ROZACOM

Package leaflet: Information for the user

Rozacom, (20 mg + 5 mg)/ml, eye drops, solution
Dorzolamide + Timolol
Please read this leaflet carefully before using this medicine because it contains important information for you.

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

Contents of the leaflet

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

1. What Rozacom is and what it is used for

Rozacom contains two active substances: dorzolamide and timolol.

• Dorzolamide belongs to a group of medicines known as "carbonic anhydrase inhibitors".
• Timolol belongs to a group of medicines known as "beta-adrenergic receptor blockers" (beta-blockers). These medicines reduce intraocular pressure through two different mechanisms.

Rozacom is indicated in the treatment of glaucoma to reduce elevated intraocular pressure when treatment with eye drops containing only a beta-adrenergic receptor blocker is insufficient.

2. Important information before using Rozacom

When not to use Rozacom

• if the patient is allergic to dorzolamide hydrochloride, timolol maleate, or any of the other ingredients of this medicine (listed in section 6),
• if the patient currently has or has previously had respiratory disorders such as asthma or severe chronic obstructive pulmonary disease (a serious lung condition that may cause wheezing, difficulty breathing, and/or persistent cough),
• if the patient has bradycardia (slow heart rate), heart failure, or cardiac arrhythmias (irregular heartbeat),
• if the patient has severe kidney disease, severe impairment of kidney function, or a history of kidney stones,
• if the patient has excessive blood acidity due to accumulation of chloride ions in the body (hyperchloremic acidosis).

If in doubt whether this medicine can be used, consult a doctor.
Warnings and precautions
Before starting to use Rozacom, discuss it with your doctor or pharmacist.
Inform your doctor about any current or past eye disorders or diseases:

• ischemic heart disease (symptoms include chest pain or pressure, shortness of breath, or a choking sensation), heart failure, low blood pressure;
• disturbances in heart rate, such as bradycardia;
• breathing problems, asthma, or chronic obstructive pulmonary disease;
• conditions associated with poor blood circulation (such as Raynaud's disease or Raynaud's phenomenon);
• diabetes, because timolol may mask the signs and symptoms of hypoglycemia (low blood sugar levels);
• hyperthyroidism, because timolol may mask its objective and subjective symptoms.

Before undergoing surgery, inform the attending physician about using Rozacom, as timolol may alter the effects of certain anesthetic drugs.
Also inform your doctor about any allergies or allergic reactions, including hives, swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing.
Inform your doctor if the patient experiences muscle weakness or has been diagnosed with myasthenia gravis (Myasthenia gravis).
If eye irritation or any new eye problem occurs, such as redness of the eye or eyelid swelling, contact your doctor immediately.
If the patient suspects that Rozacom is causing an allergic reaction or hypersensitivity (e.g., skin rash, severe skin reaction, eye redness, or itching), discontinue use of this medicine and contact a doctor immediately.
Inform your doctor if an eye infection occurs, if the eye has been injured, after eye surgery, or if a reaction occurs involving new or worsening symptoms.
After ocular administration, Rozacom may cause systemic effects.
Patients using soft contact lenses should seek medical advice before using this medicine.
Children and adolescents
Experience with the use of Rozacom in infants and children is limited.
Use in elderly patients
In clinical studies with a medicine containing dorzolamide and timolol, similar effects were observed in elderly and younger patients.
Use in patients with liver function disorders
Inform your doctor about any current or past liver diseases.
Interaction of Rozacom with other medicines
Rozacom may affect the action of other medicines, or other medicines taken by the patient may affect the action of Rozacom. This also applies to other ophthalmic anti-glaucoma medicines. Inform your doctor if you are taking or plan to take medicines that lower blood pressure, heart medications, or antidiabetic drugs.
Tell your doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines the patient plans to use. This is particularly important if:

• taking medicines that lower blood pressure or are used for heart conditions (such as calcium channel blockers, beta-adrenergic receptor antagonists, or digoxin);
• taking medicines used for cardiac arrhythmias or to restore normal heart rhythm (such as calcium channel blockers, beta-adrenergic receptor antagonists, or digoxin);
• using other eye drops containing beta-adrenergic receptor antagonists;
• taking other carbonic anhydrase inhibitors, such as acetazolamide;
• taking monoamine oxidase inhibitors (MAOIs);
• taking parasympathomimetic (cholinergic) drugs, which may be used for urinary disorders. Parasympathomimetic drugs are also sometimes used to restore normal intestinal motility;
• taking opioid drugs, such as morphine, used to treat moderate to severe pain;
• taking antidiabetic medicines;
• taking antidepressants such as fluoxetine and paroxetine;
• taking chemotherapeutic sulfonamides;
• taking quinidine (a medicine used to treat heart conditions and certain forms of malaria).

