Package Insert: Information for the User

Xalacom 50 micrograms/mL + 5 mg/mL Eye Drops Solution

Latanoprost / Timolol

Read this entire package insert carefully before starting to use this medication because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. (See section 4).

Contents of the package and additional information

Xalacom contains two active ingredients: latanoprost and timolol. Latanoprost belongs to a group of medications known as prostaglandin analogs. Timolol belongs to a group of medications called beta-blockers. Latanoprost acts by increasing the natural drainage of fluid from the interior of the eye into the bloodstream. Timolol acts by reducing the formation of fluid in the eye.

Xalacom is used to reduce eye pressure in cases of open-angle glaucoma or ocular hypertension. Both conditions are related to an increase in pressure within the eye, which can potentially affect vision. Your doctor will typically prescribe Xalacom when other medications have not worked adequately.

Xalacommay be used in adults (including elderly) but is not recommended for use in individuals under 18 years of age.

Do not use Xalacom

• If you are allergic (hypersensitive) to any of the active ingredients of Xalacom (latanoprost or timolol), to beta-blockers or to any of the other components of Xalacom(listed in section 6).
• If you have or have had in the past respiratory problems such as asthma, severe chronic obstructive pulmonary disease (a serious lung disease that may cause wheezing, difficulty breathing and/or long-term coughing).
• If you have severe heart problems or heart rhythm disorders.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Xalacom, if you have or have had in the past:

• Coronary heart disease (symptoms may include chest pain or tightness, shortness of breath or asphyxia), heart failure, low blood pressure.
• Alterations in heart rate such as slow heart rate.
• Respiratory problems, asthma or chronic obstructive pulmonary disease.
• Diseases characterized by poor blood circulation (such as Raynaud's disease or Raynaud's syndrome).
• Diabetes, as timolol may mask the signs and symptoms of low blood sugar levels.
• Hyperthyroidism, as timolol may mask signs and symptoms.
• If you are to undergo eye surgery (including cataract surgery) or have had any type of eye surgery.
• If you have eye problems (such as eye pain, irritation or inflammation in the eye or blurred vision).
• If you have dry eyes.
• If you wear contact lenses. You may continue to use Xalacom, but you must follow the instructions included in section 3 for contact lens users.
• If you have angina (particularly a type known as Prinzmetal's angina).
• If you have severe allergic reactions that usually require hospital treatment.
• If you have suffered or are suffering from a viral eye infection caused by the herpes simplex virus (HSV).

Inform your doctor that you are using Xalacom before undergoing surgery, as timolol may modify the effects of some medications used during anesthesia.

Use of Xalacom with other medications

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medication, including eye drops and over-the-counter medications.

Xalacom may affect or be affected by other medications you are using, including other eye drops for glaucoma treatment. Inform your doctor if you are using or intend to use medications to lower blood pressure, heart medications or medications to treat diabetes.

Particularly, consult your doctor or pharmacist if you are taking any of the following types of medications:

• Prostaglandins, prostaglandin analogs or prostaglandin derivatives.
• Beta-blockers.
• Epinephrine.
• Medications used to treat high blood pressure such as calcium channel blockers, guanethidine, antiarrhythmics, digitalis glycosides or cholinomimetics.
• Quinidine (used to treat heart diseases and certain types of malaria).
• Antidepressants such as fluoxetine and paroxetine.

Use of Xalacom with food and beverages

Ordinary meals, foods and beverages have no effect on when or how to use Xalacom.

Pregnancy, breastfeeding and fertility

Pregnancy

Do not use Xalacom if you are pregnant unless your doctor considers it necessary. Inform your doctor immediately if you are pregnant, think you may be pregnant or are planning to become pregnant.

Breastfeeding

Do not use Xalacom if you are breastfeeding. Xalacom may pass into breast milk. Ask your doctor for advice before taking any medication during breastfeeding.

Fertility

In animal studies, latanoprost and timolol have not been found to have any effect on male or female fertility.

Driving and operating machinery

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

Xalacom contains benzalkonium chloride and phosphate buffer.

This medication contains 0.2mg/ml of benzalkonium chloride.

Benzalkonium chloride may be absorbed by soft contact lenses and may alter the color of contact lenses. Remove contact lenses before using this medication and wait 15 minutes before reinserting them.

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 unusual sensations in your eyes, stinging or eye pain after using this medication, consult your doctor.

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

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

Use in athletes

This medication contains timolol, which may produce a positive result in doping control tests.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose for adults (including elderly) is one drop in the eye or in the affected eyes once a day.

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

Use Xalacom as your doctor has instructed you to until they tell you to stop.

Your doctor may want to perform additional heart and circulatory tests if you are using Xalacom.

Users of contact lenses

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

Instructions for use

If you useXalacom with other eye drops

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

If you use moreXalacomthan you should

If more drops than necessary have been applied to the eye, you may feel a slight irritation in the eye and the eyes may become red and tearful. This situation should resolve, but if you are concerned, contact your doctor.

If you ingestXalacom

In case of accidental ingestion of Xalacom, contact your doctor. If you ingest a large amount of Xalacom, you may feel unwell, have stomach pain, feel tired, hot, dizzy, and start sweating.

If you forgot to useXalacom

Continue with the administration of the next dose as usual. Do not use a double dose to compensate for the missed dose. If you have doubts, consult your doctor or pharmacist.

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

You can continue using the eye drops as usual, unless the side effects are severe. If you are concerned, consult your doctor or pharmacist. Do not stop using Xalacom without consulting your doctor.

The following side effects have been known to occur with the use of Xalacom. The most important side effect is the possibility of a gradual and permanent change in the color of the eye. It is also possible that Xalacom may cause severe changes in how the heart works. If you notice any change in heart rhythm or cardiac function, you must consult your doctor and tell them that you have been using Xalacom.

The following side effects may occur with Xalacom:

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

• A gradual change in the color of the eyes 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 you have eyes of a single color (blue, gray, green, or brown). The change in eye color may take years to develop. The change in eye color may be permanent and may be more noticeable if you use Xalacom 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 Xalacom has been stopped.

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

• Irritation of the eye (sensation of burning, sensation of sand in the eye, itching, stinging, and sensation of a foreign body in the eye) and eye pain.

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

• Headache.
• Redness of the eyes, eye infection (conjunctivitis), blurred vision, tearing, inflammation of the eyelids, irritation or erosion of the surface of the eye.
• Itching or prickling sensation on the skin (pruritus).

Other side effects

Like other eye medications, Xalacom (latanoprost and timolol) is absorbed into the bloodstream. The incidence of side effects after using eye drops is lower than when medications are taken orally or injected.

Although not seen with Xalacom, the following side effects have been observed with one or both of the components of Xalacom (latanoprost and timolol) and may therefore occur with the use of Xalacom. The side effects listed include reactions observed within the group of beta-blockers (e.g., timolol) when used to treat eye conditions:

• Nausea, vomiting (uncommon).
• Development of a viral eye infection caused by the herpes simplex virus (HSV).

• Generalized allergic reactions that include swelling under the skin that may occur in areas such as the face and extremities and may obstruct the airway causing difficulty swallowing or breathing, urticaria or itchy rash, localized or generalized rash, itching, sudden, severe, and potentially fatal allergic reaction.

• Low blood sugar levels.
• Dizziness.
• Difficulty sleeping (insomnia), depression, nightmares, memory loss, hallucinations.
• Fainting, stroke, insufficient blood supply to the brain, worsening of myasthenia gravis symptoms (muscular disorder), unusual sensation like pins and needles, and headache.
• Swelling at the back of the eye (macular edema), fluid-filled cyst in the colored part of the eye (iris cyst), sensitivity to light (photophobia), appearance of sunken eyes (greater depth of the eyelid fold).
• Signs and symptoms of eye irritation (e.g., burning, stinging, itching, tearing, redness), inflammation of the eyelid, inflammation in the cornea, blurred vision, and detachment of the layer under the retina and containing blood vessels after surgery that may cause visual disturbances, decreased corneal sensitivity, dry eyes, corneal erosion (damage to the anterior layer of the eyeball), drooping of the upper eyelid (causing the eye to be half-closed), double vision.
• Darkening of the skin around the eyes, changes in the eyelashes and fine hair around the eye (increase in number, length, thickness, and darkness), changes in the direction of growth of the eyelashes, swelling around the eye, swelling of the colored part of the eye (iritis/uveitis), scarring of the surface of the eye.
• Tinnitus (ringing in the ears).

• Angina, worsening of angina in patients who already had heart disease.

• Low heart rate, chest pain, palpitations (feeling the heartbeat), edema (fluid accumulation), changes in heart rhythm or speed, congestive heart failure (heart disease with difficulty breathing and swelling of feet and legs due to fluid accumulation), a type of heart rhythm disorder, heart attack, heart failure.
• Low blood pressure, poor circulation that makes the hands and feet feel numb and pale, cold hands and feet.

• Difficulty breathing, constriction of airways in the lungs (predominantly in patients with pre-existing disease), difficulty breathing, cough, asthma, worsening of asthma.
• Alteration of taste, indigestion, diarrhea, dry mouth, abdominal pain.
• Hair loss, skin rash with a silvery white appearance (psoriasiform rash) or worsening of psoriasis, skin rash.

• Muscle pain, muscle weakness not caused by exercise, fatigue.
• Sexual dysfunction, decreased libido.

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.

Reporting side effects

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

Keepout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on the packaging and on the label of the bottle that follows the CAD acronym. The expiration date is the last day of the month indicated.

Store the Xalacombottleunopened in the refrigerator (between2°Cand8°C). Once the bottle is opened, it is not necessary to store it in the refrigerator, but do not place it at a temperature above25°C. Once the bottle is opened, do not use it if more than 4 weeks have passed. When not using Xalacom, keep the bottle in the outer packaging to protect it from light.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and medicines that you do not need in the SIGREcollection pointat the pharmacy.In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that you do not need. In this way, you will help protect the environment.

Composition of Xalacom

The active principles arelatanoprost 50 micrograms/ml and timolol (in the form of maleate of timolol) 5 mg/ml.

The other components are:

Sodium chloride

Benzalkonium chloride

Sodium dihydrogen phosphate monohydrate (E339i)

Dipotassium phosphate (E339ii)

Hydrochloric acid solution (for pH adjustment to 6.0)

Sodium hydroxide solution (for pH adjustment to 6.0)

Water for injection preparations

Appearance of the product and contents of the container

Each bottle contains 2.5 ml ofXalacomeye drops.

Xalacom is a transparent and colorless liquid.

Xalacom is available in sizes of 1, 3 or 6 bottles. Some container sizes may only be marketed.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible 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

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Xalacom in Germany, Austria, Belgium, Spain, France, Greece, Netherlands, Ireland, Italy, Luxembourg, Portugal and United Kingdom (Northern Ireland).

Xalcom in Denmark, Finland, Iceland, Norway and Sweden.

Last review date of this leaflet: 06/2022

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