Label: information for the user

Arzolan 20 mg/ml eye drop solution

Dorzolamida

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

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to other peopleeven 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 do not appear in this label.

1.What isArzolanand how it is used

2.What you need to know before starting to use Arzolan

3.How to use Arzolan

4.Possible adverse effects

5.Storage of Arzolan

6.Contents of the package and additional information

Arzolanis an eye drop in sterile solution.Arzolan containsas active ingredient dorzolamida, a compound related to sulfonamides.

Dorzolamidais an ocular carbonic anhydrase inhibitor and reduces elevated intraocular pressure.

It is indicated for the treatment of elevated intraocular pressure in patients with ocular hypertension and glaucoma (open-angle glaucoma, pseudoexfoliative glaucoma).Arzolan may be used alone or in combination with other medications that decrease intraocular pressure (called beta-blockers).

No use Arzolan

• If you are allergic (hypersensitive) to dorzolamide or to any of the other components of this solution.
• If you have severe kidney problems.
• If you have a pH imbalance (acid/base equilibrium) in the blood.

Warnings and precautions

Before starting treatment with Arzolan, consult your doctor:

• If you have or have had liver problems in the past
• If you have been informed that you have a corneal defect
• If you have had an allergy to any medication
• If you have undergone or are about to undergo eye surgery
• If you have had an eye injury or have an eye infection
• If you have a history of kidney stones
• If you are taking another carbonic anhydrase inhibitor
• If you use contact lenses (see the section “Important information about the components of Arzolan”).
• If you experience any eye irritation or new eye problems, such as eye redness or swelling of the eyelids, consult your doctor immediately.
• If you suspect that Arzolan is causing an allergic reaction (for example, skin rash or itching, eye inflammation) discontinue use and consult your doctor as soon as possible.

Children and adolescents

Arzolan should only be used in children if the benefits justify the risks.Your doctor will be able to advise you.

Use of Arzolan with other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, even those obtained without a prescription.

Particularly, consult your doctor if you are using another carbonic anhydrase inhibitor such as acetazolamide.You may be using this type of medication orally, as eye drops, or in any other way.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.Inform your doctor if you are pregnant or intend to become pregnant.You should not use Arzolan during pregnancy unless your doctor recommends it.

You should not use Arzolan during breastfeeding.

Driving and operating machinery

Arzolan may cause dizziness and visual disturbances in some patients.Do not drive or operate machinery until the symptoms have disappeared.

Arzolan contains benzalkonium chloride

This medication may cause eye irritation because it contains benzalkonium chloride.

Avoid contact with soft contact lenses.

Remove contact lenses before application and wait at least 15 minutes before reinserting them.

May alter the color of soft contact lenses.

Follow exactly the administration instructions forArzolanprescribed by your doctor.Consult your doctor or pharmacist if you have any doubts.

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

WhenArzolanis used alone, the usual dose is one drop in the affected eye or eyes three times a day, i.e., in the morning, afternoon, and evening.

If your doctor has recommended the use ofArzolanwith a beta-blocker eye drop (medications that reduce the pressure inside the eye), the usual dose is one drop in the eye or eyes twice a day, for example in the morning and afternoon.

If you are going to useArzolanwith another eye drop, the applications of the different medications should be spaced at least 10 minutes apart.Similarly, when you are going to substitute another eye drop forArzolan, used to reduce eye pressure, you should discontinue the administration of the other medication after taking the appropriate dose of the day and start the administration ofArzolanthe next day.

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

Do not let the tip of the container touch the eyes or surrounding areas.The tip of the container may be contaminated with bacteria capable of causing eye infections that can cause serious eye damage, even blindness.To avoid possible contamination of the container, avoid letting the tip of the container come into contact with any surface.

Usage Instructions:

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.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 press until one drop is dispensed in the eye according to your doctor's instructions.DO NOT TOUCH THE EYE OR EYELID WITH THE TIP OF THE DROPPER.

5.Closure of the eye and pressing with the finger the inner corner of the eye with your finger for approximately two minutes helps to prevent the medication from reaching the rest of the body.

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

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

If you use moreArzolanthan you should

If too many drops are applied to the eye or you swallow part 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 useArzolan

It is essential to administerArzolanas 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 planned dose schedule normally.

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

If you interrupt treatment with Arzolan

Arzolanmust be used daily to achieve the desired effect.If you need to interrupt treatment, consult your doctor immediately.

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

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

The following terms are used to describe how often side effects have been reported:

You may experience any or all of the following side effects with Arzolan

Eye disorders:

Very common:burning and stinging

Common:inflammation or swelling of the surface of the eye or eyes and possible inflammation of the eyelid or eyelids and/or around the eye or eyes, tearing or eye itching, blurred vision, effects on the surface of the eye

Uncommon:inflammation of the middle layer of the eyeball

Rare:swelling of the surface of the eye or eyes, choroidal detachment with symptoms of visual disturbances (after filtration surgery), hypotony of the eye, redness of the eye or eyes, eye pain, crusts on the eyelid, transient myopia (which resolves upon cessation of therapy)

Gastrointestinal disorders:

Common:nausea, bitter taste

Rare:irritation of the throat, dry mouth

General disorders and administration site conditions:

Common:asthenia/fatigue

Rare:Hypersensitivity: signs and symptoms of local reactions (palpebral reactions) and systemic allergic reactions that include swelling of the face, lips, tongue, and/or throat which may cause difficulty breathing or swallowing, urticaria and itching, skin rash, shortness of breath, and rarely bronchospasm (contraction of the smooth bronchial muscle)

Nervous system disorders:

Common:headache

Rare:dizziness, numbness/tingling

Renal and urinary disorders:

Rare:formation of kidney stones

Respiratory, thoracic and mediastinal disorders:

Rare:nasal hemorrhage

Skin and subcutaneous tissue disorders:

Rare:skin inflammation

Cardiac disorders:

Frequency not known: palpitations that may be rapid or irregular, increased heart rate

Vascular disorders:

Frequency not known: 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 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: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Keep out of sight and reach of children.

Do not useArzolanafter 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.

Arzolanmust be used within 28 days after the initial opening of the bottle.Therefore, discard the bottle 4 weeks after first opening, even if solution remains.As a reminder, note the opening date of each bottle in the box space.

Medicines should not be thrown down the drains or in the trash.Deposit the containers and medicines you no longer need at the SIGRE collection pointat the pharmacy.In case of doubt, ask yourpharmacist how to dispose of the containers and medicines you no longer need.This will help protect the environment.

Composition ofArzolan

• The active ingredient is dorzolamide.Each ml contains 20 mg of dorzolamide (equivalent to dorzolamide hydrochloride).
• Theother components are mannitol, hydroxyethyl cellulose, benzalkonium chloride (as a preservative), sodium citrate, sodium hydroxide to adjust the pH, and water for injection preparations.

Appearance of the product and contents of the package

Arzolan is a sterile, isotonic, tamponed colorless, slightly viscous solution in a low-density polyethylene opaque and white bottle with a sealed dropper and a 2-piece cap.Each bottle contains 5 ml of the eye drop solution.

Arzolan is available in packages of 1 bottle with 5 ml of eye drop solution.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Tiedra Farmacéutica, S.L.

C/ Colón, 7

30510 Yecla (Murcia)

Spain

Responsible for manufacturing:

Pharmathen S.A.

6, Dervenakion str.

153 51 Pallini Attiki,

Greece

Last review date of this leaflet: 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.gob.es/