DIMAZ 20 mg/ml EYE DROPS SOLUTION

2. What you need to know before you use Dimaz

Do not useDimaz

• If you are allergic to dorzolamida or any of the other ingredients of this medicine (included in section 6);
• If you have been diagnosed with severe kidney disorder or blood pH disorder.

Warnings and precautions

Consult your doctor before starting to use Dimaz:

• if you have a history of kidney stones;
• if you have or have had liver function disorders;
• if you have been diagnosed with corneal defects;
• if you have had an allergy to any medicine in the past;
• if you have undergone eye surgery or have scheduled such surgery;
• if you have an eye infection or have suffered an eye injury.

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

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

If you use contact lenses, you must consult your doctor before using Dimaz. Before instilling this medicine, remove your contact lenses and reapply them at least 15 minutes after instillation.

Children and adolescents

Studies with dorzolamida were carried out in infants and children under 6 years of age diagnosed with glaucoma or high eye pressure (eyes). For detailed information, talk to your doctor, who will decide whether to use this medicine or not.

Elderly patients

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

Other medicines andDimaz

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines (including eye drops). This is especially important if you are taking another carbonic anhydrase inhibitor such as acetazolamide or a sulfonamide.

Pregnancy, breastfeedingand fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

You should not use this medicine during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant.

Breastfeeding

You should not use this medicine during breastfeeding. Tell your doctor if you are breastfeeding or plan to breastfeed.

Fertility

Data obtained from animals do not suggest an effect of treatment with dorzolamida on male and female fertility. No data are available in humans.

Driving and using machines

During treatment with this medicine, dizziness and visual disturbances may occur that interfere with driving and using machines. Do not drive vehicles or use machines until these symptoms disappear.

3. How to use Dimaz

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

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

If you use Dimaz as the only medicine, the usual dose is one drop in the affected eye(s) three times a day, e.g., in the morning, at noon, and at night.

If your doctor prescribes Dimaz with another medicine to reduce pressure in the eye(s), the usual dose is one drop in the affected eye(s) twice a day, e.g., in the morning and in the evening.

If you use other eye medicines at the same time, keep a 10-minute interval between the administration of these medicines. Ophthalmic ointments should be administered last.

If you need to replace a previous eye drop medicine with Dimaz, stop treatment with the previous medicine (after administration of the recommended dose that day) and start using Dimaz the next day.

Do not change the dosage 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 pack.

Before instilling the eye drops:

• When using for the first time, before administering a drop in the eye, first practice using the dropper bottle by slowly squeezing it to administer a drop in the air, away from the eye.
• When you are confident that you can administer a drop, choose the position that is most comfortable for you to instill 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 medicine.

1. If the box or bottle is damaged, do not use the medicine.

1. When using the medicine for the first time, you must unscrew the cap after making sure that the tamper-evident ring on the cap has not been broken. You should feel a slight resistance until this tamper-evident ring breaks (see Image 1).

1. If the tamper-evident ring is loose, it must be discarded because it may fall into the eye and cause injury.

1. Tilt your head back and gently pull down the 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 avoid contaminating the solution.

1. Apply one drop into the pouch by slowly pressing the bottle. Squeeze the bottle gently in the middle and let one drop fall into the eye. There may be a delay of a few seconds between pressing and the drop coming out (see Image 3). Do not squeeze too hard. If you are not sure how to administer this medicine, ask your doctor, pharmacist, or nurse.

1. 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.

1. Repeat steps 5, 6, and 7 in the other eye if your doctor has indicated so.

1. After use and before recapping, shake the bottle once downward, without touching the dropper tip, to eliminate any residual liquid on the tip. This is necessary to ensure the delivery of subsequent drops. Screw the cap back onto 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 you apply too many drops in the eye or 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forgetto use Dimaz

It is important to use this medicine as your doctor has prescribed. 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 normally.

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

If you stop usingDimaz

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you develop allergic reactions, 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 dorzolamida during clinical trials or after marketing:

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

Burning and stinging in the eyes.

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

Disease of the cornea with eye pain and blurred vision (superficial punctate keratitis), tearing, discharge with itching eyes (conjunctivitis), irritation/inflammation of the eyelids, blurred vision, headache, nausea, bitter taste, and fatigue.

Uncommon 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)

Numbness and tingling of hands and feet, transient myopia (which resolves when the medicine is stopped), fluid formation under the retina (choroidal detachment, after filtration surgery), eye pain, crusts on the eyelid, low eye pressure, corneal edema (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 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.

Frequency not known (cannot be estimated from the available data)

Breathing difficulties.

Feeling of a foreign body in the eye (feeling of having something in the eye).

Strong and irregular heartbeats.

Increased heart rate.

Increased blood pressure.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Dimaz

This medicine does not require special storage conditions.

Once opened, do not store above 25°C.

5 ml bottle:

Discard 60 days after the first opening of the bottle.

10 ml bottle:

Discard 90 days after the first opening of the bottle.

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

Do not use this medicine after the expiry date which is stated on the carton and on the label of the bottle after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition ofDimaz

• The active substance is dorzolamida. Each ml contains 20 mg of dorzolamida (in the form of 22.26 mg of dorzolamida hydrochloride).

Each drop (approximately 35 microliters (µl)) contains 0.70 mg of dorzolamida.

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

Appearance of the product and contents of the pack

Dimaz is a sterile, colorless, transparent, and viscous liquid.

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

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

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

BRILL PHARMA, S.L.

C/ Munner, 8

08022 Barcelona

Spain

Manufacturer

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 under the following names:

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

Germany - Dimaz 20 mg/ml eye drops, solution

Spain - Dimaz 20 mg/ml eye drops solution

Date of the last revision of this leaflet: June 2024

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.es/)