DORZOLAMIDE/TIMOLOL 20 MG/ML + 5 MG/ML PRESERVATIVE-FREE SINGLE DOSE EYE DROPS SOLUTION

Active substance: TIMOLOL MALEATE

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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
PACKAGE LEAFLET: INFORMATION FOR THE USER
to treat diabetes. Please tell your doctor or pharmacist if you are
Read all of this leaflet carefully before you start using this
taking or have recently taken any other medicines, including
medicine.
other eye drops or medicines obtained without a prescription.
• Keep this leaflet. You may need to read it again.
This is particularly important if any of the following apply to you:
• If you have any further questions, ask your doctor or
• You are taking antihypertensive medicines which are used to
pharmacist.
lower high blood pressure or medicines to treat heart disease
• This medicine has been prescribed for you. Do not pass it on to
such as calcium channel blockers and beta-blockers or digoxin
others. It may harm them, even if their symptoms are the same • You are taking medicines to treat a disturbed or uneven
as yours.
heartbeat such as quinidine (which may also be used to treat
• If any of the side effects gets serious, or if you notice any side
some types of malaria) or digoxin
effects not listed in this leaflet, please tell your doctor or
• You are using another eyedrop that contains a beta-blocker
pharmacist.
• You are taking another carbonic anhydrase inhibitor such as
acetazolamide. You may be taking this type of medicine by
IN THIS LEAFLET:
mouth, as eye drops, or by some other method
1. What Dorzolamide/Timolol is and what it is used for
• You are taking monoamine oxidase inhibitors (MAOIs) to treat
2. Before you use Dorzolamide/Timolol
depression or another illness
3. How to use Dorzolamide/Timolol
• You are taking a parasympathomimetic medicine which may
4. Possible side effects
have been prescribed to help you pass urine.
5. How to store Dorzolamide/Timolol
Parasympathomimetics are also a particular type of medicine
6. Further information
which are sometimes used to help restore normal movements
through the bowel
• You are taking narcotics such as morphine used to treat
1 WHAT DORZOLAMIDE/TIMOLOL IS AND WHAT IT IS
USED FOR
moderate to severe pain or if you are taking large doses of
aspirin. Although there is no evidence that dorzolamide
Dorzolamide/Timolol eye drops contain two medicines:
hydrochloride interacts with aspirin, some other medicines
dorzolamide and timolol. Dorzolamide belongs to a group of
which are related to dorzolamide hydrochloride and which are
medicines called 'carbonic anhydrase inhibitors'. Timolol belongs
taken by mouth, have been known to interact with aspirin
to a group of medicines called 'beta-blockers'. These medicines
• You are taking medicines to treat diabetes or high
lower the pressure in the eye in different ways.
blood sugar
• You are taking medicines to treat depression such
This medicine is prescribed to lower raised pressure within the
as fluoxetine or paroxetine
13 mm
eye in the treatment of glaucoma when beta-blocker eye drops
• You are taking epinephrine (adrenaline).
used alone are not adequate.
Pregnancy and breast-feeding
If left untreated this raised pressure in the eye may damage the
optic nerve resulting in deterioration of vision and possible
Use in pregnancy
blindness. If your doctor has diagnosed raised pressure in your
Tell your doctor if you are pregnant, think you could
eye, regular eye examinations and measurements of the pressure be pregnant, or are planning to become pregnant.
within your eyes will be necessary.
Do not use Dorzolamide/ Timolol if you are pregnant unless your
doctor considers it necessary.

4. Tilt your head back and pull your lower eyelid down slightly to
form a pocket between your eyelid and eye as shown.

DORZOLAMIDE/TIMOLOL 20 mg/ml + 5 mg/ml,
PRESERVATIVE-FREE, SINGLE DOSE EYE DROPS,
SOLUTION

5. Put one drop in the affected eye(s) as directed by your doctor.
Each single dose container contains enough solution for both
eyes.
6. After putting the drop into the eye, throw away the used single
dose container even if there is solution remaining to avoid
contamination of the preservative free solution.
7. Store the remaining containers in the foil pouch; the remaining
containers must be used within 15 days after opening of the
pouch. If there are any containers left 15 days after opening the
pouch they should be safely thrown away and a fresh pouch
opened. It is important to continue to use the eye drops as
prescribed by your doctor.
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.

