ROZALIN

Package leaflet: Information for the patient

ROZALIN, 20 mg/ml, eye drops, solution
Dorzolamide
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Rozalin is and what it is used for
2. Important information before using Rozalin
3. How to use Rozalin
4. Possible side effects
5. How to store Rozalin
6. Contents of the pack and other information

1. What Rozalin is and what it is used for
The active substance in Rozalin is dorzolamide hydrochloride. It inhibits carbonic anhydrase activity, thereby reducing intraocular pressure.
Indications
Rozalin is indicated to reduce elevated intraocular pressure in patients with:

• ocular hypertension,
• open-angle glaucoma,
• pseudoexfoliative glaucoma.

2. Important information before using Rozalin

When not to use Rozalin

• if the patient is allergic to dorzolamide hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
• if the patient has severe renal impairment or hyperchloremic acidosis.

Warnings and precautions
Before starting treatment with Rozalin, discuss it with your doctor or pharmacist.
Exercise particular caution when using Rozalin:

• in patients with hepatic impairment,
• in the treatment of patients with acute closed-angle glaucoma, in addition to medications reducing intraocular pressure, other therapeutic interventions are necessary. The use of dorzolamide in these patients has not been studied.
• if the patient experiences severe adverse reactions or hypersensitivity symptoms (e.g. rash, severe skin reaction, or itching), treatment should be discontinued immediately and the patient should contact their doctor,
• patients with a history of kidney stones may be at increased risk of developing urinary stones during dorzolamide treatment,
• in clinical studies, local adverse reactions were observed during long-term dorzolamide use, mainly conjunctivitis and eyelid irritation. Some of these reactions were consistent with allergic reactions, which resolved after discontinuation of the drug. In such cases, the patient should contact their doctor, who will consider whether treatment with dorzolamide should be discontinued,
• concomitant treatment with systemic carbonic anhydrase inhibitors is not recommended,
• dorzolamide should be used with caution in patients with previously diagnosed chronic corneal defects and/or a history of intraocular surgery,
• in patients who have undergone filtration surgery.

Children
The use of this medicine is not recommended in children.
Rozalin and other medicines
Inform your doctor about all medicines currently used or recently used, as well as any medicines you plan to use.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy
Rozalin must not be used during pregnancy.
Breastfeeding
It is not known whether dorzolamide is excreted in human milk. Rozalin should not be used during breastfeeding.
Considering the importance of therapy for the mother's health, the doctor will assess the need to discontinue breastfeeding or to stop using the medicine.
Driving and operating machinery
In some patients using Rozalin, adverse reactions such as dizziness and visual disturbances may occur, which could affect the ability to drive or operate machinery (see section 4. Possible side effects).
Rozalin contains benzalkonium chloride
This medicine contains 0.075 mg of benzalkonium chloride per ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may alter their color. Contact lenses should be removed before instillation and at least 15 minutes should elapse before reinsertion.
Benzalkonium chloride may also cause eye irritation, particularly in patients with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If abnormal sensations, stinging, or eye pain occur after using the medicine, contact your doctor.

3. How to use Rozalin

This medicine should always be used exactly as prescribed by the doctor. In case of doubt, consult your doctor or pharmacist.
Recommended dose
If Rozalin is the only eye medication being used, the recommended dose is one drop instilled into the affected eye(s) three times daily.
If your doctor has additionally prescribed a beta-adrenergic blocking agent in the form of eye drops to reduce intraocular pressure, the recommended dose of Rozalin is one drop into the affected eye(s) twice daily.
If your doctor decides to replace another locally administered anti-glaucoma medicine with Rozalin, discontinue the previous treatment and start using Rozalin the following day.
If another eye drop medication is being used in addition to Rozalin, at least a ten-minute interval should be maintained between instilling the different eye drops.
Do not change the dosage without consulting your doctor. If treatment must be interrupted, contact your doctor immediately. To avoid contamination of the solution, do not let the dropper tip touch the eye, surrounding areas, or any other surface.

