Rozaduo, 40 micrograms/ml + 5 mg/ml, eye drops, solution
Travoprost + Timolol

Please read this leaflet carefully before using the medicine, as 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 consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, 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.

Table of contents
What Rozaduo is and what it is used for
Important information before using Rozaduo
How to use Rozaduo
Possible side effects
How to store Rozaduo
Contents of the pack and other information

What Rozaduo is and what it is used for
Rozaduo eye drops contain two active substances (travoprost and timolol). Travoprost is a prostaglandin analogue that works by increasing the outflow of fluid from the eye, thereby reducing intraocular pressure. Timolol is a beta-adrenergic blocking agent that works by reducing the production of fluid within the eye. Together, these substances help lower intraocular pressure.

Rozaduo eye drops are used to treat elevated intraocular pressure in adults, including elderly patients. This condition may lead to the development of a disease called glaucoma.

Important information before using Rozaduo

When not to use Rozaduo:

if you are allergic to travoprost, timolol, or any of the other ingredients of this medicine (listed in section 6),
if you are allergic to prostaglandins or beta-adrenergic blocking agents,
if you currently have or have ever had respiratory problems such as: asthma, severe chronic obstructive pulmonary disease [severe lung disease that may cause wheezing, difficulty breathing, and/or persistent cough], or any other breathing difficulties,
if you have severe rhinitis,
if you have a slow heart rate, heart failure, or heart rhythm disorders (irregular heartbeat),
if the surface of your eye is clouded.

If any of the above conditions apply to you, consult your doctor.

Warnings and precautions
Before starting Rozaduo, discuss with your doctor or pharmacist if you have or have ever had any of the following:

ischemic heart disease (symptoms may include chest pain or pressure, shortness of breath, or tightness), heart failure, low blood pressure;
heart rhythm disorders, such as slow heartbeat;
breathing difficulties, asthma, or chronic obstructive pulmonary disease;
circulatory disorders (such as Raynaud's disease or Reynaud's syndrome);
diabetes, because timolol may mask the subjective and objective symptoms of hypoglycemia;
hyperthyroidism, because timolol may mask the subjective and objective symptoms of thyroid disease;
myasthenia gravis (chronic muscle fatigue);
any severe allergic reaction (skin rash, redness, itching of the eye) during treatment with Rozaduo, as regardless of the cause, adrenaline may not be effective. Therefore, when receiving any other treatment, inform your doctor that you are using Rozaduo;
cataract surgery;
eye inflammation.

Before any planned surgery, inform your doctor that you are using Rozaduo, as timolol may affect the action of certain drugs used during anesthesia.

Rozaduo may change the color of the iris (the colored part of the eye); this change may be permanent.
Rozaduo may increase the length, thickness, color, and/or number of eyelashes and may cause unusual hair growth on the eyelids.

Travoprost may be absorbed through the skin and therefore should not be used by women who are pregnant or planning to become pregnant. If any amount of the medicine comes into contact with the skin, wash it off immediately.

Children
Rozaduo is not intended for use in children and adolescents under 18 years of age.

Rozaduo and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.

Rozaduo may alter the effect of other medicines taken simultaneously, or those medicines may alter the effect of Rozaduo; this includes other eye drops used in glaucoma treatment. Inform your doctor if you are taking or plan to take:

medicines that lower blood pressure,
medicines used to treat heart conditions, including quinidine (used to treat heart rhythm disorders and certain types of malaria),
antidiabetic or antidepressant medicines such as fluoxetine and paroxetine.

Pregnancy, breastfeeding, and fertility
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine.

Do not use Rozaduo during pregnancy unless your doctor considers it absolutely necessary. If you could become pregnant, you should use an appropriate method of contraception while using this medicine.

Do not use Rozaduo while breastfeeding. Rozaduo may pass into breast milk.

Driving and operating machinery
For a short time after instillation, vision may be blurred. In some patients, Rozaduo may also cause hallucinations, dizziness, nervousness, or fatigue. Until these symptoms subside, do not drive or operate machinery.

Rozaduo contains benzalkonium chloride and macrogol glycerol hydroxystearate 40
Rozaduo contains 150 micrograms of benzalkonium chloride per milliliter of solution. Benzalkonium chloride may be absorbed by soft contact lenses and may alter their color. Remove contact lenses before instilling the drops and wait at least 15 minutes before reinserting them. Benzalkonium chloride may also cause eye irritation, especially in patients with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If you experience abnormal sensations in the eye, stinging, or pain after using the medicine, contact your doctor.

This medicine contains macrogol glycerol hydroxystearate 40, which may cause skin reactions.

How to use Rozaduo
Always use this medicine exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

Recommended dose
One drop into the affected eye or eyes once daily – in the morning or evening.
Use the medicine every day at the same time.
Rozaduo may be used in both eyes only if specifically instructed by your doctor. Continue using the medicine for as long as your doctor recommends.

Rozaduo is intended solely for instillation into the eyes and only for the patient to whom it was prescribed.

Instructions for use

Fig. 1	Immediately before first use of the bottle, open the sachet, remove the bottle (Figure 1), and write the date of opening in the space provided for this purpose on the label. Prepare the eye drop bottle and a mirror. Wash your hands. Unscrew the cap.
Fig. 2	Hold the inverted bottle between your thumb and fingers. Lean your head back. With a clean finger, gently pull the lower eyelid downwards to form a "pocket" between the eyeball and the eyelid; the drop should be instilled into this pocket (Figure 2). Bring the tip of the bottle close to the eye. For convenience, you may use a mirror.
	Do not let the dropper tip touch the eye, eyelid, surrounding areas, or any other surface. Touching may lead to contamination of the drops.
Fig. 3	Gently press the bottom of the bottle to release a single drop of Rozaduo eye drops at the appropriate time (Figure 3).
Fig. 4	After administering the eye drop, press with a finger at the inner corner of the eye near the nose for 2 minutes (Figure 4). This helps prevent the medicine from being absorbed into the rest of the body. If using drops in both eyes, repeat the procedure described above for the second eye. Immediately after use, close the bottle with the cap. Only one bottle should be used at a time. Do not open a new sachet until the next bottle is needed. To prevent infection, discard the bottle 4 weeks after first opening and use the next bottle.

If the drop does not enter the eye, repeat the instillation attempt.
Use of a higher than recommended dose of Rozaduo
If more than the recommended dose of Rozaduo has been used, flush the eye by rinsing with warm water. Do not instill any more drops until the next regularly scheduled dose.
Missed dose of Rozaduo
If a dose of Rozaduo has been missed, continue treatment according to the normal dosing schedule. Do not use a double dose to make up for the missed dose. The dose administered to the affected eye(s) should not exceed one drop per day.
Stopping treatment with Rozaduo
If treatment with Rozaduo is stopped without consulting a doctor, intraocular pressure will not be controlled, which may lead to loss of vision.
If other eye drops are being used, wait at least 5 minutes between instilling Rozaduo and applying other eye drops.
If the patient wears soft contact lenses, do not instill Rozaduo while wearing them. After instillation, wait 15 minutes before reinserting contact lenses.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
Possible adverse effects
Like all medicines, this product can cause adverse effects, although not everyone experiences them.
Usually, you can continue using the drops unless the adverse effects are severe.
If you are concerned, consult your doctor or pharmacist. Do not stop using Rozaduo without consulting your doctor.
Very common adverse effects (may occur in more than 1 in 10 people):
Eye-related symptoms: eye redness
Common adverse effects (may occur in up to 1 in 10 people):
Eye-related symptoms: surface eye inflammation with damage to the eye surface, eye pain, blurred vision, abnormal vision, dry eye, eye itching, eye discomfort, subjective and objective eye irritation symptoms (e.g., burning, stinging).
Uncommon adverse effects (may occur in up to 1 in 100 people):
Eye-related symptoms: surface eye inflammation, eyelid inflammation, conjunctival swelling, increased eyelash growth, iris inflammation, eye inflammation, light sensitivity, visual disturbances, eye fatigue, eye allergy, eye swelling, increased tear production, eyelid redness, eyelid color change, skin darkening (around the eye).
General adverse effects: drug allergy, dizziness, headache, increased or decreased blood pressure, shortness of breath, excessive hair growth, postnasal drip, skin inflammation and itching, slow heart rate.
Rare adverse effects (may occur in up to 1 in 1000 people):
Eye-related symptoms: thinning of the eye surface, inflammation of eyelid glands, damage to eye blood vessels, crusts on eyelid margins, eyelash growth in atypical locations, abnormal eyelash growth.
General adverse effects: nervousness, irregular heartbeat, hair loss, voice disturbances, breathing difficulties, cough, throat irritation, urticaria, abnormal blood test results indicating liver function, skin discoloration, excessive thirst, fatigue, nasal discomfort, discolored urine, pain in hands and feet.
Frequency not known (frequency cannot be estimated from available data):
Eye-related symptoms: eyelid drooping (eye remains half-closed), enophthalmos (eyes appear sunken), changes in iris color (colored part of the eye).
General adverse effects: rash, heart failure, chest pain, stroke, loss of consciousness, depression, asthma, rapid heartbeat, tingling or numbness, palpitations, swelling of lower limbs, taste disturbances.
Additional adverse effects:
Rozaduo is a combination of two active substances. As with other ophthalmic medications, travoprost and timolol (a beta-blocker) may be absorbed into the bloodstream. This may cause adverse effects similar to those observed with intravenous and/or oral administration of beta-adrenergic receptor blocking agents. The frequency of adverse effects after local ocular administration is lower than when these drugs are administered orally or by injection.
The following adverse effects are listed, taking into account reactions observed across the entire class of beta-blockers used in eye diseases:
Eye-related symptoms: eyelid inflammation, corneal inflammation, retinal detachment (separation of the layer beneath the retina containing blood vessels) following filtration surgery, which may cause visual disturbances, reduced corneal sensitivity, corneal ulceration (damage to the front layer of the eyeball), double vision, eye discharge, periorbital swelling, eyelid itching, eyelid eversion with redness, eye irritation and excessive tearing, blurred vision (indicative of lens opacification), swelling of ocular tissues (uveal layer), eyelid rash, halo vision, reduced eye sensitivity, internal eye pigmentation, pupil dilation, eyelash color change, eyelash texture change, abnormal visual field.
General adverse effects:

Ear and labyrinth disorders: dizziness with spinning sensation, tinnitus;
Heart and circulatory system: slow heartbeat, palpitations, edema (fluid accumulation), changes in heart rhythm and/or rate, congestive heart failure (heart disease associated with breathlessness and swelling of feet and legs due to fluid accumulation), certain types of cardiac arrhythmias, heart attack, low blood pressure, Raynaud’s phenomenon, cold hands and feet, reduced blood supply to the brain;
Respiratory system: bronchoconstriction in the lungs (especially in patients with prior history), nasal catarrh or congestion, sneezing (due to allergy), breathing difficulties, nosebleeds, dryness of nasal mucosa;
Nervous system and general disorders: difficulty sleeping (insomnia), nightmares, memory loss, hallucinations, loss of strength and energy, anxiety (excessive emotional unease);
Gastrointestinal system: taste disturbances, nausea, indigestion, diarrhea, dry mouth, abdominal pain, vomiting, constipation;
Allergic reactions: generalized allergic reactions, including subcutaneous edema which may appear on the face and limbs and may cause airway obstruction leading to difficulty in swallowing and breathing, localized or generalized rash, itching, severe, sudden life-threatening allergic reaction;
Skin: silver-white skin rash (psoriasis-like rash) or worsening of psoriasis symptoms, skin peeling, abnormal hair texture, skin inflammation with itchy rash and redness, hair color change, eyelash loss, itching, abnormal hair growth, skin redness;
Muscular tissue: worsening of subjective and objective symptoms of myasthenia (muscle disorder), unusual tingling sensations, muscle weakness and/or fatigue, muscle pain not caused by physical exercise, joint pain;
Kidney and urinary disorders: difficulty and pain during urination, urinary incontinence;
Reproductive system: sexual dysfunction, decreased libido;
Metabolism: low blood sugar, increased prostate cancer marker levels;
.

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the Marketing Authorization Holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.
How to store Rozaduo
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, sachet, or bottle after EXP. The expiry date refers to the last day of the stated month.
Before first opening: no special storage temperature requirements. Store the bottle in the sachet to protect from light.
After first opening: no special storage requirements.
To prevent infection, discard the bottle 4 weeks after first opening and use medicine from a new bottle. Record the opening date of each bottle in the space provided on the bottle label and carton.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.
Contents of the pack and other information
What Rozaduo contains
The active substances are travoprost and timolol.
Each ml of solution contains 40 micrograms of travoprost and 5 mg of timolol (as timolol maleate).
Other ingredients are benzalkonium chloride, macrogol glycerol hydroxystearate 40, trometamol, disodium edetate, boric acid, mannitol, sodium hydroxide (for pH adjustment), water for injections.
Other ingredients are benzalkonium chloride, macrogol glycerol hydroxystearate 40, trometamol, disodium edetate, boric acid, mannitol, sodium hydroxide (for pH adjustment), purified water.
What Rozaduo looks like and contents of the pack
Rozaduo eye drops is a colorless, transparent solution, practically free from particles, packed in a 5 ml plastic bottle with a colorless dropper and a white opaque cap with a tamper-evident seal.
Each bottle is placed in a sachet. Each bottle contains 2.5 ml of solution.
Pack sizes available:
Carton containing 1, 3, 4, or 6 bottles.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Manufacturer
Pharmathen S.A.
6 Dervenakion Street
Pallini Attiki 15351
Greece
Balkanpharma-Razgrad AD
68 Aprilsko vastanie Blvd.
Razgrad 7200
Bulgaria
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice
JADRAN - GALENSKI LABORATORIJ d.d.
Svilno 20
Rijeka 51000
Croatia
February 2023