Xalibur: detailed information

Patient Information Leaflet: Information for the User

XALIBUR 50 micrograms/ml eye drops, solution

Latanoprost
Generic medicine
Please read all of this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Xalibur is and what it is used for
What you need to know before using Xalibur
How to use Xalibur
Possible side effects
How to store Xalibur
Contents of the pack and other information

1. What Xalibur is and what it is used for

Xalibur contains the active substance latanaprost, which belongs to a class of medicines known as antiglaucoma and miotic agents – prostaglandin analogues. Xalibur works by increasing the natural outflow of fluid from inside the eye into the bloodstream.
Xalibur is used to treat conditions known as open-angle glaucoma and ocular hypertension in adults. Both of these conditions are associated with elevated intraocular pressure, which may eventually impair vision.

2. What you need to know before using Xalibur

Xalibur can be used in adult women and men (including the elderly). The use of Xalibur is not recommended in patients under 18 years of age.
Do not use Xalibur

If you are allergic (hypersensitive) to latanoprost or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Xalibur if you think any of the following conditions apply to you:

If you are about to undergo or have recently undergone eye surgery (including cataract surgery);
If you have eye problems (such as eye pain, irritation or inflammation, blurred vision);
If you suffer from dry eye;
If you have a type of glaucoma known as “chronic closed-angle glaucoma”, open-angle glaucoma and have an artificial lens (natural eye lens enabling focus on objects), or pigmentary glaucoma (with excessive release of pigment inside the eye);
If you have glaucoma caused by eye inflammation or by the formation of new blood vessels in the eye;
If you have risk factors for cystoid macular edema (fluid accumulation in the central part of the retina), such as diabetes or retinal blood vessel occlusion;
If your eyes are aphakic (lens absent from the eye) or pseudophakic (have an artificial lens) with rupture of the posterior lens capsule or with lenses placed in the anterior chamber;
If you suffer from severe asthma or if your asthma is not well controlled;
If you wear contact lenses. You may still use Xalibur, following the instructions for contact lens wearers provided in section 3.
If you have had or currently have a viral eye infection caused by herpes simplex virus (HSV).

Other medicines and Xalibur
Xalibur may interact with other medicines. Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including eye drops and over-the-counter medicines.
In particular, inform your doctor or pharmacist if you are taking medicines belonging to the class of prostaglandins, prostaglandin analogues, or prostaglandin derivatives, as this could paradoxically increase intraocular pressure.
Pregnancy and breastfeeding
Do not use Xalibur if you are pregnant or breastfeeding, unless your doctor considers it necessary. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine.
Driving and use of machines
When using Xalibur, you may experience transient blurred vision. If this occurs, you must not drive or operate machinery until your vision clears.
Xalibur contains benzalkonium chloride and phosphate buffers.
This medicine contains 0.2 mg/ml of benzalkonium chloride.
Benzalkonium chloride may be absorbed by soft contact lenses and may cause discoloration. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eye or corneal disorders (the eye's outermost transparent layer). If you experience unusual eye sensations, burning, or pain after using this medicine, talk to your doctor.
This medicine contains 0.295 mg of phosphate buffers per drop, equivalent to 9.34 mg/ml.
In addition to the declared information, the calculations performed to determine the stated concentrations must also be provided.
If you have severe damage to the eye's outermost transparent layer (the cornea), phosphates may very rarely cause calcium deposits leading to opaque corneal spots during treatment.

3. How to use Xalibur

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.

The recommended dose in adults (including elderly patients) is one drop once daily in the affected eye(s). The optimal effect is achieved when Xalibur is administered in the evening.

Do not use Xalibur more than once a day, as treatment efficacy may be reduced if the medicine is administered more frequently.

Use Xalibur exactly as prescribed by your doctor, until your doctor tells you to stop treatment.

Contact lens wearers
If you wear contact lenses, you must remove them before applying Xalibur. After applying Xalibur, wait 15 minutes before reinserting your contact lenses.

Instructions for use
As with other eye drops, instill one drop into the eye and press with a finger on the inner corner of the treated eye for one minute. This should be done immediately after instilling each single drop.

