Rozaprost

Package leaflet: Information for the patient

Rozaprost, 0.05 mg/ml, eye drops, solution
Latanoprostum
Please read the entire leaflet carefully before use, as it contains
important information for the patient.
Keep this leaflet for future reference.
If you have any 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 identical.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor or pharmacist. See section 4.

Table of contents

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

The active substance in Rozaprost, latanoprost, belongs to a group of medicines known as prostaglandin analogues. Rozaprost lowers intraocular pressure by increasing the natural outflow of aqueous humour from the eye into the bloodstream.
Rozaprost is used in the treatment of glaucoma, specifically open-angle glaucoma, and in the treatment of a condition known as ocular hypertension in adults. Both conditions are associated with elevated intraocular pressure and may affect vision.
Rozaprost may also be used in children of any age for the treatment of increased intraocular pressure and glaucoma.

2. Important information before using Rozaprost

Rozaprost may be used in adult women and men (including elderly patients) and in children from birth up to 18 years of age. The use of Rozaprost has not been studied in preterm newborns (born before completing 36 weeks of gestation).

When not to use Rozaprost

• if the patient is allergic (hypersensitive) to latanoprost or to any of the other ingredients of this medicine (listed in section 6).
• during pregnancy or when attempting to become pregnant.
• during breastfeeding.

Warnings and precautions

Before starting Rozaprost, discuss this with the doctor or pharmacist:

• if the adult or child has undergone eye surgery (including cataract surgery), or such surgery is planned,
• if the adult or child has eye problems (such as eye pain, irritation or eye inflammation, blurred vision),
• if the patient has dry eye,
• if the patient suffers from severe or uncontrolled asthma,
• if the patient wears contact lenses; in such case Rozaprost may be used, but the instructions for contact lens wearers provided in section 3 must be followed,
• if the patient has had or currently has a viral eye infection caused by herpes simplex virus (HSV).

Rozaprost and other medicines

Rozaprost may interact with other medicines.
Inform the doctor or pharmacist of any adult or child about all medicines (or eye drops) currently or recently used by the adult or child, including those obtained without a prescription, as well as any medicines the patient plans to take. In particular, consult the doctor or pharmacist if the patient is using prostaglandins, prostaglandin analogues, or prostaglandin derivatives.

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.

Pregnancy
Rozaprost must not be used during pregnancy.

Breastfeeding
Rozaprost must not be used during breastfeeding.

Driving and using machines
As with other eye drops, transient blurred vision may occur immediately after instillation. In such cases, driving or operating machinery must be avoided until vision clears.

Rozaprost contains a preservative – benzalkonium chloride
The medicine contains 0.2 mg of benzalkonium chloride per millilitre.
Benzalkonium chloride may be absorbed by soft contact lenses and may alter their colour. Contact lenses must be removed before instillation, and at least 15 minutes should elapse before reinserting them.
Instructions for contact lens wearers are given in section 3.
Benzalkonium chloride may also cause eye irritation, particularly in patients with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If abnormal sensations, stinging, or eye pain occur after using the medicine, consult a doctor.

Rozaprost contains phosphate buffers
The medicine contains 6.3 mg of phosphates per millilitre, equivalent to 0.2 mg per drop.
In patients with severe damage to the transparent front part of the eye (cornea), phosphates may very rarely cause corneal clouding due to calcium accumulation during treatment.

3. How to use Rozaprost
This medicine should always be used exactly as prescribed by the doctor treating the adult or child. If in doubt, consult the treating doctor or a pharmacist.

The recommended dose for adults (including elderly patients) 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 daily, as this may reduce the effectiveness of treatment.

Rozaprost should always be used for as long as directed by the treating doctor.

Use of contact lenses
Contact lenses must be removed before administering Rozaprost eye drops. Contact lenses may be reinserted 15 minutes after administration of Rozaprost.

To correctly administer Rozaprost, follow these instructions:

1. Wash your hands and sit or stand comfortably.
2. Before first use, ensure the bottle is originally sealed.
3. To open the bottle, break the security ring by unscrewing the cap counterclockwise.
4. If the security ring becomes loose after removing the cap, discard it before using the medicine.
5. Tilt the head backward and pull down the lower eyelid of the affected eye with a finger.
6. Hold the dropper tip close to the eye. Do not touch the dropper tip to the eye, eyelid, surrounding areas, or any other surface. This may contaminate the drops. Using contaminated drops may lead to serious complications, including loss of vision.
7. Gently squeeze the bottle so that one drop falls into the eye. Then release the lower eyelid.
8. Press with a finger on the inner corner of the eye near the nose. Keep pressing for one minute without opening the eye.
9. Repeat the procedure for the other eye if treatment of both eyes has been prescribed by the doctor.
10. After instillation, replace the cap on the bottle.

