Rozalin

Package Leaflet: Information for the Patient

ROZALIN, 20 mg/ml, Eye Drops, Solution

Dorzolamidum

Read the package leaflet carefully before using the medicine, as it contains

important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor and is intended for your use only. Do not give it to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Rozalin and what is it 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 package and other information

1. What is Rozalin and what is it used for

The active substance of Rozalin is dorzolamid hydrochloride. It inhibits the activity of carbonic anhydrase, which leads to a decrease in intraocular pressure.

Indications for Use

Rozalin is recommended to reduce increased intraocular pressure in patients with:

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

2. Important information before using Rozalin

When not to use Rozalin

• if you are allergic to dorzolamid hydrochloride or any other ingredient of this medicine (listed in section 6).
• if you have severe renal impairment or hyperchloremic acidosis.

Warnings and Precautions

Before starting treatment with Rozalin, discuss it with your doctor or pharmacist.
Be particularly cautious when using Rozalin:

• in patients with liver failure,
• in the treatment of patients with acute angle-closure glaucoma, in addition to administering drugs that reduce intraocular pressure, other therapeutic interventions are also necessary. The use of dorzolamid in these patients has not been studied.
• in patients who experience severe side effects or symptoms of hypersensitivity (e.g., rash, severe skin reaction, or itching), discontinue the use of the medicine and contact your doctor,
• patients with a history of kidney stones may be at increased risk of developing kidney stones in connection with the use of dorzolamid,
• in clinical trials, during long-term use of dorzolamid, local side effects were observed, mainly conjunctivitis and eyelid irritation. Some of these symptoms had the course of an allergic reaction, which disappeared after discontinuation of the medicine. In these situations, contact your doctor, who will consider the need to discontinue treatment with dorzolamid.
• in patients treated with oral carbonic anhydrase inhibitors, concomitant treatment with dorzolamid is not recommended,
• in patients with previously diagnosed chronic corneal defects and (or) a history of intraocular procedures, dorzolamid should be used with caution,
• in patients after filtration procedures.

Children

The use of Rozalin in children is not recommended.

Rozalin and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
Pregnancy
Do not use Rozalin in pregnant women.
Breastfeeding
It is not known whether dorzolamid is excreted in breast milk. Rozalin should not be used during breastfeeding.
Considering the importance of therapy for the mother's health, the doctor will consider the possibility of discontinuing breastfeeding or using the medicine.

Driving and using machines

In some patients using Rozalin, there is a possibility of side effects that may affect the ability to drive vehicles and operate machinery, such as dizziness and vision disturbances (see section 4. Possible side effects).

Rozalin contains benzalkonium chloride

The medicine contains 0.075 mg of benzalkonium chloride per 1 ml.
Benzalkonium chloride may be absorbed by soft contact lenses and change their color. Remove contact lenses before instillation and wait at least 15 minutes before reinserting.
Benzalkonium chloride may also cause eye irritation, especially in people with dry eye syndrome or corneal disorders (the transparent layer on the front of the eye). If you experience any abnormal sensations in the eye, stinging, or eye pain after using the medicine, contact your doctor.

3. How to use Rozalin

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Recommended dose
If Rozalin is the only eye medicine you are using, it is recommended to instill one drop into the affected eye (eyes) three times a day.
If your doctor has also prescribed a beta-adrenergic blocker eye drop to reduce intraocular pressure, the recommended dose of Rozalin is one drop into the affected eye (eyes) twice a day.
If your doctor decides to replace another anti-glaucoma medicine with Rozalin, discontinue the other medicine and start using Rozalin the next day.
If you are using another eye drop medicine in addition to Rozalin, wait at least 10 minutes between instillations.
Do not change the dose without consulting your doctor. If you need to discontinue the use of the medicine, consult your doctor immediately. To avoid contamination of the solution, do not touch the dropper tip to the eye, its surroundings, or any other surface.

Instructions for use

• 1. Before using the medicine for the first time, make sure the bottle is originally sealed with a strip. In a new package, the gap between the bottle and the cap is normal.
• 2. To open the bottle, break the protective strip by twisting the cap.
• 3. Tilt your head back and pull the lower eyelid down to create a pocket between the eyelid and the eye.
• 4. Turn the bottle upside down and gently press the thumb or index finger on the wall until one drop of the medicine falls into the eye. DO NOT TOUCH THE DROPPER TIP TO THE EYE, EYELID, OR OTHER SURFACES.
• 5. Close your eye and press the inner corner of the eye with your finger for about two minutes. This helps prevent the medicine from entering the entire body.
• 6. If your doctor has prescribed instillation into the second eye, repeat steps 3, 4, and 5.
• 7. The dropper is designed to measure exactly one drop, so DO NOT ENLARGE THE OPENING IN THE DROPPER.
• 8. After instillation, screw the bottle cap back on. However, do not tighten it too much.
• 9. After using the prescribed amount of medicine, a small amount of it remains in the package. This is an intentional excess to ensure the use of the prescribed amount of medicine (5 ml). Do not try to squeeze out the excess solution from the package.

Using Rozalin in patients with renal or hepatic impairment

Inform your doctor about any past or current kidney or liver diseases.
Additional information: see section 2 - Warnings and precautions.

Using a higher dose of Rozalin than recommended

In case of swallowing the contents of the bottle, contact your doctor immediately.

Missing a dose of Rozalin

Rozalin should be used as directed by your doctor. If you miss a dose, use it as soon as possible. However, if it is almost time for the next dose, do not use the missed dose, and return to the previously established dosing schedule.
Do not use a double dose to make up for the missed dose.

Discontinuing the use of Rozalin

If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Rozalin can cause side effects, although not everybody gets them.
If you experience allergic reactions, including rash, swelling of the face, lips, tongue, and/or
throat, which may cause difficulty breathing or swallowing, or other severe side effects, discontinue
the use of Rozalin and contact your doctor or the Emergency Department of the nearest hospital
immediately.
The most common side effects associated with the use of dorzolamid and local symptoms were:

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

The most common (in about 3% of patients) reason for discontinuing treatment with Rozalin was eye side effects, mainly drug-induced conjunctivitis and eyelid reactions. Rarely, uveitis and skin rash were observed. In one case, kidney stones were reported.
After the introduction of dorzolamid into clinical practice, the following side effects were reported:
Side effects are listed in order of their likelihood of occurrence.
Very common:more than 1 in 10 patients

• burning and stinging of the eyes.

Common:less than 1 in 10 patients

• headache,
• superficial punctate keratitis,
• tearing, conjunctivitis, eyelid inflammation,
• itching of the eyes, eye irritation, vision disturbances,
• nausea, bitter taste, fatigue.

Uncommon:less than 1 in 100 patients

• uveitis.

Rare:less than 1 in 1000 patients

• paresthesia, dizziness,
• irritation, including redness, pain, eyelid sticking, transient myopia,
• corneal edema, decreased intraocular pressure,
• choroidal detachment after filtration procedures,
• epistaxis, throat irritation, dry mouth,
• contact dermatitis,
• severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis),
• kidney stones,
• hypersensitivity reactions: subjective and objective symptoms of local reactions, including reactions in the eyelids, and symptoms of general allergic reactions, including angioedema, bronchospasm, urticaria, itching.

Unknown:cannot be estimated from available data

• dyspnea,
• feeling of a foreign body in the eye (feeling that something is in the eye),
• palpitations, which may be rapid or irregular (heart pounding),
• tachycardia,
• increased blood pressure.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Rozalin

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Keep the bottle in the outer packaging.
Shelf life after first opening the bottle: 4 weeks.
Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the package and other information

What Rozalin contains

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

What Rozalin looks like and contents of the package

Eye drops, solution.
Packaging: white bottle with a dropper made of LDPE and a white cap made of HDPE and LDPE in a cardboard box.
Available package sizes:
Box containing 1 or 3 bottles of 5 ml solution each.
Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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

Date of last revision of the leaflet: