Latanoprost Horus Pharma

Leaflet attached to the packaging: information for the user

Latanoprost Horus Pharma, 50 micrograms/ml, eye drops, solution in

single-dose containers
Latanoprostum

Read the 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 the doctor treating the patient's child, pharmacist, or nurse.
• This medicine has been prescribed specifically for this person or their child. 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 any side effects not listed in this leaflet, tell the doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

1. What is Latanoprost Horus Pharma and what is it used for

Latanoprost Horus Pharma belongs to a group of medicines known as prostaglandin analogs.
Latanoprost Horus Pharma works by increasing the natural outflow of aqueous fluid
from the eye into the bloodstream.
Latanoprost Horus Pharma is used to treat open-angle glaucomaand
intraocular hypertension. Both conditions are associated with increased pressure
within the eye and affect vision quality.
Latanoprost Horus Pharma may also be used in children of any age to treat increased
intraocular pressure and glaucoma.

2. Important information before using Latanoprost Horus Pharma

Latanoprost Horus Pharma can be used in adult men and women (including
patients of advanced age) and in children and adolescents from birth to 18 years.
The use of Latanoprost Horus Pharma has not been studied in premature newborns (born before the end of the 36th week of pregnancy).

When not to use Latanoprost Horus Pharma

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

Warnings and precautions

Before starting to use Latanoprost Horus Pharma, discuss it with the doctor treating the adult or child, pharmacist, or nurse:

• if the adult or child has had eye surgery (including cataract surgery), or if it is planned,
• if the adult or child has eye problems (such as eye pain, irritation, or inflammation, blurred vision),
• if the adult or child has dry eyes,
• if the adult or child has severe or uncontrolled asthma,
• if the adult or child uses contact lenses. Latanoprost Horus Pharma can be used, but follow the instructions for contact lens wearers (see section 3),
• if the adult has had a viral eye infection in the past or currently has one, caused by the herpes simplex virus (HSV).

Latanoprost Horus Pharma and other medicines

Tell the doctor or pharmacist about all medicines currently being taken by the adult or child, and about medicines that the patient plans to take. Latanoprost Horus Pharma may interact with other medicines, and therefore, it is not recommended to use two or more prostaglandins, prostaglandin analogs, or prostaglandin derivatives.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before using this medicine.
Latanoprost Horus Pharma should not be used during pregnancy or breastfeeding.

Driving and using machines

After using Latanoprost Horus Pharma, vision disturbances may occur for a short time. In this case, do not drive vehiclesor operate tools or machines until normal vision returns.

3. How to use Latanoprost Horus Pharma

This medicine should always be used as directed by the doctor treating the adult or child. In case of doubts, consult a doctor or pharmacist.
The recommended dose for adults (including elderly patients) and children is one drop into the affected eye (eyes) once a day, preferably in the evening.
The single-dose container should be used immediately after opening; any remaining product should be discarded.
Do not use Latanoprost Horus Pharma more than once a day, as more frequent administration may reduce the effectiveness of treatment.
Latanoprost Horus Pharma should be used for as long as the doctor recommends for the adult or child.

People wearing contact lenses

If the adult or child wears contact lenses, they should be removed before using Latanoprost Horus Pharma. After using Latanoprost Horus Pharma, wait 15 minutes before reinserting the contact lenses.
Instructions for use:

• 1. Wash your hands and sit or stand in a comfortable position.
• 2. Unscrew the cap of the single-dose container.
• 3. Using your finger, gently pull down the lower eyelid of the affected eye.
• 4. Bring the tip of the container close to the eye, but do not touch the eye.
• 5. Gently squeeze the container so that one drop falls into the eye, then release the lower eyelid.
• 6. Press the corner of the affected eye near the nose. Hold for 1 minute, keeping the eye closed.
• 7. Repeat the steps for the other eye, if the doctor has recommended it.
• 8. Discard the single-dose container.

Using Latanoprost Horus Pharma with other eye drops

Wait at least 5 minutes between using Latanoprost Horus Pharma and other eye drops.

Using a higher dose of Latanoprost Horus Pharma than recommended

In case of accidental administration of a higher dose, moderate eye irritation may occur with tearing and redness. These symptoms should resolve, but if the patient is concerned, they should consult the doctor treating the adult or child for advice.
If Latanoprost Horus Pharma is accidentally ingested by an adult or child, consult a doctor immediately.

Missing a dose of Latanoprost Horus Pharma

If a dose is missed, 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 a doctor or pharmacist.

Stopping the use of Latanoprost Horus Pharma

If the patient wants to stop using the medicine, they should consult a doctor.
In case of any further doubts about using this medicine, consult a doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been observed after using Latanoprost Horus Pharma:
Very common(may affect 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, known as the iris. In patients with mixed eye color (blue-brown, gray-brown, yellow-brown, or green-brown), these changes may be more noticeable than in patients with uniform eye color (blue, gray, green, or brown). Any changes in eye color may appear within a few years, although they are normally observed within 8 months of treatment. The change in eye color may be permanent and may be more noticeable if Latanoprost Horus Pharma is used in only one eye. It does not appear that the change in iris color is associated with any discomfort. After stopping Latanoprost Horus Pharma, the change in eye color does not progress.

Common(may affect up to 1 in 10 people):

• Redness of the eyes.
• Eye irritation (feeling of burning, grit, 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, consult a doctor, pharmacist, or nurse within a week. It may be necessary to verify the treatment to ensure the patient receives proper therapy.
• Gradual change in the appearance of eyelashes and eyelid hairs around the treated eye, particularly in people of Japanese descent. These changes include, for example, change in color (darkening), lengthening, thickening, and increased number of eyelashes.

Uncommon(may affect up to 1 in 100 people):

• Irritation or erosion on the surface of the eye, eyelid inflammation, eye pain, sensitivity to light (photophobia), conjunctivitis.

Rare(may affect up to 1 in 1000 people):

• Swelling of the eyelids, dryness of the eyes, inflammation or irritation of the surface of the eye (keratitis), blurred vision, inflammation of the colored part of the eye (uveitis), swelling of the macula (macular edema),
• Skin rash.
• Chest pain (angina), palpitations
• Asthma, shortness of breath (dyspnea)
• Chest pain
• Headache, dizziness
• Muscle pain, joint pain
• Nausea.
• Vomiting.

Very rare(may affect up to 1 in 10,000 people)

• Inflammation of the iris, symptomatic swelling or scratches/damage to 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 cyst).
• Local skin reactions on the eyelids, darkening of the eyelid skin.
• Worsening of asthma
• Severe itching of the skin
• Development of a viral eye infection caused by the herpes simplex virus (HSV)

In very rare cases, in some patients with significantly damaged cornea (the transparent membrane covering the front of the eyeball), cloudy spots on the cornea have been observed during treatment due to the deposition of calcium.
Side effects that occur more frequently in the population of children and adolescents than in the adult population are runny nose, itching of the nose, and fever.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, tell the doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of the 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
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 Latanoprost Horus Pharma

• The medicine should be stored 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.
• Store in a refrigerator (2°C - 8°C). After opening the sachet, store at a temperature below 25°C for no more than 7 days.
• Medicines should not be disposed of via wastewater or household waste containers. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Latanoprost Horus Pharma contains

• The active substance is latanoprost in a dose of 50 micrograms/ml.
• The other ingredients of the medicine are: sodium dihydrogen phosphate monohydrate, disodium phosphate anhydrous, sodium chloride, water for injections.

What Latanoprost Horus Pharma looks like and what the pack contains

Latanoprost Horus Pharma is a clear, transparent, sterile solution of eye drops in single-dose containers. Each single-dose container contains 0.2 ml of eye drops.
Pack sizes:
15, 30, 45, 60, 90, 120 single-dose containers of 0.2 ml.
The sachet contains 5 single-dose containers. The sachet is in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
HORUS PHARMA
22, Allée Camille Muffat
INEDI 5
06200 Nice
France
Manufacturer
GENETIC S.P.A
Contrada Canfora
84084 Fisciano (SA)
Italy

This medicine is authorized in the Member States of the European Economic Area under the following names:

Netherlands

Xalof 0.05 mg/ml oogdruppels, oplossing in verpakking voor éénmalig gebruik

Belgium

Xalof 0.05 mg/ml collyre en solution en récipient unidose

France

XIOP 50 microgrammes/mL, collyre en solution en récipient unidose

Spain

Xiop 50 microgramos/ml colirio en solución en envase unidosis
LuxembourgXalof 0.05 mg/ml collyre en solution en récipient unidose

Poland

Latanoprost Horus Pharma 50 mikrogramów/ml, krople do oczu, roztwór w pojemnikach jednodawkowych
Date of last revision of the leaflet:12/2023