Dorzolamide/timolol Aurovitas 20 mg/ml + 5 mg/ml eye drops solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Dorzolamide/Timolol Aurovitas 20mg/ml + 5mg/ml eye drops solution

Dorzolamide/Timolol

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Dorzolamide/Timolol Aurovitas is and what it is used for
2. What you need to know before using Dorzolamide/Timolol Aurovitas
3. How to use Dorzolamide/Timolol Aurovitas
4. Possible side effects
5. How to store Dorzolamide/Timolol Aurovitas
6. Contents of the container and other information

1. What Dorzolamida/Timolol Aurovitas is and what it is used for

Dorzolamida/Timolol Aurovitas is a combination of two medicines: dorzolamide and timolol.

Dorzolamide belongs to a group of medicines called "carbonic anhydrase inhibitors".

Timolol belongs to a group of medicines called "beta-blockers".

These medicines reduce pressure in the eye in different ways.

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

2. What you need to know before using Dorzolamide/Timolol Aurovitas

Do not use Dorzolamide/Timolol Aurovitas:

• if you are allergic to dorzolamide hydrochloride, timolol maleate, beta-blockers, or any of the other ingredients of this medicine (listed in section 6).
• if you currently have or have previously had breathing problems such as asthma, severe chronic obstructive bronchitis (a serious lung disease that may cause wheezing, difficulty breathing, and/or long-term cough),
• if you suffer from severe kidney disease or have a history of kidney stones,
• if you have excess blood acidity caused by an accumulation of chlorides in the blood (hyperchloremic acidosis),
• if you have certain heart problems, including certain heart rhythm disorders that may cause abnormally slow heartbeat or severe heart failure.

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

Warnings and precautions

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

Consult your doctor before starting to use this medicine if you currently have or have previously had:

• coronary heart disease (symptoms may include chest pain or tightness, shortness of breath or suffocation), heart failure, low blood pressure,
• heart rhythm disorders such as slow heartbeat,
• breathing problems, asthma, or chronic obstructive pulmonary disease,
• a condition causing 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,
• overactivity of the thyroid gland, 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 alter the effects of certain medications used during anesthesia.

Also inform your doctor about any allergies or allergic reactions, such as hives, swelling of the face, lips, tongue, and/or throat, which 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 any new eye problems, such as eye redness or eyelid swelling, inform your doctor immediately.

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

Inform your doctor if an eye infection occurs, if you sustain an eye injury, if you undergo eye surgery, or if other reactions occur or symptoms worsen.

When dorzolamide/timolol is instilled into the eye, it may affect the whole body.

If you wear soft contact lenses, you should consult your doctor before using this medicine.

Children and adolescents

Limited clinical data are available on the use of Dorzolamide/Timolol Aurovitas in infants and children.

Use in elderly patients

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

Use in patients with hepatic impairment

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

Use in athletes

Patients should be advised that this medicine contains timolol, which may result in a positive doping test.

Other medicines and Dorzolamide/Timolol Aurovitas

Dorzolamide/Timolol Aurovitas may affect or be affected by other medicines you are taking, including other eye drops for glaucoma treatment. Inform your doctor if you are using or plan to use medicines to lower blood pressure, heart medications, or medicines to treat diabetes. Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines. This is particularly important if you are:

• Taking antihypertensive medicines used to lower blood pressure or to treat heart conditions (such as calcium channel blockers, beta-blockers, or digoxin).
• Taking medicines to treat an irregular or abnormal heartbeat, such as calcium channel blockers, beta-blockers, or digoxine.
• Using another eye drop containing a beta-blocker.
• Taking another carbonic anhydrase inhibitor such as acetazolamide.
• Taking monoamine oxidase inhibitors (MAOIs).
• Taking a parasympathomimetic medicine that may have been prescribed to help you pass urine. Parasympathomimetics are also a specific type of medicine sometimes used to help restore normal intestinal movements.
• Taking narcotics such as morphine, used to treat moderate to severe pain.
• Taking medicines to treat diabetes.
• Taking antidepressants known as fluoxetine and paroxetine.
• Taking a sulfa-based medicine.
• Taking quinidine (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 become pregnant, consult your doctor or pharmacist before using this medicine.

