Xalatan 50 micrograms/ml eye drops solution

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Xalatan 50 micrograms/ml eye drops solution

Latanoprost

Read all of this leaflet carefully before you start 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, the doctor treating your child, or pharmacist.
• This medicine has been prescribed only for you or your child and must not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, talk to your doctor, the doctor treating your child, or pharmacist, even if the effects are not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Xalatan is and what it is used for

2. What you need to know before using Xalatan

3. How to use Xalatan

4. Possible side effects

5. How to store Xalatan

6. Contents of the container and other information

1. What Xalatan is and what it is used for

Xalatan belongs to a group of medicines known as prostaglandin analogues. It works by increasing the natural outflow of fluid from inside the eye into the bloodstream.

Xalatan is used to treat conditions known as open-angle glaucoma and ocular hypertension in adults. Both conditions are associated with increased pressure inside the eye, which may eventually affect vision.

Xalatan is also used to treat elevated intraocular pressure and glaucoma in children and infants of all ages.

2. What you need to know before using Xalatan

Xalatan can be used in adult men and women (including elderly patients) and in children from birth up to 18 years of age. Xalatan has not been studied in premature children (less than 36 weeks gestation).

Do not use Xalatan

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

Warnings and precautions

If you consider that any of the following situations apply to you or your child, consult your doctor, your child's doctor, or pharmacist before using Xalatan or before administering it to your child:

• If you or your child have had or are going to have eye surgery (including cataract surgery).
• If you or your child have eye problems (such as eye pain, irritation or inflammation, blurred vision).
• If you or your child have dry eyes.
• If you or your child have severe asthma or asthma that is not well controlled.
• If you or your child wear contact lenses. You may continue using Xalatan, but you must follow the instructions provided in section 3 for contact lens wearers.
• If you have had or currently have a viral eye infection caused by herpes simplex virus (HSV).

Using Xalatan with other medicines

Xalatan may interact with other medicines. Inform your doctor, your child's doctor, or pharmacist if you or your child are using or have recently used any other medicines (or eye drops), including those obtained without a prescription. In particular, consult your doctor or pharmacist if you know you are taking prostaglandins, prostaglandin analogs, or prostaglandin derivatives.

Pregnancy and breastfeeding

You should not use Xalatan if you are pregnant or breastfeeding unless your doctor considers it necessary. If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Driving and using machines

Blurred vision may occur for a short period of time when using Xalatan. If this happens to you, do not drive and do not operate tools or machinery until your vision returns to normal.

Xalatan 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 change the color of contact lenses. You must remove your contact lenses before using this medicine and wait 15 minutes before reinserting them.

Benzalkonium chloride may also cause eye irritation, particularly if you have dry eyes or corneal disorders (the transparent front part of the eye). If you experience an abnormal sensation in the eyes, stinging, or eye pain after using this medicine, consult your doctor.

This medicine contains 6.3 mg/ml of phosphates, equivalent to 0.2 mg per drop.

If you have a severe injury to the transparent front part of the eye (the cornea), phosphates may, in very rare cases, cause cloudy areas in the cornea due to calcium deposits occurring during treatment.

3. How to use Xalatan

Follow exactly the administration instructions for Xalatan given by your doctor, or by the doctor treating your child. Consult your doctor, the doctor treating your child, or the pharmacist if you have any doubts.

The recommended dose for adults (including elderly patients) and children is one drop in the affected eye or eyes once daily. It is preferable to administer it in the evening.

Do not use Xalatan more than once a day; treatment efficacy may decrease if administered more frequently.

Use Xalatan exactly as directed by your doctor or the doctor treating your child, until they tell you to stop.

Contact lens wearers

If you or your child wears contact lenses, they must be removed before using Xalatan. After applying Xalatan, wait 15 minutes before reinserting the contact lenses.

Instructions for use

If you use Xalatan with other eye drops

Wait at least 5 minutes between applying Xalatan and administering other eye drops.

If you use more Xalatan than you should

If you have applied more drops into the eye than you should have, you may experience mild eye irritation, redness, and tearing; this condition should resolve on its own. However, if you are concerned, contact your doctor or your child's doctor.

In case of accidental ingestion of Xalatan by you or your child, consult your doctor or pharmacist as soon as possible, or call the Toxicology Information Service at telephone number: 91 562 04 20.

If you forget to use Xalatan

Continue with the next dose as usual. Do not apply an extra drop into the eye to make up for the missed dose. If you have any doubts, consult your doctor or pharmacist.

