Package Insert: Information for the Patient

Dimaz 20mg/ml eye drop solution

Dorzolamida

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

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for 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, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

Dimazis an ophthalmic medication without preservatives in sterile drop form that contains dorzolamide as the active ingredient. Dorzolamide belongs to a group of medications 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 reduce eye pressure (called beta-blockers).

No useDimaz

• If you are allergic to dorzolamida or any of the other components of this medication (listed in section 6);
• If you have been diagnosed with severe kidney disease or a blood pH disorder.

Warnings and precautions

Consult your doctor before starting to useDimaz:

-If you have a history of kidney stones;

-If you have or have had any liver function disorders;

-If you have been diagnosed with corneal defects;

-If you have had an allergy to any medication in the past;

-If you have undergone eye surgery or have scheduled surgery;

-If you have an eye infection or have had an eye injury.

If you experience eye irritation or symptoms such as redness or itching in the eye and/or eyelids during the use of this medication, consult your doctor immediately.

If you suspect that this medication is causing an allergic reaction (symptoms: skin rash, itching, swelling of the lips, eyes, and mouth, difficulty breathing, wheezing), stop using this medication and consult your doctor immediately.

If you wear contact lenses, you must consult your doctor before usingDimaz. Before instilling this medication, remove your contact lenses and reapply them at least 15minutes after instillation.

Children and adolescents

Studies were conducted with dorzolamida in infants and children under 6 years old diagnosed with glaucoma or elevated intraocular pressure (eyes). For detailed information, speak with your doctor, who will decide whether to use this medication or not.

Older patients

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

Other medications andDimaz

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication(including eye drops). This is particularly important if you are taking another carbonic anhydrase inhibitor such as acetazolamide or a sulfonamide.

Pregnancy, lactationand fertility

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

Pregnancy

You should not use this medication during pregnancy. Inform your doctor if you are pregnant or intend to become pregnant.

Lactation

You should not use this medication during breastfeeding. Inform your doctor if you are breastfeeding or intend to breastfeed.

Fertility

Animal studies do not suggest an effect of dorzolamida treatment on male and female fertility. No human data are available.

Driving and operating machinery

During treatment with this medication, dizziness and visual disturbances may occur that interfere with driving and operating machinery. Do not drive vehicles or use machinery until these symptoms have disappeared.

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.

If Dimaz is used as the only medication, the usual dose is one drop in the affected eye(s) three times a day, for example, in the morning, at noon, and at night.

If your doctor prescribes Dimaz with another medication to reduce eye pressure, the usual dose is one drop in the affected eye(s) two times a day, for example, in the morning and in the afternoon.

If you use other eye medications simultaneously, maintain a 10-minute interval between the administration of these medications. Ophthalmic ointments should be administered last.

If it is necessary to replace a previous eye drop medication with Dimaz, stop treatment with the previous medication (after administering the recommended dose that day) and start using Dimaz the next day.

Do not modify the dosing regimen of Dimaz without consulting your doctor.

Dimaz is a sterile solution that does not contain preservatives. See also Section 6 - Appearance of the product and contents of the package.

Before instilling the eye drop:

-When using for the first time, before administering a drop in the eye, first practice the use of the dropper bottle by slowly pressing it to administer a drop in the air, away from the eye.

-When confident that a drop can be administered, choose the position that feels most comfortable for instilling the drops (you can sit, lie on your back, or stand in front of a mirror).

Instructions for use:

1.Wash your hands carefully before using this medication.

2.If the box or bottle is damaged, do not use the medication.

3.When using the medication for the first time, remove the cap after ensuring that the sealed ring of the cap has not been broken. You should feel a slight resistance until this tamper-evident ring breaks (see Image 1).

4.If the tamper-evident ring is loose, discard it because it may fall into the eye and cause injury.

5.Tilt your head back and gently lower your lower eyelid to form a pouch between the eye and the eyelid (see Image 2). You should avoid contact between the tip of the bottle and the eyes, eyelids, or fingers to prevent contamination of the solution.

6.Apply one drop to the pouch by slowly pressing the bottle. Squeeze the bottle gently in the middle and let a drop fall into the eye. There may be a delay of a few seconds between the pressure and the drop's release (see Image 3). Do not squeeze too hard. If unsure how to administer this medication, ask your doctor, pharmacist, or nurse.

7.Close your eye and press the inner corner of the eye with your finger for about two minutes. This helps prevent the drop from reaching the rest of the body.

8.Repeat steps 5, 6, and 7 in the other eye if your doctor has instructed you to do so.

9.After use and before re-capping, shake the bottle once downwards, without touching the tip of the dropper, to remove any residual liquid in the tip. This is necessary to ensure the delivery of subsequent drops. Tighten the cap of the bottle after application (see Image 4).

If a drop does not reach the eye, try again.

Image 1Image 2Image 3Image 4

If you use more Dimaz than you should

If too many drops are applied to the eye or you swallow part of the contents of the bottle, contact 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, indicating the medication and the amount ingested.

If you forgetto use Dimaz

It is essential to use this medication as prescribed by your doctor. If you forget to administer 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 dosing schedule normally.

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

If you interrupt treatment withDimaz

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

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

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

If you develop an allergic reaction, such as hives, swelling of the face, lips, tongue, and (or) throat, which cause difficulty breathing and swallowing or severe skin reactions with blistering or peeling, stop using this medicine and contact your doctor immediately.

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

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

Burning and stinging sensation in the eyes.

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

Corneal disease with eye pain and blurred vision (superficial punctate keratitis), tearing, discharge with itchy eye sensation (conjunctivitis), eyelid irritation/inflammation, blurred vision, headache, nausea, bitter taste, and fatigue.

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

Inflammation of the iris and ciliary body of the eye (iridocyclitis).

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

Tickling and numbness of hands and legs, transient myopia (which resolves upon discontinuing the use of the medicine), formation of fluid under the retina (choroidal detachment, after glaucoma filtration surgery), eye pain, crusts on the eyelid, low eye pressure, corneal edema (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 with blisters or peeling (Stevens-Johnson syndrome, toxic epidermal necrolysis), allergic reactions such as skin rash, hives, itching. In rare cases, swelling of the lips, eyes, and mouth, difficulty breathing, and wheezing.

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, 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 theSpanish System for 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 medicine.

This medication does not require special storage conditions.

Once opened, do not store at a temperature above 25°C.

5 ml bottle:

Discard 60 days after the first bottle opening.

10 ml bottle:

Discard 90 days after the first bottle opening.

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

Do not use this medication after the expiration date that appears on the box and on the bottle label after CAD. The expiration date is the last day of the month indicated.

Medications should not be thrown away through drains or in the trash. Dispose of containers and medications you no longer need at the SIGRE Pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. In this way, you will help protect the environment.

Composition ofDimaz

• The active ingredient is dorzolamide.Cada ml contains 20 mg of dorzolamide (in the form of 22,26 mg of hydrochloride of dorzolamide).

Cada gota (approximately 35microliters (µl)) contains 0.70 mg of dorzolamide.

• The other components are hydroxyethylcellulose, mannitol, sodium citrate, sodium hydroxide (to adjust pH),water for injectable preparations.

Appearance of the product and contents of the packaging

Dimazis a sterile, colorless, transparent, and viscous liquid.

It is presented in white LDPE bottles (5 ml, 11 ml) with a HDPE multidose dropper applicator, which prevents contamination of the content thanks to a silicone valve system and filtered air return to the bottle and the HDPE screw cap, and the cardboard box.

Packaging sizes:1 x 5 ml, 3 x 5 ml, 1 x 10 ml, 2 x 10 ml.

Only some packaging sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

BRILL PHARMA, S.L.

C/ Munner, 8

08022 Barcelona

Spain

Responsible for manufacturing

Rafarm S.A.

Thesi Pousi Xatzi Agiou Louka

Paiania, 190 02

Greece

FRINO Pharm e.K.

Keplerweg 3

82538 Geretsried

Germany

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

Republic of Czech -Dorzolamide Farmaprojects 20 mg/ml eye drops, solution

Germany -Dimaz 20 mg/ml eye drops, solution

Spain -Dimaz 20 mg/ml eye drops in solution

Last review date of this leaflet: June 2024

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