Patient leaflet - Dorzolamide 20 mg / ml eye drops solution
1. WHAT DORZOLAMIDE
IS AND WHAT IT IS USED FOR
It is an eye drop and each bottle contains 5 ml of Dorzolamide. The active ingredient in Dorzolamide 20 mg/ml eye drops, solution is
dorzolamide hydrochloride which belongs to a group of medicines called ‘carbonic anhydrase inhibitors’. Dorzolamide is used to reduce pressure within the eye in glaucoma or ocular hypertension (raised pressure in the eye) and can be used either alone or in addition to other medicines called ‘beta-blockers’.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE DORZOLAMIDE
Do not use Dorzolamide:
- If you are allergic (hypersensitive) to dorzolamide hydrochloride or to any of the other ingredients in this medicine (listed in section 6) - if you have severe kidney impairment or problems, or a prior history of kidney stones
Warnings and precautions
Talk to your doctor or pharmacist before using Dorzolamide, if you: - Have any medical problems now or have had in the past, including eye problems and eye surgeries, and about any allergies to any
medications.
- Develop any eye irritation or any new eye problems such as redness of the eye or swelling of the eyelids, contact your doctor immediately.
- Suspect that Dorzolamide is causing an allergic reaction (for example, skin rash, severe skin reaction or itching) stop its use and contact your doctor immediately.
- Now have, or have had, any liver problems in the past.
- Wear contact lenses (see sub-section below: "Dorzolamide contains the preservative benzalkonium chloride").
Children
Dorzolamide has 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 20 mg/ml Eye Drops, Solution
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines particularly another carbonic anhydrase inhibitor such as acetazolamide, or a sulfa drug.
Pregnancy, breast-feeding and fertility
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 using Dorzolamide. Dorzolamide should not be used in pregnancy or during breast-feeding.
Driving and using machines
Dorzolamide may cause dizziness and blurred vision in some patients. Do not drive or operate machinery until you feel well or your vision is clear.
Dorzolamide contains 0.075mg of the preservative benzalkonium chloride in each ml. Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of contact lenses. You should remove contact lenses before using Dorzolamide 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 Dorzolamide, talk to your doctor.
3. HOW TO USE DORZOLAMIDE
Always use Dorzolamide exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
If you wear contact lenses, remove these before applying the eye drops. Wait at least 15 minutes before putting your lenses back.
Dosage
The appropriate dosage and duration of treatment will be established by your doctor.
When Dorzolamide is used alone, the usual dose is one drop in the affected eye(s) in the morning, in the
afternoon and in the evening. - When Dorzolamide is used with a beta-blocker eye drop, the usual dose is one drop in the affected eye(s) in the morning and in the evening. If you are using Dorzolamide with another eye drop, the drops should be applied at least 10 minutes apart.
Instructions for use:
Dorzolamide is for use as eye drops only; do not swallow.
Always wash your hands before applying eye drops. Apply one drop of Dorzolamide in each affected eye in the following way:
1.Tilt your head back and look at the ceiling.
2.Gently pull the lower eyelid down until there is a small pocket.
3.Squeeze the upturned dropper bottle to release a drop into your eye. 4.Close your eye and press the inner corner of the eye with your finger for about two minutes. This helps to stop the medicine from getting into the rest of the body
5.Replace and tighten the cap immedi-ately after use.
Do not allow the dropper tip to touch the eye, areas around the eye, or any surface. It may become contaminated with bacteria that can cause eye infections leading to serious damage of the eye, even loss of vision. The dispenser tip is designed to provide a single drop; therefore, do NOT enlarge the hole of the dispenser tip.
Children
Dorzolamide has 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.
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
If you use more Dorzolamide than you should
If you put too many drops in your eye or the contents of the container are swallowed, you should contact your doctor immediately since it may cause sleepiness, nausea, dizziness, headache, fatigue, abnormal dreams and difficulty in swallowing which may require hospital treatment.
If you forget to use Dorzolamide
If you forget a dose, apply it as soon as you have realised it. However, if it is almost time for your next dose, skip the missed dose and continue with the next dose as planned. Do not use a double dose to make up for a forgotten dose.
If you stop using Dorzolamide
Do not stop using Dorzolamide without talking to your doctor first.
If you have any further questions on the use of Dorzolamide, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Dorzolamide can cause side effects, although not everybody gets them.
Serious side effects
Stop using Dorzolamide and immediately contact your doctor if you develop any of the following symptoms (general allergic reaction): rash; swelling of the face, lips, tongue, or throat; difficulty in breathing or swallowing.
The following side effects have been reported with Dorzolamide either during clinical trials or during post-marketing experience:
Very Common possible side effects: (these may affect more than 1in 10 users)
- Burning and stinging of the eyes.
Common: may affect up to 1 in 10 patients:
- Disease of the cornea with sore eye and blurred vision (superficial punctate keratitis), inflammation or irritation of the eyelid, discharge with itching of the eyes (conjunctivitis), watery eyes, blurred vision.
- Fatigue, weakness, headache, feeling sick (nausea), bitter taste.
Uncommon: may affect up to 1 in 100 patients:
- Inflammation of the iris.
Rare: may affect up to 1 in 1,000 patients:
- Tingling or numbness of the hands or feet.
- Swelling of the cornea (with symptoms of visual disturbances), low pressure in the eye, development of fluid under the retina (choroidal detachment, following filtration surgery), temporary shortsightedness which resolves when treatment is stopped, eye irritation including redness, eye pain, eyelid crusting.
- Kidney stones, dizziness, nose bleed, throat irritation, dry mouth.
- Severe skin reactions including blisters, localized skin rash (contact dermatitis), and general allergic type reactions such as rash, swelling of the lips, eyes and mouth, shortness of breath, and more rarely wheezing.
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 - Forceful heartbeat that may be rapid or irregular (Palpitations)
- Increased heart rate
- Increased blood pressure
Abnormal sensitivity of the eyes to light.
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 Website:
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
Keep this medicine out of the sight and reach of children.
Do not use this medicine if you notice that the tamper evident seal has been broken or damaged before you first open it.
Do not use this medicine after the expiry date which is stated on the bottle label and the carton following EX or EXP. The expiry date refers to the last day of that month.
This medicine should be used within 4 weeks after first opening, even if the bottle is not empty; any residual product should be thrown away.
Do not store the bottle above 25˚C. 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 contains
The active substance is dorzolamide. Each ml of solution contains 20 mg dorzolamide (as 22.26 mg dorzolamide hydrochloride). - The other ingredients are
Benzalkonium chloride, hydroxyethylcellulose (E1525), mannitol (E421), sodium citrate dihydrate (E331), hydrochloric acid (E507) or sodium hydroxide (E524), water for injection.
What Dorzolamide looks like and contents of the pack
This medicine is a clear, colourless to nearly colourless, slightly viscous solution in a plastic bottle containing 5 ml of the solution.
Dorzolamide eye drops is available in packs of 1.
Marketing Authorisation Holder: Blumont Pharma Ltd.,
23 Moortown Close,
Grantham, NG31 9GG, UK
Manufacturer:
Farmigea S.p.A, Via G.B. Oliva 8, 56121 Pisa, Italy
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This leaflet was last revised on 09/2026
PL31103/0019
Dorzolamide 20 mg/ml eye drops, solution
dorzolamide