Patient leaflet - DORZOLAMIDE 20MG/ML EYE DROPS SOLUTION.
1 What Dorzolamide eye drops are and what they are used for 2 What you need to know before
you use Dorzolamide eye drops 3 How to use Dorzolamide eye drops
4 Possible side effects
5 How to store Dorzolamide eye drops
6 Contents of the pack and other information
1 What Dorzolamide eye drops are and what they are used for
Dorzolamide eye drops are a sterile eye drop solution. Dorzolamide eye drops contain dorzolamide, a sulphonamide-related compound, as the active ingredient.
Dorzolamide is an ophthalmic carbonic anhydrase inhibitor which reduces high pressure in the eye.
It is indicated in the treatment of elevated intra-ocular pressure in conditions such as ocular hypertension and glaucoma (open-angle glaucoma, pseudo-exfoliative glaucoma). Dorzolamide eye drops can be used alone or in addition to other medicines which lower the pressure in the eye (so-called beta-blockers).
2 What you need to know before
you use Dorzolamide eye drops Do not use Dorzolamide eye drops if you
- are allergic to dorzolamide or any of the other ingredients of this medicine (listed in section 6)
- have severe kidney problems.
Warnings and precautions
Talk to your doctor before using Dorzolamide eye drops if you:
- have or have had liver problems in the past
- have been told you have a corneal defect
- have had any allergies to any medicines
- have had, or are about to have eye surgery
- have suffered an eye injury or have an eye infection
- have a prior history of kidney stones
- are taking orally another carbonic anhydrase inhibitor
- wear contact lenses (see the section ‘Dorzolamide eye drops contain benzalkonium chloride’).
You should contact your doctor immediately if you develop any eye irritation or any new eye problems such as redness of the eye or swelling of the surface layer of the eye or eyelids.
Stop using Dorzolamide eye drops and contact your doctor immediately if you suspect that Dorzolamide eye drops are causing an allergic reaction (for example, skin rash, severe skin reactions with blistering of the skin which may affect the mouth, eyes and genitals, itching, inflammation of the eye).
Children
Dorzolamide eye drops have been studied in infants and children less than 6 years of age who have raised pressure in the eye(s) or have been diagnosed with glaucoma. For more information, talk to your doctor.
Other medicines and Dorzolamide eye drops
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular you should tell your doctor if you are taking another carbonic anhydrase inhibitor such as acetazolamide. You may be taking this type of medicine by mouth, as eye drops, or by some other method.
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.
Dorzolamide eye drops should not be used during pregnancy unless your doctor still recommends it.
Dorzolamide eye drops should not be used while breast-feeding.
Driving and using machines
Dorzolamide eye drops may cause dizziness and visual disturbances in some patients. Do not drive or use any tools or machines until the symptoms have cleared.
Dorzolamide eye drops contain benzalkonium chloride
This medicine contains 0.075 mg benzalkonium chloride in each ml.
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 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.
When Dorzolamide eye drops are used alone, the usual dose is one drop in the affected eye(s) three times a day, for example in the morning, in the afternoon and in the evening.
If your doctor has recommended you use Dorzolamide eye drops with a beta-blocker eye drop (medicines which lower the pressure of the eye), then the usual dose is one drop of Dorzolamide eye drops in the affected eye(s) two times a day, for example in the morning and in the evening.
If you use Dorzolamide eye drops with another eye drop, leave at least 10 minutes between putting in Dorzolamide eye drops and the other medicine. Alternatively, if you are going to use Dorzolamide eye drops to replace another eye drop medicine used to lower eye pressure, you should stop using the other medicine after using the proper dosing on one day, then start Dorzolamide eye drops on the next day.
Do not change the dosage of the drug without consulting your doctor. If you must stop treatment, contact your doctor immediately.
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. Package leaflet: Information for the user
Dorzolamide 20mg/ml Eye Drops Solution continued top of next column
continued over page
Date sent:
Date received:
Item number:
Originator:
Origination Date:
Revision Date:
Revised By:
Supplier:
1.
2.
3.
4.
5.
6.
CRF number:
1.
2.
3.
4.
5.
6.
Digital signature
Instructions for proper use:
It is recommended that you wash your hands before putting in your eye drops. It may be easier to apply your eye drops in front of a mirror.
