Xaloptic Free

Leaflet attached to the packaging: patient information

Xaloptic Free, 50 micrograms/ml, eye drops, solution in a single-dose container

Latanoprost

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.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific adult or 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 those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Xaloptic Free and what is it used for

Xaloptic Free contains latanoprost and belongs to a group of medicines called prostaglandin analogues. It works by increasing the natural outflow of fluid from the eye into the bloodstream.
Xaloptic Free is indicated in adults for the treatment of one type of glaucoma called open-angle glaucomaand for the treatment of intraocular hypertension. These conditions are associated with increased intraocular pressure and may result in impaired vision.
Xaloptic Free may also be used in children of all ages for the treatment of increased intraocular pressureand glaucoma.

2. Important information before using Xaloptic Free

Xaloptic Free can be used in adults and children from birth to 18 years. It has not been studied in premature neonates (born before 36 weeks of gestation).

When not to use Xaloptic Free

• 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 treatment with Xaloptic Free, the patient should discuss it with their doctor, pharmacist, or nurse:

• 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 disease (such as eye pain, irritation of the eye surface, 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 wears contact lenses. To continue using Xaloptic Free, the patient should follow the instructions for using contact lenses (see section 3).
• if the patient has had or has a viral eye infection caused by the herpes simplex virus (HSV).

Xaloptic Free and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.
Xaloptic Free may interact with other medicines, and it is not recommended to use two or more prostaglandins, prostaglandin analogues, or prostaglandin derivatives.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should ask their doctor or pharmacist for advice before using this medicine.
Xaloptic Free should not be usedin pregnant or breastfeeding women.

Driving and using machines

While using Xaloptic Free, blurred vision may occur, which is a temporary symptom. In such cases, the patient should not driveor operate any tools or machines until their vision is clear again.

Xaloptic Free contains phosphates

The medicine contains 6.3 mg of phosphates per milliliter. In patients with severe damage to the clear, transparent layer of the eye (cornea), phosphates may rarely cause corneal clouding due to calcium deposits during treatment.

3. How to use Xaloptic Free

This medicine should always be used exactly as prescribed by the doctor or pharmacist. If the patient is unsure, they should ask their doctor or pharmacist.
The recommended dose for adults (including the elderly) and children is one drop once daily into the affected eye(s). 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.
Xaloptic Free should not be used more than once daily, as this may reduce the effectiveness of the treatment.
Xaloptic Free should be used as directed by the doctor until they decide to stop the treatment.

Using contact lenses:

Before administering Xaloptic Free to the eye, the patient should remove their contact lenses. Contact lenses may be reinserted 15 minutes after using Xaloptic Free.

Instructions for use:

The patient should follow these instructions to ensure proper use of Xaloptic Free:

• 1. Wash hands, then sit or stand comfortably.
• 2. Twist and remove the protective tip of the single-dose container.
• 3. Gently pull down the lower eyelid of the affected eye.
• 4. Bring the tip of the single-dose container close to the eye without touching it.
• 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 eye nearest the nose with a finger for one minute, without opening the eye.
• 7. Repeat these steps with the other eye, if the doctor has also prescribed treatment for that eye.
• 8. Discard the single-dose container.

Using Xaloptic Free with other eye drops

Wait at least 5 minutes between using Xaloptic Free and administering other eye drops.

Using more than the recommended dose of Xaloptic Free

If more drops are administered than recommended, moderate eye irritation may occur, with redness and tearing. If the patient is unsure, they should contact their doctor.
If the patient accidentally ingests Xaloptic Free, they should contact their doctor as soon as possible.

Missing a dose of Xaloptic Free

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 the patient is unsure, they should ask their doctor or pharmacist.

Stopping treatment with Xaloptic Free

If the patient wants to stop using Xaloptic Free, they should consult their doctor.
If the patient has any further questions about using this medicine, they should ask their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Xaloptic Free can cause side effects, although not everybody gets them.
The following side effects are known to occur with latanoprost:

• Very common(may affect more than 1 in 10 people):

Gradual change in eye color by increasing the amount of brown pigment in the colored part of the eye called the iris. If the patient has mixed-color eyes (e.g., blue-brown, gray-brown, yellow-brown, and green-brown), the occurrence of these changes is more likely than if the patient has single-color eyes (blue, gray, green, or brown). Eye color changes may occur after several years of treatment but are most likely to occur during the first 8 months of treatment. The change in eye color may be permanent and more noticeable if Xaloptic Free is used in one eye only. The change in eye color is not associated with any other disease. The change in eye color does not progress after stopping Xaloptic Free treatment.

• Eye redness.
• Eye irritation (including feelings of burning, grittiness, itching, stinging, or the sensation of having something in the eye). If eye irritation is severe enough to cause excessive tearing or to make the patient want to stop using Xaloptic Free, they should contact their doctor, pharmacist, or nurse within one week. It may be necessary to verify the treatment to ensure the patient receives proper treatment.
• Gradual change in the appearance of the eyelashes of the treated eye and mild hair growth around it, observed mainly in people of Japanese descent. These changes include darkening, lengthening, thickening, and increased number of eyelashes.

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

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

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

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

Rare(may affect up to 1 in 1,000 people):

• Inflammation of the iris, signs of swelling or scratching/damage to the eye surface, swelling around the eye (periorbital); change in the direction of eyelash growth or the appearance of a double 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.
• Viral eye infections caused by the herpes simplex virus (HSV).

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

• Worsening of angina symptoms in patients with heart disease, sunken appearance of the eyes (deepening of the eyelid fold).

In very rare cases, in some patients with severe damage to the clear, transparent layer of the eye (cornea), cloudy spots have appeared on the cornea due to calcium deposits during treatment.
Side effects that occur more frequently in the pediatric and adolescent population than in the adult population are runny nose and fever.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych (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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Xaloptic Free

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
The notation on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/L means the batch number.
Store in a refrigerator (2°C - 8°C).
After opening the sachet: Store in a temperature below 25°C for a maximum of 7 days.
Use the contents of the single-dose container immediately after opening. After use, discard the single-dose container.
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 pack and other information

What Xaloptic Free contains

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

What Xaloptic Free looks like and contents of the pack

Xaloptic Free is a clear, colorless, sterile solution for eye drops in single-dose containers. Each single-dose container contains 0.2 ml of eye drops.
Xaloptic Free is available in packs containing 15, 30, 45, 60, 90, 120 single-dose containers of 0.2 ml.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Genetic S.p.A.
Contrada Canfora
84084 Fisciano (SA)
Italy
Date of last revision of the leaflet:June 2022