Prospecto: information for the user

Dorzolamida/Timolol Aurovitas 20mg/ml + 5mg/ml eye drops in solution

Dorzolamida/Timolol

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

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you, and you must not give it to other people, 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 prospect. See section 4.

1. What isDorzolamida/Timolol Aurovitasand for what it is used

2. What you need to knowbefore starting to use Dorzolamida/Timolol Aurovitas

3. How to use Dorzolamida/Timolol Aurovitas

4. Possible adverse effects

5. Storage ofDorzolamida/Timolol Aurovitas

6. Contents of the package and additional information

Dorzolamida/Timolol Aurovitas is a combination of two medications: dorzolamida and timolol.

Dorzolamida belongs to a group of medications called "carbonic anhydrase inhibitors".

Timolol belongs to a group of medications called "beta blockers".

These medications lower eye pressure in different ways.

Dorzolamida/timolol is prescribed to reduce high eye pressure in the treatment of glaucoma when the use of a beta-blocker eye drop alone is not suitable.

No use Dorzolamida/Timolol Aurovitas:

• If you are allergic to dorzolamide hydrochloride, timolol maleate, beta-blockers, or any of the other components of this medication (listed in section 6),
• If you have or have had respiratory problems such as asthma, severe chronic obstructive pulmonary disease (a serious lung disease that can cause wheezing, difficulty breathing, and/or coughing for a long time),
• If you have severe kidney disease or a history of kidney stones,
• If you have excessive blood acidity caused by a buildup of chloride in the blood (hyperchloremic acidosis),
• If you have certain heart problems, including certain arrhythmias that can cause an abnormally slow or weak heartbeat, or severe heart failure.

If you are unsure whether you should use this medication, consult your doctor or pharmacist.

Warnings and Precautions:

Consult your doctor or pharmacist before starting to use dorzolamide/timolol.

Consult your doctor before starting to use this medication if you have or have had:

- Coronary heart disease (symptoms may include chest pain or pressure, shortness of breath, or asphyxia), heart failure, low blood pressure,

- Arrhythmias such as a slow heartbeat,

- Respiratory problems, asthma, or chronic obstructive pulmonary disease,

- A condition that causes poor blood circulation (such as Raynaud's disease or Raynaud's syndrome),

- Diabetes, as dorzolamide/timolol Aurovitas may mask the signs and symptoms of low blood sugar,

- Hyperthyroidism, as dorzolamide/timolol Aurovitas may mask its signs and symptoms,

Inform your doctor before undergoing surgery that you are using dorzolamide/timolol, as timolol may affect the effects of some anesthetics.

Also inform your doctor about any allergies or allergic reactions, such as hives, swelling of the face, lips, tongue, and/or throat, that may cause difficulty breathing or swallowing.

Inform your doctor if you have muscle weakness or have been diagnosed with myasthenia gravis,

If you develop any eye irritation or new eye problems, such as redness of the eyes or swelling of the eyelids, inform your doctor immediately.

If you suspect that dorzolamide/timolol is causing an allergic reaction or hypersensitivity (such as skin rash, severe skin reaction, or redness and itching in the eye), stop using this medication and consult your doctor immediately.

Inform your doctor if you develop an eye infection, if you suffer a corneal injury, if you undergo eye surgery, or if you develop other reactions or worsening of symptoms.

When dorzolamide/timolol is instilled in the eye, it may affect the entire body.

If you use soft contact lenses, consult your doctor before using this medication.

Children and Adolescents:

There is limited clinical data on the administration of dorzolamide/timolol Aurovitas in infants and children.

Use in Elderly Patients:

In studies with dorzolamide/timolol solution, the effects of dorzolamide/timolol solution were similar in elderly patients and younger patients.

Use in Patients with Liver Disease:

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

Use in Athletes:

Warn patients that this medication contains timolol, which may produce a positive result in doping control tests.

Other Medications and Dorzolamide/Timolol Aurovitas:

Dorzolamide/Timolol Aurovitas 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 have used:

• Beta-blockers used to reduce blood pressure or treat heart disease (such as calcium channel blockers and digoxin).
• Medications for arrhythmias such as calcium channel blockers, beta-blockers, or digoxin.
• Another eye drop containing a beta-blocker.
• Another carbonic anhydrase inhibitor such as acetazolamide.
• MAOIs (monoamine oxidase inhibitors).
• Parasympathomimetics that may have been prescribed to help you urinate. Parasympathomimetics are also a type of medication that may be used to help restore normal bowel movements.
• Narcotics such as morphine, used to treat moderate to severe pain.
• Medications for diabetes.
• Antidepressants such as fluoxetine and paroxetine.
• Sulfonamide-based medications.
• Quinidine (used to treat heart disease and some types of malaria).

