DORZOLAMIDA 20 mg /Ml + 5 Mg/Ml Eye Drops, Solution

PROSPECTO: INFORMATION FOR THE USER

Dorzolamida/TimololMEIJI 20mg/ml + 5mg/ml eye drops in solution

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

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, 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 prospectus. See section 4.

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

2.What you need to know before starting to use Dorzolamida/Timolol MEIJI.

3.How to use Dorzolamida/Timolol MEIJI.

4.Possible adverse effects.

5.Storage of Dorzolamida/Timolol MEIJI.

6.Contents of the package and additional information.

Dorzolamida/Timolol MEIJIis 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 MEIJIis prescribed to reduce elevated intraocular pressure in the treatment of glaucoma when the use of a beta-blocker eye drop as monotherapy is not suitable.

Do not use Dorzolamida/Timolol MEIJI

• If you are allergic (hypersensitive) to dorzolamide hydrochloride, timolol maleate, beta-blockers, or any of the other components of this medication (including those listed in section 6).
• If you have or have had respiratory problems such as asthma or chronic obstructive pulmonary disease (severe lung disease that can cause wheezing, difficulty breathing, or prolonged coughing).
• If you have a severe kidney disease, or a history of kidney stones.
• If you have an imbalance in your blood pH (acid-base balance). If you have excessive acidity in your blood caused by a buildup of chloride in your blood (hyperchloremic acidosis).
• If you have certain heart conditions, including certain irregular heart rhythms that can cause an abnormally slow or irregular heartbeat, or acute heart failure.

If you think you have any of these conditions, do not use Dorzolamida/Timolol MEIJI until you have consulted with your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Dorzolamida/Timolol MEIJI:

• If you have a history of heart disease, your doctor may monitor your pulse and other signs of this disease during treatment with Dorzolamida/Timolol MEIJI.
• If you have or have had cardiovascular disease, for example, Prinzmetal's angina (chest pain while resting), other heart problems (such as heart failure), coronary heart disease (symptoms may include chest pain or pressure, difficulty breathing, or asphyxia), or low blood pressure.
• If you have or have had liver problems, if you have muscle weakness, or if you have been diagnosed with myasthenia gravis (muscle weakness).
• If you have or have had respiratory problems, asthma, or chronic obstructive pulmonary disease.
• If your blood circulation is poor (such as Raynaud's disease or Raynaud's syndrome).
• If you have diabetes, as timolol can mask the signs and symptoms of low blood sugar levels.
• If you have hyperthyroidism, as timolol can mask the signs and symptoms.
• About any allergies to medications you have had.

Inform your doctor or dentist before undergoing surgery and anesthesia (including dental surgery), as Dorzolamida/Timolol MEIJI may cause a sudden drop in blood pressure associated with the use of anesthetic.

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

If conjunctivitis (eye irritation and redness), swelling of the eyes or eyelids, skin rash, or itching around the eye develops, consult your doctor immediately. These symptoms may be due to an allergic reaction or be an adverse effect of Dorzolamida/Timolol MEIJI (see "Possible adverse effects").

Inform your doctor if an eye infection occurs, if you suffer an eye injury, if you undergo eye surgery, or if you develop a reaction that includes new symptoms or worsening of existing ones.

When Dorzolamida/Timolol MEIJI is instilled in the eye, it may affect the rest of the body.

If you use soft contact lenses, it is essential to remove them before applying the eye drops, and wait at least 15 minutes before reinserting them, as the preservative benzalkonium chloride may alter the color of your soft contact lenses.

Children and adolescents

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

Older patients

In studies with dorzolamide/timolol eye drops, the effects of this medication were similar in older patients and adult patients.

Use in patients with liver impairment

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

Use in athletes

This medication contains timolol, which may produce a positive result in doping control tests.

Use of Dorzolamida/Timolol MEIJI with other medications

Dorzolamida/Timolol MEIJI may affect or be affected by other medications you are taking, including other eye drops for glaucoma treatment. Inform your doctor if you are using or plan to use medications to reduce blood pressure, heart medications, or diabetes medications.

