Label: Information for the User

Visucopt 20mg/ml + 5mg/ml, eye drop solution in single-dose container
(dorzolamida/timolol)

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 who have the same symptoms as you, as it may harm them.
• If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect not listed in this label. See section 4.

Visucopt unidosis contains two active ingredients: dorzolamide and timolol

These medicines lower eye pressure in different ways.

Visucopt unidosis is prescribed to reduce high eye pressure in the treatment of glaucoma when the use of a beta-blocker alone is not enough.

• If you are allergic to the active ingredients (dorzolamide hydrochloride, timolol maleate) or to any of the other components of this medication (listed in section 6)
• If you have or have had in the past respiratory problems such as asthma or chronic obstructive pulmonary disease (a severe lung disease that may cause wheezing, difficulty breathing, or prolonged coughing)
• If you have a low heart rate, heart failure, or cardiac rhythm disorders (irregular heart rate)
• If you have severe kidney problems or severe kidney insufficiency, or a history of kidney stones
• If you have excessive blood acidity caused by the accumulation of chloride (hyperchloremic acidosis)

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Visucopt unidose if you have or have had in the past:

Inform your doctor:

The instillation of Visucopt unidose in the eye may affect the entire body.

Use in children and adolescents

The experience with Visucopt unidose in infants and children is limited.

Use in elderly patients

In studies conducted with dorzolamide/timolol, the effects of the combination of the two active ingredients were similar in elderly patients and younger patients.

Use in patients with liver dysfunction (hepatic insufficiency)

Inform your doctor of any liver problems you have or have had in the past.

Drug testing

The use of this medication may produce positive results in doping controls.

Other medications and Visucopt unidose

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those purchased without a prescription.

Visucopt unidose may affect or be affected by other medications you are using, including other eye drops for glaucoma treatment.

Inform your doctor if you are using or plan to use medications to lower blood pressure, to treat cardiovascular diseases (cardiopathies), or to treat diabetes.

Inform your doctor:

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Use during pregnancy

Visucopt unidose should not be used during pregnancy.

Use during breastfeeding

Do not use Visucopt unidose if you are breastfeeding. Timolol may pass into breast milk.

Driving and operating machinery

The influence of Visucopt unidose on the ability to drive and operate machinery is small. However, there are adverse effects associated with the use of Visucopt unidose, such as transient blurred vision, which may affect your ability to drive or operate machinery. Do not drive or operate machinery until you feel well or until your vision clears up.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Your doctor will determine the appropriate dose and treatment duration.

The recommended dose is one drop of Visucopt unidosis in the affected eye or eyes in the morning and at night.

If you are using Visucopt unidosis together with other eye drops, they must be instilled with at least 10 minutes of difference.

Do not change the medication dose without consulting your doctor.

Do not let the cap of the container touch the eye or the surrounding areas. It could become contaminated with bacteria that may produce eye infections causing serious eye damage, even vision loss. To avoid possible container contamination, wash your hands before using this medication and keep the container away from contact with any surface. A new unidose must be opened immediately before each use; each container contains a sufficient amount of solution for both eyes if your doctor has told you to use the drops in both eyes.

Usage Instructions

Open the aluminum foil package containing the individual unidose containers. Note the date of the first opening on the package.

• Wash your hands and sit or stand in a comfortable position.
• Remove the strip of containers from the package.
• Separate a unidose container from the strip.
• Place the rest of the strip back in the bag and fold the edge to close it.
• To open the container, turn the tab to remove it.

• Hold the container between your thumb and index finger. Note that the tip of the container should not protrude more than 5 mm above the edge of the index finger.

• Incline your head backward or lie down and look upward.
• Tilt your lower eyelid to form a space between the eyelid and the eye.
• Bring the tip of the unidose container close to the eye without touching it.
• Gently press the unidose container to dispense one drop in the eye, according to your doctor's instructions. Do not blink while instilling the drop in the eye. Release your lower eyelid.

• Close your eye and press the inner corner of your eye with your finger for approximately two minutes. This helps prevent the drop from reaching the rest of your body.

• Repeat the process in the other eye if your doctor has instructed you to do so.
• Dispose of the unidose container and the remaining contents.

Keep the remaining containers in the aluminum foil package and use them within 7 days after opening the package. If there are containers left 7 days after opening the package, dispose of them safely and open a new package.

If you use more Visucopt unidosis than you should

If you put too many drops in your eye or swallow the contents of the container, you may feel dizzy, have difficulty breathing, or experience a slowing of your heart rate. Contact your doctor immediately.

In case of overdose or accidental ingestion, go to a medical center or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you forget to use Visucopt unidosis

It is essential to use Visucopt unidosis as prescribed by your doctor. If you forget a dose, administer it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and continue with the usual dosing schedule. Do not use a double dose to compensate for the missed dose.

If you interrupt treatment with Visucopt unidosis

If you want to stop using this medication, talk to your doctor first.

If you have any other questions about using this medication, ask your doctor or pharmacist.