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

Using Rozaprost with other eye drops
If other topical ophthalmic medicines are being used, they should be administered at least 5 minutes apart.

Overdose of Rozaprost
If more drops than recommended are administered, moderate eye irritation with redness and tearing may occur. These symptoms should resolve, but if the patient is concerned, they should contact the treating doctor for advice.
In case of accidental ingestion of Rozaprost by an adult or child, seek immediate medical advice from a doctor.

Missed dose of Rozaprost
If a dose is missed, the next dose should be taken at the scheduled time. Do not use a double dose to make up for a missed dose. If you have any further doubts, consult your doctor or pharmacist.

Stopping Rozaprost
If you have any further questions about the use of this medicine, consult the treating doctor or a pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Known adverse effects occurring after use of Rozaprost:

Very common (affects more than 1 in 10 people):

• Gradual change in eye colour due to increased amount of brown pigment in the coloured part of the eye, called the iris. Patients with mixed eye colour (blue-brown, grey-brown, yellow-brown or green-brown) have a higher probability of this change occurring compared to patients with uniform eye colour (blue, grey, green or brown). Any changes in eye colour may develop over years, although they usually appear within 8 months of treatment. The colour change may be permanent and may be more noticeable in people using Rozaprost in only one eye. This type of change does not appear to be associated with any problems. Such changes do not progress further after discontinuation of Rozaprost.
• Eye redness.
• Eye irritation (burning sensation, 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 desire to discontinue the medicine, consult a doctor, pharmacist or nurse immediately (within one week). Re-evaluation of treatment may be necessary to ensure appropriate management for the patient.
• Gradual change in the appearance of eyelashes and surrounding hairs in the treated eye, particularly in people of Japanese origin. These changes include, among others, darkening, lengthening, thickening and increased number of eyelashes.

Common (affects more than 1 in 100 but less than 1 in 10 people):

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

Uncommon (affects more than 1 in 1,000 but less than 1 in 100 people):

• Eyelid swelling, dry eye, infections or irritation of the eye surface (keratitis), blurred vision, inflammation of the coloured part of the eye (uveitis), retinal swelling (macular oedema);
• Rash;
• Chest pain (angina), sensation of rapid or irregular heartbeat (palpitations);
• Asthma, shortness of breath (dyspnoea);
• Chest pain;
• Headache, dizziness;
• Muscle pain, joint pain;
• Nausea;
• Vomiting.

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

• Iritis, symptomatic swelling or defects/damage to the eye surface, periorbital swelling (periorbital oedema), changes in eyelash growth direction or development of an additional row of eyelashes, scarring on the eye surface, formation of fluid-filled cysts in the coloured part of the eye (iris cysts);
• Local skin reactions on the eyelids; darkening of eyelid skin;
• Worsening of asthma;
• Acute skin itching;
• Viral eye infections caused by herpes simplex virus (HSV).

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

• Sunken eye appearance;
• Worsening of angina in patients with heart disease.

In very rare cases, corneal deposits of calcium have occurred during treatment in some patients with significantly damaged transparent membrane covering the front part of the eyeball (cornea), leading to corneal opacities.

Adverse effects occurring more frequently in children and adolescents than in adults are cold (nasopharyngitis) and fever.

Reporting of adverse effects

If any adverse effects occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. 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
Phone: +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 marketing authorization holder.

Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Rozaprost

Keep this 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 stated month.
Until first opening, store the medicine at 2–8°C (in the refrigerator). Protect from light.
Shelf life after first opening of the container: 4 weeks. After first opening, the medicine may be stored at temperatures below 25°C.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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), disodium phosphate anhydrous,
monosodium dihydrogen phosphate monohydrate, sodium hydroxide, 0.1N hydrochloric acid, water for injections.

What Rozaprost looks like and contents of the pack
Eye drops, solution.
The solution is a clear, colourless liquid.
Container made of LDPE with a dropper made of LDPE and a cap made of HDPE, in a cardboard box.
Each bottle contains 2.5 ml of eye drop solution, equivalent to approximately 80 drops.
Pack sizes: 1 x 2.5 ml, 3 x 2.5 ml.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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