Patient leaflet - Dorzolamide/timolol 20 mg / ml + 5 mg / ml eye drops solution
1. WHAT DORZOLAMIDE/TIMOLOL IS AND WHAT IT IS USED FOR
Dorzolamide/Timolol contains two medicines:
dorzolamide hydrochloride and timolol maleate.
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 eyedrop medicine used alone is not adequate.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE DORZOLAMIDE/TIMOLOL
Do not use Dorzolamide/Timolol
if you are allergic to dorzolamide
hydrochloride, timolol maleate 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 long-standing cough). if you have a slow heartbeat, heart failure or disorders of heart rhythm (irregular heartbeats).
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 acidosis).
If you are not sure whether you should use this medicine, contact your doctor or pharmacist. Warnings and precautions
Talk to your doctor 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 heartbeat.
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.
Children
There is limited experience with Dorzolamide/ Timolol in infants and children.
Elderly
In studies with Dorzolamide/Timolol, the effects of this medicine 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. Other medicines and Dorzolamide/Timolol
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. Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. 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, beta-blockers 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
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not use Dorzolamide/Timolol if you are pregnant unless your doctor considers it necessary.
Breast-feeding
Do not use Dorzolamide/Timolol if you are breast-feeding. Timolol may get into breastmilk. 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.
Dorzolamide/Timolol contains Benzalkonium Chloride
This medicine contains 0.075 mg benzalkonium chloride in each ml of solution.
Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. You should remove contact lenses before using this medicine and put them back 15 minutes afterwards.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor.
3. 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. Your doctor will establish the appropriate dosage and duration of treatment.
The recommended 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 bottle 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 bottle, wash your hands before using this medicine and keep the tip of the bottle 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
Do not use the bottle if the
plastic safety strip around the
neck is missing or broken.
When opening the bottle for the
first time, tear off the plastic
safety strip.
Every time you use Dorzolamide/
Timolol:
- 1. Wash your hands.
- 2. Open the bottle. Take special care that the tip of the dropper does not touch your eye, the skin around your eye or your fingers
- 3.
Tilt your head backwards and
hold the bottle upside down
over the eye.
- 4.
Pull the lower eyelid
downwards and look up. Hold
and gently squeeze the sides
of the bottle and let 1 drop fall
into the space between the
lower eyelid and the eye.
- 5.
Close your eye and press the
inner corner of the eye with
your finger for about 2 minutes.
This helps to stop the medicine
from getting into the rest of the
body.
- 6.
Repeat steps 3 to 5 with the
other eye if instructed to do so
by your doctor.
- 7.
Put the cap back on and close
the bottle tightly.
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 feel that your heart rate has slowed. Contact your doctor immediately.
continued overleaf Unopened Opened
As stated in leaflet
Package leaflet
130 x 550 mm
TBA
TW271543 (MAT)
UK
All
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TBA
9 points (Reg text)
TW239388 (MAT) 24/09/2026 25/09/2026 25/09/2026
Black C
If you forget to use Dorzolamide/Timolol
It is important to use 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 use 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 product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them. Serious side effects:
If you experience any of the following side effects, stop using this medicine and seek immediate medical advice as these could be signs of a reaction to the medicine.
Generalised 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, shortness of breath, hives or itchy rash, localised and generalised rash, itchiness, severe sudden life-threatening allergic reaction.
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.
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 (may affect more than 1 in 10 people):
Burning and stinging of the eyes, unusual taste. Common side effects (may affect up to 1 in 10 people):
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 realising 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 (may affect up to 1 in 100 people):
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, shortness of breath, 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 (may affect up to 1 in 1,000 people):
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 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, forceful heartbeat that may be rapid or irregular (palpitations), 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:
Not known (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, hallucination, foreign body sensation in eye, abnormal sensitivity of the eyes to light, increased heart rate and increased blood pressure.
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE DORZOLAMIDE/TIMOLOL
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 after ¨EXP.¨. The expiry date refers to the last day of that month.
Keep the bottle in the outer carton in order to protect from light. After first opening, store below 25 °C. 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.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Dorzolamide/Timolol contains
The active substances are dorzolamide hydrochloride and timolol maleate. Each ml contains 20 mg of dorzolamide (as 22.26 mg dorzolamide hydrochloride) and 5 mg of timolol (as 6.83 mg timolol maleate). The other ingredients are: hydroxyethyl cellulose, mannitol (E421), sodium citrate dihydrate (E331), sodium hydroxide (E524), water for injections. Benzalkonium chloride is added as a preservative.
What Dorzolamide/Timolol looks like and contents of the pack
Dorzolamide/Timolol is a clear, colourless to nearly colourless, slightly viscous solution supplied in a white LDPE bottle with white LDPE dropper and white HDPE screw cap.
Dorzolamide/Timolol is available in pack sizes of 1, 3 and 6 dropper containers of 5ml. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Tillomed Laboratories Limited
220 Butterfield, Great Marlings
Luton, LU2 8DL, United Kingdom
Manufacturer
RAFARM S.A.
Thesi Pousi- Xatzi Agiou Louka Paiania 190 02 Greece
Hard to read?
To get this information in large print or another format, please email medical.information@tillomed.com or call 0800 970 6115
This leaflet was last revised in September 2026.
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