10 mm
10 mm

2 BEFORE YOU USE DORZOLAMIDE/TIMOLOL

Do NOT use Dorzolamide/Timolol Single Dose Eye Drops,
Solution
• 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 severe kidney impairment or problems, or have a
disturbance in the pH (acid/alkali balance) of your blood
• 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).
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.

Use in breast-feeding
Tell your doctor if you are breast-feeding or intend to breastfeed. Do not use Dorzolamide/Timolol if you are breast-feeding.
Timolol may get into your milk.
Ask your doctor or pharmacist for advice before taking any
medicine.
Driving and using machines
Potential side effects such as blurred vision may affect some
patients’ ability to drive and/or operate machinery. If you
experience any problems do not drive or operate machinery and
contact your doctor for further advice.

3 HOW TO USE DORZOLAMIDE/TIMOLOL
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) two times a day,
for example 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. If you must stop treatment, contact your doctor
immediately (see 'If you stop using Dorzolamide/Timolol',
below).
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 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 this medicine.
Instructions for use
The solution from one individual single dose container is to be
Tell your doctor if you have muscle weakness or have been
used immediately after opening for administration to the affected
diagnosed as having myasthenia gravis.
eye(s). Since sterility cannot be maintained after the individual
single dose container is opened, a new container must be
If you develop conjunctivitis (redness and irritation of the eye[s]), opened prior to each use and must be discarded immediately
swelling of the eye or eyelids, skin rash, severe skin reaction, or
after administration.
itching in and around the eye contact your doctor immediately.
It is recommended that you wash your hands before putting in
Such symptoms may be due to an allergic reaction or may be a
your eye drops. You may find it easier to apply your drops in
side effect of this medicine (See ‘Possible side effects’).
front of a mirror.
Tell your doctor if you develop an eye infection, receive an eye
injury, have eye surgery, develop other reactions or worsening of 1. Open the foil pouch which contains individual single dose
symptoms.
containers.
2. First wash your hands then break off one single dose container
Dorzolamide/Timolol has not been studied in patients wearing
from the strip as shown.
contact lenses. If you wear soft contact lenses, you should
consult your doctor before using Dorzolamide/Timolol.
Tell your doctor before you have an operation or an anaesthetic
(even at the dentist) that you are using Dorzolamide/Timolol as
timolol may change the effects of some medicines used during
anaesthesia.
Use in children
There is limited experience with this medicine in infants and
children.
Use in the elderly
In studies with this product (preserved formulation), 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.

3. Twist open the top of the single dose container, as shown.

13 mm

• Swelling and/or irritation in and around the eye(s), drooping of
the upper eyelid (making the eye stay half-closed), eyelid
crusting, detachment of the layer below the retina that contains
blood vessels following filtration surgery which may cause
visual disturbances, low pressure which may be accompanied
by visual changes / disturbances, double vision
• Ringing noises in your ear
• Low blood-pressure, chest pain, palpitations, changes in the
rhythm or speed of the heartbeat, heart attack, oedema (fluid
build-up), congestive heart failure (heart disease with shortness
of breath and swelling of the feet and legs due to fluid buildup), a type of heart rhythm disorder, cold hands and feet,
Raynaud's phenomenon (poor blood circulation which makes
the toes and fingers numb and change colour), leg cramps
and/or leg pain when walking (claudication)
• Shortness of breath, cough, difficulty breathing, constriction of
the airways in the lungs (predominantly in patients with pre
existing disease), runny nose, nose bleed
• Throat irritation, dry mouth, diarrhoea
• Rash or inflammation of the skin, skin rash with white silvery
coloured appearance (psoriasiform rash) or worsening of
psoriasis, hair loss
• Peyronie’s disease (which may cause a curvature of the penis)
• Unusual muscle weakness or pain not caused by exercise or
tiredness
• Generalised 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.
Side effects the frequency of which is unknown (frequency
cannot be estimated from the available data)
• Low blood glucose levels
• Heart failure
• Abdominal pain, vomiting
• Muscle pain not caused by exercise
• Sexual dysfunction.

