Xalatan

Package Leaflet: Information for the Patient

Xalatan,50 μg/ml, eye drops, solution
Latanoprostum

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 those not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Contents of the Package Leaflet

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

1. What Xalatan is and what it is used for

Xalatan belongs to a group of medicines known as prostaglandin analogues. Xalatan works by increasing the natural outflow of aqueous fluid from the eye into the bloodstream.
Xalatan is used in adults to treat open-angle glaucomaand ocular hypertension. Both conditions are associated with increased pressure in the eye and can affect your vision.
Xalatan may also be used in children of all ages to treat increased intraocular pressureand glaucoma.

2. Important information before using Xalatan

Xalatan can be used in adults, including the elderly, and in children from birth to 18 years. The use of Xalatan in premature infants (less than 36 weeks gestational age) has not been studied.
When not to use Xalatan:

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

Warnings and Precautions

If any of the following apply to you, tell your doctor before using Xalatan:

• if you have had eye surgery (including cataract surgery) or if one is planned,
• if you have eye problems (such as eye pain, irritation, or inflammation, blurred vision),
• if you have dry eye,
• if you have severe or uncontrolled asthma,
• if you wear contact lenses. You can use Xalatan but follow the instructions for contact lens wearers (see section 3),
• if you have had a viral infection of the eye (caused by the herpes simplex virus).

Xalatan and Other Medicines

Xalatan may interact with other medicines. Tell your doctor or pharmacist about all medicines you are taking, including those you have bought without a prescription, and any you plan to take.

Pregnancy and Breast-feeding

Xalatan should not be used during pregnancy or breast-feeding, unless your doctor considers it necessary.
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.

Driving and Using Machines

After using Xalatan, your vision may be blurred for a short time. Do not drive or use machines until your vision is clear again.

Xalatan Contains Benzalkonium Chloride and Phosphate Buffers

The medicine contains 0.2 mg of benzalkonium chloride per milliliter.
Benzalkonium chloride may be absorbed by soft contact lenses and change their color. Remove contact lenses before using Xalatan and wait at least 15 minutes before putting them back.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eye or corneal disorders. If you experience any abnormal sensations in the eye, such as stinging or burning, after using Xalatan, consult your doctor.

3. How to Use Xalatan

Use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose for adults (including the elderly) and children is one drop into the affected eye(s) once daily, preferably in the evening.
Do not use Xalatan more than once daily, as it may reduce the effect of the treatment.
Use Xalatan for as long as your doctor tells you to.

Using Contact Lenses

Remove contact lenses before using Xalatan. You can put them back 15 minutes after using Xalatan.

Instructions for Use of Xalatan

• 1. Wash your hands, stand or sit comfortably.
• 2. Remove the protective ring (which can be discarded) (Figure 1).
• 3. Remove the protective cap (Figure 2) and keep it.
• 4. Gently pull down the lower eyelid of the affected eye (Figure 3).
• 5. Place the tip of the bottle close to the eye. Do not touch the eye with the dropper.
• 6. Gently squeeze the bottle to release one drop into the eye. Then release the lower eyelid.
• 7. Close your eye and press the inner corner of your eye with your finger for 1 minute.
• 8. Repeat the steps for the other eye, if your doctor has told you to.
• 9. Replace the protective cap on the bottle.

Using Xalatan with Other Eye Drops

If you are using other eye drops, wait at least 5 minutes between using Xalatan and the other eye drops.

Using More Xalatan than Prescribed

If you use more Xalatan than you should, it is unlikely to cause problems. If you are concerned, contact your doctor for advice.

Forgetting to Use Xalatan

If you forget to use Xalatan, use it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not use a double dose to make up for a forgotten dose.

Stopping Xalatan Treatment

If you want to stop using Xalatan, talk to your doctor 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, Xalatan can cause side effects, although not everybody gets them.
Known side effects of Xalatan:

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, known as the iris. This change may be more noticeable in patients with mixed-colored eyes (blue/brown, grey/brown, yellow/brown, or green/brown) than in patients with uniformly colored eyes (blue, grey, green, or brown). Any changes in eye color may take several years to develop and are likely to be permanent. The change in eye color may be more noticeable if Xalatan is used in one eye only.
• Eye redness.
• Eye irritation (feeling of burning, grittiness, itching, stinging, or the sensation of having something in the eye). If you experience eye irritation that is severe or persistent, you should contact your doctor, pharmacist, or nurse within a week. Your treatment may need to be reviewed to ensure you are receiving the most effective treatment.
• Gradual change in the appearance of the eyelashes and the fine hairs around the treated eye, particularly in people of Japanese descent. These changes include increased length, thickness, and/or color (darkening) of the eyelashes.

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

• Eye surface disorders, inflammation of the eyelids, eye pain, increased sensitivity to light (photophobia), inflammation of the conjunctiva.

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

• Swelling of the eyelids, dry eye, infections or inflammation of the surface of the eye (keratitis), blurred vision, inflammation of the iris (iritis), swelling of the macula (macular edema).
• Rash.
• Chest pain (angina), 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):

• Iritis, symptomatic changes to the surface of the eye, swelling around the eye (periorbital edema), changes in the direction of eyelash growth or the appearance of additional rows of eyelashes, scarring on the surface of the eye, formation of fluid-filled areas within the iris (iris cysts).
• Local skin reactions on the eyelids, darkening of the eyelid skin.
• Worsening of asthma.
• Severe itching of the skin.
• Viral infections of the eye caused by the herpes simplex virus.

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

• Worsening of angina in patients with heart disease, feeling of sunken eyes.

Cold and flu-like symptoms are more common in children and adolescents than in adults.
In very rare cases, in patients with significantly damaged clear layer on the front of the eye (cornea), calcium deposits on the cornea have been reported during treatment.

Reporting Side Effects

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

5. How to Store Xalatan

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 label after EXP. The expiry date refers to the last day of that month.
Store the bottle in the outer carton in order to protect from light.
Do not store above 25°C. The product should be used within 4 weeks of first opening.
After using Xalatan, keep the bottle in the outer carton to protect it from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the Pack and Other Information

What Xalatan Contains

• The active substance is latanoprost. 1 ml of solution contains 50 micrograms of latanoprost.
• The other ingredients are sodium chloride, benzalkonium chloride (0.2 mg/ml), sodium dihydrogen phosphate monohydrate, disodium phosphate anhydrous, water for injections.

One drop contains approximately 1.5 micrograms of latanoprost.

What Xalatan Looks Like and Contents of the Pack

Xalatan, eye drops, solution is a clear, colorless solution.
Pack contents:
Bottle (5 ml), dropper, white cap, transparent polyethylene protective cap in a cardboard box.
Each bottle contains 2.5 ml of eye drop solution, equivalent to approximately 80 drops.
The drops are available in packs containing 1 bottle of 2.5 ml and packs containing 3 bottles of 2.5 ml.

Marketing Authorisation Holder:

Upjohn EESV
Rivium Westlaan 142
2909 LD Capelle aan den IJssel
Netherlands

Manufacturer:

Pfizer Manufacturing Belgium NV
Rijksweg 12
2870 Puurs-Sint-Amands
Belgium
For further information, contact the Marketing Authorisation Holder:

Mylan Healthcare Sp. z o.o.

tel. 22 546 64 00
Date of last revision of the leaflet:10/2023

Other Sources of Information

More detailed information on this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products http://urpl.gov.pl