Paediatric population
Safety and efficacy data are not available in children. Therefore, the use of Xalibur in children and adolescents (under 18 years of age) is not recommended.

If you use Xalibur with another eye drop
Wait at least 5 minutes between administering Xalibur and another eye drop.

If you use more Xalibur than you should
Putting too many drops into the eyes may cause mild irritation, tearing, and eye redness. These effects should be temporary, but if you are concerned, contact your doctor for advice.
Contact your doctor as soon as possible if you have accidentally swallowed Xalibur.

If you forget to use Xalibur
Continue with your next dose at the usual time. Do not use a double dose to make up for the forgotten dose. If you have any doubts, consult your doctor or pharmacist.

If you stop using Xalibur
You should inform your doctor if you intend to stop treatment with Xalibur.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.

The following are known side effects associated with the use of Xalibur.

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

Gradual change in eye colour due to increased brown pigment in the coloured part of the eye (iris). This change is more likely if your eyes are of mixed colour (blue-brown, grey-brown, yellow-brown or green-brown) rather than uniform colour (blue, grey, green or brown). Any change in eye colour may occur after several years, although it usually appears within the first 8 months of treatment. The colour change may be permanent and may be more noticeable if you use Xalibur in only one eye. There appear to be no associated problems related to the change in eye colour. After discontinuation of treatment with Xalibur, no further change in eye colour has been observed.
Redness of the eyes.
Eye irritation [burning sensation, gritty sensation, itching, stabbing pain (pinprick sensation) or foreign body sensation in the eyes]. If you experience irritation severe enough to cause excessive tearing or that leads to discontinuation of the medicine, contact your doctor, pharmacist or nurse immediately (within one week). Your therapy may need to be reviewed to ensure adequate treatment of your condition.
Gradual changes in the eyelashes of the treated eye and changes in the fine hair around the treated eye, mostly observed in people of Japanese origin. These changes include increased darkening, lengthening, thickening and increased number of eyelashes. Eyelash changes are reversible upon discontinuation of treatment.

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

Irritation or abrasion of the eye surface (punctate keratitis), inflammation of the eyelid margin (blepharitis), eye pain, light sensitivity (photophobia), conjunctivitis.

Uncommon (may affect up to 1 in 100 people):
Swelling of the eyelids, dry eyes, inflammation or irritation of the eye surface (keratitis), blurred vision, inflammation of the coloured part of the eye (uveitis), swelling of the retina (macular edema).
Skin rash.
Chest pain (angina), awareness of heartbeat (palpitations).
Asthma, shortness of breath (dyspnea).
Chest pain.
Headache, dizziness.
Muscle pain (myalgia), joint pain (arthralgia).

Rare (may affect up to 1 in 1,000 people):
Inflammation of the iris (iritis), symptoms related to swelling or abrasion/damage of the eye surface, swelling around the eyes (periorbital edema), altered eyelash direction (trichiasis) or abnormal eyelash growth, scarring of the eye surface (ocular conjunctival pseudopemphigoid), fluid-filled area in the coloured part of the eye (iris cysts).
Skin reactions on the eyelids, darkening of the skin of the eyelids.
Worsening of asthma.
Intense skin itching.
Development of a viral eye infection caused by herpes simplex virus (HSV).

Very rare (may affect up to 1 in 10,000 people):
Worsening of angina in patients already affected by heart disease, sunken appearance of the eye (enophthalmos).
Very rarely, cases of calcium deposits (corneal calcification) have been reported in association with the use of eye drops containing phosphates, leading to significant corneal damage.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Xalibur

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack. The expiry date refers to the last day of that month.
Store in a refrigerator (2-8°C), in the original packaging to protect the medicine from light.
After first opening, the bottle should be stored at a temperature not exceeding 25°C, and the medicine must be used within 28 days; after this period, any remaining medicine must be discarded.
Record the date of first opening in the space provided on the carton.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Xalibur contains
The active substance is latanoprost.
Each ml of solution contains 50 micrograms of latanoprost. One drop contains approximately 1.5 micrograms of latanoprost.
The other components are: Benzalkonium chloride, Sodium chloride, Monosodium dihydrogen phosphate monohydrate (E339i), Disodium hydrogen phosphate anhydrous (E339ii), Water for injections.

