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Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

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Dorzolamide Preservative-Free 20 mg/ml eye drops, solution in single-dose container

⚠ This medicine appears to have been discontinued

The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.

If you were prescribed this medicine, other products containing Dorzolamide hydrochloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Dorzolamide hydrochloride

Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What it is and what it is used for

for Dorzolamide Preservative-Free 20 mg/ml eye drops, solution contains dorzolamide which belongs to a group of medicines called "carbonic anhydrase inhibitors". This medicine is prescribed to lower raised pressure in the eye and to treat glaucoma. This medicine can be used alone or in addition to other medicines which lower the pressure in the eye (so-called beta-blockers).

What you need to know before you take it

e Dorzolamide Preservative-Free 20 mg/ml eye drops, solution Do not use Dorzolamide Preservative-Free 20 mg/ml eye drops, solution –

if you are allergic to dorzolamide hydrochloride or any of the other ingredients of this medicine (listed in section 6). if you have severe kidney impairment or problems, or a prior history of kidney stones. if you have too much acidity in your blood (a condition called 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 or pharmacist before using Dorzolamide Preservative-Free 20 mg/ml eye drops, solution. Tell your doctor or pharmacist about any medical problems you have now or have had in the past, including eye problems and eye surgeries, and about any allergies to any medications. 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 Preservative-Free 20 mg/ml eye drops, solution is causing an allergic reaction (for example, skin rash, severe skin reaction, or itching), stop using this medicine and contact your doctor immediately. If you wear contact lenses, you should consult your doctor before using Dorzolamide PreservativeFree 20 mg/ml eye drops, solution. Use in children Dorzolamide eye drops, solution (preserved formulation) 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. Use in elderly In studies with Dorzolamide eye drops, solution (preserved formulation), 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 Preservative-Free 20 mg/ml eye drops, solution Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines (including eye drops). This is particularly important if you are taking another carbonic anhydrase inhibitor such as acetazolamide, or a sulpha drug. 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 any medicine. Pregnancy You should not use this medicine during pregnancy. Tell your doctor if you are pregnant or intend to become pregnant. Breast-feeding You should not use this medicine during breast-feeding. Tell your doctor if you are breast-feeding or intend to breast-feed. 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 Preservative-Free 20 mg/ml eye drops, solution, such as dizziness and 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. This medicinal product contains phosphate buffers If you suffer from severe damage to the clear layer at the front of the eye (the cornea), phosphates may cause in very rare cases cloudy patches on the cornea due to calcium build-up during treatment.

How to take it

Dorzolamide Preservative-Free 20 mg/ml eye drops, solution 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 this medicine is used alone, the recommended dose is one drop in the affected eye(s) in the morning, in the afternoon and in the evening.

If your doctor has recommended you use this medicine with a beta-blocker eye drop to lower eye pressure, then the recommended dose is one drop of Dorzolamide Preservative-Free 20 mg/ml eye drops, solution in the affected eye(s) in the morning and in the evening. If you are using Dorzolamide Preservative-Free 20 mg/ml eye drops, solution with another eye drop, the drops should be instilled at least 10 minutes apart. Do not change the dose of the drug without consulting your doctor. Do not allow the tip of the single-dose 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 single-dose container, wash your hands before using this medicine and keep the tip of the single-dose container away from contact with any surface. Instructions for use: The solution from one individual single-dose container of Dorzolamide Preservative-Free 20 mg/ml eye drops, solution is to be used immediately after opening for administration to the affected eye(s). Since sterility cannot be maintained after the individual single-dose container is opened, a new container must be opened prior to each use and must be discarded immediately after administration. Each single-dose container contains enough solution for both eyes. 1. Open the foil sachet which contains the individual single dose containers. 2. First wash your hands then break off one single-dose container from the strip and twist open the top of the single-dose container as shown.