Like all medications, this medication may cause side effects, although not everyone will experience them.

Timolol is absorbed into the blood, which distributes it throughout the body, similar to other eye medications.

This may cause side effects similar to those observed with oral medications of the same group (beta-blockers). The incidence of side effects after ocular administration is lower than with oral administration.

If you experience allergic reactions, such as swelling of the face and extremities with difficulty breathing or swallowing, hives or itchy rash, localized and generalized eruption, itching or a severe and potentially fatal allergic reaction, stop using this medication and consult your doctor immediately.

The following side effects have been reported with dorzolamide/timolol eye drops or with one of its components during clinical trials or post-marketing experience:

Very common(may affect more than 1 in 10patients)

-eye burning and stinging

-taste alteration

Common(may affect up to 1 in 10patients)

-headache

-redness and inflammation inside and around the eyes, tearing or itching in the eyes, corneal erosion (lesion of the layer located on the anterior part of the eyeball), swelling or irritation inside and around the eyes, sensation of a foreign body in the eye, decreased corneal sensitivity (not feeling something inside the eye and absence of pain), eye pain, dryness of the eyes, blurred vision

-sinusitis (sensation of tension or fullness in the nose)

-weakness/fatigue and tiredness.

Uncommon(may affect up to 1 in 100patients)

-depression

-dizziness, fainting

-inflammation of the iris (a part of the eye), visual disturbances (including refractive changes in some cases due to withdrawal of treatment with miotics)

-slow heart rate

-difficulty breathing (dyspnea)

-indigestion

-kidney stones

Rare(may affect up to 1 in 1,000patients)

-allergic reactions such as skin rash, hives, itching, in rare cases swelling of the lips, eyes, and mouth, wheezing, or severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis)

-sleep problems, nightmares, memory loss

-cerebral ischemia (decreased blood flow to the brain), increased signs and symptoms of myasthenia gravis (muscular disorder), decreased libido, tingling or numbness of the hands or feet

-temporary myopia that may resolve upon discontinuation of treatment, retinal detachment after filtration surgery, which may cause visual disturbances due to fluid accumulation, eyelid drooping, double vision, formation of crusts on the eyelids, corneal inflammation (causing visual disturbances), low intraocular pressure

-ear noises

-changes in heart rhythm or rate, congestive heart failure (heart disease, with difficulty breathing and swelling of the feet and legs due to fluid accumulation), edema (fluid accumulation), chest pain, myocardial infarction, low blood pressure, excessive constriction of blood vessels (Raynaud's phenomenon), swelling or coldness of the hands and feet, reduced circulation in the arms and legs, leg cramps or pain when walking (claudication), stroke

-difficulty breathing, deterioration of lung function, nasal congestion or discharge, nasal bleeding, constriction of pulmonary airways, cough

-throat irritation, dry mouth, diarrhea

-skin inflammation due to contact with certain substances (contact dermatitis), hair loss, psoriasiform skin eruption (white silvery rash)

-systemic lupus erythematosus (a disease that can cause inflammation of internal organs)

-Peyronie's disease (which can cause the penis to curve)

Other side effects listed are the reactions commonly observed with the corresponding pharmacological class of eye beta-blockers:

Unknown frequency(cannot be estimated from available data)

-low blood sugar levels

-heart failure, a type of cardiac arrhythmia

-abdominal pain, vomiting

-muscle pain not caused by exercise

-sexual dysfunction

-wheezing

-sensation of a foreign body in the eye (sensation of having something inside the eye)

-strong heart palpitations, which may be rapid or irregular (palpitations).

-increased heart rate

-increased blood pressure

Reporting of 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 theSSpanish Medication Adverse Reaction Reporting System:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Store in the original packaging to protect it from light.

Once the aluminum pouch is opened, store below 25°C and use within 7days; unused packaging should be discarded. Single-dose packaging must be used immediately after opening; opened single-dose packaging with residual medication should be discarded.

Medications should not be thrown away through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE drop-off point at the pharmacy. If unsure, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

• 20 mg of the active ingredient dorzolamide 20 mg (corresponding to 22.26 mg of dorzolamide hydrochloride) and 5 mg of the active ingredient timolol (corresponding to 6.83 mg of timolol maleate).
• The other components are mannitol, sodium citrate, hydroxyethylcellulose, sodium hydroxide, and water for injection preparations.

Aspect of the product and contents of the packaging

Visucopt single-dose is a transparent and colorless solution.

Each package contains 6 , 12, 18 or 24 aluminum blisters, each of which contains 5 single-dose polyethylene containers with 0.166 ml of solution. Each box contains 30, 60, 90 or 120 single-dose containers.

Only some package sizes may be commercially available.

Marketing authorization holder
VISUfarma S.p.A.

Via Alberto Cadlolo 21-00136 Rome,

Italy

Responsible for manufacturing

Genetic S.p.A.,

Contrada Canfora,

84084 Fisciano (SA)

Italy

Last review date of this leaflet: March 2023

The 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/