015
PL 00289/1130
3-29122920/D
87033-D

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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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