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

4. Put one drop in the affected eye(s) as directed by your doctor.

5. 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. 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 single-dose containers in the sachet; the remaining single-dose containers must be used within 15 days after opening of the sachet. Write down the date of first opening on the sachet. If there are any containers left 15 days after opening the sachet they should be safely thrown away and a fresh sachet opened. It is important to continue to use the eye drops as prescribed by your doctor. If you use more Dorzolamide Preservative-Free 20 mg/ml eye drops, solution than you should If you put too many drops in your eye or swallow any of the contents of the container, you should contact your doctor immediately. If you forget to use Dorzolamide Preservative-Free 20 mg/ml eye drops, solution It is important to take this medicine as prescribed by your doctor. If you miss a dose, take 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 Preservative-Free 20 mg/ml eye drops, solution 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.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you develop allergic reactions including hives, swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing, you should stop using this medicine and seek immediate medical advice. The following side effects have been reported with dorzolamide either during clinical trials or during post-marketing experience: Very common side effects: (affects more than 1 user in 10) Burning and stinging of the eyes. Common side effects: (affects 1 to 10 users in 100) Disease of the cornea with sore eye and blurred vision (superficial punctuate keratitis), discharge with itching of the eyes (conjunctivitis), irritation/inflammation of the eyelid, blurred vision, headache, nausea, bitter taste, and fatigue. Uncommon side effects: (affects 1 to 10 users in 1,000) Inflammation of the iris. Rare side effects: (affects 1 to 10 users in 10,000) Tingling or numbness of the hands or feet, temporary shortsightedness which may resolve when treatment is stopped, development of fluid under the retina (choroidal detachment, following filtration surgery), eye pain, eyelid crusting, low pressure in the eye, swelling of the cornea (with symptoms of visual disturbances), eye irritation including redness, kidney stones, dizziness, nose bleed, throat

irritation, dry mouth, localized skin rash (contact dermatitis), severe skin reactions, allergic type reactions such as rash, hives, itching, in rare cases possible swelling of the lips, eyes and mouth, shortness of breath, and more rarely wheezing. Not known: (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 and 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 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.

How to store it

Dorzolamide Preservative-Free 20 mg/ml eye drops, solution Keep this medicine out of the sight and reach of children. Do not use the unopened sachets of this medicine after the expiry date which is stated by the six digits following EX (or EXP) on the outer carton and foil package. The first two digits indicate the month; the last four digits indicate the year. The expiry date refers to the last day of that month. Expiry date on each single-dose container which is stated by the four digits following EXP, the first two digits indicate the month; the last two digits indicate the year. The expiry date refers to the last day of that month. Do not store above 30°C. You can use Dorzolamide Preservative-Free 20 mg/ml eye drops, solution 15 days after first opening the sachet. Discard any unused single-dose containers after that time. Discard the opened single-dose container with any remaining solution immediately after first use. 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 Preservative-Free 20 mg/ml eye drops, solution contains The active substance is dorzolamide. Each ml contains dorzolamide hydrochloride equivalent to 20 mg of dorzolamide. The other ingredients are hydroxyethyl cellulose, mannitol, sodium citrate, sodium hydroxide and water for injections What Dorzolamide Preservative-Free 20 mg/ml eye drops, solution looks like and contents of the pack Dorzolamide Preservative-Free 20 mg/ml eye drops, solution in single-dose container is available in 0.2 ml in low density polyethylene single dose container in an aluminium sachet. Pack sizes: 10 x 0.2 ml (1 sachet with 10 single dose containers) 15 x 0.2 ml (1 sachet with 15 single dose containers) 30 x 0.2 ml (2 sachets with 15 single dose containers or 3 sachets with 10 single dose containers)

50 x 0.2 ml (5 sachets with 10 single dose containers) 60 x 0.2 ml (4 sachets with 15 single dose containers or 6 sachets with 10 single dose containers) 90 x 0.2 ml (6 sachets with 15 single dose containers or 9 sachets with 10 single dose containers) 120 x 0.2 ml (8 sachets with 15 single dose containers or 12 sachets with 10 single dose containers) Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Brown & Burk UK Ltd 5 Marryat Close, Hounslow West Middlesex, Tw4 5DQ, United Kingdom PLGB 25298/0363 This leaflet was last revised in 01/2026.

Frequently asked questions about Dorzolamide Preservative-Free 20 mg/ml eye drops, solution in single-dose container

How do I take Dorzolamide Preservative-Free 20 mg/ml eye drops, solution in single-dose container?

Dorzolamide Preservative-Free 20 mg/ml eye drops, solution in single-dose container comes as eye drops containing 20mg/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.

What is the active substance in Dorzolamide Preservative-Free 20 mg/ml eye drops, solution in single-dose container?

The active substance in Dorzolamide Preservative-Free 20 mg/ml eye drops, solution in single-dose container is dorzolamide hydrochloride.

Are there equivalent medicines to Dorzolamide Preservative-Free 20 mg/ml eye drops, solution in single-dose container?

Medicines with the same active substance, strength and form include: Eydelto 20mg/ml eye drops solution, Trusopt 20 mg/ml Eye drops, solution, Dorzolamide 20 mg/ml eye drops, solution. In total there are 5 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Dorzolamide Preservative-Free 20 mg/ml eye drops, solution in single-dose container, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.

Can I get Dorzolamide Preservative-Free 20 mg/ml eye drops, solution in single-dose container without a prescription?

Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Dorzolamide hydrochloride (16 medicines)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

Dorzolamide Preservative-Free 20mg/ml eye drops, solution is indicated:

- as adjunctive therapy to beta-blockers,

- as monotherapy in patients unresponsive to beta-blockers or in whom beta- blockers are contraindicated, in the treatment of elevated intra-ocular pressure in:

- ocular hypertension,

- open-angle glaucoma,

- pseudoexfoliative glaucoma.

4.2. Posology and method of administration

Posology

When used as monotherapy, the dose is one drop of dorzolamide in the conjunctival sac of the affected eye(s), three times daily.

When used as adjunctive therapy with an ophthalmic beta-blocker, the dose is one drop of dorzolamide in the conjunctival sac of the affected eye(s) two times daily.

When substituting dorzolamide for another ophthalmic anti-glaucoma agent, discontinue the other agent after proper dosing on one day, and start dorzolamide on the next day.

If more than one topical ophthalmic drug is being used, the drugs should be administered at least ten minutes apart.

Patients should be instructed to wash their hands before use and avoid allowing the tip of the container to come into contact with the eye or surrounding structures.

Patients should also be instructed that ocular solutions, if handled improperly, can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.

Dorzolamide Preservative-Free 20mg/ml eye drops, solution is a sterile solution that does not contain a preservative. The solution from one individual single-dose container is to be used immediately after opening for administration to the affected eye(s). Since sterility cannot be maintained after the individual single-dose container is opened, any remaining contents must be discarded immediately after administration. Each single-dose container contains enough solution for both eyes.

Paediatric population

Limited clinical data in paediatric patients with administration of dorzolamide (preserved formulation) three times a day are available. (For information regarding paediatric dosing see section 5.1.)

Method of administration

1 Open the sachet which contains the individual single-dose containers.

2 First wash your hands then break off one single-dose container from the strip and twist open the top.

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

4 Instill one drop in the affected eye(s) as directed by the physician.

5 When using nasolacrimal occlusion or closing the eyelids for 2 minutes, the systemic absorption is reduced. This may result in a decrease in systemic side effects and an increase in local activity.

6 After instillation, discard the used single-dose container even if there is solution remaining.

7 Store the remaining single-dose containers in the sachet; the remaining single-dose containers must be used within 15 days after opening of the sachet.

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Dorzolamide has not been studied in patients with severe renal impairment (CrCl < 30 ml/min) or with hyperchloraemic acidosis. Because dorzolamide and its metabolites are excreted predominantly by the kidney, dorzolamide is therefore contra-indicated in such patients.

4.4. Special warnings and precautions for use

Dorzolamide has not been studied in patients with hepatic impairment and should therefore be used with caution in such patients.

The management of patients with acute angle-closure glaucoma requires therapeutic interventions in addition to ocular hypotensive agents. Dorzolamide has not been studied in patients with acute angle-closure glaucoma.

Dorzolamide contains a sulphonamido group, which also occurs in sulphonamides and although administered topically, is absorbed systemically. Therefore the same types of adverse reactions that are attributable to sulphonamides may occur with topical administration, including severe reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis. If signs of serious reactions or hypersensitivity occur, discontinue the use of this preparation.

Therapy with oral carbonic anhydrase inhibitors has been associated with urolithiasis as a result of acid-base disturbances, especially in patients with a prior history of renal calculi. Although no acid-base disturbances have been observed with dorzolamide, urolithiasis has been reported infrequently. Because dorzolamide is a topical carbonic anhydrase inhibitor that is absorbed systemically, patients with a prior history of renal calculi may be at increased risk of urolithiasis while using dorzolamide.

If allergic reactions (e.g. conjunctivitis and eyelid reactions) are observed, treatment discontinuation should be considered.

There is a potential for an additive effect on the known systemic effects of carbonic anhydrase inhibition in patients receiving an oral carbonic anhydrase inhibitor and dorzolamide. The concomitant administration of dorzolamide and oral carbonic anhydrase inhibitors is not recommended.

Corneal oedemas and irreversible corneal decompensations have been reported in patients with pre-existing chronic corneal defects and/or a history of intra- ocular surgery while using Dorzolamide solution multidose (preserved formulation). Topical dorzolamide should be used with caution in such patients.

Choroidal detachment concomitant with ocular hypotony have been reported after filtration procedures with administration of aqueous suppressant therapies.

Dorzolamide Preservative-Free 20mg/ml eye drops, solution has not been studied in patients wearing contact lenses.

Paediatric population

Dorzolamide has not been studied in patients less than 36 weeks gestational age and less than 1 week of age. Patients with significant renal tubular immaturity should only receive dorzolamide after careful consideration of the risk benefit balance because of the possible risk of metabolic acidosis.