Pregnancy and Lactation:

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

Use in Pregnancy:

Do not use dorzolamide/timolol Aurovitas if you are pregnant unless your doctor considers it necessary.

Use in Lactation:

Do not use dorzolamide/timolol Aurovitas if you are breastfeeding. Timolol may pass into breast milk.

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 dorzolamide/timolol, such as blurred vision, that may affect your ability to drive and/or operate machinery. Do not drive or operate machinery until you feel well and your vision is clear.

Dorzolamide/Timolol Aurovitas contains benzalkonium chloride:

Benzalkonium chloride may be absorbed by soft contact lenses and may alter the color of the lenses. 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. Consult your doctor if you feel a strange sensation, burning, or pain in the eye after using this medication.

Dorzolamida/Timolol Apotex contains sodium:

This medication contains less than 1 mmol of sodium (23 mg) per bottle; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again if you have any doubts.

The appropriate dose and treatment duration will be established by your doctor.

The recommended dose is one drop in the affected eye or eyes twice a day, for example in the morning and at night.

If you useDorzolamida/Timolol Aurovitasat the same time as another eye drop, leave at least 10 minutes between the application ofDorzolamida/Timolol Aurovitas and the other medication.

Do not change the medication dose without consulting your doctor. If you must interrupt treatment, consult your doctor immediately.

Do not let the tip of the container touch your eye or the surrounding areas. You may contaminate the container with bacteria that can cause eye infections that can cause serious eye damage, even vision loss. To avoid possible contamination of the container, avoid letting the tip of the container come into contact with any surface.

To ensure a correct dose – the tip of the dropper should not be enlarged.

Usage Instructions:

It is recommended that you wash your hands before using the eye drop.

It may be easier to apply the eye drop in front of a mirror.

1.Before using the medication for the first time, make sure the safety seal on the neck of the bottle is intact. When the bottle has not been opened yet, it is normal for there to be a space between the bottle and the cap.

2.Remove the cap from the bottle.

3.Incline your head back and separate the lower eyelid slightly, forming a small separation between the eyelid and the eye (see diagram 1).

4.Invert the bottle, and press to dispense a single drop into the eye. DO NOT TOUCH THE EYE OR EYELID WITH THE TIP OF THE DROPPER (see diagram 1).

5.Closure of the eye and pressing with your finger the inner corner of the eye with your finger for

approximately two minutes. This helps to prevent the medication from reaching the rest of the

body.(see diagram 2).

6.Repeat steps 3 to 5 with the other eye if your doctor has instructed you to do so.

7.Replace the cap and close the bottle immediately after use.

If you use moreDorzolamida/Timolol Aurovitasthan you should

It is essential to maintain the dose that your doctor has indicated. If too many drops are applied to the eye or if you swallow some of the contents of the bottle, you may feel unwell, for example, you may feel dizzy, have difficulty breathing, or notice that your heart is beating more slowly. If you experience any of these effects, seek medical attention 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 medication and the amount used. It isrecommended to bring the packaging and the medication leaflet.

If you forgot to useDorzolamida/Timolol Aurovitas

It is essential to use Dorzolamida/Timolol Aurovitas as indicated 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 usual dose schedule.

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

If you interrupt treatment withDorzolamida/Timolol Aurovitas

If you want to interrupt the use of 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.

You can usually continue using the eye drops unless the side effects are severe. If you are concerned, speak with your doctor or pharmacist. Do not stop using Dorzolamida/Timolol Aurovitas without speaking with your doctor.

If you experience any of the following severe side effects, stop using this medicine immediately and inform your doctor right away or visit the nearest hospital emergency room.

-Generalized allergic reactions including skin swelling that can occur in areas such as the face and limbs, and that can obstruct airways, causing difficulty breathing or swallowing, urticaria or itchy rash, localized and generalized rash, itching, sudden severe allergic reaction that can be life-threatening.

-Severe disease with intense peeling and swelling of the skin, blistering of the skin, mouth, eyes, genitals, and fever. Generalized skin rash with pinkish-red spots, especially on the palms of the hands or soles of the feet that can blister.

Like other eye medicines, Dorzolamida/Timolol Aurovitas is absorbed into the bloodstream. This can cause side effects similar to those observed with beta-blockers administered orally and/or intravenously. The incidence of side effects after topical ocular administration is lower than when the medicines are taken, for example, orally or injected.

