VISUCOPT 20mg/ml + 5mg/ml EYE DROPS SOLUTION

Introduction

Package Leaflet: Information for the User

Visucopt 20mg/ml + 5mg/ml, Eye Drops Solutiondorzolamida/timolol

Read the package leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Visucopt and what is it used for

Visucopt contains two active substances: dorzolamida and timolol

• Dorzolamida belongs to a group of medicines called “carbonic anhydrase inhibitors”.
• Timolol belongs to a group of medicines called “beta-blockers”.

These medicines lower eye pressure in different ways.

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

2. What you need to know before you use Visucopt

Do not use Visucopt

• if you are allergic to the active substances (dorzolamida hydrochloride, timolol maleate) or any of the other ingredients of this medicine (listed in section 6)
• if you have or have had in the past respiratory problems such as asthma or severe chronic obstructive pulmonary disease (a serious lung disease that can cause wheezing, difficulty breathing, or prolonged coughing)
• if you have a slow heart rate, heart failure, or heart rhythm disorders (irregular heartbeat)
• if you have severe kidney problems or severe kidney failure, or a history of kidney stones
• if you have excessive blood acidity, caused by the accumulation of chloride (hyperchloremic acidosis)

Warnings and Precautions

Talk to your doctor or pharmacist before you start using Visucopt if you have or have had in the past:

• cardiovascular diseases/coronary heart disease (symptoms may include chest pain or tightness, difficulty breathing, or shortness of breath), heart failure, low blood pressure; heartbeat abnormalities, such as slow heartbeat
• respiratory problems, asthma, or chronic obstructive pulmonary disease
• poor blood circulation (such as Raynaud's disease or Raynaud's syndrome)
• diabetes, as timolol, one of the active substances of Visucopt, can mask the signs and symptoms of hypoglycemia
• overactive thyroid gland, as timolol can mask the signs and symptoms of this disorder

Tell your doctor:

• if you are using Visucopt and need to undergo surgery, as timolol may affect the effects of some medicines used during anesthesia
• if you have been diagnosed with severe myasthenia (muscle weakness)
• if you experience eye irritation or new eye problems such as eye redness or eyelid swelling, contact your doctor immediately
• if you experience an eye infection, suffer an eye injury, undergo eye surgery, or experience other reactions, such as the appearance of new symptoms or the worsening of pre-existing symptoms.

Instilling Visucopt in the eye can affect the whole body.

Use in Children and Adolescents

Experience with Visucopt in infants and children is limited.

Use in Elderly Patients

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

Use in Patients with Impaired Liver Function (Liver Failure)

Tell your doctor about any liver problems you have or have had in the past.

Doping Tests

The use of this medicine may produce positive results in doping tests.

Other Medicines and Visucopt

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those obtained without a prescription.

Visucopt may affect or be affected by other medicines you are using, including other eye drops for the treatment of glaucoma.

Tell your doctor if you are using or plan to use medicines to lower blood pressure, to treat heart diseases (cardiopathies), or to treat diabetes.

Tell your doctor:

• if you are taking medicines to lower blood pressure or to treat heart diseases (such as calcium antagonists, beta-blockers, or digoxin).
• if you are taking medicines to treat heart disorders or heartbeat abnormalities (such as calcium antagonists, beta-blockers, or digoxin).
• if you are using another eye drop that contains an active substance belonging to the class of “beta-blockers”, ask your doctor for more information.
• if you are taking another medicine for high eye pressure (carbonic anhydrase inhibitor, such as acetazolamide).
• if you are taking medicines called “monoamine oxidase inhibitors (MAOIs)”, used to treat depression.
• if you are taking a medicine belonging to the class of “parasympathomimetics” that you have been prescribed to help you urinate. Parasympathomimetics are also a specific type of medicine that is sometimes used to help normalize bowel movements.
• if you are taking “narcotics” such as morphine, used to treat severe pain.
• if you are taking medicines to treat diabetes.
• if you are taking known antidepressants, such as fluoxetine and paroxetine.
• if you are taking “sulfonamides”.
• if you are taking “quinidine”, which is used to treat heart conditions and some types of malaria.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Use During Pregnancy

Visucopt should not be used during pregnancy.

Use During Breastfeeding

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

Driving and Using Machines

Visucopt has a minor influence on the ability to drive and use machines. However, there are side effects associated with the use of Visucopt, such as transient blurred vision, that may affect your ability to drive or use machines. Do not drive or use machines until you feel well or until your vision has cleared.

Visucopt Contains Benzalkonium Chloride

.

This medicine contains 0.075 mg of benzalkonium chloride per 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 medicine and wait 15 minutes before putting them back.