- 1. Before using the medication for the first time, be sure that the tamper-proof seal on the bottle neck is unbroken. A gap between the bottle and the cap is normal for an unopened bottle.
- 2. Take off the cap of the bottle.
- 3. Tilt your head back and gently pull your lower eyelid down to form a small pocket between your eyelid and your eye (see picture 1).
- 4. Turn the bottle upside down and squeeze it 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. Close your eye and press the inner corner of the eye with your finger for about two minutes (see picture 2). 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 straight after you have used it.
If you use more Dorzolamide eye drops than you should
If you put too many drops in your eye or swallow any of the contents, you should contact your doctor immediately.
If you forget to use Dorzolamide eye drops
It is important to use Dorzolamide eye drops 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 use a double dose to make up for a forgotten dose.
If you stop using Dorzolamide eye drops
Dorzolamide eye drops should be used every day to work properly. If you must stop treatment, contact your doctor immediately.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4 Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using this medicine and seek immediate medical advice if you develop allergic reactions.
Symptoms of allergic reactions include the following:
- swelling of the face, lips, tongue, and/ or throat which may cause difficulty in breathing or swallowing
- severe skin reactions with blistering of the skin which may affect the mouth, eyes and genitals
- hives.
The following side effects may be seen with Dorzolamide eye drops:
Very common (may affect more than 1 in 10 people):
- burning and stinging of the eyes.
Common (may affect up to 1 in 10 people):
- disease of the cornea with sore eye and blurred vision (superficial punctuate keratitis), inflammation or swelling of the surface layer of the eye(s) and possible inflammation of the eyelid(s) and/or skin around the eye(s), watering or itching of the eye(s), blurred vision, effects on the surface of the eye
- nausea, bitter taste
- asthenia/fatigue
- headache.
Uncommon (may affect up to 1 in 100 people):
- inflammation of the middle layer of the eye.
Rare (may affect up to 1 in 1,000 people):
swelling of the surface layer of the eye(s), choroidal detachment which may be accompanied by visual changes/ disturbances (following eye surgery), ocular hypotony, redness of the eye(s), eye pain, crusting of the eyelid(s), temporary short sightedness (which stops when the medicine is discontinued)
- throat irritation, dry mouth
- hypersensitivity: signs and symptoms of local reactions (palpebral reactions) and systemic allergic reactions including swelling of the face, lips, tongue, and/ or throat which may cause difficulty in breathing or swallowing, hives and itching, rash, shortness of breath and more rarely bronchospasm (contraction of the smooth muscle in the bronchi)
- dizziness, numbness/tingling sensation
- formation of urinary calculi
- bleeding from the nose
- severe skin reactions, skin inflammation.
Not known (frequency cannot be estimated from the available data):
- shortness of breath
- foreign body sensation in eye (feeling that there is something in your eye)
- abnormal sensitivity of the eyes to light
- forceful heartbeat that may be rapid or irregular (palpitations)
- increased heart rate
- increased blood pressure.
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 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 eye drops
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 bottle label and the 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. Store below 30°C.
Dorzolamide eye drops should be used within 28 days after the bottle is first opened. Therefore, you must throw away the bottle 4 weeks after you first opened it, even if some solution is left. To help you remember, write down the date that you opened it in the space on the carton.
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 eye drops contains
- The active substance is dorzolamide. Each ml contains 20mg dorzolamide (as dorzolamide hydrochloride).
- The other ingredients are mannitol, hydroxy ethyl cellulose, benzalkonium chloride (as a preservative), sodium citrate, sodium hydroxide for pH adjustment and water for injection.
What Dorzolamide eye drops look like and contents of the pack
Dorzolamide eye drops are a sterile, isotonic, buffered, slightly viscous, clear, colourless aqueous solution in a white opaque medium density polyethylene bottle with a sealed dropper tip and a two-piece cap assembly. Each bottle contains 5ml of the eye drop solution.
Dorzolamide eye drops are available in packs containing 1 bottle.
Marketing Authorisation Holder
Accord, Barnstaple, EX32 8NS, UK
Manufacturers
FAMAR S.A.
Plant A
63 Agiou Dimitriou Street
174 56 Alimos
Athens Greece
PHARMATHEN S.A.
Dervenakion 6
Pallini 15351
Attikis Greece
This leaflet was last revised in January 2026.
continued top of next column