DORZOLAMIDE/TIMOLOL AUROVITAS 20mg/ml + 5 mg/ml EYE DROPS SOLUTION

Introduction

Package Leaflet: Information for the User

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

Dorzolamida/Timolol

Read this 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, do not pass it on to others, even if their symptoms are the same as yours, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Dorzolamida/Timolol Aurovitas and what is it used for
2. What you need to know before you start using Dorzolamida/Timolol Aurovitas
3. How to use Dorzolamida/Timolol Aurovitas
4. Possible side effects
5. Storage of Dorzolamida/Timolol Aurovitas
6. Package contents and further information

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

Dorzolamida/Timolol Aurovitas is a combination of two medicines: 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 decrease the pressure in the eye in different ways.

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

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

Do not use Dorzolamida/Timolol Aurovitas:

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

If you are not sure if you should use this medicine, consult your doctor or pharmacist.

Warnings and precautions

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

Consult your doctor before starting to use this medicine, if you have or have had in the past:

• coronary heart disease (symptoms that may include chest pain or tightness, shortness of breath or asphyxia), heart failure, low blood pressure,
• heart rhythm disorders such as slow heartbeat,
• respiratory problems, asthma or chronic obstructive pulmonary disease,
• disease that causes poor blood circulation (such as Raynaud's disease or Raynaud's syndrome),
• diabetes, as Dorzolamida/Timolol Aurovitas may mask the signs and symptoms of low blood sugar,
• hyperthyroidism because Dorzolamida/Timolol Aurovitas may mask its signs and symptoms,

Tell your doctor before having surgery that you are using dorzolamida/timolol, as timolol may change the effects of some medicines used during anesthesia.

Also, inform your doctor about any allergy or allergic reaction, such as hives, swelling of the face, lips, tongue and/or throat, which can cause difficulty breathing or swallowing.

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

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

If you suspect that dorzolamida/timolol is causing 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.

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

When dorzolamida/timolol is instilled in the eye, it can affect the whole body.

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

Children and adolescents

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

Use in elderly patients

In studies with dorzolamida/timolol eye drops, solution, the effects of dorzolamida/timolol eye drops, solution were similar in both elderly and younger patients.

Use in patients with liver impairment

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

Use in athletes

Patients should be warned that this medicine contains timolol, which can produce a positive result in doping tests.

Other medicines and Dorzolamida/Timolol Aurovitas

Dorzolamida/Timolol Aurovitas 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, heart medicines, or medicines to treat diabetes. Tell your doctor or pharmacist that you are using, have recently used, or may need to use any other medicine. This is especially important if you are:

• Taking anti-hypertensive medicines used to lower blood pressure or to treat heart diseases (such as calcium channel blockers and beta-blockers or digoxin).
• Taking medicines to treat an irregular heartbeat, such as calcium channel blockers, beta-blockers, or digoxin.
• Using another eye drop that contains a beta-blocker.
• Taking another carbonic anhydrase inhibitor such as acetazolamide.
• Taking monoamine oxidase inhibitors (MAOIs).
• Taking a parasymphaticomimetic medicine that may have been prescribed to help you urinate. Parasymphaticomimetics are also a type of medicine that is sometimes used to help restore normal bowel 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 diseases and some types of malaria).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Use during pregnancy

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

Use during breastfeeding

Do not use Dorzolamida/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. There are side effects associated with dorzolamida/timolol, such as blurred vision, that can affect your ability to drive and/or operate machines. Do not drive or operate machines until you feel well and your vision is clear.

Dorzolamida/Timolol Aurovitas contains benzalkonium chloride

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

Benzalkonium chloride can cause eye irritation, especially if you have dry eye or other corneal diseases (the transparent layer of the front of the eye). Consult your doctor if you feel any strange sensation, itching, or pain in the eye after using this medicine.

Dorzolamida/Timolol Apotex contains sodium:

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

3. How to use Dorzolamida/Timolol Aurovitas

Follow the instructions for administration of this medicine exactly as indicated 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 doctor.

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

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

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

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

In order to ensure a correct dose, the dropper tip should not be enlarged.

Instructions for use:

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

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

1. Before using the medicine for the first time, make sure the security strip on the neck of the bottle is intact. When the bottle has not been opened yet, it is normal to have a space between the bottle and the cap.
2. Remove the cap from the bottle.
3. Tilt your head back and gently pull the lower eyelid down, creating a small space between the eyelid and the eye (see drawing 1).
4. Invert the bottle and press until a single drop is dispensed into the eye. DO NOT TOUCH THE EYE OR EYELID WITH THE DROPPER TIP (see drawing 1).
5. Close the eye and press the inner corner of the eye with your finger for approximately two minutes. This helps prevent the medicine from reaching the rest of the body. (see drawing 2).