Benzalkonium chloride may cause eye irritation, especially if you have dry eyes or other corneal diseases (the transparent layer on the front of the eye). Talk to your doctor if you feel any unusual sensation, itching, or pain in the eye after using this medicine.

3. How to Use Visucopt

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again. Your doctor will determine the correct dose and duration of treatment.

The recommended dose is one drop of Visucopt in the affected eye(s) in the morning and at night.

If you are using Visucopt with other eye drops, they should be administered at least 10 minutes apart.

Do not change the dose of the medicine without consulting your doctor.

Do not let the bottle cap touch the eye or the areas surrounding it. It could become contaminated with bacteria that can cause eye infections leading to serious damage to the eye, including loss of vision. To avoid possible contamination, wash your hands before using this medicine and keep the bottle away from contact with any surface. If you think your medication may be contaminated or if you contract an eye infection, contact your doctor immediately to ask if you should continue using this bottle.

Instructions for Use

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 not to let the tip of the dropper touch the eye, the skin around the eye, or your fingers.
• Tilt your head back, hold the bottle 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. Gently press the bottle to release one drop into the eye, according to your doctor's instructions. Release the lower eyelid.

• Close your 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 told you to do so.
• Close the cap tightly. Do not overtighten it to avoid damaging the bottle or cap.
• The dropper is designed to release one drop at a time; therefore, DO NOT enlarge the dropper hole.

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 notice a slowing of the heart rate. Contact your doctor immediately.

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

If you forget to use Visucopt

It is important that you use Visucopt as prescribed by your doctor. If you forget a dose, use 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 make up for the missed dose.

If you stop using Visucopt

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

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Timolol is absorbed into the bloodstream, which distributes it throughout the body, similar to other eye medicines. This can cause side effects similar to those seen with medicines of the same group (beta-blockers) taken orally. The incidence of side effects after eye 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 or generalized rash, itching, or a severe and sudden life-threatening allergic reaction, stop using this medicine and go to the doctor immediately.

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

Very Common(may affect more than 1 in 10 people)

- eye burning and stinging

- altered taste

Common(may affect up to 1 in 10 people)

- headache

- redness inside and around the eyes, tearing or itching in the eyes, corneal erosion (damage to the layer on the front of the eyeball), swelling or irritation inside and around the eyes, feeling of a foreign body in the eye, decreased corneal sensitivity (not noticing something is in the eye and absence of pain), eye pain, dry eye, blurred vision

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

- weakness/fatigue and tiredness

Uncommon(may affect up to 1 in 100 people)

- depression

- dizziness, fainting

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

- slow heart rate

- difficulty breathing (dyspnea)

- indigestion

- kidney stones

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

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

- sleep disorders, nightmares, memory loss

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

- temporary myopia that may resolve upon discontinuation of treatment, detachment of the layer under the retina that contains blood vessels after filtration surgery, which can cause visual disturbances due to fluid accumulation, drooping eyelids, double vision, formation of crusts on the eyelids, inflammation of the cornea (causing visual disturbances), low eye pressure

- ringing in the ears

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

- difficulty breathing, worsening of lung function, runny nose or nasal congestion, nosebleeds, constriction of airways, cough

- throat irritation, dry mouth, diarrhea

- skin irritation due to contact with certain substances (contact dermatitis), hair loss, skin rash of silvery white color (psoriasiform rash)

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

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

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

Frequency Not Known(cannot be estimated from the available data)

- low blood sugar levels

- heart failure, a type of heart rhythm disorder

- abdominal pain, vomiting

- muscle pain not caused by exercise

- sexual dysfunction

- wheezing

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

- strong heartbeats, which can be fast or irregular (palpitations)

- increased heart rate

- increased blood pressure

Reporting of Side Effects

If you experience side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Visucopt

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

Store in the original package to protect from light.

Do not use this medicine after the expiry date (EXP) that appears on the carton and bottle. The expiry date is the last day of the month indicated.

Once the bottle is opened, do not store the medicine above 25°C and use it within 28 days; after this period, discard the unused medicine. Write the date of first opening on the space provided on the packaging.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the Pack and Other Information

Each ml of solution contains:

• 20 mg of the active ingredient dorzolamida 20 mg (corresponding to 22.26 mg of dorzolamida 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, benzalkonium chloride, sodium hydroxide, and water for injectable preparations.

Appearance of the product and packaging content

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

Each package contains a 5 ml bottle.

Marketing authorization holder

VISUfarma S.p.A.

Via Alberto Cadlolo 21-00136 Rome,

Italy

Manufacturer

Genetic S.p.A.,

Contrada Canfora,

84084 Fisciano (SA), Italy

Date of the last revision of this leaflet:March 2023

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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