Description of the appearance of Xalibur and contents of the pack
Xalibur eye drops, solution, is a clear, colourless liquid.
Xalibur is available in a pack containing 1 bottle of 2.5 ml.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Viatris Pharma S.r.l.
Via Vittor Pisani 20
20124 Milano
Manufacturer
Genetic S.p.A. – Contrada Canfora – Fisciano (SA)

Package leaflet: information for the user

XALIBUR 50 micrograms/ml eye drops, solution in single-dose container

Latanoprost
Equivalent medicine
Please read this leaflet carefully before using this medicine as it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Xalibur is and what it is used for
What you need to know before using Xalibur
How to use Xalibur
Possible side effects
How to store Xalibur
Contents of the pack and other information

1. What Xalibur is and what it is used for

Xalibur contains the active substance latanoprost, which belongs to a class of medicines known as antiglaucoma agents and miotics – prostaglandin analogues. Xalibur works by increasing the natural outflow of fluid from inside the eye into the bloodstream.
Xalibur is used to treat conditions known as open-angle glaucoma and ocular hypertension in adults. Both of these conditions are associated with increased intraocular pressure, which may eventually impair vision.

2. What you need to know before using Xalibur

Xalibur can be used in adult women and men (including elderly patients). The use of Xalibur is not recommended in patients under 18 years of age.
Do not use Xalibur

If you are allergic (hypersensitive) to latanoprost or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Xalibur if you think any of the following conditions apply to you:

If you are about to undergo or have recently undergone eye surgery (including cataract surgery);
If you have eye problems (such as eye pain, irritation or inflammation, blurred vision);
If you suffer from dry eye;
If you suffer from a type of glaucoma known as “chronic closed-angle glaucoma”, open-angle glaucoma and have an artificial intraocular lens (the natural lens of the eye that allows focusing on objects), or pigmentary glaucoma (with excessive release of pigment inside the eye);
If you suffer from glaucoma caused by eye inflammation or abnormal growth of new blood vessels in the eye;
If you have risk factors for cystoid macular edema (accumulation of fluid in the central part of the retina), such as due to diabetes or retinal blood vessel occlusion;
If your eyes are aphakic (lacking the natural lens) or pseudophakic (with an artificial intraocular lens) with posterior lens capsule rupture or with anterior chamber lenses;
If you have severe asthma or if your asthma is not well controlled;
If you wear contact lenses. You may still use Xalibur by following the instructions for contact lens wearers provided in section 3.
If you have had or currently have a viral eye infection caused by the herpes simplex virus (HSV).

Other medicines and Xalibur
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including eye drops and medicines without a prescription.
In particular, inform your doctor or pharmacist if you are taking medicines belonging to the class of prostaglandins, prostaglandin analogues, or prostaglandin derivatives, as these may paradoxically increase intraocular pressure.
Pregnancy and breastfeeding
Do not use Xalibur if you are pregnant or breastfeeding, unless your doctor considers it necessary. If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before using this medicine.
Driving and using machines
When using Xalibur, you may experience transient blurred vision. If this occurs, you must not drive or operate machinery until your vision is clear again.
Xalibur contains phosphate buffers.
This medicine contains 0.295 mg of phosphate buffers per drop, equivalent to 1.8686 mg/0.2 ml in each single-dose container.
If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may very rarely cause cloudy corneal deposits due to calcium accumulation during treatment.