Instructions for use

1. Before first use, ensure the bottle is originally sealed with a security band. In a new package, the gap between the bottle and cap is normal.
2. To open the bottle, break the security band by unscrewing the cap.
3. Tilt your head backward and pull the lower eyelid downward to create a small pocket between the eyelid and the eyeball.
4. Invert the bottle and gently press with your thumb or index finger on the side until one drop of the medicine is dispensed into the eye. DO NOT LET THE DROPPER TIP TOUCH THE EYE, EYELID, OR ANY OTHER SURFACES.
5. Close the eye and press gently on the inner corner of the eye (near the nose) with a finger for about two minutes. This helps prevent the medicine from draining into the systemic circulation.
6. If your doctor has instructed you to instill the drop in the other eye, repeat steps 3, 4, and 5 for the second eye.
7. The dropper is designed to deliver exactly one drop; therefore, DO NOT ENLARGE THE OPENING OF THE DROPPER.
8. After instillation, screw the cap back on the bottle. Do not over-tighten.
9. After using the prescribed amount of medicine, a small additional amount may remain in the container. This is an intentional surplus to ensure the prescribed volume (5 mL) can be fully administered. Do not attempt to squeeze out the remaining solution.

Use of Rozalin in patients with kidney or liver function disorders
Inform your doctor about any past or current kidney or liver diseases.
Additional information: see section 2 – Warnings and precautions.

Overdose of Rozalin
If the contents of the bottle are accidentally swallowed, contact a doctor immediately.

Missed dose of Rozalin
Rozalin should be used as prescribed by your doctor. If you miss a dose, instill it as soon as possible. However, if it is almost time for the next dose, do not administer the missed dose; resume your regular dosing schedule.
Do not use a double dose to make up for a missed dose.

Stopping treatment with Rozalin
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If the patient experiences allergic reactions, including rash, swelling of the face, lips, tongue and/or
throat, which may cause difficulty in breathing or swallowing, or other serious adverse reactions occur,
treatment with Rozalin should be discontinued immediately and the patient should contact a doctor or
the nearest hospital Emergency Department without delay.

The most commonly observed adverse reactions associated with dorzolamide administration, as well as local symptoms, included:

• bitter taste in the mouth,
• burning and stinging in the eyes,
• blurred vision, eye itching, tearing,
• headache, conjunctivitis, blepharitis,
• nausea, eyelid irritation, and feelings of weakness and fatigue.

The most common reason (in approximately 3% of patients) for discontinuation of treatment with Rozalin was ocular adverse reactions, particularly drug-induced conjunctivitis and eyelid reactions. Iridocyclitis and rash were observed rarely. Urinary stones were reported in one case.

Following the introduction of dorzolamide-containing medicinal products into clinical use, the following adverse reactions have been reported:
Adverse reactions are listed in order of their likelihood of occurrence.

Very common: more than 1 in 10 patients

• burning and stinging in the eyes.

Common: not more than 1 in 10 patients

• headache,
• superficial punctate keratitis,
• tearing, conjunctivitis, blepharitis,
• eye itching, eye irritation, visual disturbances,
• nausea, bitter taste, fatigue.

Uncommon: not more than 1 in 100 patients

• iridocyclitis.

Rare: not more than 1 in 1,000 patients

• paresthesia, dizziness,
• irritation including redness, pain, eyelid sticking, transient myopia,
• corneal edema, reduced intraocular pressure,
• choroidal detachment following filtration surgery,
• epistaxis, throat irritation, dry mouth,
• contact dermatitis,
• severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis),
• urinary stones,
• hypersensitivity reactions: subjective and objective symptoms of local reactions, including eyelid reactions, and symptoms of systemic allergic reactions, including angioedema, bronchospasm, urticaria, pruritus.

Not known: cannot be estimated from available data

• dyspnea,
• foreign body sensation in the eye (feeling that something is in the eye),
• strong, possibly rapid or irregular heartbeat (palpitations),
• increased heart rate,
• increased blood pressure,
• unusual sensitivity of the eyes to light.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Rozalin

Keep the medicine out of sight and reach of children.
Store below 25°C.
Keep the bottle in the outer packaging.
Keep the bottle tightly closed.
Do not use after the expiry date stated on the label.
The shelf life after first opening the bottle is 4 weeks.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Rozalin contains
The active substance is dorzolamide. 1 ml of solution contains 20 mg of dorzolamide in the form of
dorzolamide hydrochloride.
The other ingredients are: mannitol, sodium citrate, hydroxyethylcellulose, benzalkonium chloride
(1 N solution), sodium hydroxide (1 N solution), water for injections.

What Rozalin looks like and contents of the pack
Eye drops, solution.
Pack: white bottle with dropper made of LDPE and white screw cap made of HDPE and LDPE, in a cardboard box.
Available pack sizes:
Box containing 1 or 3 bottles with 5 ml of solution.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
tel. +48 22 732 77 00

Manufacturer
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Rafarm S.A.,
Paiania 19002,
Attiki, Greece
January 2026