Xalofree

Package leaflet: Information for the patient

Xalofree, 50 micrograms/ml, eye drops, solution
Latanoprost
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents:

1. What Xalofree is and what it is used for
2. What you need to know 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

The active substance in Xalofree belongs to a group of medicines called prostaglandin analogues. These reduce intraocular pressure by increasing the natural outflow of fluid from inside the eye into the bloodstream.
Xalofree is indicated in adults (including elderly patients) for the treatment of a type of glaucoma called open-angle glaucoma and for the treatment of elevated intraocular pressure. These conditions are associated with increased intraocular pressure and may consequently affect vision.
Xalofree may also be used in children of any age for the treatment of elevated intraocular pressure and glaucoma.

2. Important information before using Xalofree

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

When not to use Xalofree

• 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, suspects she may be pregnant, or is planning to become pregnant
• if the patient is breast-feeding

Warnings and precautions
Before starting treatment with Xalofree, discuss with the patient's doctor or pharmacist:

• if the adult or child has severe or uncontrolled asthma
• if the adult or child has undergone eye surgery (including cataract surgery), or if such surgery is planned
• if the adult or child has an eye disease (such as eye pain, ocular surface irritation or inflammation, blurred vision)
• if the adult or child has dry eye
• if the adult or child wears contact lenses. For continued use of Xalofree, follow the instructions regarding contact lens use (see section 3)
• if the patient has had or currently has a viral eye infection caused by herpes simplex virus (HSV)

Xalofree with other medicines
Tell the doctor or pharmacist of any medicines the patient is currently taking, has recently taken, or might take in the future.
Xalofree may interact with other medicines; therefore, concomitant use of two or more prostaglandins, prostaglandin analogues, or prostaglandin derivatives is not recommended.

Pregnancy and breast-feeding
If the patient is pregnant or breast-feeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine.
Xalofree must not be used in pregnant women or in women who are breast-feeding.

Driving and using machines
This medicine has a minor influence on the ability to drive and use machines. The use of eye drops may cause transient blurred vision. If this adverse effect occurs, the patient should not drive or operate machinery. Caution should be exercised when driving or operating machinery until the patient knows how they react to the medicine.

Xalofree contains phosphates
The medicine contains 6.4 mg of phosphates per millilitre. In patients with severe corneal damage (the transparent front part of the eye), phosphates may very rarely lead to corneal calcification and clouding during treatment.

3. How to use Xalofree

This medicine should always be used exactly as recommended by the doctor treating the adult or child.
If in doubt, consult the doctor treating the adult or child, or a pharmacist.
Dosage
The recommended dose for adults (including elderly patients) and children is 1 drop into the affected eye(s) once daily, preferably in the evening. It is not recommended to use Xalofree more than once a day, as this may reduce the effectiveness of treatment.
Xalofree should always be used for as long as the treating doctor has advised for the adult or child.
Use of contact lenses

• Before administering Xalofree to the eye of an adult or child, contact lenses must be removed. Contact lenses may be reinserted 15 minutes after using Xalofree.

Instructions for using the eye drops
Follow the instructions below, which will help ensure correct use of Xalofree:

1. Wash your hands, then sit or stand comfortably.
2. Remove the cap (Figure 1).
3. Place your thumb on the dosing aid at the top of the bottle and the other fingers on the base of the bottle. Hold the bottle upside down (Figure 2). Before first use, press the bottle with the dropper tip pointing downwards about 10 times to activate the pump mechanism, until the first drop appears.
4. Tilt the head backwards, then gently pull down the lower eyelid with a finger to create a "pocket" between the eyeball and the eyelid.
5. Bring the dropper tip as close as possible to the eye without touching it.
6. Press the dosing aid on the top of the bottle and the base of the bottle to release one drop into the eye, then release the lower eyelid (Figure 3).
7. Close the eye and then press with a finger on the corner of the eye nearest to the nose (Figure 4). Maintain this pressure for one minute, keeping the eye closed.
8. If necessary, administer a drop into the other eye in the same way.
9. Immediately after use, replace the cap on the bottle tip.

