ROZACOM 20 mg/5 mg Drops

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Rozacom, (20 mg + 5 mg)/ml, Eye Drops, Solution
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Contents of the Package Leaflet
3. What Rozacom is and what it is used for
4. Important information before using Rozacom
   1. When not to use Rozacom
   2. Warnings and precautions
   3. Children and adolescents
   4. Use in elderly patients
   5. Use in patients with liver function disorders
   6. Rozacom and other medicines
   7. Pregnancy and breastfeeding
   8. Driving and using machines
   9. Rozacom contains benzalkonium chloride
5. How to use Rozacom
   1. Instructions for use
   2. Using more than the recommended dose of Rozacom
   3. Missing a dose of Rozacom
   4. Stopping the use of Rozacom
6. Possible side effects
   1. Reporting side effects
7. How to store Rozacom
8. Contents of the pack and other information
   1. What Rozacom contains
   2. What Rozacom looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Date of last revision of the leaflet:

Package Leaflet: Information for the User

Rozacom, (20 mg + 5 mg)/ml, Eye Drops, Solution

Dorzolamid + Timolol

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package 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 you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Contents of the Package Leaflet

• 1. What Rozacom is and what it is used for
• 2. Important information 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 called "carbonic anhydrase inhibitors".
• Timolol belongs to a group of medicines called "beta-adrenergic receptor blockers" (beta-adrenolytics). These medicines reduce intraocular pressure by two different mechanisms.

Rozacom is used to treat glaucoma to reduce high intraocular pressure, when the use of eye drops containing only a beta-adrenergic receptor blocker is not sufficient.

2. Important information before using Rozacom

When not to use Rozacom

• if you are allergic to dorzolamide hydrochloride, timolol maleate or any of the other ingredients of this medicine (listed in section 6).
• if you currently have or have had respiratory problems such as asthma or severe chronic obstructive pulmonary disease (a serious lung disease that may cause wheezing, breathing difficulties and/or a persistent cough),
• if you have a slow heart rate, heart failure or irregular heart rhythm (irregular heartbeat),
• if you have severe kidney disease or severe kidney function disorders or a history of kidney stones,
• if you have excessive acidification of the blood due to the accumulation of chloride ions in the body (hyperchloremic acidosis).

In case of doubt, consult your doctor before using this medicine.

Warnings and precautions

Before starting treatment with Rozacom, discuss it with your doctor or pharmacist.
Tell your doctor about all current or past eye disorders and diseases:

• ischemic heart disease (symptoms include chest pain or feeling of pressure in the chest, shortness of breath or feeling of suffocation), heart failure, low blood pressure;
• heart rate disorders, such as slow heart rate;
• breathing difficulties, asthma or chronic obstructive pulmonary disease;
• diseases related to poor blood circulation (such as Raynaud's disease or Raynaud's syndrome);
• diabetes, as timolol may mask the objective and subjective symptoms of hypoglycemia (low blood sugar levels);
• hyperthyroidism, as timolol may mask its objective and subjective symptoms.

Before surgery, inform your doctor about the use of Rozacom, as timolol may affect the action of certain anesthetics.
Also, tell your doctor about any allergies and allergic reactions, including hives, facial swelling, lip swelling, tongue swelling and/or throat swelling that may cause difficulty breathing and swallowing.
Tell your doctor if you have experienced muscle weakness or been diagnosed with myasthenia gravis (Myasthenia gravis).
If you experience eye irritation or any new eye problems, such as eye redness or eyelid swelling, seek medical attention immediately.
If you suspect that Rozacom is causing an allergic reaction or hypersensitivity (e.g., skin rash, severe skin reaction, redness, or eye itching), discontinue use of this medicine and contact your doctor immediately.
Tell your doctor if you have an eye infection, have had eye trauma, have had eye surgery, or have experienced a reaction accompanied by the appearance of new or worsening symptoms.
After administration to the eye, Rozacom may cause systemic effects.
Before using this medicine, people wearing soft contact lenses should consult their doctor.

Children and adolescents

Experience with the use of Rozacom in infants and children is limited.

Use in elderly patients

In studies with a medicine containing dorzolamide and timolol, similar effects were observed in elderly and younger patients.

Use in patients with liver function disorders

Tell your doctor about any current or past liver diseases.