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Use during pregnancy
Do not use this medicine during pregnancy unless considered necessary by a doctor.
Use during breastfeeding
Do not use this medicine while breastfeeding. Timolol may pass into human milk. Consult a doctor before taking any medicine during breastfeeding.
Driving and operating machinery
No studies have been conducted on the effect on the ability to drive or operate machinery. Some adverse effects associated with the use of Rozacom, such as blurred vision, may affect the ability to drive and/or operate machinery. Patients who feel unwell or have blurred vision should not drive or operate machinery.
Rozacom 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 change 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 abnormal sensations in the eye, stinging, or eye pain occur after using the medicine, contact your doctor.

3. How to use Rozacom

This medicine should always be used exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist. The doctor will determine the appropriate dose and duration of treatment.

Recommended dose
Usually, one drop into the conjunctival sac of the affected eye(s) is administered once in the morning and once in the evening.

If other eye drops are used simultaneously with Rozacom, an interval of at least 10 minutes should be maintained before administering the next medicine.

Do not change the dose without first consulting your doctor.

Do not allow the dropper tip to touch the eye or surrounding areas. The medicine may become contaminated with bacteria, which could lead to eye infection, possibly resulting in serious eye damage or even loss of vision. To avoid possible contamination, wash your hands before using this medicine and avoid contact between the dropper tip and any surface. If the patient suspects that the medicine may have become contaminated or if an eye infection occurs, contact your doctor immediately regarding further use of the current container.

Instructions for use

1. Before first use, ensure that the bottle is originally sealed.
2. To open the bottle, break the security ring by unscrewing the cap in a counter-clockwise direction.
3. Tilt the head backwards and gently pull down the lower eyelid to create a pouch between the eyelid and the eyeball.
4. Invert the bottle and gently squeeze until one drop of medicine is dispensed into the eye. A slight pressure on the sides of the bottle is sufficient to deliver exactly one drop. DO NOT enlarge the opening of the dropper. DO NOT TOUCH THE EYE, EYELID, OR ANY SURFACES WITH THE DROPPER TIP.
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 rest of the body.
6. If your doctor has instructed you to instill the drops into the other eye, repeat steps 3, 4, and 5.
7. After instilling Rozacom, press gently with a finger on the area at the inner corner of the eye near the nose or close the eye for two minutes. This helps prevent the medicine from being absorbed into the systemic circulation.
8. After administration, securely screw the cap back onto the bottle.

After using the prescribed amount of medicine, a small additional amount may remain in the container. This surplus is intentionally included to ensure that the prescribed amount can be fully administered. Therefore, do not attempt to squeeze out the remaining solution.

Overdose of Rozacom
If too many drops are administered into the eye or if the contents of the bottle are accidentally swallowed, symptoms such as dizziness, breathing difficulties, or a sensation of slowed heart rate may occur. Seek immediate medical attention.

Missed dose of Rozacom
Rozacom should be used as directed by your doctor.
If a dose is missed, administer it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and return to the regular dosing schedule.
Do not administer a double dose to make up for a missed dose.

Stopping Rozacom treatment
Do not discontinue this medicine without first consulting your doctor.

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

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, although not everyone will experience them.
Treatment with eye drops can usually be continued unless the adverse effects are severe. If you have any concerns, please contact your doctor or pharmacist. Do not stop using Rozacom without consulting your doctor.

Generalised allergic reactions, including subcutaneous swelling, may occur in the areas of the face and limbs and may cause airway obstruction and difficulties with swallowing or breathing, urticaria or itchy rash, localised and generalised rash, itching, as well as severe, sudden and life-threatening allergic reactions.

