Rozaprost

Package Leaflet: Information for the Patient

Rozaprost, 0.05 mg/ml, eye drops, solution
Latanoprost

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 specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Rozaprost and what is it used for

The active substance of Rozaprost, latanoprost, belongs to a group of medicines known as prostaglandin analogues. Rozaprost lowers the pressure in the eye by increasing the natural outflow of aqueous fluid from the eye into the bloodstream.
Rozaprost is used to treat glaucoma (including open-angle glaucoma) and ocular hypertension in adults. Both conditions are associated with increased intraocular pressure, which can affect vision.
Rozaprost may also be used in children of all ages to treat increased intraocular pressure and glaucoma.

2. Important information before using Rozaprost

Rozaprost can be used in adults, including the elderly, and in children from birth to 18 years. The use of Rozaprost has not been studied in premature infants (born before 36 weeks of gestation).

When not to use Rozaprost

• during pregnancy or when trying to conceive.
• during breastfeeding.

Warnings and precautions

Before starting treatment with Rozaprost, discuss it with your doctor or pharmacist.

Rozaprost and other medicines

Rozaprost may interact with other medicines.
Tell your doctor or pharmacist about all medicines (or eye drops) you are currently taking or have recently taken, including those available without a prescription, as well as any medicines you plan to take. In particular, consult your doctor or pharmacist if you are taking prostaglandins, prostaglandin analogues, or prostaglandin derivatives.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before using this medicine.
Pregnancy
Rozaprost should not be used during pregnancy.
Breastfeeding
Rozaprost should not be used during breastfeeding.

Driving and using machines

As with other eye drops, a transient period of blurred vision may occur after administration. In this case, do not driveor operate machines until the vision disturbance has resolved.

Rozaprost contains a preservative - benzalkonium chloride

The medicine contains 0.2 mg of benzalkonium chloride per milliliter.
Benzalkonium chloride may be absorbed by soft contact lenses and change their color. Remove contact lenses before administering Rozaprost and wait at least 15 minutes before putting them back on.
Instructions for contact lens wearers, see section 3.
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 pain in the eye after using the medicine, contact your doctor.

Rozaprost contains phosphates

The medicine contains 6.3 mg of phosphates per milliliter, which corresponds to 0.2 mg per drop.
In patients with severe damage to the transparent, front part of the eye (cornea), phosphates may rarely cause corneal clouding due to calcium deposition during treatment.

3. How to use Rozaprost

This medicine should always be used exactly as your doctor has instructed.
In case of doubts, consult your doctor or pharmacist.

Recommended dose for adults (including the elderly) and children is 1 drop into the affected eye(s) once daily, preferably in the evening. It is not recommended to use Rozaprost more than once a day, as this may reduce the effectiveness of the treatment.
Rozaprost should be used for as long as your doctor has prescribed.

Using contact lenses

Remove contact lenses before administering Rozaprost. Contact lenses can be put back on 15 minutes after administration.
To administer Rozaprost correctly, follow these instructions:

• 1. Wash your hands and sit or stand comfortably.
• 2. Before using the medicine for the first time, make sure the bottle is sealed.
• 3. To open the bottle, break the security ring by twisting the cap in the opposite direction to the arrow.
• 4. If the security ring is loose after removing the cap, discard it before using the medicine.
• 5. Tilt your head back and pull the lower eyelid down with your finger.
• 6. Place the tip of the bottle close to the eye. Do not touch the dropper to the eye, eyelid, or surrounding areas.This can lead to infection. Using infected drops can lead to serious complications, even vision loss.
• 7. Gently squeeze the bottle to release one drop into the eye. Then release the lower eyelid.
• 8. Press the corner of the eye near the nose with your finger for 1 minute without opening your eye.
• 9. Repeat the steps for the other eye if your doctor has also prescribed treatment for that eye.
• 10. After administration, screw the bottle cap back on.

If you feel that the effect of the medicine is too strong or too weak, consult your doctor.

Using Rozaprost with other eye drops

If you are using other local eye medicines, wait at least 5 minutes between administrations.

Using a higher dose of Rozaprost than recommended

In case of accidental administration of a higher dose, moderate eye irritation with redness and tearing may occur. These symptoms should resolve, but if you are concerned, consult your doctor for advice.
If Rozaprost is accidentally ingested, immediately consult your doctor.

Missing a dose of Rozaprost

If you miss a dose, take the next dose at the scheduled time. Do not take a double dose to make up for the missed dose. If you have any further doubts, consult your doctor or pharmacist.

Stopping treatment with Rozaprost

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

4. Possible side effects

Like all medicines, Rozaprost can cause side effects, although not everybody gets them.
Known side effects of Rozaprost:

• Gradual change in eye color due to increased 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 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 in one eye only. It seems that the change in eye color is not associated with any problems. This type of change does not progress after stopping Rozaprost.
• Eye redness.
• Eye irritation (feeling of burning, grittiness, itching, stinging, or foreign body sensation in the eye). If eye irritation occurs, which is severe enough to cause excessive tearing or a desire to stop using the medicine, consult your 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 (affects more than 1 in 100 but less than 1 in 10 people):

• Eye surface damage or defects, eyelid margin inflammation, eye pain; sensitivity to light (photophobia), conjunctivitis.

Uncommon (affects more than 1 in 1000 but less than 1 in 100 people):

• Swollen eyelids, dry eye, infections or irritations of the eye surface (corneal inflammation), blurred vision, inflammation of the colored part of the eye (uveitis), swelling of the macula (macular edema);
• Rash;
• Chest pain (angina), palpitations;
• Asthma, shortness of breath (dyspnea);
• Chest pain;
• Headache, dizziness;
• Muscle pain, joint pain;
• Nausea;
• Vomiting.

Rare (affects more than 1 in 10,000 but less than 1 in 1000 people):

• Inflammation of the iris, symptomatic corneal deposits or damage, swelling around the eye (periorbital edema), changes in the direction of eyelash growth or the appearance of an extra row of eyelashes, scarring on the eye surface, formation of fluid-filled areas 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;
• Eye infections caused by the herpes simplex virus (HSV).

Very rare (affects less than 1 in 10,000 people)

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

In very rare cases, in some patients with significantly damaged cornea, calcium deposits on the cornea have occurred during treatment.
Side effects that occur more frequently in the pediatric and adolescent population than in adults are runny nose and fever.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 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 to gather more information on the safety of this medicine.

5. How to store Rozaprost

Keep the medicine out of the 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.
Before opening, store the medicine in a refrigerator (2-8°C). Protect from light.
Shelf life after first opening: 4 weeks. After first opening, the medicine can be stored at a temperature below 25°C.
Medicines should 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 Rozaprost contains

The active substance is latanoprost. 1 ml of solution contains 50 micrograms of latanoprost.
One drop contains approximately 1.5 micrograms of latanoprost.
The other ingredients are sodium chloride, benzalkonium chloride (0.2 mg/ml), anhydrous disodium phosphate, sodium dihydrogen phosphate monohydrate, sodium hydroxide, hydrochloric acid 0.1N, water for injections.

What Rozaprost looks like and contents of the pack

Eye drops, solution.
The solution is a clear, colorless liquid.
LDPE bottle with an LDPE dropper and an HDPE cap in a cardboard box.
Each bottle contains 2.5 ml of eye drop solution, which corresponds to approximately 80 drops.
Package sizes: 1 x 2.5 ml, 3 x 2.5 ml.
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
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: