Rozaprost Mono

Leaflet attached to the packaging: patient information

Rozaprost Mono, 50 micrograms/mL, eye drops, solution

Latanoprost

Please read the contents of the leaflet carefully before using the medicine, as it contains important information for the patient.

• Please keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Rozaprost Mono and what is it used for

Rozaprost Mono contains latanoprost and belongs to a group of medicines called prostaglandin analogs.
It works by increasing the natural outflow of fluid from the eye into the blood.
Rozaprost Mono is used to treat conditions called open-angle glaucomaand
ocular hypertension in adults. Both of these conditions are associated with increased pressure in the eyeball, which can ultimately affect vision unfavorably.
Rozaprost Mono is also used to treat increased eye pressure and glaucoma in adolescents, children, and infants.

2. Important information before using Rozaprost Mono

Rozaprost Mono can be used in adult men and women (including the elderly) and in children from birth to 18 years of age. Its use has not been studied in premature infants (born before 36 weeks of gestation).

When not to use Rozaprost Mono:

• if the patient is allergic to latanoprost or any of the other ingredients of this medicine (listed in section 6),
• if the patient is pregnant or plans to become pregnant,
• if the patient is breastfeeding.

Warnings and precautions

Before starting to use Rozaprost Mono, the patient should discuss it with their doctor or pharmacist.

• If the adult or child has had eye surgery (including cataract surgery) or is scheduled to have it,
• If the adult or child has eye problems (such as eye pain, irritation, or inflammation, blurred vision),
• if the patient complains of dry eyes,
• if the patient has severe or uncontrolled asthma,
• if the patient wears contact lenses; in this case, Rozaprost Mono can be used, but the patient should follow the instructions for contact lens wearers presented in section 3,
• if the patient has had or currently has a viral eye infection caused by the herpes simplex virus (HSV).

Rozaprost Mono and other medicines

The patient should tell their doctor or pharmacist about all medicines (or eye drops) they are currently taking or have recently taken, including those that are available without a prescription, as well as any medicines they plan to take.
Rozaprost Mono may interact with other medicines, and it is not recommended to use two or more prostaglandins, prostaglandin analogs, or prostaglandin derivatives at the same time.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine. Rozaprost Mono should not be used in pregnant or breastfeeding women.

Driving and using machines

While using Rozaprost Mono, blurred vision may occur, which is a temporary symptom. In this case, the patient should not driveor operate any tools or machines until their vision returns to normal.

3. How to use Rozaprost Mono

This medicine should always be used exactly as prescribed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.
The recommended dose for adults (including the elderly) and children is one drop once a day into the affected eye or eyes. The medicine is best administered in the evening.
The contents of the single-dose container should be used immediately after opening; any remaining medicine should be discarded.
Rozaprost Mono should not be used more than once a day, as more frequent use may reduce the effectiveness of the treatment.
The patient should use Rozaprost Mono as prescribed by their doctor until they are advised to stop using the medicine.

Patients wearing contact lenses

Patients wearing contact lenses should remove them before using Rozaprost Mono. After administering the medicine, they should wait 15 minutes before reinserting the lenses.
Instructions for use:

• 1. Wash your hands and sit or stand comfortably.
• 2. Twist and remove the cap from the single-dose container.
• 3. Pull the lower eyelid of the affected eye down.

• 4. Place the tip of the single-dose container near the eye, but in such a way that it does not touch the eye's surface.
• 5. Gently squeeze the single-dose container to release one drop into the eye, then release the lower eyelid.
• 6. Press the corner of the affected eye near the nose with your finger. Hold for 1 minute without opening the eye.
• 7. Repeat these steps with the second eye, if the doctor has also prescribed treatment for that eye.
• 8. Discard the single-dose container.

Using Rozaprost Mono with other eye drops.

Wait at least 5 minutes between using Rozaprost Mono and administering other eye drops.

Using a higher dose of Rozaprost Mono than recommended

Administering more drops than recommended may cause mild eye irritation with redness and tearing. These symptoms should resolve on their own, but if the patient is concerned, they should consult their doctor for advice.
If Rozaprost Mono is accidentally ingested by an adult or child, they should contact their doctor immediately.

Missing a dose of Rozaprost Mono

The patient should continue with their usual dosing schedule at the scheduled times. They should not use a double dose to make up for a missed dose. If they have any doubts, they should consult their doctor or pharmacist.

Stopping the use of Rozaprost Mono

Before stopping the use of Rozaprost Mono, the patient should consult their doctor or pharmacist.
If the patient has any further doubts about using this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Rozaprost Mono can cause side effects, although not everybody gets them.
Very common side effects (occurring in more than 1 in 10 people)

• Gradual change in eye color due to an increase in the amount of brown pigment in the colored part of the eye, called the iris. Patients with mixed eye color (blue-brown, gray-brown, yellow-brown, or green-brown) are more likely to experience this change compared to patients with a single eye color (blue, gray, green, or brown). Any changes in eye color may develop over several years, although they usually appear within 8 months of treatment. The change in eye color may be permanent and may be more noticeable in patients using Rozaprost Mono in only one eye. It seems that the change in eye color is not associated with any problems. This type of change does not progress after stopping the use of Rozaprost Mono.
• Eye redness.
• Eye irritation (feeling of burning, grittiness, itching, stinging, or feeling of a foreign body in the eye). If eye irritation occurs that is severe enough to cause excessive tearing or a desire to stop using the medicine, the patient should consult their doctor, pharmacist, or nurse within a week. It may be necessary to verify the treatment to ensure the patient receives proper treatment.
• Gradual change in the appearance of eyelashes and hair around the treated eye, particularly in people of Japanese descent. These changes include darkening, lengthening, thickening, and increased number of eyelashes.

Common side effects (occurring in more than 1 in 100 but less than 1 in 10 people)

• Eye irritation or defects on the surface of the eye, inflammation of the eyelid margins, eye pain, sensitivity to light (photophobia), conjunctivitis.

Uncommon side effects (occurring in more than 1 in 1000 but less than 1 in 100 people)

• Eyelid swelling, dry eye, inflammation or irritation of the eye surface (keratitis), blurred vision, inflammation of the colored part of the eye (uveitis), swelling of the macula (macular edema).
• Rash.
• Chest pain (angina), feeling of heartbeat (palpitations).
• Asthma, shortness of breath (dyspnea).
• Chest pain.
• Headache, dizziness.
• Muscle pain, joint pain.

Rare side effects (occurring in more than 1 in 10,000 but less than 1 in 1000 people)

• Inflammation of the iris, symptomatic swelling or defects on the surface of the eye, swelling around the eye (periorbital edema), changes in the direction of eyelash growth or the appearance of an additional row of eyelashes, scarring on the surface of the eye, formation of fluid-filled spaces in the colored part of the eye (iris cysts). Local skin reactions on the eyelids, darkening of the eyelid skin.
• Worsening of asthma.
• Severe itching of the skin.
• Viral eye infections caused by the herpes simplex virus (HSV).

Very rare side effects (occurring in less than 1 in 10,000 people)

• Worsening of angina in patients with heart disease,
• Feeling of sunken eyes.

In very rare cases, some patients with significantly damaged corneas (the transparent membrane covering the front of the eyeball) during treatment have developed corneal deposits due to the deposition of calcium.
Side effects observed more frequently in children and adolescents than in adults were runny nose and fever.

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the representative of the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Rozaprost Mono

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label after EXP. The expiry date refers to the last day of the month stated.
The batch number (Lot) on the carton and sachet means the batch number.
Store in a refrigerator (2°C – 8°C).
After opening the sachet: Store below 25°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Rozaprost Mono contains

• The active substance is latanoprost; 1 mL of the medicine contains 50 micrograms of latanoprost.
• The other ingredients are: sodium dihydrogen phosphate monohydrate, disodium phosphate anhydrous, sodium chloride, water for injections.

What Rozaprost Mono looks like and contents of the pack

Rozaprost Mono is a clear, colorless solution in single-dose containers. Each single-dose container contains 0.2 mL of eye drops.
Rozaprost Mono is available in packs containing 30 or 90 single-dose containers of 0.2 mL.
Not all pack sizes may be marketed.

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Manufacturer

Genetic S.p.A.
Nucleo Industriale
Contrada Canfora
84084 Fisciano (SA)
Italy
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

This medicinal product has been authorized in the EEA member states under the following names:

Poland
Rozaprost Mono

Date of last revision of the leaflet: