DORZOLAMIDE ARISTO 20 mg/ml EYE DROPS SOLUTION

Introduction

Package Leaflet: Information for the User

Dorzolamida Aristo 20 mg/mL Eye Drops Solution

Dorzolamida

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, 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 side effects, consult 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 Aristo and what is it used for
2. What you need to know before taking Dorzolamida Aristo
3. How to use Dorzolamida Aristo
4. Possible side effects
5. Storage of Dorzolamida Aristo
6. Package Contents and Additional Information

1. What is Dorzolamida Aristo and what is it used for

Dorzolamida Aristo is a sterile eye drop solution. Dorzolamida Aristo contains the active ingredient dorzolamida, which belongs to a group of medications called "carbonic anhydrase inhibitors".

This medication is prescribed to reduce high pressure in the eye and to treat glaucoma.

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

2. What you need to know before taking Dorzolamida Aristo

Do not use Dorzolamida Aristo

• if you are allergic to dorzolamida or any of the other components of this medication (listed in section 6).
• if you have severe kidney problems or a history of kidney stones.

Warnings and Precautions

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

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

If you suspect that this medication is causing an allergic reaction (e.g., skin rash, severe skin reaction, or itching), discontinue its use 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.

Elderly Patients

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

Patients with Liver Impairment

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

Other Medications and Dorzolamida Aristo

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

This is particularly important if you are using another carbonic anhydrase inhibitor such as acetazolamide, or a sulfa medication.

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 plan 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 plan to breastfeed.

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 Aristo, such as dizziness and blurred vision, that may affect your ability to drive and/or operate machines. Do not drive or operate machines 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 per mL of solution.

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

Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases (the transparent layer on the front of the eye). Consult your doctor if you feel any unusual sensation, stinging, or pain in the eye after using this medication.

3. How to use Dorzolamida Aristo

Follow the administration instructions for this medication exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

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

When Dorzolamida Aristo is used alone, the recommended dose is one drop in the affected eye(s) in the morning, afternoon, and evening.

If your doctor has recommended using 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 evening.

If you are using this medication with another eye drop, the drops should be instilled with a minimum time interval of 10 minutes.

Do not let the tip of the container touch the eyes or the surrounding areas. It may be contaminated with bacteria that can cause eye infections that can lead to serious damage to the eyes, including vision loss. 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 if you can continue using this bottle.

Instructions for Use:

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

Sit down, if possible, in front of a mirror to facilitate application.

1. Before using the medication 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 down the lower eyelid, creating a small gap between the eyelid and the eye.
4. Invert the bottle and press until a single drop is dispensed into the eye according to your doctor's instructions. DO NOT TOUCH THE EYE OR EYELID WITH THE DROPPER TIP. Close your eye and press the inner corner of your eye with your finger for about 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 more Dorzolamida Aristo than you should

If you apply too many drops in the eye or 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 Toxicology Information Service, phone: 91 562 04 20.

If you forget to use Dorzolamida Aristo

It is important to administer this medication 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 scheduled dosing program as usual.

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

If you stop using Dorzolamida Aristo

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

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Stop using this medication and seek immediate medical attention if you develop allergic reactions such as hives, swelling of the face, lips, tongue, and/or throat that can cause difficulty breathing or swallowing.

The following side effects have been reported with dorzolamida 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), secretion with itching of the eyes (conjunctivitis), eyelid irritation/inflammation, blurred vision
• nausea, bitter taste
• fatigue
• headache

Uncommon Side Effects: (affect up to 1 in 100 people)

• Iritis (inflammation of the iris).

Rare Side Effects: (affect up to 1 in 1000 people)

• Numbness or tingling of the hands or feet
• Transient myopia that resolves when therapy is stopped
• Development of fluid under the retina (choroidal detachment, after filtration surgery)
• Eye pain
• Crusts on the eyelid
• Low eye pressure
• Corneal inflammation (with symptoms of visual disturbances)
• Eye irritation including redness
• Kidney stones
• Dizziness
• Nosebleeds
• Throat irritation
• Dry mouth
• Localized skin rash (contact dermatitis)
• Severe skin reactions
• Allergic reactions such as skin rash, hives, itching, and in rare cases, swelling of the lips, eyes, and mouth, difficulty breathing, and more rarely, difficulty swallowing.

Frequency Not Known (cannot be estimated from available data):

• Breathing difficulties
• Feeling of a foreign body in the eye (feeling of having something in the eye)
• Strong heartbeats that can be fast or irregular (palpitations)
• Increased heart rate
• Increased blood pressure

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Dorzolamida Aristo

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

Do not use this medication after the expiration date stated 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 Aristo should be used within 28 days of opening the bottle for the first time. Therefore, you should discard the bottle 4 weeks after opening it for the first time, even if there is still solution left. As a reminder, write the opening date of each bottle on the box and on the bottle.

Medications should not be disposed of in wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Dorzolamida Aristo

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

Appearance of Dorzolamida Aristo and Package Contents

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

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

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aristo Pharma Iberia, S.L.

C/Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

Manufacturer

Pharmathen S.A.

6, Dervenakion str.

153 51 Pallini Attiki,

Greece

This medication is authorized in the Member States of the European Economic Area under the following names:

This package leaflet was last revised in January 2023

Detailed and up-to-date information on this medication can be found on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/