If you stop using Xalatan

If you wish to stop using Xalatan, consult your doctor or your child's doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The following are known adverse effects when using Xalatan:

Very common adverse effects (may affect more than 1 in 10 patients):

• Gradual change in eye color due to an increase in brown pigment in the colored part of the eye known as the iris. If you have mixed-color eyes (blue-brown, gray-brown, yellow-brown or green-brown), you are more likely to experience this change than if your eyes are of a single color (blue, gray, green or brown). The change in eye color develops gradually over years, although it is typically noticeable after about 8 months of treatment. The change in eye color may be permanent and may be more pronounced if Xalatan is used in only one eye. The change in eye color does not appear to be associated with any eye problems. The change in eye color does not progress once treatment with Xalatan is discontinued.
• Eye redness.
• Eye irritation (burning sensation, gritty feeling in the eye, itching, pain, and foreign body sensation in the eye). If you experience severe eye irritation causing excessive tearing or making you consider stopping treatment, consult your doctor, pharmacist, or nurse as soon as possible (within one week). Your treatment may need to be reviewed to ensure you are receiving the appropriate therapy for your condition.
• Gradual changes in the eyelashes of the treated eye and in the fine hair around the treated eye, observed in most Japanese patients. These changes include increased pigmentation (darkening), lengthening, thickening, and increased number of eyelashes.

Common adverse effects (may affect up to 1 in 10 patients):

• Irritation or erosion on the eye surface, eyelid inflammation (blepharitis), eye pain, and light sensitivity (photophobia), conjunctivitis.

Uncommon adverse effects (may affect up to 1 in 100 patients):

• Eyelid swelling, dry eye, inflammation or irritation of the eye surface (keratitis), blurred vision, inflammation of the colored part of the eye (uveitis), swelling of the retina (macular edema).
• Skin rash.
• Chest pain (angina), awareness of heartbeats (palpitations).
• Asthma, difficulty breathing (dyspnea).
• Chest pain.
• Headache, dizziness.
• Muscle pain, joint pain.
• Nausea, vomiting.

Rare adverse effects (may affect up to 1 in 1,000 patients):

• Inflammation of the iris (iritis), symptoms of swelling or injury/damage to the eye surface, swelling around the eye (periorbital edema), misdirected eyelashes or an additional row of eyelashes, scarring of the eye surface, fluid accumulation in the colored part of the eye (iris cyst), light sensitivity (photophobia).
• Skin reactions on the eyelids, darkening of the eyelid skin.
• Worsening of asthma.
• Intense skin itching.
• Development of a viral eye infection caused by the herpes simplex virus (HSV).

Very rare adverse effects (may affect up to 1 in 10,000 patients):

• Worsening of angina in patients who also have heart problems, appearance of sunken eyes (increased depth of the eyelid crease).

Adverse effects observed in children at a higher frequency than in adults include runny nose, nasal itching, and fever.

In very rare cases, some patients with severe damage to the transparent front part of the eye (cornea) have developed cloudy areas in the cornea due to calcium deposits occurring during treatment.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Xalatan

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and on the bottle. The expiry date refers to the last day of the month indicated.

Store the unopened Xalatan bottle at room temperature (do not store above 25°C), protected from light.

After opening the bottle, store it at room temperature (do not store above 25°C); it must be used within 4 weeks of opening. When not in use, keep the bottle in the outer packaging to protect it from light.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Xalatan

• The active substance is latanoprost 50 micrograms/ml.

• The other components are: benzalkonium chloride, sodium chloride, monohydrate sodium dihydrogen phosphate (E339i), and anhydrous disodium phosphate (E339ii), dissolved in water for injections.

Nature of the product and pack contents

Xalatan eye drops is a clear, colourless liquid.

Xalatan is available in pack sizes of 1, 3 and 6 bottles. Only some pack sizes may be marketed.

Each bottle contains 2.5 ml of Xalatan eye drops.

Marketing Authorisation Holder

Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer

Pfizer Manufacturing Belgium NV
Rijksweg 12
2870 Puurs-Sint-Amands (Belgium)

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Viatris Pharmaceuticals, S.L.U.
C/ General Aranaz, 86
28027 Madrid
Spain

Date of the most recent review of this leaflet: July 2022

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Xalatan: Germany, Austria, Belgium, Cyprus, Denmark, Spain, Finland, France, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, United Kingdom.

“Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/”