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 container, you may feel unwell, for example you
may become light-headed, have difficulty breathing or a
headache, feel that your heart rate has slowed, feel sick or tired. If If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor, particularly
you feel any of the above effects you should seek medical
if you experience any changes/visual disturbance when using
attention immediately.
Dorzolamide/Timolol after eye surgery.
If you forget to use Dorzolamide/Timolol
It is important to use your medicine as prescribed by your doctor. 5 HOW TO STORE DORZOLAMIDE/TIMOLOL
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 • Keep out of the reach and sight of children.
to your regular dosing schedule. Do not apply a double dose to
• Do not use this medicine after the expiry date which is stated
make up for the forgotten dose.
on the container and carton. The expiry date refers to the last
day of that month.
If you stop using Dorzolamide/Timolol
• Discard any unused single dose containers after 15 days of
If you want to stop using this medicine talk to your doctor first.
first opening the pouch.
Never abruptly stop using this medicine since this may worsen
• Discard the opened single dose container with any remaining
certain symptoms, especially if you have coronary heart disease
solution immediately after first use.
or an overactive thyroid.
• Store below 25°C.
• Do not refrigerate or freeze.
If you have any further questions on the use of this product, ask
• Keep the containers in the outer carton in order to protect from
your doctor or pharmacist.
light.
• Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
4 POSSIBLE SIDE EFFECTS
medicines no longer required. These measures will help to
protect the environment.
Like all medicines Dorzolamide/Timolol can cause side effects,
although not everybody gets them.
You can usually carry on taking the drops, unless the effects are
6 FURTHER INFORMATION
serious. If you're worried, talk to a doctor or pharmacist. Do not
stop using Dorzolamide/Timolol without speaking to your doctor. What Dorzolamide/Timolol contains
• The active substances are dorzolamide and timolol. Each
Rarely (in 1 to 10 users in 10,000), allergic reactions such as
millilitre contains 20 mg dorzolamide as 22.26 mg dorzolamide
swelling of the lips, eyes and mouth, wheezing or severe skin
hydrochloride and 5 mg timolol as 6.83 mg timolol maleate.
reactions with blistering or peeling may occur. If you develop
• The other ingredients are hydroxyethylcellulose, mannitol,
such effects, you should seek medical attention immediately.
sodium citrate dihydrate, sodium hydroxide, and water for
injections.
Tell your doctor if you develop an eye infection or develop other
eye reactions or worsening of symptoms.
What Dorzolamide/Timolol looks like and contents of the pack
The following have been seen with Dorzolamide/Timolol. Like
other medicines applied into the eyes, timolol is absorbed into
the blood. This may cause similar side effects to those seen with
intravenous and/or oral beta-blocking agents. The 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:
Very common side effects (affect more than 1 user in 10):
• Burning and stinging in and around the eye(s)
• Taste disturbances: some patients have reported a bitter taste
after putting in their eye drops.
Common side effects (affect 1 to 10 users in 100):
• Headache
• Signs and symptoms of eye irritation (e.g. burning, stinging,
itching, tearing, redness), inflammation of the eyelid,
inflammation of the cornea, corneal erosion (damage to the
front layer of the eyeball), decreased corneal sensitivity (not
realising you have got something in your eye and not feeling
pain) dry eye(s), eye pain, blurred vision
• Sinusitis
• Nausea
• Weakness/tiredness.

• Clear, colourless slightly viscous solution. Each foil pouch
contains either 5 or 15 low-density polyethylene single dose
containers containing 0.2 ml of solution.
• It is available in pack sizes of 5, 20, 30, 60 and 120 single dose
containers. Not all pack sizes may be marketed.
Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG.
Manufacturer
Ivax Pharmaceuticals UK, Runcorn, WA7 3FA.
This leaflet was last revised in February 2012.
PL 00289/1239

Uncommon side effects (affect 1 to 10 users in 1,000):
• Dizziness, depression
• Inflammation of the iris (the coloured part of the eye), changes
in eyesight
• Slowing of your heart rate, fainting
• Shortness of breath/breathlessness
• Indigestion
• Kidney stones.
Rare side effects (affect 1 to 10 users in 10,000):
• Systemic lupus erythematosus (a red blotchy rash mainly on
the face which may be accompanied by fatigue, fever, joint
pain, muscle pain)
• Numbness/tingling sensation, unusual sensations like pins
and needles, stroke, reduced blood supply to the brain,
difficulty sleeping (insomnia), nightmares, memory loss,
decreased sex drive, increases in signs and symptoms of
myasthenia gravis (muscle disorder)

PE2524
87796-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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