The frequency of possible adverse effects listed below is defined according to the following convention:
Very common (affects more than 1 in 10 people)
Common (affects 1 to 10 in 100 people)
Uncommon (affects 1 to 10 in 1,000 people)
Rare (affects 1 to 10 in 10,000 people)
Not known (frequency cannot be estimated from the available data)

During clinical trials or after marketing of the medicine, the following adverse effects have been reported related to Rozacom or to one of its active ingredients:

Very common:
Sensation of burning and stinging in the eye, altered taste sensation.

Common:
Redness of the eyes and skin around the eyes, tearing or itching of the eyes, corneal abrasions (damage to the front layer of the eye), swelling and/or irritation of the eyes and skin around the eyes, sensation of a foreign body in the eye, decreased corneal sensitivity (inability to feel a foreign body in the eye and inability to feel pain), eye pain, dry eyes, blurred vision, headache, sinusitis (feeling of pressure or fullness in the nose), nausea, fatigue and feeling of tiredness.

Uncommon:
Dizziness, depression, uveitis, visual disturbances, including refractive changes (in some cases due to discontinuation of miotic drugs), bradycardia (slowed heart rate), fainting, breathing difficulties (dyspnoea), indigestion, and kidney stones.

Rare:
Systemic lupus erythematosus (an autoimmune disease that may cause inflammation of internal organs), tingling or numbness of the hands or feet, insomnia, nightmares, memory loss, worsening of objective and subjective symptoms of myasthenia (a muscle disorder), decreased libido, stroke, transient myopia which may resolve after discontinuation of the medicine, detachment after filtration surgery of the layer beneath the retina containing blood vessels, which may lead to visual disturbances, ptosis (drooping eyelid, with eyelids half-closed), double vision, formation of crusts on the eyelids, corneal oedema (with subjective visual disturbances), low intraocular pressure, tinnitus, hypotension (low blood pressure), changes in heart rhythm or rate, congestive heart failure (a heart condition characterised by shortness of breath and swelling of the feet and legs due to fluid accumulation), oedema (fluid accumulation), cerebral ischaemia (reduced blood flow to the brain), chest pain, palpitations (accelerated and/or irregular heartbeat), myocardial infarction, Raynaud's disease, swelling of the hands and feet or cold hands and feet and poor circulation in the upper and lower limbs, leg muscle cramps and/or leg pain while walking (claudication), dyspnoea, respiratory failure, rhinitis (nasal inflammation), nosebleeds, narrowing of airways in the lungs, cough, throat irritation, dry mouth, diarrhoea, contact dermatitis, hair loss, silvery-white skin rash (psoriasis-like rash), Peyronie's disease (which may lead to penile curvature), allergic reactions such as rash, urticaria, itching, and in rare cases, swelling of the lips, eyelids and oral cavity, wheezing or severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Like other medicines applied locally to the eyes, timolol is absorbed into the systemic circulation, which may result in adverse effects similar to those observed after oral administration of beta-adrenergic receptor blocking agents. Adverse effects occur less frequently with topical eye drops than with oral or injectable administration of such medicines.

Among the additional adverse effects listed above are reactions typical of the therapeutic class of beta-adrenergic blocking agents used in ophthalmic disorders.

Not known:
Low blood sugar levels, heart failure, cardiac rhythm disturbances, abdominal pain, vomiting, muscle pain unrelated to physical exertion, sexual dysfunction, dyspnoea, sensation of a foreign body in the eye (feeling that something is in the eye), hallucinations, tachycardia (increased heart rate), increased blood pressure, unusual sensitivity of the eyes to light.

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

5. How to store Rozacom

Keep the medicine out of sight and reach of children.
Store below 25°C.
Keep the bottle in the outer packaging to protect from light.
Shelf life after first opening: 4 weeks.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Rozacom contains

• The active substances are dorzolamide and timolol. Each millilitre of solution contains 20 mg of dorzolamide (as 22.26 mg dorzolamide hydrochloride) and 5 mg of timolol (as 6.83 mg timolol maleate).
• Other components are: mannitol, sodium citrate, hydroxyethylcellulose, benzalkonium chloride, sodium hydroxide, water for injections. Benzalkonium chloride is added as a preservative.

What Rozacom looks like and contents of the pack
Eye drops, solution.
Pack: white LDPE bottle with dropper and white LDPE/HDPE cap in a cardboard box.
Pack contains 5 ml of eye drops.
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
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
tel. +48 22 732 77 00
January 2026