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Package leaflet: Information for the patient
Dorzolamide / Timolol 20 mg/ml + 5 mg/ml, eye drops, solution
Read all of this leaflet carefully before you start using this medicine because it contains important
information for you.
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 only. Do not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
If you get any side effects, talk to your doctor, or pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet
What Dorzolamide / Timolol is and what it is used for
What you need to know before you use Dorzolamide / Timolol
How to use Dorzolamide / Timolol
Possible side effects
How to store Dorzolamide / Timolol
Contents of the pack and other information


What Dorzolamide / Timolol is and what it is used for

Dorzolamide / Timolol 20 mg/ml + 5 mg/ml, eye drops, solution contains two medicines: dorzolamide and

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.


What you need to know before you use Dorzolamide / Timolol

Do not use Dorzolamide / Timolol:
if you are allergic to dorzolamide or timolol or any of the other ingredients of this medicine (listed in
section 6).
if you have now or had in the past respiratory problems, such as asthma or severe chronic obstructive
bronchitis (severe lung disease which may cause wheeziness, difficulty in breathing and/or longstanding cough).
if you have a slow heart beat, heart failure or disorders of heart rhythm (irregular heart beats).
if you have severe kidney disease or 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
If you are not sure whether you should use this medicine, contact your doctor or pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before using Dorzolamide / Timolol.
Tell your doctor about any medical or eye problems 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.
• disturbances of heart rate such as slow heart beat.
• breathing problems, asthma or chronic obstructive pulmonary disease.


poor blood circulation disease (such as Raynaud’s disease or Raynaud’s syndrome).
diabetes as timolol may mask signs and symptoms of low blood sugar.
overactivity of the thyroid gland as timolol may mask signs and symptoms.

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.
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.
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, severe skin reaction, or redness and itching of the eye), stop using this medicine 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 Dorzolamide / Timolol (the
preservative benzalkonium chloride may possibly discolor the lenses).
There is limited experience with Dorzolamide / Timolol in infants and children.
In studies with Dorzolamide / Timolol, the effects of this medicine were similar in both elderly and younger
Patients with liver impairment
Tell your doctor about any liver problems you now have or have suffered from in the past.
Other medicines and Dorzolamide / Timolol
Tell your doctor or pharmacist if you are using, have recently used or might use any 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 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,
beta-blockers or digoxin).
taking medicines to treat a disturbed or irregular heartbeat such as calcium channel blockers, betablockers or digoxin.
using another eye drop that contains a beta-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 is 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 antidepressants known as fluoxetine and paroxetine.

taking a sulfa medicine.
taking quinidine (used to treat heart conditions and some types of malaria).

Pregnancy and breast-feeding
Do not use Dorzolamide / Timolol if you are pregnant unless your doctor considers it necessary.
Do not use Dorzolamide / Timolol if you are breast-feeding. Timolol may get into your milk. Ask your
doctor for advice before taking any medicine during breast-feeding.
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.


How to use Dorzolamide / Timolol

Always use this medicine exactly as your doctor or pharmacist 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
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 instilled at least 10 minutes apart.
Do not change the dose of the medicine without consulting your doctor.
Do not allow the tip of the container to touch the eye or areas around the 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
The tamper-proof seal on the bottle neck must be unbroken before the product is being used for the
first time. A gap between the bottle and the cap is normal for an unopened bottle.
Wash your hands and take off the cap of the bottle.
Tilt your head back and pull your lower lid down slightly to form a pocket between your eyelid and
your eye.
Invert the bottle and squeeze until a single drop is dispensed into the eye. THE EYE OR EYELID
After using Dorzolamide/Timolol Warren press a finger into the corner of your eye, by the nose, or
close your eyelids for 2 minutes. This helps to stop the medicine from getting into the rest of the body.
Repeat steps 3 & 4 with the other eye if instructed to do so by your doctor..
The cap must be put back on and the bottle must be closed straight after it has been used.
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 container, among other effects,
you may become light-headed, have difficulty breathing, or feel that your heart rate has slowed. Contact your
doctor immediately.
If you forget to use Dorzolamide / Timolol
It is important to take this medicine as prescribed by your doctor.
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 take 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.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.




Like all medicines, this medicine 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 without speaking to your doctor.
Generalized 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,
localized and generalized rash, itchiness, severe sudden life-threatening allergic reaction.
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 adverse reactions have been reported with Dorzolamide / Timolol 20 mg/ml / 5 mg/ml eye
drops, solution or one of its components either during clinical trials or during post-marketing experience:
Very Common:
Burning and stinging of the eyes, unusual taste
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 realizing 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: 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 excrutiating, cramping pain in their low back and/or side, groin or abdomen)
Systemic lupus erythematosus (an immune disease which may cause an inflammation of internal organs),
tingling or numbness of the hands or feet, 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, impaired lung function, runny or
stuffed nose, nose bleed, constriction of the airways in the lungs, 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:
Not known:
Low blood glucose levels, heart failure, a type of heart rhythm disorder, abdominal pain, vomiting, muscle
pain not caused by exercise, sexual dysfunction.
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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not
listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you
can help provide more information on the safety of this medicine.
United Kingdom: Yellow Card Scheme at:


How to store Dorzolamide / Timolol

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label of the bottle and on the carton after
EXP:. The expiry date refers to the last day of that month.
Store below 25 °C. Keep the bottle in the outer carton in order to protect from light.
You can use Dorzolamide / Timolol for 28 days after first opening the bottle.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help protect the environment.

Contents of the pack and other information
What Dorzolamide / Timolol contains
The active substances are dorzolamide and timolol.
Each ml contains 20 mg of dorzolamide (as dorzolamide hydrochlorid) and 5 mg of timolol (as timolol
The other ingredients are hydroxyethyl cellulose, mannitol (E421), sodium citrate (E331), sodium
hydroxide (E524) for pH adjustment, and water for injection. Benzalkonium chloride is added as a
What Dorzolamide / Timolol contains looks like and contents of the pack
Dorzolamide / Timolol 20 mg/ml / 5 mg/ml Eye Drops, Solution is a clear, colourless to nearly colourless
slightly viscous solution filled in gamma sterilized translucent low density polyethylene (LDPE) bottle with
natural LDPE nozzle and white high density polyethylene (HDPE) cap in a cardboard box.
Pack sizes:
1 x 5 ml (single 5 ml bottle)
3 x 5 ml (three 5 ml bottles)
6 x 5 ml (six 5 ml bottles)
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer


The Marketing Authorisation Holder:
U Staré tvrze 285/21,
196 00 Praha 9,
Czech Republic
Jarková 269/17
Šarišské Michaľany 082 22 Slovak

This leaflet was last revised in April 2016.



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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.