XALATAN 50 micrograms/ml eye drops solution

Introduction

PATIENT INFORMATION 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 further questions, ask your doctor, or the doctor treating your child, or your pharmacist.
• This medicine has been prescribed for you or your child only. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor, or the doctor treating your child, or your pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What Xalatan is and what it is used for
2. What you need to know before you use Xalatan
3. How to use Xalatan
4. Possible side effects
5. Storing Xalatan

1. Contents of the pack and further 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 the eye into the bloodstream.

Xalatan is used to treat conditions known as open-angle glaucomaand ocular hypertensionin adults. Both of these conditions are linked to an increase in the pressure within the eye, which can lead to vision problems.

Xalatan is also used to treat increased pressure in the eye and glaucoma in children and babies of all ages.

2. What you need to know before you use Xalatan

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

Do not useXalatan

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

Warnings and precautions

If you think any of the following apply to you or your child, tell your doctor, or the doctor treating your child, or your pharmacist before using Xalatan:

• 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 uncontrolled asthma.
• If you or your child wear contact lenses. You can continue to use Xalatan but follow the instructions in section 3 for contact lens wearers.
• If you have had a viral infection of the eye caused by the herpes simplex virus (HSV).

Using Xalatan with other medicines

Xalatan may have interactions with other medicines. Tell your doctor, or the doctor treating your child, or your pharmacist if you or your child are using or have recently used other medicines (or eye drops), including those obtained without a prescription. In particular, tell your doctor or pharmacist if you know you are taking prostaglandins, prostaglandin analogues or prostaglandin derivatives.

Pregnancy and breastfeeding

You should not use Xalatanif 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, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

When using Xalatan, you may experience blurred vision for a short time. If this happens, do not driveor use tools or machines until your vision is clear again.

Xalatan containsbenzalkonium 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 colour of the contact lenses. You should remove your contact lenses before using this medicine and wait 15 minutes after application before putting them back.

Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the transparent front part of the eye). If you experience any unusual sensation in the eye, stinging or eye pain after using this medicine, tell your doctor.

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

If you have severe damage to the transparent front part of the eye (the cornea), phosphates may rarely cause cloudy areas on the cornea due to calcium deposits during treatment.

3. How to use Xalatan

Use Xalatan exactly as your doctor, or the doctor treating your child, has told you. If you are not sure, ask your doctor, or the doctor treating your child, or your pharmacist.

The recommended dose for adults (including the elderly) and children is one drop into the affected eye(s) once daily. It is best to do this in the evening.

Do not use Xalatan more than once a day; the effectiveness of the treatment may decrease if it is used more frequently.

Use Xalatan as your doctor, or the doctor treating your child, has told you until they tell you to stop.

Contact lens wearers

If you or your child wear contact lenses, you should remove them before using Xalatan. Wait 15 minutes after application before putting the contact lenses back in.

Instructions for use

If you are usingXalatan with other eye drops

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

If you use moreXalatan than you should

If you have accidentally applied more drops than you should, you may experience eye irritation and your eyes may become red and watery; this should pass, but if you are concerned, contact your doctor or the doctor treating your child.

In case of accidental ingestion by you or your child, contact your doctor or pharmacist immediately, or call the Toxicology Information Service on +34 91 562 04 20.

If you forget to useXalatan

Continue with the next dose as usual. Do not apply an extra drop to make up for the missed dose. If you are unsure, talk to your doctor or pharmacist.

If you stop usingXalatan

If you want to stop using Xalatan, talk to your doctor or the doctor treating your child.

If you have any other questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Xalatan can cause side effects, although not everybody gets them.

The following are known side effects of using Xalatan:

Very common side effects(may affect more than 1 in 10 people):

• Gradual change in eye colour by increasing the amount of brown pigment in the coloured part of the eye known as the iris. If you have mixed-colour eyes (blue-brown, grey-brown, yellow-brown or green-brown), you are more likely to experience this change than if your eyes are a single colour (blue, grey, green or brown). The change in eye colour takes years to develop and is usually noticeable after 8 months of treatment. The change in eye colour may be permanent and may be more noticeable if Xalatan is used in one eye only. The change in eye colour does not appear to be associated with any problems. The change in eye colour does not progress once Xalatan treatment is stopped.
• Redness of the eye.
• Eye irritation (feeling of stinging, feeling of grit in the eye, itching, pain and feeling of something in the eye).
• Gradual change in the eyelashes of the treated eye and the fine hair around the treated eye, seen in most patients of Japanese origin. These changes include an increase in colour (darkening), length, thickness and number of eyelashes.

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

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

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

• Swelling of the eyelids, dry eye, inflammation or irritation of the surface of the eye (keratitis), blurred vision, inflammation of the coloured part of the eye (uveitis), swelling of the retina (macular oedema).
• Skin rash.
• Chest pain (angina), feeling your heartbeat (palpitations).
• Asthma, difficulty breathing (dyspnoea).
• Chest pain.
• Headache, dizziness.
• Muscle pain, joint pain.
• Nausea, vomiting.

Rare side effects(may affect up to 1 in 1,000 people):

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

Very rare side effects(may affect up to 1 in 10,000 people):

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

Side effects seen in children more frequently than in adults are runny nose and itchy nose and fever.

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

If you experience any side effect, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing 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 carton and bottle. The expiry date is the last day of the month stated.

Store the unopened bottle of Xalatan at room temperature (below 25°C), protected from light.

Once the bottle is opened, store it at room temperature (below 25°C); it should be used within 4 weeks of opening. When not 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. Return the bottle and any remaining medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Xalatan composition

• The active substance is latanoprost 50 micrograms/ml.

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

Appearance and pack size

Xalatan eye drops are a clear, colourless liquid.

Xalatan is available in pack sizes of 1, 3 and 6 bottles. Not all pack sizes may be marketed.

Each bottle contains 2.5 ml of Xalatan eye drops.

Marketing authorisation holder

Viatris Healthcare, S.L.

Calle General Aranaz, 86, 3rd floor

28027 Madrid

Spain

Manufacturer

Pfizer Manufacturing Belgium NV

Rijksweg 12

2870 Puurs-Sint-Amands (Belgium)

Local representative

Viatris Pharmaceuticals, S.L.U.

Calle General Aranaz, 86

28027 Madrid

Spain

Date of last revision of this leaflet: July 2022

This medicine 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 medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/"