Xalofree

Package Leaflet: Information for the Patient

Xalofree, 50 micrograms/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.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet:

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

1. What Xalofree is and what it is used for

Xalofree contains the active substance latanoprost, which belongs to a group of medicines called prostaglandin analogues. These medicines reduce pressure in the eye by increasing the natural outflow of fluid from the eye into the bloodstream.
Xalofree is used in adults (including the elderly) to treat high pressure in the eye (glaucoma) and ocular hypertension. These conditions are associated with increased pressure in the eye, which can lead to vision problems.
Xalofree may also be used in children of all ages to treat increased eye pressure and glaucoma.

2. Important information before using Xalofree

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

When not to use Xalofree

• if you are allergic to latanoprost or any of the other ingredients of this medicine (listed in section 6)
• if you are pregnant, think you may be pregnant, or are planning to have a baby
• if you are breast-feeding

Warnings and precautions

Before starting treatment with Xalofree, you should discuss this with your doctor or pharmacist:

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

Xalofree and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take.
Xalofree may interact with other medicines, and it is not recommended to use two or more prostaglandins, prostaglandin analogues, or prostaglandin derivatives.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
Xalofree should not be used during pregnancy or breast-feeding.

Driving and using machines

Xalofree has a minor effect on the ability to drive and use machines. Using eye drops may cause temporary blurred vision. If this side effect occurs, do not drive or operate machinery. Be careful when driving or operating machinery until you know how Xalofree affects you.

Xalofree contains phosphates

The medicine contains 6.4 mg of phosphates per milliliter. In patients with severe damage to the clear front part of the eye (cornea), phosphates may, in very rare cases, cause corneal clouding due to calcium deposits during treatment.

3. How to use Xalofree

Use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Dosage

The recommended dose for adults (including elderly patients) and children is 1 dropinto the affected eye(s) once daily, preferably in the evening. Do not use Xalofree more than once daily, as this may reduce the effectiveness of the treatment.
Xalofree should be used for as long as your doctor recommends.

Using contact lenses

• Before administering Xalofree to the eye, remove contact lenses. Contact lenses can be reinserted 15 minutes after using Xalofree.

Instructions for using the drops

Follow these steps to help you use Xalofree correctly:

• 1. Wash your hands, then sit or stand comfortably.
• 2. Remove the cap (Figure 1).

• 3. Place your thumb on the dosing aid on top of the bottle and your other fingers on the bottom of the bottle. Hold the bottle upside down (Figure 2). Before first use, press the bottle 10 times with the dropper facing down to activate the pump mechanism until the first drop appears.
• 4. Tilt your head back and gently pull down the lower eyelid to create a "pocket" between your eye and eyelid.
• 5. Bring the tip of the dropper close to your eye without touching it.
• 6. Press the dosing aid on top of the bottle and the bottom of the bottle to release one drop into your eye, then release the lower eyelid (Figure 3).
• 7. Close your eye and press the corner of your eye near your nose (Figure 4) for about 1 minute, keeping your eye closed. This helps prevent the medicine from draining into your tear duct.
• 8. If you need to use drops in both eyes, repeat the steps for your other eye.
• 9. Put the cap back on the bottle immediately after use.

Figure 1.
Figure 2.
Figure 3.
Figure 4.
Only open one bottle of Xalofree at a time. Do not open the bottle until you are ready to use the drops.
Discard the 2.5 ml bottle 30 days after first opening, and the 7.5 ml bottle 90 days after first opening to prevent infections. After this time, use a new bottle.
To help you remember when you opened the bottle, write the date you first opened it on the carton.

Using Xalofree with other eye drops

If you are using other eye drops, leave at least 5 minutes between using Xalofree and the other eye drops. Apply eye ointments last.

Using more Xalofree than you should

Be careful not to squeeze the bottle too hard, as this may cause more than one drop to be released into your eye.
If you accidentally use more drops than you should, you may experience moderate eye irritation, redness, and tearing. These symptoms should go away on their own, but if you have any concerns, talk to your doctor or pharmacist.
If you accidentally swallow Xalofree, contact your doctor as soon as possible.

Missing a dose of Xalofree

If you miss a dose, wait until it is time for your next dose. Do not use two doses at the same time.

Stopping Xalofree treatment

Do not stop using Xalofree without talking to your doctor or pharmacist first.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Xalofree can cause side effects, although not everybody gets them.
The following side effects have been reported:

Very common(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 (iris). If you have mixed-color eyes (e.g., blue-brown, grey-brown, yellow-brown, or green-brown), this change is more likely than if you have single-color eyes (blue, grey, green, or brown). Eye color changes may occur after several years of treatment but are most likely to occur within the first 8 months of treatment. The change in eye color may be permanent and more noticeable if you are using Xalofree in only one eye. The change in eye color does not affect the inside of the eye and does not progress after stopping Xalofree treatment.
• Eye redness.
• Eye irritation (including feelings of burning, grittiness, itching, stinging, or the sensation of something in the eye). If you experience eye irritation that is severe enough to make your eyes water excessively or make you want to stop using Xalofree, contact your doctor, pharmacist, or nurse within a week. Your treatment may need to be reviewed to ensure you are receiving the right treatment.
• Gradual change in the appearance of the eyelashes of the treated eye and mild hair growth around the eye, mainly observed in people of Japanese descent. These changes include darkening, lengthening, thickening, and increased number of eyelashes.

Common(affect less than 1 in 10 people):

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

Uncommon(affect less than 1 in 100 people):

• Swelling of the eyelids, dry 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), feeling of heart pounding (palpitations).
• Asthma, shortness of breath (dyspnea).
• Chest pain.
• Headache, dizziness.
• Muscle pain, joint pain.
• Nausea, vomiting.

Rare(affect less than 1 in 1,000 people):

• Inflammation of the iris, signs of swelling or scratching/damage to the surface of the eye, 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 surface of the eye, 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(affect less than 1 in 10,000 people):

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

Side effects that occur more frequently in children and adolescents than in adults are runny nose and fever.
Other side effects reported with phosphate-containing eye drops:
In patients with severe damage to the clear front part of the eye (cornea), phosphates may, in very rare cases, cause corneal clouding due to calcium deposits during treatment.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly to the national reporting system via the contact details listed below.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Xalofree

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiry date refers to the last day of that month.
The packaging is marked with "EXP" (expiry date) and "Lot" (batch number).
Do not store above 25°C.
Do not freeze.
After opening the 2.5 ml bottle: 30 days.
After opening the 7.5 ml bottle: 90 days.
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 Xalofree contains

• The active substance is latanoprost. Each milliliter of eye drop solution contains 50 micrograms of latanoprost.

One drop contains approximately 1.5 micrograms of latanoprost.

• The other ingredients are sodium chloride, disodium phosphate, sodium dihydrogen phosphate monohydrate, polysorbate 80, disodium edetate, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), water for injections.

What Xalofree looks like and contents of the pack

Xalofree is a clear, colorless solution.
The pack consists of an HDPE bottle with a multidose dropper and pump (PP, HDPE, LDPE), a cap (HDPE), and a polypropylene dosing aid, in a cardboard box.
Pack sizes:
1 bottle of 2.5 ml
1 bottle of 7.5 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
tel. + 48 22 364 61 01

Manufacturer

Lomapharm GmbH
Langes Feld 5, Emmerthal, Niedersachsen, 31860,
Germany

Date of last revision of the package leaflet: