Label: information for the user

TRUSOPT 20 mg/ml eye drops solution

dorzolamida

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

TRUSOPT contains dorzolamide, which belongs to a group of medicines called "carbonic anhydrase inhibitors".

This medicine is prescribed to lower high eye pressure and to treat glaucoma. This medicine may be used alone or in combination with other eye pressure-lowering medicines (called beta-blockers).

Do not use TRUSOPT

• If you are allergic to hydrochloride of dorzolamide or to any of the other components of this medication (listed in section 6).
• If you have severe kidney problems or a history of kidney stones.

Warnings and precautions

Consult your doctor or pharmacist before starting to use TRUSOPT.

Inform your doctor or pharmacist if you have or have had any medical problems, including eye problems and eye surgeries, and if you have any allergies to any medication.

If you experience any eye irritation or new eye problems, such as redness of the eye or swelling of the eyelids, consult 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 medication and consult your doctor immediately.

Children

TRUSOPT has been studied in infants and children under 6 years of age who had high pressure in the eye(s) or had been diagnosed with glaucoma. For more information, consult your doctor.

Older patients

In studies with TRUSOPT, the effects of this medication were similar in older patients and younger patients.

Use in patients with liver impairment

Inform your doctor if you have or have had liver problems.

Use of TRUSOPT with other medications

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medication (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, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

You should not use this medication during pregnancy. Inform your doctor if you are pregnant or plan to become pregnant.

Breastfeeding

If treatment with this medication is required, breastfeeding is not recommended. Inform your doctor if you are breastfeeding or plan to breastfeed.

Driving and operating machinery

No studies have been conducted on the effects on the ability to drive or operate machinery. There are adverse effects associated with TRUSOPT, such as dizziness and blurred vision, that 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 medication contains approximately 0.002 mg of benzalkonium chloride in each drop, equivalent to 0.075 mg/ml.

Benzalkonium chloride can be absorbed by soft contact lenses, altering their color. Remove contact lenses before using this medication and wait 15 minutes before reinserting them.

Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases (transparent layer at the front of the eye). Consult your doctor if you feel a strange sensation, burning or pain in the eye after using this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. The appropriate dosage and treatment duration will be established by your doctor.

When this medication is the only drug used, the recommended dose is one drop in the affected eye(s) in the morning, afternoon, and night.

If your doctor has recommended using this medication together with a beta-blocker eye drop to reduce eye pressure, the recommended dose is one drop of TRUSOPT in the affected eye(s) in the morning and at night.

If you use TRUSOPT with another eye drop, the drops must be instilled with a minimum time interval of 10 minutes.

Do not let the tip of the container touch the eyes or surrounding areas. It may be contaminated with bacteria capable of causing eye infections that can cause severe eye damage, including loss of vision. To avoid possible contamination of the container, wash your hands before using this medication and avoid the tip of the container coming into contact with any surface. If you believe your medication may be contaminated, or if you develop an eye infection, consult your doctor immediately if you can continue using this package.

Usage Instructions

Do not use the package if the plastic safety strip around the neck of the package is not there or is broken. When opening the package for the first time, remove the plastic safety strip.

Each time you use TRUSOPT:

If you use more TRUSOPT than you should

If too many drops are applied to the eye or if you swallow something from the container, you must inform your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone (91) 562 04 20, indicating the medication and the amount ingested.

If you forget to use TRUSOPT

It is essential to administer this medication as instructed by your doctor. If you forget to apply a dose, administer it as soon as possible. However, if it is almost time for the next dose, do not administer the missed dose and continue with the regular dosing schedule.

Do not use a double dose to compensate for the missed doses.

If you interrupt treatment with TRUSOPT

If you want to stop using this medication, consult your doctor first. If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you develop allergic reactions such as hives, swelling of the face, lips, tongue, and/or throat that may cause difficulty breathing or swallowing, stop using this medicine and consult your doctor immediately.

The following side effects have been reported with TRUSOPT during clinical trials or after marketing:

Very common side effects:(may affect more than 1 in 10 people)

Burning and stinging of the eyes.

Common side 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 side effects:(may affect up to 1 in 100 people)

Iritis inflammation.

Rare side effects:(may affect up to 1 in 1,000 people)

Tingling or numbness of the hands or feet, transient myopia that resolves upon cessation of therapy, development of fluid under the retina (choroidal detachment, after glaucoma filtration surgery), eye pain, eyelid crusts, low eye pressure, corneal inflammation (with visual disturbance symptoms), ocular irritation including redness, kidney stones, dizziness, nasal bleeding, throat irritation, dry mouth, localized skin rash (contact dermatitis), severe skin reactions, allergic-type reactions such as skin rash, hives, itching, in rare cases swelling of the lips, eyes, and mouth, shortness of breath, and more rarely difficulty breathing.

Frequency not known:(cannot be estimated from available data)

Difficulty breathing, sensation of a foreign body in the eye (sensation of having something in the eye), strong heartbeats that may be rapid or irregular (palpitations),increased heart rate, and increased blood pressure.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label of the container and the box after ‘CAD’. The expiration date is the last day of the month indicated.

TRUSOPT should be used within a period of 28 days after opening the container.

This medication does not require any special storage temperature. Store the container in the outer packaging to protect it from light.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and the medications that you do not need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and the medications that you do not need. By doing so, you will help protect the environment.

Composition of TRUSOPT

• The active ingredient 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 injection preparations. Benzalkonium chloride is added as a preservative.

Appearance of the product and contents of the container

TRUSOPT is a clear, colorless to almost colorless, slightly viscous solution.

TRUSOPT is presented in a transparent white plastic container with 5 ml of solution. The plastic container is closed with a white screw cap.

The security strip found on the label of the container provides evidence that the medication has not been inadequately manipulated.

Container 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)

Only some container sizes may be commercially marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Santen Oy

Niittyhaankatu 20

33720 Tampere

Finland

Responsible manufacturer

Santen Oy

Kelloportinkatu 1

33100 Tampere

Finland

Local representative

Santen Pharmaceutical Spain S.L.

Acanto, 22, 7th floor

28045 – Madrid

This medication is authorized in the member states of the European Economic Area with the following names:

Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Netherlands, Portugal, Spain, and Sweden:

TRUSOPT

Last review date of this leaflet:06/2023

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/