Xalatan 50 microgramos/ml colirio en solución

PRODUCT INFORMATION FOR THE USER

Xalatan 50 micrograms/mL eye drops solution

Latanoprost

Read this entire leaflet carefully before you start 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 questions, ask your doctor, or the doctor treating your child, or your pharmacist.
• This medicine has been prescribed for you or your child alone. Do not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor, or the doctor treating your child, or your pharmacist, even if they are not listed in this leaflet. See section 4.

6. Contents of the pack and additional information

Xalatanbelongs to a group of medications known as prostaglandin analogs. It works by increasing the natural drainage of fluid from the inside of the eye to the bloodstream.

Xalatanis used totreat certain diseases known asopen-angle glaucomaandocular hypertensionin adults. Both diseases are related to an increase in pressure within the eye, which can potentially affect vision.

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

Xalatancan 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 children (less than 36 weeks of gestation).

Do not useXalatan

• If you are allergic (hypersensitive) to latanoprost or to any of the other components ofthis medication (including those listed in section 6).

Warnings and precautions

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

• If you or your child have undergone or are to undergo 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 use contact lenses. You may continue to use Xalatan, but you must follow the instructions included in section 3 for contact lens users.
• If you have suffered or are suffering from a viral eye infection caused by the herpes simplex virus (HSV).

Use of Xalatan with other medications

Xalatan may interact with other medications. Inform your doctor, the doctor treating your child, or the pharmacist if you or your child are using or have recently used other medications (or eye drops), even those obtained without a prescription.Particularly, consult your doctor or pharmacist if you know you are taking prostaglandins, prostaglandin analogs, or prostaglandin derivatives.

Pregnancy and breastfeeding

You should not use Xalatanif you are pregnant or breastfeedingunless your doctor considers it necessary.If you are pregnant or breastfeeding, believe you may be pregnant, or intend to become pregnant, consult your doctor before using this medication.

Driving and operating machinery

When using Xalatan, blurred vision may appear for a short period of time. If this happens,do not driveor use tools or machinery until your vision returns to normal.

Xalatan containsbenzalkonium chloride and phosphate buffers

This medication contains 0.2mg/ml of benzalkonium chloride.

Benzalkonium chloride may be absorbed by soft contact lenses and may change the color of the contact lenses. Remove your contact lenses before using this medication and reinsert them 15minutes later.

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

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

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

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

The recommended dose for adults (including elderly) and children is one drop in the eye or in the affected eyes once a day. It is preferable to administer it at night.

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

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

Users of contact lenses

If you or your child use contact lenses, you must remove them before using Xalatan. After applying Xalatan, wait 15 minutes before putting the contact lenses back on.

Usage instructions

If you useXalatan with other eye drops

Wait at least 5 minutes between the application of Xalatan and the administration of other eye drops.

If you use moreXalatanthan you should

If more drops have been applied to the eye than necessary, you may feel a slight irritation in the eye and also the eyes may become red and tearful; this situation should disappear, but if you are concerned, contact your doctor or the doctor treating your child.

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

If you forgot to useXalatan

Continue with the administration of the next dose in the usual manner. Do not apply an additional drop to the eye to compensate for the missed dose. If you have doubts, consult your doctor or pharmacist.

If you interrupt the treatment withXalatan

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

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications,this medicationcan cause side effects, although not everyone will experience them.

The following are known side effects when using Xalatan:

Frequent side effects(may affect more than 1 in 10 patients):

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

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

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

Less common side effects(may affect up to 1 in 100 patients):

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

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

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

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

• Worsening of angina in patients with underlying heart problems, appearance of sunken eyes (greater depth of the eyelid crease).

The side effects observed in children at a frequency greater 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 in the cornea due to calcium deposits produced during treatment.

If you consider any of the side effects you are experiencing to be severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting side effects:

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

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

Do not use this medication after the expiration date that appears on the packaging and in the bottle. The expiration date is the last day of the month indicated.

Store the unopened bottle ofXalatanat room temperature (do not store above25ºC), protected from light.

Once the bottle is opened, store it at room temperature (do not store above25ºC); it must be used within 4 weeks of opening. When not using Xalatan, store the bottle in the outer packaging to protect it from light.

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications that you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of Xalatan

• The active ingredient islatanoprost50 micrograms/ml.

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

Appearance of the product and contents of the packaging

Xalataneye drops are a transparent and colorless liquid.

Xalatanis available in sizes of 1, 3, and 6 bottles. Some packaging sizes may only be commercially marketed.

Each bottle contains 2.5 ml ofXalataneye drops.

Marketing Authorization Holder

Viatris Healthcare, S.L.

General Aranaz Street, 86,3rd floor

28027 Madrid

Spain

Responsible for Manufacturing

Pfizer Manufacturing Belgium NV

Rijksweg 12

2870 Puurs-Sint-Amands(Belgium)

Local Representative

Viatris Pharmaceuticals, S.L.U.

General Aranaz Street, 86

28027 Madrid

Spain

Last review date of this leaflet: July 2022

This medicine is authorized in the member states of the European Economic Area with the following names:

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

“Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/”