4.5. Interaction with other medicinal products and other forms of interaction

Specific drug interaction studies have not been performed with dorzolamide.

In clinical studies, dorzolamide was used concomitantly with the following medications without evidence of adverse interactions: timolol ophthalmic solution, betaxolol ophthalmic solution and systemic medications including ACE inhibitors, calcium channel blockers, diuretics, non-steroidal anti- inflammatory drugs including aspirin, and hormones (e.g. oestrogen, insulin, thyroxine).

Association between dorzolamide and miotics and adrenergic agonists has not been fully evaluated during glaucoma therapy.

4.6. Fertility, pregnancy and lactation

Pregnancy

Dorzolamide should not be used during pregnancy. There are no or limited amount of data from the use of dorzolamide in pregnant women. In rabbits, dorzolamide produced teratogenic effects at maternotoxic doses (see section 5.3).

Breast-feeding

It is unknown whether dorzolamide/metabolites are excreted in human milk. Available pharmacodynamic/toxicological data in animals have shown excretion of dorzolamide/metabolites in milk. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Dorzolamide Preservative-Free 20mg/ml eye drops, solution therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman. A risk to the newborns/infants cannot be excluded.

Fertility

Animal data do not suggest an effect of treatment with dorzolamide on male and female fertility. Human data are lacking

4.7. Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. Possible side effects such as dizziness and visual disturbances may affect the ability to drive and use machines.

4.8. Undesirable effects

In a multiple-dose, double-masked, active-treatment (Dorzolamide solution multidose) controlled, two period crossover multiclinic study, the safety profile of Dorzolamide Preservative-Free 20mg/ml eye drops, solution was similar to that of Dorzolamide multidose solution.

Dorzolamide multidose solution (preserved formulation) was evaluated in more than 1,400 individuals in controlled and uncontrolled clinical studies. In long term studies of 1,108 patients treated with Dorzolamide solution multidose as monotherapy or as adjunctive therapy with an ophthalmic beta- blocker, the most frequent cause of discontinuations from treatment were drug-related ocular adverse effects in approximately 3% of patients primarily conjunctivitis and eyelid reactions.

The following adverse effects have been reported either during clinical trials or during post-marketing experience with dorzolamide:

[Very common: (≥ 1/10), Common: (≥ 1/100 to <1/10), Uncommon: (≥ 1/1,000 to <1/100), Rare: (≥ 1/10,000 to <1/1,000), Not known: (cannot be estimated from the available data)]

Nervous system disorders:

Common: headache

Rare: dizziness, paraesthesia

Cardiac disorders:

Not known: Palpitations, Tachycardia

Eye disorders:

Very common: burning and stinging

Common: superficial punctate keratitis, tearing, conjunctivitis, eyelid inflammation, eye itching, eyelid irritation, blurred vision

Uncommon: iridocyclitis

Rare: irritation including redness, pain, eyelid crusting, transient myopia (which resolved upon discontinuation of therapy), corneal oedema, ocular hypotony, choroidal detachment following filtration surgery

Not known: foreign body sensation in eye, Photophobia

Respiratory, thoracic, and mediastinal disorders:

Rare: epistaxis

Not known: dyspnoea

Gastrointestinal disorders: Common: nausea, bitter taste Rare: throat irritation, dry mouth

Skin and subcutaneous tissue disorders:

Rare: contact dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis

Renal and urinary disorders:

Rare: urolithiasis

Vascular Disorder:

Not known: Hypertension

General disorders and administration site conditions:

Common: asthenia/fatigue

Rare: hypersensitivity: signs and symptoms of local reactions (palpebral reactions) and systemic allergic reactions including angioedema, urticaria and pruritus, rash, shortness of breath, rarely bronchospasm

Investigations:

Dorzolamide was not associated with clinically meaningful electrolyte disturbances.

Paediatric population

See section 5.1.

Adverse reactions reported in phosphate containing eye drops:

Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas.

Reporting of suspected adverse reactions:

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions the Yellow Card Scheme, website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

Only limited information is available with regard to human overdose by accidental or deliberate ingestion of dorzolamide hydrochloride.

Symptoms

The following have been reported with oral ingestion: somnolence; topical application: nausea, dizziness, headache, fatigue, abnormal dreams, and dysphagia.

Treatment

Treatment should be symptomatic and supportive. Electrolyte imbalance, development of an acidotic state, and possible central nervous system effects may occur. Serum electrolyte levels (particularly potassium) and blood pH levels should be monitored.

💬 Ask about this leaflet

Ask anything about Dorzolamide Preservative-Free 20 mg/ml eye drops, solution in single-dose container. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.

Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.

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