Figure 1. Figure 2. Figure 3. Figure 4.
Only one bottle of medicine should be opened and used at any one time. Do not remove the cap until the drops are needed.
The 2.5 ml bottle should be discarded 30 days after first opening, and the 7.5 ml bottle 90 days after first opening, to prevent infection. After this time, the patient should use a new bottle.
To better monitor the storage period of the drops after first opening, the patient should write the date of opening on the carton in the space provided.
Using Xalofree with other eye drops
If the patient is using other eye drops at the same time, including drops containing thiomersal, at least a 5-minute interval should be maintained between the administration of each medicine. Ointments should be used last.
Use of a higher than recommended dose of Xalofree
Exercise caution when pressing the bottle to ensure that only one drop enters the affected eye.
If more drops are administered, moderate eye irritation with redness and tearing may occur. These symptoms should resolve, but if in doubt, contact the doctor treating the adult or child.
If Xalofree is accidentally ingested by an adult or child, contact a doctor as quickly as possible.
Missed dose of Xalofree
If a dose is missed at the usual time, wait until the next scheduled dose. Do not use a double dose to make up for the missed dose.
Stopping treatment with Xalofree
If considering stopping treatment with Xalofree, consult the doctor treating the adult or child, or a pharmacist.
If there are any further doubts regarding the use of this medicine, consult the doctor treating the adult or child, or a pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
The following adverse reactions are known:
Very common (occur in more than 1 in 10 patients):

• Gradual change in eye colour due to increased amount of brown pigment in the coloured part of the eye called the iris. If the patient has mixed-coloured eyes (i.e. blue-brown, grey-brown, yellow-brown, green-brown), these changes are more likely to occur than in patients with eyes of a single colour (blue, grey, green or brown). Changes in eye colour may occur after several years of treatment, but most commonly occur within the first 8 months of treatment. The colour change may be long-lasting and more noticeable when Xalofree is used in only one eye. Changes in eye colour are not associated with other pathological changes. Changes in eye colour do not progress after discontinuation of the medicine.
• Eye redness.
• Eye irritation (including burning sensation, feeling of sand in the eyes, itching, stinging or foreign body sensation in the eye). If eye irritation is severe enough to cause excessive tearing or desire to discontinue the medicine, consult a doctor, pharmacist or nurse promptly (within one week). Treatment may need to be reviewed to ensure appropriate management for the patient.
• Gradual changes in the appearance of eyelashes in the treated eye and mild eyelid hair growth around it, most commonly observed in people of Japanese origin. These changes include darkening, lengthening, thickening and increased number of eyelashes.

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

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

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

• Eyelid swelling, dry eyes, inflammation or irritation of the eye surface (keratitis), blurred vision, inflammation of the coloured part of the eye (uveitis), retinal swelling (macular oedema).
• Skin rash.
• Chest pain (angina), sensation of rapid or irregular heartbeat (palpitations).
• Asthma, shortness of breath (dyspnoea).
• Chest pain.
• Headache, dizziness.
• Muscle pain, joint pain.
• Nausea, vomiting.

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

• Iritis, symptoms of eye surface swelling or blurred/damaged eye surface, swelling around the eye (periorbital oedema); change in the direction of eyelash growth or development of a double row of eyelashes, scarring on the eye surface, formation of fluid-filled cysts in the coloured part of the eye (iris cysts).
• Local skin reactions on the eyelids, darkening of eyelid skin.
• Worsening of asthma.
• Acute skin itching.
• Viral eye infections caused by herpes simplex virus (HSV).

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

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

Adverse reactions occurring more frequently in children and adolescents than in adults include nasal inflammation (catarrh) and fever.
Other adverse reactions reported with the use of eye drops containing phosphates:
In patients with severe damage to the transparent front part of the eye (cornea), phosphates may very rarely cause corneal clouding during treatment due to calcium deposits.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Xalofree

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label following
EXP. The expiry date refers to the last day of the stated month.
The marking on the packaging following EXP indicates the expiry date, and following Lot indicates the batch number.
Do not store above 25°C.
Do not freeze.
Period of use after first opening of the 2.5 ml bottle: 30 days.
Period of use after first opening of 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 ml 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, monosodium dihydrogen phosphate monohydrate, polysorbate 80, disodium edetate, sodium hydroxide (for pH adjustment), hydrochloric acid diluted (for pH adjustment), water for injections.

What Xalofree looks like and contents of the pack
Xalofree is a colourless, clear solution.
The pack consists of an HDPE bottle with a multidose dropper 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 Authorisation Holder and Manufacturer
Marketing Authorisation 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