3. How to use Xalibur

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose for adults (including elderly patients) is one drop once daily in the eye(s) to be treated. The optimal effect is achieved when Xalibur is administered in the evening.
Do not use Xalibur more than once a day, as the effectiveness of treatment may be reduced if the medicine is administered more frequently.
Continue using Xalibur as directed by your doctor, until your doctor tells you to stop treatment.
Contact lens wearers
If you wear contact lenses, you must remove them before applying Xalibur. After applying Xalibur, you must wait 15 minutes before reinserting your contact lenses.
Instructions for use
As with other eye drops, instill one drop into the eye and press gently with a finger on the inner corner of the treated eye for one minute. This should be done immediately after instilling each drop.
Paediatric population
Safety and efficacy data are not available in children. Therefore, the use of Xalibur in children and adolescents (under 18 years of age) is not recommended.
If you use Xalibur with another eye drop
Wait at least 5 minutes between administering Xalibur and any other eye drop.
If you use more Xalibur than you should
Putting too many drops into the eyes may cause mild irritation, tearing, and eye redness. These effects should be temporary, but if you are concerned, contact your doctor for advice.
Contact your doctor as soon as possible if you have accidentally swallowed Xalibur.
If you forget to use Xalibur
Continue with your next dose at the usual time. Do not use a double dose to make up for the forgotten dose. If you have any doubts, consult your doctor or pharmacist.
If you stop using Xalibur
You should inform your doctor if you intend to stop treatment with Xalibur.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following are known side effects with the use of Xalibur:

Very common (may affect 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. This change is more likely if your eyes are of mixed colour (blue-brown, grey-brown, yellow-brown or green-brown) rather than uniform colour (blue, grey, green or brown). Any change in eye colour may occur after several years, although it generally appears within the first 8 months of treatment. The change in colour may be permanent and may be more noticeable if you use Xalibur in only one eye. There appear to be no problems associated with the change in eye colour. After stopping treatment with Xalibur, no further change in eye colour has been observed.

Red eyes.
Eye irritation [burning sensation, sensation of sand in the eyes, itching, stinging pain (pinprick sensation) or foreign body sensation in the eyes]. If you experience irritation severe enough to cause excessive tearing or that leads to discontinuation of the medicine, contact your doctor, pharmacist or nurse immediately (within one week). Your treatment may need to be reviewed to ensure adequate management of your condition.
Gradual changes in the eyelashes of the treated eye and changes in the fine hair around the treated eye, mostly observed in people of Japanese origin. These changes include increased darkening, lengthening, thickening and increased density of the eyelashes. Eyelash changes are reversible upon discontinuation of treatment.

Common (may affect up to 1 in 10 people):
Irritation or abrasion of the eye surface (punctate keratitis), inflammation of the eyelid margin (blepharitis), eye pain, light sensitivity (photophobia), conjunctivitis.

Uncommon (may affect up to 1 in 100 people):
Swelling of the eyelids, dry eyes, inflammation or irritation of the eye surface (keratitis), blurred vision, inflammation of the coloured part of the eye (uveitis), swelling of the retina (macular oedema).
Skin rash
Chest pain (angina), awareness of heartbeat (palpitations)
Asthma, shortness of breath (dyspnoea)
Chest pain
Headache, dizziness
Muscle pain (myalgia), joint pain (arthralgia)

Rare (may affect up to 1 in 1,000 people):
Inflammation of the iris (iritis), symptoms related to swelling or abrasion/damage of the eye surface, swelling around the eyes (periorbital oedema), altered direction of eyelash growth (trichiasis) or abnormal eyelash growth, scarring of the eye surface (ocular conjunctival pseudopemphigoid), fluid-filled area in the coloured part of the eye (iris cyst).
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).

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Xalibur

Keep this 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 that month.
Store in a refrigerator (2-8°C), in the original packaging to protect the medicine from light.
After first opening the aluminium pouch: store at a temperature not exceeding 25°C for a maximum of 7 days; after this period, any remaining containers must be discarded.
The single-dose container must be used immediately after opening; any leftover medicine must be discarded.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Xalibur contains
The active substance is latanoprost.
50 micrograms of latanoprost are contained in 1 ml of solution. One drop contains approximately 1.5
micrograms of latanoprost.
The other components are: Sodium chloride, Monosodium dihydrogen phosphate monohydrate (E339i), Disodium
hydrogen phosphate anhydrous (E339ii), Water for injections.
Description of the appearance of Xalibur and contents of the pack
Xalibur eye drops, solution is a colourless, clear liquid.
Xalibur is available in a carton containing 30 single-dose containers of 0.2 ml each.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Viatris Pharma S.r.l.
Via Vittor Pisani 20
20124 Milano
Manufacturer
Genetic S.p.A. – Contrada Canfora – Fisciano (SA)