Xaloptic

Package Leaflet: Information for the Patient

Xaloptic, 0.005% (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. The medicine may harm them, even if their symptoms are the same as yours.
• 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 Xaloptic and what is it used for
• 2. Important information before using Xaloptic
• 3. How to use Xaloptic
• 4. Possible side effects
• 5. How to store Xaloptic
• 6. Contents of the pack and other information

1. What is Xaloptic and what is it used for

The active substance of Xaloptic belongs to a group of medicines called prostaglandin analogues. They lower
the pressure in the eye by increasing the natural outflow of fluid from the eye into the bloodstream.
Xaloptic is indicated in adults for the treatment of one type of glaucoma called open-angle glaucoma and
for the treatment of ocular hypertension. These conditions are associated with increased pressure in the
eye and can eventually affect vision.
Xaloptic may also be used in children of all ages for the treatment of increased intraocular pressure and
glaucoma.

2. Important information before using Xaloptic

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

When not to use Xaloptic

• if the patient is allergicto latanoprost or any of the other ingredients of this medicine (listed in section 6)
• if the patient is pregnant, thinks she may be pregnant or plans to become pregnant
• if the patient is breast-feeding.

Warnings and precautions

Before starting treatment with Xaloptic, the patient should discuss it with their doctor or pharmacist:

• if the patient has severe or uncontrolled asthma
• if the patient has had eye surgery (including cataract surgery), or is scheduled to have it
• if the patient has eye disease (such as eye pain, irritation of the eye surface, or inflammation, blurred vision)
• if the patient has dry eyes
• if the patient uses contact lenses. To continue using Xaloptic, follow the instructions for using contact lenses (see section 3)
• if the patient has had a viral eye infection caused by the herpes simplex virus (HSV).

Xaloptic and other medicines

Xaloptic may interact with other medicines. The patient should tell their doctor or pharmacist about all
medicines they are taking, or have recently taken, and about any medicines they plan to take.

Pregnancy and breast-feeding

If the patient is pregnant or breast-feeding, thinks she may be pregnant or is planning to have a baby,
she should consult her doctor before using this medicine.
Xaloptic should not be used in pregnant or breast-feeding women.

Driving and using machines

Using eye drops may cause temporary blurred vision. If this happens, the patient should not drive or
operate machinery. The patient should be careful when driving or operating machinery until they know
how Xaloptic affects them.

Xaloptic contains benzalkonium chloride (as a preservative) and phosphates

The medicine contains 0.2 mg of benzalkonium chloride per milliliter.
Benzalkonium chloride may be absorbed by soft contact lenses and may change their color. The patient
should remove contact lenses before administering Xaloptic and wait at least 15 minutes before
reinserting them. See section 3 "Using contact lenses".
Benzalkonium chloride may also cause eye irritation, especially in people with dry eye syndrome or
corneal disorders (the transparent layer at the front of the eye). If the patient experiences any abnormal
sensations in the eye, stinging, or pain in the eye after using the medicine, they should contact their doctor.
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 deposits during treatment.

3. How to use Xaloptic

This medicine should always be used exactly as the doctor has instructed. If the patient is unsure, they
should ask their doctor or pharmacist.

Recommended dosage for adults (including elderly patients) and children:

The recommended dose is 1 dropinto the affected eye(s) once daily, preferably in the evening. It is not
recommended to use Xaloptic more than once daily, as this may reduce the efficacy of the treatment.
Xaloptic should be used for as long as the doctor has prescribed it for the patient.

Using contact lenses:

• The patient should avoid contact with soft contact lenses.
• Before administering Xaloptic to the eye, the patient should remove their contact lenses. Contact lenses
  can be reinserted 15 minutes after using Xaloptic.

Instructions for using the drops

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

• 1. Wash hands, then sit or stand comfortably.
• 2. Remove the protective cap.
• 3. Gently pull down the lower eyelid of the affected eye.
• 4. Bring the tip of the dropper close to the eye without touching it.
• 5. Gently squeeze the bottle to release one drop into the eye, then release the lower eyelid.
• 6. Close the eye and press the corner of the eye near the nose for one minute, keeping the eye closed.
• 7. If necessary, repeat the same steps for the other eye.
• 8. Replace the cap on the bottle.