Use during pregnancy

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

Use during breastfeeding

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

Driving and using machines

No studies have been conducted on the effects on the ability to drive or use machines. Adverse effects associated with dorzolamide/timolol, such as blurred vision, may affect your ability to drive and/or operate machinery. Do not drive or operate machinery until your vision is clear and you feel well.

Dorzolamide/Timolol Aurovitas contains benzalkonium chloride

Benzalkonium chloride may be absorbed by soft contact lenses and may alter the color of contact lenses. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them.

Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases (the transparent layer at the front of the eye). Consult your doctor if you experience a foreign body sensation, stinging, or eye pain after using this medicine.

Dorzolamide/Timolol Aurovitas contains sodium:

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

3. How to use Dorzolamida/Timolol Aurovitas

Follow exactly the instructions for administering this medicine as given by your doctor. If you are unsure, consult your doctor or pharmacist again.

The appropriate dose and duration of treatment will be determined by your physician.

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

If you are using Dorzolamida/Timolol Aurovitas at the same time as another eye drop, leave at least 10 minutes between the application of Dorzolamida/Timolol Aurovitas and the other medicine.

Do not change the dose of this medicine without consulting your doctor. If you need to stop treatment, consult your doctor immediately.

Do not let the tip of the container touch your eye or surrounding areas. It may become contaminated with bacteria that can cause eye infections leading to serious eye damage, including loss of vision. To avoid possible contamination of the container, avoid contact between the tip of the dropper and any surface.

To ensure correct dosing, the dropper tip must not be enlarged.

Instructions for use:

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

It may be easier to administer the drops while looking into a mirror.

1. Before using the medicine for the first time, ensure that the security strip on the neck of the bottle is intact. When the bottle has not yet been opened, it is normal for there to be a gap between the bottle and the cap.

2. Remove the cap from the bottle.

3. Tilt your head backwards slightly and gently pull down the lower eyelid to create a small pocket between the eyelid and the eye (see drawing 1).

4. Turn the bottle upside down and gently squeeze to release one single drop into the eye. DO NOT TOUCH THE EYE OR EYELID WITH THE DROPPER TIP (see drawing 1).

5. Close your eye and press gently with your finger on the inner corner of the eye for approximately two minutes. This helps prevent the medicine from draining into the rest of your body (see drawing 2).

6. Repeat steps 3 to 5 in the other eye if instructed by your doctor.

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

If you use more Dorzolamida/Timolol Aurovitas than you should

It is important to follow the dose prescribed by your doctor. If too many drops are applied or if you accidentally swallow some of the solution, you may feel unwell—for example, you may feel dizzy, have difficulty breathing, or notice your heart beating more slowly. If you experience any of these symptoms, seek medical attention immediately.

In case of overdose or accidental ingestion, go to a Medical Center or call the Toxicology Information Service at telephone number 91 562 04 20, stating the name of the medicine and the amount taken. It is recommended to bring the medicine packaging and leaflet with you.

If you forget to use Dorzolamida/Timolol Aurovitas

It is important to use Dorzolamida/Timolol Aurovitas as directed by your doctor.

If you forget to apply a dose, apply it as soon as possible. However, if it is almost time for your next dose, do not take the missed dose; instead, continue with your regular dosing schedule.

Do not use a double dose to make up for a missed dose.

If you stop using Dorzolamida/Timolol Aurovitas

If you wish to stop using this medicine, consult your doctor first.

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

4. Possible adverse effects

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

You can generally continue using the eye drops unless the effects are severe. If you are concerned, speak to your doctor or pharmacist. Do not stop using Dorzolamide/Timolol Aurovitas without first talking to your doctor.

If you experience any of the following serious adverse effects, stop using this medicine immediately and inform your doctor or go to the nearest hospital emergency department.

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

• Severe illness with extensive peeling and swelling of the skin, blistering of the skin, mouth, eyes, genitals, and fever. Skin rash with pink-red spots, particularly on the palms of the hands or soles of the feet, which may blister.

Like other medicines applied to the eyes, Dorzolamide/Timolol Aurovitas is absorbed into the bloodstream. This may cause adverse effects similar to those seen with beta-blocking agents administered "orally" and/or "intravenously". The incidence of adverse effects after ophthalmic topical administration is lower than when medicines are taken orally or injected.

The frequency of the 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 in 100 people)
Uncommon (affects 1 to 10 in 1,000 people)
Rare (affects 1 to 10 in 10,000 people)
Frequency not known (cannot be estimated from available data)

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

Very common adverse effects (may affect more than 1 in 10 people):
Eye burning and stinging, altered taste.

Common adverse effects (may affect up to 1 in 10 people):
Eye and surrounding redness, eye tearing or itching, corneal erosion (damage to the front layer of the eyeball), eye and surrounding inflammation and/or irritation, sensation of a foreign body in the eye, reduced corneal sensitivity (inability to perceive foreign objects in the eye and absence of pain), eye pain, dry eyes, blurred vision, headache, sinusitis (feeling of pressure or congestion in the nose), weakness/tiredness and fatigue.

Uncommon adverse effects (may affect up to 1 in 100 people):
Dizziness, depression, iris inflammation, visual disturbances including changes in refraction (in some cases due to discontinuation of miotic therapy), decreased heart rate, fainting, shortness of breath, indigestion, and kidney stones.

Rare adverse effects (may affect up to 1 in 1,000 people):
Systemic lupus erythematosus (an immune disease that may cause inflammation of internal organs), tingling or numbness in the hands or feet, insomnia, nightmares, memory loss, increase in signs and symptoms of myasthenia gravis (muscle disorder), decreased sexual desire, stroke, transient myopia which may resolve upon discontinuation of treatment, retinal detachment of the blood vessel-containing layer after filtration surgery which may cause visual disturbances, drooping eyelids (causing the eye to remain partially closed), double vision, eyelid crusting, corneal swelling (with symptoms of visual disturbances), low eye pressure, ringing in the ears, low blood pressure, changes in heart rate or rhythm, chest pain, palpitations (faster and/or irregular heartbeat), myocardial infarction, Raynaud's phenomenon, congestive heart failure (heart disease with shortness of breath and swelling of 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 reduced circulation in arms or legs, leg cramps and/or leg pain when walking (claudication), difficulty breathing, worsening of pulmonary function, runny or congested nose, nosebleeds, constriction of airways in the lungs, cough, throat irritation, dry mouth, diarrhea, contact dermatitis, hair loss, skin rash with silvery appearance (psoriasiform rash), Peyronie's disease (which may cause penile curvature), allergic-type reactions such as skin rash, urticaria, itching, and in rare cases possible swelling of lips, eyes and mouth, wheezing, or severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Frequency not known (cannot be estimated from available data):
Low blood glucose levels, heart failure, heart rhythm disorders, abdominal pain, vomiting, muscle pain not caused by exercise, sexual dysfunction, abnormal sensitivity of the eyes to light.

Breathing difficulty, sensation of a foreign body in the eye.

Hallucinations, increased heart rate, increased blood pressure.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist, especially if you experience any visual changes or disturbances when using Dorzolamide/Timolol Aurovitas after eye surgery.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dorzolamide/Timolol Aurovitas

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage temperature.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point in your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Dorzolamide/Timolol Aurovitas

• The active substances are dorzolamide and timolol. Each ml contains 20 mg of dorzolamide (as 22.26 mg of dorzolamide hydrochloride) and 5 mg of timolol (as 6.83 mg of timolol maleate).
• The other components are mannitol (E421), hydroxyethyl cellulose, benzalkonium chloride (as preservative), sodium citrate (E331), sodium hydroxide (E524) for pH adjustment, and water for injections.

Appearance of the medicine and contents of the pack

This medicine is an aqueous, sterile, colourless, transparent, slightly viscous eye drop solution.

Dorzolamide/Timolol Aurovitas is supplied in a white opaque high-density polyethylene bottle with a low-density polyethylene dropper with sealed tip and a high-density polyethylene screw cap with a tamper-evident band. Each bottle contains 5 ml of ophthalmic solution.

Dorzolamide/Timolol Aurovitas is available in packs containing 1, 3 or 6 bottles of 5 ml each.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

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

Date of the most recent revision of this leaflet: January 2026

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