Product Information for the User

Visucopt 20mg/ml + 5mg/ml, Eye Drops Solution
dorzolamida/timolol

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

• Keep this product information, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only to 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 product information. See section 4.

Product Information Content

1. What Visucopt is and for what it is used
2. What you need to know before starting to use Visucopt
3. How to use Visucopt
4. Possible adverse effects
5. Storage of Visucopt
6. Contents of the package and additional information

Visucopt contains two active ingredients: dorzolamide and timolol

These medicines lower eye pressure in different ways.

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

No use Visucopt

• if you are allergic to the active ingredients (dorzolamide hydrochloride, timolol maleate) or to any of the other components of this medication (listed in section6)
• if you have or have had in the past respiratory problems such as asthma or chronic obstructive pulmonary disease (a severe lung disease that can cause wheezing, difficulty breathing, or prolonged coughing)
• if you have low heart rate, heart failure, or cardiac rhythm disorders (irregular heart rate)
• if you have severe kidney problems or severe renal insufficiency, or a history of kidney stones
• if you have excessive blood acidity, caused by the accumulation of chloride (hyperchloremic acidosis)

Advertencias y precauciones

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

Inform your doctor:

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

Uso en niños y adolescentes

The experience with Visucopt in infants and children is limited.

Uso en personas de edad avanzada

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

Uso en pacientes con alteración de la función hepática (insuficiencia hepática)

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

Pruebas antidopaje

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

Otros medicamentos y Visucopt

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 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:

Embarazo y lactancia

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

Uso durante el embarazo

Visucopt should not be used during pregnancy.

Uso durante la lactancia

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

Conducción y uso de máquinas

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

Visucopt contains benzalkonium chloride

.

This medication contains 0.075 mg of benzalkonium chloride in each milliliter, equivalent to 0.375 mg/5 ml. Benzalkonium chloride may 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 of 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 or pharmacist. If in 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 in the affected eye or eyes in the morning and at night.

If you are using Visucopt with other eye drops, they must be instilled with at least a 10-minute interval.

Do not change the medication dose without consulting your doctor.

Do not let the bottle cap come into contact with the eye or surrounding areas. It could become contaminated with bacteria that can cause serious eye infections, even vision loss. To avoid possible contamination, wash your hands before using this medication and keep the bottle away from any surface. If you believe your medication may be contaminated or if you contract an eye infection, contact your doctor immediately to consult on whether to continue using this bottle.

Usage Instructions

Do not use the container if the plastic safety ring around the neck of the bottle is missing or broken.

• Wash your hands and sit or stand in a comfortable position.
• Remove the cap. Be careful that the tip of the dropper does not touch the eye, the skin around the eye, or your fingers.
• Incline your head back, keep the container upside down over the eye, and bring the tip of the bottle close to the eye without touching it.

• Pull the lower eyelid down and look up. Press the bottle gently to dispense one drop in the eye, as instructed by your doctor. Release the lower eyelid.

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

• Repeat the process in the other eye if your doctor has instructed you to do so.
• Close the cap tightly. Do not over-tighten it to avoid damaging the bottle or cap.
• The dropper is configured to dispense one drop at a time; therefore, DO NOT enlarge the dropper opening.

If you use more Visucopt than you should

If you put too many drops in the eye or swallow the contents of the container, you may feel dizzy, have difficulty breathing, or experience a slowing of 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

It is essential to use Visucopt 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 regular dosing schedule. Do not use a double dose to compensate for the missed dose.

If you interrupt treatment with Visucopt

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 medicines, this medicine can 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 can cause side effects similar to those observed with oral medications in 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 limbs with difficulty breathing or swallowing, hives or itchy rash, localized and generalized rash, itching or a severe and potentially fatal allergic reaction, stop using this medicine and see 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 during 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 irritation inside and around the eyes, tearing or itching in the eyes, corneal erosion (lesion of the layer located on the front 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

-iris inflammation (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 discontinuing treatment, detachment of the layer located below the retina and containing blood vessels after surgery to filter, 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 eye pressure

-ear noises

-changes in heart rhythm or speed, 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 rash (white silvery rash)

-systemic lupus erythematosus (a systemic autoimmune 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 heartbeats, which may be rapid or irregular (palpitations)

-increased heart rate

-increased blood pressure

Reporting of side effects

If you experience side effects, consult your doctor or pharmacist, even if they are possible side effects that do not appear in this leaflet. You can also report them directly through theSSpanish System for Pharmacovigilance of Medicines for Human Use: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.

Store in the original packaging to protect it from light.

Do not use this medication after the expiration date (CAD) that appears on the box and in the bottle. The expiration date is the last day of the month indicated.

Once the bottle is opened, do not store the medication above 25°C and use it within a period of 28días; after this period, discard the unused medication. Note the date of the first opening in the corresponding space on the packaging.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and unused medications that you no longer need at the SIGRE collection point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications that you no longer need. By doing so, you will help protect the environment.

Each milliliter of solution contains:

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

Appearance of the product and contents of the packaging

Visucopt is a transparent and colorless solution presented in a polyethylene bottle.

Each package contains a 5 ml bottle.

Holder of the marketing authorization

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/

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