Trusopt 20 mg/ml eye drops solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
TRUSOPT 20 mg/ml eye drops solution
dorzolamide
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What TRUSOPT is and what it is used for
- What you need to know before using TRUSOPT
- How to use TRUSOPT
- Possible side effects
- How to store TRUSOPT
- Contents of the pack and other information
1. What TRUSOPT is and what it is used for
TRUSOPT contains dorzolamide, which belongs to a group of medicines called "carbonic anhydrase inhibitors".
This medicine is prescribed to lower elevated pressure in the eye and to treat glaucoma. This medicine may be used alone or in combination with other medicines that reduce pressure in the eye (called beta-blockers).
2. What you need to know before using TRUSOPT
Do not use TRUSOPT
- if you are allergic to dorzolamide hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
- if you have severe kidney problems or disorder, or a history of kidney stones.
Warnings and precautions
Talk to your doctor or pharmacist before starting to use TRUSOPT.
Inform your doctor or pharmacist if you have or have had any medical conditions, including eye problems and eye surgeries, and if you have any allergies to any medications.
If you experience any eye irritation or new eye disorder, such as redness of the eye or swelling of the eyelids, consult your doctor immediately.
If you suspect that TRUSOPT is causing you an allergic reaction (for example, skin rash, serious skin reaction or itching), stop using this medicine and consult your doctor immediately.
Children
TRUSOPT has been studied in infants and children under 6 years of age who had elevated pressure in the eye(s) or had been diagnosed with glaucoma. For further information, consult your doctor.
Elderly patients
In clinical studies with TRUSOPT, the effects of this medicine were similar in elderly patients and younger patients.
Use in patients with hepatic impairment
Inform your doctor if you have or have had liver problems.
Use of TRUSOPT with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines (including eye drops). This is particularly important if you are taking another carbonic anhydrase inhibitor such as acetazolamide, or a sulfonamide.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy
You should not use this medicine during pregnancy. Inform your doctor if you are pregnant or intend to become pregnant.
Breastfeeding
If treatment with this medicine is required, breastfeeding is not recommended. Inform your doctor if you are breastfeeding or intend to breastfeed.
Driving and use of machines
No studies on the effects on the ability to drive or use machines have been performed. There are adverse 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 of benzalkonium chloride per drop, equivalent to 0.075 mg/ml.
Benzalkonium chloride may be absorbed by soft contact lenses, altering their color. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride may cause ocular irritation, especially if you have dry eye or other corneal diseases (the transparent layer at the front of the eye). Consult your doctor if you experience a foreign body sensation, stinging, or eye pain after using this medicine.
3. How to use TRUSOPT
Follow exactly the instructions for administration of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again. The appropriate dosage and duration of treatment will be determined by your doctor.
When this medicine is used as the sole treatment, the recommended dose is one drop in the affected eye(s) in the morning, afternoon, and evening.
If your doctor has advised you to use this medicine together with a beta-blocking eye drop to reduce intraocular pressure, the recommended dose is one drop of TRUSOPT in the affected eye(s) in the morning and evening.
If you are using TRUSOPT with another eye drop, the drops should be administered with a minimum interval of 10 minutes between them.
Do not let the tip of the container touch the eyes or surrounding areas. It may become contaminated with bacteria that can cause eye infections leading to serious damage to the eyes, and even loss of vision. To avoid possible contamination of the container, wash your hands before using this medicine and avoid letting the tip of the container come into contact with any surface. If you think your medicine may be contaminated, or if you develop an eye infection, consult your doctor immediately about whether you should continue using this container.
Instructions for use
Do not use the container if the plastic security strip around the neck of the container is missing or broken. When opening the container for the first time, remove the plastic security strip.
Each time you use TRUSOPT:
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If you use more TRUSOPT than you should
If you apply too many drops into the eye or swallow any of the contents of the container, you must inform your doctor immediately.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone (91) 562 04 20, indicating the medication and the amount ingested.
If you forget to use TRUSOPT
It is important to use this medicine exactly as your doctor has told you. If you forget to instill a dose, you should do so as soon as possible. However, if it is almost time for the next dose, do not administer the missed dose and continue with your regular dosing schedule.
Do not use a double dose to make up for a forgotten dose.
If you stop using TRUSOPT
If you wish to discontinue treatment with this medicine, consult your doctor first. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everybody gets them.
If you develop allergic reactions such as hives, swelling of the face, lips, tongue and/or throat which may cause difficulty in breathing or swallowing, stop using this medicine immediately and consult your doctor without delay.
The following adverse effects have been reported with TRUSOPT during clinical trials or after marketing:
Very common adverse effects: (may affect more than 1 in 10 people)
Burning and stinging of the eyes.
Common adverse effects: (may affect up to 1 in 10 people)
Corneal disease with eye pain and blurred vision (superficial punctate keratitis), itchy eye discharge (conjunctivitis), eyelid irritation/inflammation, blurred vision, headache, nausea, bitter taste, and fatigue.
Uncommon adverse effects: (may affect up to 1 in 100 people)
Inflammation of the iris.
Rare adverse effects: (may affect up to 1 in 1,000 people)
Tingling or numbness of the hands or feet, transient myopia which resolves upon discontinuation of therapy, development of fluid under the retina (choroidal detachment, after filtration surgery), eye pain, eyelid crusting, low eye pressure, corneal inflammation (with symptoms of visual disturbances), ocular irritation including redness, kidney stones, dizziness, nasal bleeding, throat irritation, dry mouth, localized skin rash (contact dermatitis), serious skin reactions, allergic-type reactions such as skin rash, urticaria, itching, in rare cases swelling of the lips, eyes and mouth, breathlessness, and more rarely difficulty in breathing.
Frequency not known: (cannot be estimated from the available data)
Difficulty in breathing, sensation of a foreign body in the eye (feeling like something is in the eye), strong heartbeats which may be rapid or irregular (palpitations), increased heart rate, increased blood pressure, and abnormal sensitivity of the eyes to light.
Reporting of adverse effects
If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of TRUSOPT
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label of the container and the carton after 'EXP'. The expiry date is the last day of the month indicated.
TRUSOPT must be used within 28 days after opening the container.
This medicine does not require any special storage temperature. Store the container in the outer packaging to protect it from light.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of TRUSOPT
- The active substance is dorzolamide.
- Each ml contains 22.26 mg of dorzolamide hydrochloride equivalent to 20 mg of dorzolamide.
- The other components are hydroxyethylcellulose, mannitol, sodium citrate, sodium hydroxide, and water for injections. Benzalkonium chloride is added as a preservative.
Nature of the product and pack contents
TRUSOPT is a clear, colorless to almost colorless, slightly viscous solution.
TRUSOPT is supplied in a translucent white container containing 5 ml of solution. The plastic container is closed with a white screw cap.
The security strip on the container label provides evidence that the medicine has not been inappropriately tampered with.
Pack sizes:
1 x 5 ml (one 5 ml container)
3 x 5 ml (three 5 ml containers)
6 x 5 ml (six 5 ml containers)
Some pack sizes may not be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Santen Oy
Niittyhaankatu 20
33720 Tampere
Finland
Manufacturer
Santen Oy
Kelloportinkatu 1
33100 Tampere
Finland
Local Representative
Santen Pharmaceutical Spain S.L.
Acanto, 22, 7th floor
28045 – Madrid
Spain
This medicinal product is authorized in the European Economic Area member states under the following names:
Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, the Netherlands, Portugal, Spain, and Sweden:
TRUSOPT
Date of the most recent review of this leaflet: 01/2026
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/