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

This is particularly important if you are:

• Taking medications to reduce blood pressure or treat heart disease (such as calcium channel blockers, beta-blockers, or digoxin).
• Taking medications to treat an irregular heartbeat, such as calcium channel blockers, beta-blockers, or digoxin.
• Using another eye drop that contains beta-blockers.
• Using another carbonic anhydrase inhibitor, such as acetazolamide. You may be taking this type of medication orally, as eye drops, or by another route.
• Taking monoamine oxidase inhibitors (MAOIs) or selective serotonin reuptake inhibitors (SSRIs) used to treat depression or other conditions.
• Taking a cholinergic agonist that may have been prescribed to help you urinate. Cholinergic agonists are also a type of medication that may be used to help restore normal bowel movements.
• Taking narcotics, such as morphine used to treat moderate to severe pain, or if you are taking high doses of aspirin. Although there is no evidence that dorzolamide hydrochloride interacts with aspirin, other medications related to dorzolamide hydrochloride, administered orally, interact with aspirin.
• Taking medications to treat diabetes or have high blood sugar levels.
• Taking epinephrine (adrenaline).
• Taking antidepressants such as fluoxetine and paroxetine.
• Taking a sulfonamide.
• Taking quinidine (used to treat heart conditions and some types of malaria) or digoxin.
• Dorzolamida/Timolol MEIJI may affect or be affected by other medications you are taking, such as other eye drops for glaucoma treatment.

Pregnancy and lactation

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

Pregnancy

Do not use Dorzolamida/Timolol MEIJI if you are pregnant, unless your doctor considers it necessary. Inform your doctor if you are pregnant or plan to become pregnant.

Lactation

Do not use Dorzolamida/Timolol MEIJI if you are breastfeeding. Timolol may pass into breast milk. Consult your doctor before taking any medication during breastfeeding.

Driving and operating machinery

No studies have been conducted on the adverse effects on the ability to drive or operate machinery. There are adverse effects associated with Dorzolamida/Timolol MEIJI, such as blurred vision, which may affect your ability to drive and/or operate machinery. Do not drive or operate machinery until you feel well or your vision is clear.

Dorzolamida/Timolol MEIJI contains benzalkonium chloride

This medication may cause eye irritation due to the presence of benzalkonium chloride.

Avoid contact with soft contact lenses.

Remove contact lenses before applying the eye drops and wait at least 15 minutes before reinserting them, as benzalkonium chloride may alter the color of your soft contact lenses.

Alter the color of soft contact lenses.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

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

If you use Dorzolamida/Timolol MEIJI at the same time as another eye drop, the drops must be applied at least 10 minutes apart.

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 eyes or the surrounding areas. It may be contaminated with bacteria capable of causing eye infections that can cause severe eye damage, including loss of vision. To avoid possible contamination of the container, avoid letting the tip of the container come into contact with any surface. If you think your medication may be contaminated, or if you develop an eye infection, consult your doctor immediately to find out if you can continue using the bottle.

To ensure correct dosing, the tip of the dropper must not beenlarged.

Usage Instructions:

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

It may be helpful to administer the eye drop in front of a mirror.

1.Beforeusingthemedicationforthefirsttime,makesurethatthesecuritytabontheneckofthebottleisintact.
Whenthebottlehasnotyetbeenopened,itisnormalfortheretobeaspacebetweenthebottleandthecap.

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.

4. Invert the bottle, and gently press until dispensing one drop into the eye as instructed by your doctor. DO NOTTOUCHTHEEYEORTHELOWEREYELIDWITHTHETIPOFTHEDROPPER.

5.Repeat steps 3 and 4 in the other eye if instructed by your doctor.

6.Close the bottle with the cap immediately after use.

After usingDorzolamida/Timolol MEIJI, close your eye and press the inner corner of your eye with your finger for approximately two minutes. This helps prevent the medication from entering the rest of your body.

If you use more Dorzolamida/TimololMEIJI than you should

It is essential to maintain the dosage prescribed by your doctor. If you apply too many drops to your eye or swallow some of the contents of the bottle, you may feel unwell, for example, dizziness, have difficulty breathing, or notice that your heart is beating slower. If you experience any of the mentioned effects, seek medical attention immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone915620420 indicating the medication and the amount ingested.

If you forgot to use Dorzolamida/Timolol MEIJI

It is essential to administer Dorzolamida/TimololMEIJI as instructed 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 regular dosing schedule.

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

If you interrupt treatment with Dorzolamida/Timolol MEIJI

Consult your doctor immediately if you want to interrupt treatment.

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

Like all medications,Dorzolamida/Timolol MEIJIcan 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, consult a doctor or pharmacist. Do not stop using Dorzolamida/TimololMEIJI without informing your doctor.

If you develop generalized allergic reactions including hives (or skin eruption with itching), generalized or localized skin eruptions, sudden severe potentially fatal allergic reaction, swelling under the skin (which can occur in areas such as the face and extremities and can obstruct the airways, which can cause difficulty breathing or swallowing), you must stop using Dorzolamida/TimololMEJII and inform your doctor immediately.

The following adverse reactions have been reported with Dorzolamida/Timolol MEIJI or one of its components during clinical trials or after marketing:

Very common(mayaffectmorethan1in10patients)

Burning and stinging of the eyes, alteration of taste.

Common(mayaffectupto1in100patients)

Redness in and around the eye or eyes, tearing or eye itching, corneal erosion (damage to the front layer of the eyeball),inflammation and/or irritation in and around the eye or eyes, sensation of having something in the eye, decreased corneal sensitivity (does not appreciate having 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), nausea, weakness/fatigueand tiredness.

Uncommon(mayaffectupto1in1,000patients)

Dizziness, depression, iris inflammation, alterations in vision, including refractive changes(in some cases due to suspension of miotic therapy), decreased heart rate, fainting, difficulty breathing (dyspnea), indigestion and kidney stones (often characterized by a sudden onset of pain and crampsin the lower and/or lateral back, groin or abdomen).

Rare(mayaffectupto1in10,000patients)

SLE (systemic lupus erythematosus) (a disease that can cause inflammation of internal organs), tingling or numbness of the handsor feet, difficulty sleeping (insomnia), nightmares, memory loss, an increase in signs and symptoms of myasthenia gravis (muscular disorder), decreased libido,stroke, transient myopia that resolves upon cessation of treatment, detachment of the lower layer of the retina, which containsblood vessels, after filtration surgery, which can cause visual disturbances, drooping eyelid(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,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), chest pain, palpitations (irregular heart rhythm), heart attack, Raynaud's phenomenon,swollen or cold hands and feet and decreased circulation in arms or legs, leg cramps and/or leg pain when walking (claudication), shortness of breath, deterioration of lung function, nasal congestion or discharge, nasal bleeding, bronchial constriction in the lungs,cough, throat irritation, dry mouth, diarrhea, contact dermatitis, hair loss, psoriasis-like skin eruption (erythema psoriasiforme), Peyronie's disease (which can cause penile curvature), allergic reactions such asskin eruption, hives, itching, in rare cases possible swelling of the lips, eyes, and mouth, wheezing, or severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Like other eye medications, timolol is absorbed into the bloodstream. This can cause side effects similar to those that appear with oral beta-blockers. The incidence of side effects after topical ocular administration is lower than when the medications, for example, are taken orally or injected. Additional listed side effects include reactions that appear within the class of beta-blockers when used to treat eye disorders:

Unknown frequency(cannotbeestimatedfromavailabledata)

Low blood sugar, heart failure, a type of heart rhythm alteration, strong heartbeats that may be rapid or irregular (palpitations), abdominal pain, vomiting, muscle pain not caused by exercise, sexual dysfunction, difficulty breathing, sensation of foreign body in the eye (sensation of having something in the eye), increased heart rate, increased blood pressure, hallucinations.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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 Vigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep out of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Store below 30°C

Dorzolamida/TimololMEIJI must be used within 28days after the first opening. Therefore, discard the bottle 4weeks after its first opening, even if there is still some solution left. To help remember the date, write the opening date in the space provided on the box.

Medicines should not be thrown down the drains or in the trash. Deposit the containers and medicines you do not need at the SIGREPoint of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medicines you do not need. In this way, you will help protect the environment.

Composition of Dorzolamida/Timolol MEIJI

• The active principles are dorzolamida and timolol. Each ml contains 20mg of dorzolamida (as 22,26mg of hydrochloride of dorzolamida) and 5mg of timolol (as 6,83mg of timolol maleate).
• The other components are mannitol(E-421), hydroxyethyl cellulose, benzalkonium chloride, sodium citrate (E-331), sodium hydroxide(E-524) for pH adjustment and water for injection preparations.

Appearance of the product and contents of the packaging

Dorzolamida/TimololMEIJI isa sterile aqueous eye drop solution, transparent, colorless and free of particles.

Dorzolamida/TimololMEIJI is presented in a white opaque low-density polyethylene dispenser bottle with a low-density polyethylene dropper and sealed with a high-density polyethylene screw cap, containing 5ml of eye drop solution.

Packaging sizes: 1 bottle of 5 ml.

Holder of the marketing authorization and responsible manufacturer

Meiji Pharma Spain, S.A.

Avda. de Madrid, 94

28802 Alcalá de Henares, Madrid (Spain)

Last review date of this leaflet:February 2023

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