Xalacom

Leaflet attached to the packaging: patient information

Xalacom,(0.05 mg + 5 mg)/ml, eye drops, solution
Latanoprost + Timolol

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Xalacom and what is it used for

Xalacom contains two active substances: latanoprost and timolol. Latanoprost belongs to a group of medicines called prostaglandin analogs, and timolol belongs to a group of medicines called beta-adrenergic blockers.
Latanoprost works by increasing the outflow of fluid from the eye into the bloodstream. Timolol works by reducing the amount of fluid produced in the eye.
Xalacom is used to reduce intraocular pressure in patients with open-angle glaucoma or increased intraocular pressure.
Both conditions are associated with increased intraocular pressure and can affect vision quality. The doctor will usually recommend using Xalacom if the action of other medicines has not been sufficient.

2. Important information before using Xalacom

Xalacom can be used in adult patients (including the elderly), but it is not recommended for use in patients under 18 years of age.

When not to use Xalacom

• if the patient is allergic (hypersensitive) to the active substances (latanoprost and/or timolol), beta-adrenergic blockers, or any of the other ingredients of this medicine (listed in section 6),
• if the patient has respiratory problems, such as asthma, severe obstructive pulmonary disease (severe lung disease that can cause wheezing, difficulty breathing, and/or prolonged coughing),
• if the patient has severe heart problems or arrhythmias.

Warnings and precautions

Before starting treatment with Xalacom, the patient should inform their doctor or pharmacist if they have or have had:

• coronary heart disease (symptoms may include chest pain or tightness, shortness of breath, or wheezing), heart failure, low blood pressure,
• heart rhythm disorders, such as slow heart rate,
• breathing difficulties, asthma, or chronic obstructive pulmonary disease,
• diseases related to poor blood circulation (such as Raynaud's disease or Raynaud's syndrome),
• diabetes, as timolol may mask the symptoms of low blood sugar,
• hyperthyroidism, as timolol may mask the symptoms,
• planned eye surgery (including cataract surgery) or if it has been performed in the past,
• eye problems (such as eye pain, irritation of the eye surface, conjunctivitis, or blurred vision),
• dry eyes,
• if the patient uses contact lenses. The patient can continue to use the medicine, but they should follow the instructions for using contact lenses contained in section 3,
• angina (especially Prinzmetal's angina),
• severe allergic reactions requiring hospital treatment,
• herpetic keratitis in history or herpetic keratitis caused by the Herpes Simplex virus (HSV).

Before surgery, the patient should inform their doctor about using Xalacom, as timolol may affect the action of certain medicines used during anesthesia.

Xalacom and other medicines

The patient should tell their doctor or pharmacist about all medicines (including eye drops) they are currently taking or have recently taken, including those that are available without a prescription, as well as any medicines they plan to take.
Xalacom may interact with other medicines, including eye drops used to treat glaucoma. The patient should inform their doctor about using or planning to use medicines that lower blood pressure, heart medicines, or medicines used to treat diabetes.
The patient should inform their doctor or pharmacist if they are using a medicine from any of these groups:

• prostaglandins, analogs, or derivatives of prostaglandins,
• beta-adrenergic blockers,
• epinephrine,
• blood pressure-lowering medicines, such as oral calcium channel blockers, guanethidine, antiarrhythmic medicines, cardiac glycosides, or parasympathomimetics,
• quinidine (used to treat heart disorders and some types of malaria),
• antidepressants, such as fluoxetine, paroxetine.

Xalacom with food and drink

Consuming standard meals, food, or drinks does not affect when or how to use Xalacom.

Pregnancy, breastfeeding, and fertility

Pregnancy
Xalacom should not be used during pregnancy unless the doctor decides it is necessary.
The patient should inform their doctor immediately if they are pregnant, think they may be pregnant, or plan to have a baby.
Breastfeeding
Xalacom should not be used during breastfeeding. Xalacom may pass into human milk. Before using any medicine during breastfeeding, the patient should consult their doctor.
Fertility
In animal studies, no effect of latanoprost and timolol on male or female fertility has been found.

