Prospect: information for the user

Dorzolamida Aristo 20 mg/mL eye drops solution

Dorzolamida

Read this prospect carefully before starting to use this medicine, because 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 medicine has been prescribed only to you and should not be given 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 is Dorzolamida Aristo and what is it used for

2. What you need to know before starting to use Dorzolamida Aristo

3. How to use Dorzolamida Aristo

4. Possible adverse effects

5. Storage of Dorzolamida Aristo

6. Contents of the package and additional information

Dorzolamida Aristois an eye drop in sterile solution.Dorzolamida Aristo containsas active ingredient dorzolamida, which belongs to a group of medicines called “carbonic anhydrase inhibitors”.

This medication is prescribed to reduce elevated eye pressure and to treat glaucoma.

This medication may be used alone or in combination with other medications that decrease eye pressure (called beta-blockers).

Do not use Dorzolamida Aristo

-if you are allergic to dorzolamida or any of the other ingredients of this medication (listed in section 6).

-if you have severe kidney problems or a history of kidney stones.

Warnings and precautions

Inform your doctor or pharmacist before starting to use Dorzolamida Aristo if you have or have had any medical condition, including eye problems and eye surgeries, and if you have any allergy to any medication.

If you experience any eye irritation or new eye disorder, such as eye redness or eyelid swelling, consult your doctor immediately.

If you suspect that this medication is causing an allergic reaction (for example, skin rash, severe skin reaction or itching) stop its administration and consult your doctor immediately.

Children

Dorzolamida has been studied in infants and children under 6 years of age who had high pressure in the eye(s) or had been diagnosed with glaucoma. For more information, consult your doctor.

Older patients

In studies with dorzolamida, the effects of this medication were similar in older patients and younger patients.

Patients with liver impairment

Inform your doctor if you suffer or have suffered from liver problems.

Other medications and Dorzolamida Aristo

Inform your doctor or pharmacist if you are using or have used recently or may have to use any other medication (including eye drops).

This is particularly important if you are using another carbonic anhydrase inhibitor such as acetazolamida, or a sulfonamide.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Pregnancy

You should not use this medication during pregnancy. If you are pregnant, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Breastfeeding

If treatment with this medication is required, breastfeeding is not recommended. Inform your doctor if you are breastfeeding or intend to breastfeed.

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 Dorzolamida Aristo, such as dizziness and blurred vision, that 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 Aristo contains the preservative benzalkonium chloride.

This medication contains 0.075 mg of benzalkonium chloride in each mL of solution.

Benzalkonium chloride can 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 (transparent layer at the front of the eye). Consult your doctor if you feel a strange sensation, burning or pain in the eye after using this medication.

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

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

WhenDorzolamida Aristo is used alone, the recommended dose is one drop in the affected eye(s) in the morning, afternoon, and at night.

If your doctor has recommended the use of Dorzolamida Aristo with a beta-blocker eye drop to reduce intraocular pressure, the recommended dose is one drop in the affected eye(s) in the morning and at night.

If you use this medication with another eye drop, the drops must be instilled with a minimum interval of 10 minutes.

Do not let the tip of the container touch the eyes or surrounding areas.The tip may be contaminated with bacteria capable of causing eye infections that can result in severe eye damage, including loss of vision.To avoid possible contamination of the container, avoid letting the tip come into contact with any surface.If you believe your medication may be contaminated, or if you develop an eye infection, consult your doctor immediately if you can continue using this bottle.

Instructions for use:

It is recommended to wash your hands before applying the eye drop.

Position yourself, if possible, in front of a mirror to facilitate application.

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.Tilt your head back and separate the lower eyelid slightly, forming a small separation between the eyelid and the eye.

4.Invert the bottle and press until one drop is dispensed into the eye according to your doctor's instructions.DO NOT TOUCH THE EYE OR EYELID WITH THE TIP OF THE DROPPER.Close your eye and press the inner corner of the eye with your finger for approximately two minutes. This helps prevent the drop from reaching the rest of the body.

5.Repeat steps 3 and 4 in the other eye if your doctor has instructed you to do so.

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

If you use moreDorzolamida Aristothan you should

If too many drops are applied to the eye or if you swallow some of the contents of the bottle, consult your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20.

If you forgot to useDorzolamida Aristo

It is essential to administerthis medicationas your doctor has instructed.

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 dose.

If you interrupt treatment withDorzolamida Aristo

If you want to discontinue using this medication, consult your doctor first.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Stop using this medicine and seek medical advice immediately if you develop allergic reactions such ashives, swelling of the face, lips, tongue, and/or throat that may cause difficulty breathing or swallowing..

The following side effects have been reported with dorzolamide during clinical trials or after marketing.

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

• Burning and stinging of the eyes.

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

• Corneal disease with eye pain and blurred vision (superficial punctate keratitis),tear production with eye itching (conjunctivitis), eyelid irritation/inflammation, blurred vision
• nausea, bitter taste
• fatigue
• headache

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

• Iris inflammation.

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

• tingling or numbness of the hands or feet
• transient myopia that resolves upon cessation of therapy
• development of fluid under the retina(choroidal detachment, after glaucoma filtration surgery)
• eye pain
• crusts on the eyelid
• low eye pressure
• corneal inflammation (with visual disturbance symptoms)
• eye irritation including redness
• kidney stones
• dizziness
• nasal bleeding
• throat irritation
• dry mouth
• localized skin rash (contact dermatitis)
• severe skin reactions
• allergic reactions such as skin rash, hives, itching, in rare cases swelling of the lips, eyes, and mouth, shortness of breath, and more rarely difficulty breathing.

Unknown frequency (cannot be estimated from available data):

• difficulty breathing
• sensation of a foreign body in the eye (sensation of having something in the eye)
• strong heartbeats that may be rapid or irregular (palpitations)
• increased heart rate
• increased blood pressure

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 usethis medicationafter the expiration date that appears on the packaging after CAD.The expiration date is the last day of the month indicated.

Store the bottle in the outer packaging to protect it from light.Store below 30°C.

Dorzolamida Aristomust be used within 28 days after the initial opening of the bottle.Therefore, discardthe bottle 4 weeks after first opening, even if solution remains.As a reminder, note the opening date of each bottle on the box and on the bottle.

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

Composition of Dorzolamida Aristo

• The active ingredient is dorzolamida. Each mL contains 20 mg of dorzolamida (equivalent to dorzolamida hydrochloride).
• The other components are mannitol (E421), hydroxyethyl cellulose, benzalkonium chloride solution 50% (as a preservative), sodium citrate, sodium hydroxide to adjust the pH, and water for injectable preparations.

Appearance of Dorzolamida Aristo and contents of the packaging

Dorzolamida Aristo is a sterile, isotonic, buffered, clear, colorless, slightly viscous aqueous solution in a low-density polyethylene opaque and white bottle with a sealed dropper and a two-piece cap. Each bottle contains 5 mL of the eye drop solution.

Dorzolamida Aristo is available in packaging of 1, 3, or 6 bottles with 5 mL of eye drop solution.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Aristo Pharma Iberia, S.L.

C/Solana, 26

28850, Torrejón de Ardoz

Madrid. Spain

Responsible for manufacturing

Pharmathen S.A.

6, Dervenakion str.

153 51 Pallini Attiki,

Greece

This medicine is authorized in the member states of the European Economic Area with the following names:

This leaflet has been reviewed in January 2023

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