The frequency of possible side effects listed below is defined using the following convention:

Very common (affects more than 1 in 10 people)

Common (affects 1 to 10 people in 100)

Uncommon (affects 1 to 10 people in 1,000)

Rare (affects 1 to 10 people in 10,000)

Frequency unknown (cannot be estimated from available data)

The following adverse reactions have been reported with dorzolamida/timolol or one of its components during clinical trials or during post-marketing experience:

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

Burning and stinging of the eyes, alteration of taste

Common side effects(may affect up to 1 in 10 people):

Redness of the eye or eyes and surrounding area, tearing or itching of the eye or eyes, erosion of the cornea (damage to the front layer of the eyeball), inflammation and/or irritation of the eye or eyes and surrounding area, sensation of having something in the eye, decreased sensitivity of the cornea (does not feel that there is something in the eye and does not feel pain), eye pain, dry eyes, blurred vision, headache, sinusitis (sensation of tension or congestion in the nose), weakness/fatigue and tiredness.

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

Dizziness, depression, inflammation of the iris,alterations of vision including refractive changes(in some cases due to suspension of miotic therapy), decreased heart rate, fainting,shortness of breath, indigestion and kidney stones.

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

SLE (systemic lupus erythematosus) (a disease that can cause inflammation of internal organs), tingling or numbness of the hands or feet, insomnia, nightmares, memory loss,increased signs and symptoms of myasthenia gravis (muscular disorder), decreased libido, stroke, transient myopia that may resolve upon cessation of treatment,retinal detachment that can cause visual disturbances, drooping eyelids (causing the eye to remain half-closed), double vision, crusts on the eyelid, corneal edema (with visual disturbance symptoms), low eye pressure, ringing in the ear, low blood pressure, changes in heart rhythm or rate, chest pain, palpitations (irregular or rapid heartbeats), myocardial infarction, Raynaud's phenomenon, congestive heart failure (heart disease with shortness of breath and swelling of the feet and legs due to fluid accumulation), edema (fluid accumulation), cerebral ischemia (reduced blood flow to the brain), swollen or cold hands and feet, and decreased circulation in the arms or legs, leg cramps and/or pain when walking (claudication), shortness of breath, deterioration of lung function, nasal congestion or discharge, nosebleed, bronchial constriction in the lungs, cough, throat irritation, dry mouth, diarrhea, contact dermatitis, hair loss, psoriasiform skin rash with a silvery appearance, Peyronie's disease (which can cause curvature of the penis), allergic reactions such as skin rash, urticaria, itching, in rare cases possible swelling of the lips, eyes, and mouth, wheezing, or severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Frequency unknown(cannot be estimated from available data):

Low blood sugar, heart failure, arrhythmia, abdominal pain, vomiting, muscle pain not caused by exercise, sexual dysfunction.

Difficulty breathing, sensation of a foreign body in the eye (sensation of having something in the eye).

Hallucinations, increased heart rate, increased blood pressure.

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist, particularly if you experience any visual changes when using Dorzolamida/Timolol Aurovitas after eye surgery.

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 the Spanish System for the 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 packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature.

Dorzolamida/Timolol Aurovitas must be used within 28 days after the first opening of the bottle. Therefore, discard the bottle 4 weeks after the first opening, even if there is remaining eye drops. To help you remember, write the date you opened the bottle in the space provided on the carton.

Medications should not be disposed of through drains or trash. Deposit the containers and medications you no longer need at the SIGRE collection point of the pharmacy.Ask your pharmacist how to dispose of the containers and medications you no longer need. This way, you will help protect the environment.

Composition of Dorzolamida/Timolol Aurovitas

• The active principles are dorzolamida and timolol. Each ml contains 20mg of dorzolamida(as 22,26mg of dorzolamida hydrochloride) and 5mg of timolol (as 6,83mg of timolol maleate).
• The other components are mannitol (E421), hydroxyethyl cellulose, benzalkonium chloride (as a preservative), sodium citrate (E331), sodium hydroxide (E524) for pH adjustment and water for injection preparations.

Appearance of the product and contents of the container

This medication is an aqueous solution, sterile, colorless, transparent, slightly viscous eye drop.

Dorzolamida/Timolol Aurovitas se is presented in an opaque white medium-density polyethylene bottle with a low-density polyethylene tip cap and a high-density polyethylene screw cap with a safety strip. Each bottle contains 5 ml of eye drops.

Dorzolamida/Timolol Aurovitasis available in containers with 1, 3 or 6 bottles of 5 ml each.

Only some container sizes may be commercially marketed.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer

Pharmathen S.A.

6 Dervenakion str.

15351 Pallini, Attiki

Greece

Or

Famar S.A., Plant A

63 Agiou Dimitriou Street

174 56 Alimos

Greece

Last review date of this leaflet:January 2023

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