Rozacom and other medicines

Rozacom may affect the action of other medicines or other medicines used by the patient may affect the action of Rozacom. This also applies to other anti-glaucoma eye medicines. Tell your doctor about taking or planning to take medicines that lower blood pressure, heart medicines, or anti-diabetic medicines.
Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to use. This is especially important in the case of:

• taking medicines that lower blood pressure or are used for heart diseases (such as calcium channel blockers, beta-adrenergic receptor blockers, or digoxin);
• taking medicines used for heart rhythm disorders or restoring a regular heart rhythm (such as calcium channel blockers, beta-adrenergic receptor blockers, or digoxin);
• using other eye drops containing beta-adrenergic receptor blockers;
• taking other carbonic anhydrase inhibitors, such as acetazolamide;
• taking monoamine oxidase inhibitors (MAOIs);
• taking medicines with a parasympathomimetic (cholinergic) effect, which may be used for urinary disorders. Parasympathomimetic medicines are also sometimes used to restore normal motility (mobility) of the intestines;
• taking opioid medicines, such as morphine, used to treat moderate to severe pain;
• taking anti-diabetic medicines;
• taking antidepressant medicines, such as fluoxetine and paroxetine;
• taking chemotherapeutic agents from the sulfonamide group;
• taking quinidine (a medicine used to treat heart diseases and certain forms of malaria).

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.
Use during pregnancy
Do not use this medicine during pregnancy, unless your doctor considers it necessary.
Use during breastfeeding
Do not use this medicine while breastfeeding. Timolol may pass into breast milk.
Before taking any medicine during breastfeeding, consult your doctor.

Driving and using machines

No studies have been conducted on the ability to drive vehicles or operate machinery. Some side effects associated with the use of Rozacom, such as blurred vision, may affect the ability to drive vehicles and/or operate machinery. Patients who feel unwell or have blurred vision should not drive vehicles or operate machinery.

Rozacom contains benzalkonium chloride

The medicine contains 0.075 mg of benzalkonium chloride per 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 disorders affecting the cornea (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 Rozacom

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Your doctor will determine the correct dose and duration of treatment.
Recommended dose
Usually, one drop is instilled into the conjunctival sac of the affected eye(s) in the morning and evening.
If you are using other eye drops in addition to Rozacom, wait at least 10 minutes between instillations.
Do not change the dose of the medicine without consulting your doctor.
Do not touch the dropper tip to the eye or its surroundings. The medicine may become contaminated with bacteria, which can cause eye infection leading to serious damage to the eye, even vision loss. To avoid possible contamination, wash your hands before using this medicine and avoid touching the dropper with any surface. If you think the medicine may have become contaminated or if you have an eye infection, contact your doctor immediately regarding further use of the current package.

Instructions for use

• 1. Before first use, make sure the bottle is originally sealed.
• 2. To open the bottle, break the protective ring by twisting the cap in the opposite direction of the arrow.
• 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 squeeze it until one drop of medicine falls into the eye. Light pressure on the bottle walls is enough to measure one drop accurately. DO NOT ENLARGE THE OPENING OF THE DROPPER. DO NOT TOUCH THE DROPPER TIP TO THE EYE, EYELID, OR OTHER SURFACES.
• 5. Close your eye and press the inner corner of your 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 of the medicine into the second eye, repeat steps 3, 4, and 5.
• 7. After instillation of Rozacom, press the area around the inner corner of your eye with your finger for 2 minutes. This can help prevent the medicine from entering the body.
• 8. After instillation, screw the bottle cap back on.

After using the prescribed amount of medicine by your doctor, a small amount of medicine remains in the package. This is an intentional excess to ensure the use of the prescribed amount of medicine. Therefore, do not attempt to squeeze out the excess solution from the package.

Using more than the recommended dose of Rozacom

In case of instillation of too many drops or ingestion of the bottle contents, among other symptoms, dizziness, breathing difficulties, or a feeling of slow heart rate may occur. Contact your doctor immediately.

Missing a dose of Rozacom

Rozacom 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 your regular dosing schedule.
Do not use a double dose to make up for a missed dose.