Using Xaloptic with other eye drops

If the patient needs to use other eye drops, especially those containing thiomersal, they should wait at least
5 minutes after using Xaloptic.

Using more than the recommended dose of Xaloptic

The patient should be careful when squeezing the bottle to avoid releasing more than one drop into the
eye.
If more drops are released, it may cause moderate eye irritation with redness and tearing. If the patient
is unsure, they should consult their doctor.
If the patient accidentally swallows Xaloptic, they should contact their doctor as soon as possible.

Missing a dose of Xaloptic

If the patient misses a dose at the usual time, they should wait until the next dose is due. The patient should
not use a double dose to make up for the missed dose.

Stopping treatment with Xaloptic

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

4. Possible side effects

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

• Very common(occurring in more than 1 in 10 patients):

• 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 eyes of one color
  (blue, gray, green, or brown). Eye color changes may occur after several years of treatment, but they
  most often occur within the first 8 months of treatment. The change in eye color may be permanent and
  more noticeable if Xaloptic 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 treatment.

Common(occurring in less than 1 in 10 patients):

• Eye redness.
• Eye irritation (including feelings of burning, grittiness, itching, stinging, or the sensation of a foreign body
  in the eye). If eye irritation 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 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.

Uncommon(occurring in less than 1 in 100 patients):

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

Rare(occurring in less than 1 in 1,000 patients):

• Swelling of the eyelids, dry eyes, 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).
• Skin rash.
• Chest pain (angina pectoris), feeling of heartbeat (palpitations).
• Asthma, shortness of breath (dyspnea).
• Chest pain.
• Headache, dizziness.
• Muscle pain, joint pain.
• Nausea, vomiting.

Very rare(occurring in less than 1 in 10,000 patients):

• Inflammation of the iris, symptoms of swelling or scratching/damage to the eye surface, swelling around
  the eye (periorbital edema); 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).

Not known(frequency cannot be estimated from the available data):

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

Side effects that occur more frequently in the pediatric and adolescent population than in adults are
common cold and fever.
In very rare cases, in some patients with severe damage to the outer, transparent layer of the eye
(cornea), calcium deposits caused cloudy spots on the cornea during treatment.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their
doctor or pharmacist. 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
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 collected on the safety of the medicine.

5. How to store Xaloptic

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label. The expiry date refers to the
last day of that month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the
abbreviation Lot means the batch number.
Before the first opening, Xaloptic should be stored and transported in a cool place (2°C to 8°C), protected
from light. Do not freeze.
After the first opening of the bottle: Store in a temperature below 25°C and use within 4 weeks.
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 contains

• The active substance is latanoprost. Each milliliter of the eye drop solution contains 0.05 mg (50 micrograms)
  of latanoprost.
• The other ingredients are sodium chloride, benzalkonium chloride, sodium dihydrogen phosphate monohydrate,
  disodium phosphate anhydrous, water for injections.

What Xaloptic looks like and contents of the pack

Xaloptic is a colorless, clear solution. 2.5 ml of the eye drop solution (bottle content) contains 125 micrograms
of latanoprost.
Pack size:
1 bottle x 2.5 ml
3 bottles x 2.5 ml
One bottle contains approximately 82 drops.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Pharmaceutical Works POLPHARMA S.A.
Pelplińska 19, 83-200 Starogard Gdański, Poland
phone: +48 22 364 61 01

Manufacturer

Pharmaceutical Works POLPHARMA S.A.
Pelplińska 19, 83-200 Starogard Gdański, Poland
FAMAR S.A.
63, Ag. Dimitrou Aven.
174 56 Alimos, Athens, Greece
FARMIGEA S.p.A
VIA G.B. OLIVA, 8 – 56121 PISA (PI)
Italy
Date of last revision of the leaflet:June 2022