Repeat steps 3 to 5 with the other eye if your doctor has indicated it.

Replace the cap and close the bottle immediately after use.

If you use more Dorzolamida/Timolol Aurovitas than you should

It is important that you keep the dose that your doctor has indicated. If you apply too many drops in the eye or 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 beats more slowly. If you experience any of these effects, you should 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 medicine and the amount used. It is recommended to bring the packaging and the package leaflet of the medicine.

If you forget to use Dorzolamida/Timolol Aurovitas

It is important to use Dorzolamida/Timolol Aurovitas as your doctor has indicated.

If you forget to apply a dose, you should 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 dosing schedule.

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

If you interrupt treatment with Dorzolamida/Timolol Aurovitas

If you want to interrupt the use of this medicine, consult your doctor first.

If you have any other 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 all people suffer from them.

It can usually be continued to be used, unless the effects are severe. If you are concerned, talk to your doctor or pharmacist. Do not stop using Dorzolamida/Timolol Aurovitas without talking to your doctor.

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

• Generalized allergic reactions including swelling under the skin that can occur in areas such as the face and limbs, and can obstruct the airways, causing difficulty breathing or swallowing, hives or itchy rash, localized and generalized rash, itching, severe sudden 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. Rash with pink-red spots especially on the palms of the hands or soles of the feet that can blister.

Like other eye medications, Dorzolamida/Timolol Aurovitas is absorbed into the bloodstream. This can cause adverse effects similar to those observed with beta-blockers administered orally and/or intravenously. The incidence of adverse effects after topical ophthalmic administration is lower than when medications are taken, for example, 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 people in 100)

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

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

Frequency not known (cannot be estimated from the 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 adverse effects(may affect more than 1 in 10 people):

Burning and stinging of the eyes, alteration of taste

Common adverse 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, corneal erosion (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 (not appreciating that something is in the eye and not feeling pain), eye pain, dry eyes, blurred vision, headache, sinusitis (feeling of tension or congestion in the nose), weakness/fatigue and fatigue.

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

Dizziness, depression, inflammation of the iris, vision changes including modifications of refraction (in some cases due to the suspension 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 can cause inflammation of the internal organs), tingling or numbness of the hands or feet, insomnia, nightmares, memory loss, increased signs and symptoms of myasthenia gravis (muscle disorder), decreased sexual desire, stroke, transient myopia that may resolve when treatment is stopped, detachment of the layer of the retina that contains blood vessels after filtration surgery that can cause visual disturbances, drooping eyelids (making the eye remain half-closed), double vision, crusts on the eyelid, swelling of the cornea (with symptoms of visual disturbances), low eye pressure, ringing in the ears, low blood pressure, changes in heart rate or speed, chest pain, palpitations (faster and/or irregular 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 leg pain when walking (claudication), shortness of breath, worsening of lung function, runny or congested nose, nasal bleeding, constriction of the airways in the lungs, cough, throat irritation, dry mouth, diarrhea, contact dermatitis, hair loss, skin rash with a silvery-white appearance (psoriasiform rash), Peyronie's disease (which can cause curvature of the penis), allergic reactions such as skin rash, hives, itching, in rare cases possible swelling of the lips, eyes, and mouth, wheezing, or severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Frequency not known(cannot be estimated from the available data):

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

Breathing difficulties, sensation of a foreign body in the eye (feeling of having something in the eye).

Hallucinations, increased heart rate, increased blood pressure.

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Dorzolamida/Timolol Aurovitas

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medicine does not require any special storage temperature.

Dorzolamida/Timolol Aurovitas should be used within 28 days after the first opening of the bottle. Therefore, the bottle should be discarded 4 weeks after the first opening, even if there is still eye drop solution left. To help you remember, write the date you opened the bottle in the space provided on the carton.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Dorzolamida/Timolol Aurovitas

• The active ingredients are dorzolamida and timolol. Each ml contains 20 mg of dorzolamida (as 22.26 mg of dorzolamida hydrochloride) and 5 mg of timolol (as 6.83 mg 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 injectable preparations.

Appearance of the Product and Package Contents

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

Dorzolamida/Timolol Aurovitas is presented in a white opaque medium-density polyethylene bottle with a sealed low-density polyethylene dropper tip and a high-density polyethylene screw cap with a security strip. Each bottle contains 5 ml of ophthalmic solution.

Dorzolamida/Timolol Aurovitas is available in packages with 1, 3, or 6 bottles of 5 ml each.

Only some package 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 last revision of this leaflet:January 2023

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