Stopping the use of Rozacom

Before discontinuing this medicine, consult your doctor.
If you have any further 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.
Eye drop treatment can usually be continued, unless the side effects are severe. If you are concerned, contact your doctor or pharmacist. Do not stop using Rozacom without consulting your doctor.
Generalized allergic reactions, including swelling under the skin, may occur in the face and limbs and cause respiratory tract obstruction and difficulty swallowing or breathing, hives, itching rash, local and generalized rash, itching, and severe, life-threatening allergic reaction.
The frequency of possible side effects listed below is defined as follows:
Very common (occurring in more than 1 in 10 people)
Common (occurring in 1 to 10 people in 100)
Uncommon (occurring in 1 to 10 people in 1,000)
Rare (occurring in 1 to 10 people in 10,000)
Unknown (frequency cannot be estimated from available data)
During clinical trials or after the marketing of the medicine, the following side effects related to Rozacom or one of its active substances have been reported:
Very common:
Burning and stinging in the eye, change in taste.
Common:
Redness of the eyeball and skin around the eye, tearing or itching of the eye, corneal erosion (damage to the front layer of the eyeball), swelling and/or irritation of the eyeball and skin around the eye, feeling of a foreign body in the eye, decreased corneal sensitivity (not feeling a foreign body in the eye and not feeling pain), eye pain, dry eyes, blurred vision, headache, sinusitis (feeling of tension or fullness in the nose), nausea, weakness, and feeling of fatigue.
Uncommon:
Dizziness, depression, uveitis, vision disorders, including refractive changes (in some cases due to the withdrawal of pupil-constricting medicines), slow heart rate, fainting, breathing difficulties (shortness of breath), indigestion, and kidney stones.
Rare:
Systemic lupus erythematosus (an autoimmune disease that can cause inflammation of internal organs), tingling or numbness of hands or feet, insomnia, nightmares, memory loss, worsening of myasthenia gravis symptoms (muscle disorder), decreased libido, stroke, transient myopia, which may resolve after discontinuation of the medicine, detachment of the layer under the retina, which can cause vision disorders, drooping eyelids (eyelids are half-closed), double vision, formation of crusts on the eyelids, corneal edema (with symptoms of vision disorders), low eye pressure, ringing in the ears, low blood pressure, changes in heart rhythm or rate, congestive heart failure (heart disease characterized by shortness of breath and swelling of the feet and legs due to fluid accumulation), edema (fluid accumulation), cerebral ischemia (reduced blood flow to the brain), chest pain, palpitations (rapid and/or irregular heart rhythm), myocardial infarction, Raynaud's disease, swelling of hands and feet or cold hands and feet, and impaired circulation in the upper and lower limbs, muscle cramps in the legs and/or leg pain when walking (intermittent claudication), shortness of breath, respiratory failure, rhinitis (runny nose), nosebleeds, bronchospasm, throat irritation, dry mouth, diarrhea, contact dermatitis, hair loss, white-silver rash (psoriasis-like rash), Peyronie's disease (which may cause penile curvature), allergic reactions, such as rash, hives, itching, and in rare cases, swelling of the lips, eyelids, and mouth, wheezing, or severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis).
As with other eye medicines, timolol is absorbed into the bloodstream, which can cause side effects similar to those observed after oral administration of beta-adrenergic receptor blockers. Side effects occur less frequently after the use of eye drops than after oral administration or injections of these medicines.
Among the additional side effects listed, reactions typical of the therapeutic group of beta-adrenergic medicines used in ophthalmic disorders are included.
Unknown:
Low blood sugar, heart failure, heart rhythm disorders, abdominal pain, vomiting, muscle pain unrelated to physical exertion, sexual function disorders, shortness of breath, feeling of a foreign body in the eye, hallucinations, rapid heartbeat, increased blood pressure.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist, or nurse.
Side effects can be reported directly to the Department of Post-Marketing Surveillance 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rozacom

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 to protect it from light.
Shelf life after first opening: 4 weeks.
Medicines should not be disposed of 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 pack and other information

What Rozacom contains

• The active substances of the medicine are dorzolamide and timolol. Each milliliter of solution contains 20 mg of dorzolamide (as 22.26 mg of dorzolamide hydrochloride) and 5 mg of timolol (as 6.83 mg of timolol maleate).
• The other ingredients 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.
Packaging: White bottle with a dropper made of LDPE with a white cap made of LDPE and HDPE in a cardboard box.
The package contains 5 ml of eye drops.
Available pack sizes:
Box containing 1 or 3 bottles of 5 ml solution.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

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

Date of last revision of the leaflet: