Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Trusopt 20 mg/ml Eye drops, solution
⚠ 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.
What it is and what it is used for
for
TRUSOPT 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).
2.
What you need to know before you take it
e TRUSOPT
Do not use TRUSOPT –
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.
Warnings and precautions Talk to your doctor or pharmacist before using TRUSOPT. 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 TRUSOPT is causing an allergic reaction (for example, skin rash, severe skin reaction or itching), stop using this medicine and contact your doctor immediately.
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Children TRUSOPT 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. Elderly In studies with TRUSOPT, 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 TRUSOPT 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 this medicine. Pregnancy You should not use this medicine during pregnancy. Tell your doctor if you are pregnant or intend to become pregnant. Breast-feeding If treatment with this medicine is required, breast-feeding is not recommended. 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 TRUSOPT, 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. TRUSOPT contains benzalkonium chloride This medicine contains approximately 0.002 mg benzalkonium chloride in each drop which is equivalent to 0.075 mg/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 take it
TRUSOPT
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.
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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 TRUSOPT in the affected eye(s) in the morning and in the evening. If you are using TRUSOPT with another eye drop, the drops should be instilled at least 10 minutes apart. 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, 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 container. Instructions for use Do not use the container if the plastic safety strip around the neck is missing or broken. When opening the container for the first time, tear off the plastic safety strip. Every time you use TRUSOPT: 1. Wash your hands. 2. Open the container. Take special care that the tip of the dropper container does not touch your eye, the skin around your eye or your fingers. 3. Tilt your head backwards and hold the container upside down over the eye.
4. Pull the lower eyelid downwards and look up. Hold and gently squeeze the container on the flattened sides of the container and let one 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 two 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 container tightly.
If you use more TRUSOPT 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.
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If you forget to use TRUSOPT 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 TRUSOPT 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. 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 TRUSOPT 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 user 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: (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 and 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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine. United Kingdom: Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. 4 trusopt MD uk_ie 20230314 [1A 086 delete ocumeter]
Ireland: HPRA Pharmacovigilance, website: www.hpra.ie.
5.
How to store it
TRUSOPT
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 container label and the carton after 'EXP'. The expiry date refers to the last day of that month. TRUSOPT should be used within 28 days after the container is opened. This medicinal product does not require any special temperature storage conditions. Store container in outer carton in order to protect from light. 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 TRUSOPT contains The active substance is dorzolamide. Each ml contains 22.26 mg of dorzolamide hydrochloride equivalent to 20 mg of dorzolamide. The other ingredients are hydroxyethyl cellulose, mannitol, sodium citrate, sodium hydroxide, and water for injections. Benzalkonium chloride is added as a preservative. What TRUSOPT looks like and contents of the pack TRUSOPT is a clear, colourless to nearly colourless slightly viscous solution. TRUSOPT is filled into a white translucent plastic container with 5 ml of solution. The plastic container is closed with a white screw cap. Tamper evidence is provided by a safety strip on the container label. Pack sizes: 1 x 5 ml (single 5 ml container) 3 x 5 ml (three 5 ml containers) 6 x 5 ml (six 5 ml containers) Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder in UK and Ireland: Santen Oy, Niittyhaankatu 20, 33720 Tampere, Finland Manufacturer: Santen Oy, Kelloportinkatu 1, 33100 Tampere, Finland This leaflet was last revised in March 2023.
How can I learn more about TRUSOPT, increased eye pressure or glaucoma? This leaflet gives you the most important information about TRUSOPT. If you have any questions after you have read it, ask your doctor or pharmacist, who can give you more information about TRUSOPT and your eye condition. 5 trusopt MD uk_ie 20230314 [1A 086 delete ocumeter]
Further information about glaucoma is available from: International Glaucoma Association (IGA) Woodcote House 15 Highpoint Business Village Henwood, Ashford Kent, TN24 8DH Tel: 01233 648170 Registered Charity number 274681. Alternatively, if you or someone you know has problems with their vision, and you require further advice or information, please phone the Royal National Institute for the Blind (RNIB) Helpline on 0303 123 9999. (The IGA and RNIB are independent UK charities and are not associated with Santen Oy.)
Santen Oy, Niittyhaankatu 20, 33720 Tampere, Finland.
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Frequently asked questions about Trusopt 20 mg/ml Eye drops, solution
How do I take Trusopt 20 mg/ml Eye drops, solution?
Trusopt 20 mg/ml Eye drops, solution 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 Trusopt 20 mg/ml Eye drops, solution?
The active substance in Trusopt 20 mg/ml Eye drops, solution is dorzolamide hydrochloride.
Are there equivalent medicines to Trusopt 20 mg/ml Eye drops, solution?
Medicines with the same active substance, strength and form include: Eydelto 20mg/ml eye drops solution, Dorzolamide 20 mg/ml eye drops, solution, Dorzolamide 20mg/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 Trusopt 20 mg/ml Eye drops, solution, 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 Trusopt 20 mg/ml Eye drops, solution 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.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: dorzolamide hydrochloride
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
TRUSOPT 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.
Patients should be informed of the correct handling of the containers.
Paediatric population
Limited clinical data in paediatric patients with administration of dorzolamide three times a day are available. (For information regarding paediatric dosing see section 5.1.)
Method of administration
1. Wash your hands
2. Open the container. Take special care that the tip of the dropper container does not touch your eye, the skin around your eye or your fingers.
3. Tilt your head backwards and hold the container upside down over the eye.
4. Pull the lower eyelid downwards and look up. Hold and gently squeeze the container on the flattened sides of the container and let one drop fall into the space between the lower eyelid and the eye.
5. Press a finger into the corner of your eye, by the nose, or close your eyelids for 2 minutes. This helps to stops the medicine from getting into the rest of the body.
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. 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 container tightly.
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 eye-lid reactions) are observed, discontinuation of treatment 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 TRUSOPT. 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.
Benzalkonium chloride
Benzalkonium chloride has been reported to cause eye irritation, symptoms of dry eyes and may affect the tear film and corneal surface. Should be used with caution in dry eye patients and in patients where the cornea may be compromised. Patients should be monitored in case of prolonged use.
Contact Lens Use
TRUSOPT contains benzalkonium chloride as preservative. Contact lenses should be removed prior to application and wait at least 15 minutes before reinsertion. Benzalkonium chloride is known to discolour soft 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)
Breastfeeding
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 TRUSOPT 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
TRUSOPT was evaluated in more than 1400 individuals in controlled and uncontrolled clinical studies. In long-term studies of 1108 patients treated with TRUSOPT as monotherapy or as adjunctive therapy with an ophthalmic beta-blocker, the most frequent cause of discontinuation (approximately 3%) from treatment with TRUSOPT was drug-related ocular adverse reactions, primarily conjunctivitis and lid reactions.
The following adverse reactions 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
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
Cardiac disorders:
Not known: palpitations, tachycardia
Vascular disorders:
Not known: hypertension
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
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.
Reporting 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 via the Yellow Card Scheme at: 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 Trusopt 20 mg/ml Eye drops, solution. 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.
Medicines containing Dorzolamide hydrochloride
- Dorzolamide 20 mg/ml eye drops, solution
- Dorzolamide 20mg/ml eye drops, solution
- Dorzolamide Preservative-Free 20 mg/ml eye drops, solution in single-dose container
- Dorzolamide Santen 20 mg/ml eye drops, solution in single-dose container
- Eydelto 20mg/ml eye drops solution
- Vizidor 20 mg Eye drops solution