Driving and using machines

After using Xalacom, blurred vision may occur for a short period. If the patient experiences this type of discomfort, they should not drive or operate machinery until the symptoms have resolved.

Xalacom 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. The patient should remove their contact lenses before using Xalacom and wait at least 15 minutes before putting them back on.
Benzalkonium chloride may also cause eye irritation, especially in patients with dry eye syndrome or disorders related to the cornea (the transparent layer on the front of the eye). If the patient experiences abnormal sensations in the eye, stinging, or eye pain after using the medicine, they should contact their doctor.
The medicine contains 6.3 mg of phosphates per milliliter, which corresponds to 0.2 mg per drop.
In patients with severe damage to the transparent, anterior part of the eye (cornea), phosphates may rarely cause corneal clouding due to calcium deposition during treatment.

3. How to use Xalacom

This medicine should always be used exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.
The recommended dose for adult patients (including the elderly) is one drop into the affected eye(s) once a day.
Xalacom should not be used more than once a day, as this may reduce the effectiveness of the treatment.
Xalacom should be used as directed by the doctor, who will decide when to stop the treatment.
If the patient is using Xalacom, the doctor may recommend additional heart and circulatory system tests.

Using contact lenses

If the patient uses contact lenses, they should remove them before using Xalacom. After using Xalacom, the patient should wait 15 minutes before putting their contact lenses back on.

Instructions for using Xalacom

1. Wash your hands and sit or stand comfortably. 2. Remove the colorless protective cap (the cap can be discarded).	Fig. 1
3. Remove the screw cap. The screw cap should be kept.	Fig. 2
4. Gently pull down the lower eyelid of the affected eye. 5. Place the tip of the bottle close to the eye, without touching it. 6. Gently squeeze the bottle to release one drop into the eye, then release the lower eyelid.	Fig. 3

7. After using Xalacom, press the area of the eye where the eye meets the nose (Fig. 4) for two minutes with your finger. This helps prevent latanoprost and timolol from entering the bloodstream.

Fig. 4

• 8. If the doctor recommends it, the procedure should be repeated on the second eye.
• 9. After use, replace the screw cap.

Using Xalacom with other eye drops

If the patient is using other eye drops at the same time, they should be administered at least 5 minutes apart.

Using a higher dose of Xalacom than recommended

If more drops are administered than recommended, eye irritation and tearing, as well as eye redness, may occur. These symptoms should resolve on their own, but if the patient is concerned, they should consult their doctor for advice.

Accidental ingestion of Xalacom

In case of accidental ingestion of Xalacom, the patient should consult their doctor. If a large amount of eye drops is ingested, the patient may experience discomfort, stomach pain, fatigue, facial flushing, and dizziness.

Missing a dose of Xalacom

If a dose is missed, the patient should take the next dose at the scheduled time. The patient should not take a double dose to make up for the missed dose. If the patient has any further doubts about using this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Xalacom can cause side effects, although not everybody gets them.
Eye drops can usually be used until the side effects are not serious.
In case of doubts, the patient should consult their doctor or pharmacist. The patient should not stop using Xalacom without consulting their doctor.
The following are known side effects that have occurred with Xalacom.
The most important side effect is the possibility of gradual, permanent eye color change. Xalacom may also cause serious heart problems. The patient should inform their doctor if they notice any changes related to normal heart function or heart problems and inform them about using Xalacom.
Known side effects that have occurred with Xalacom:

• Very common(may occur more often than in 1 in 10 people):

gradual change in eye color associated with an increase in the amount of brown pigment in the colored part of the eye called the iris. In patients whose iris color is a mixture of colors (such as blue-brown, gray-brown, yellow-brown, or green-brown), these changes can be noticed much more often than in people with single-color eyes (blue, gray, green, or brown). Eye color changes may develop over several years. The change in eye color may be permanent and more noticeable if only one eye is treated with Xalacom. The change in eye color appears to be harmless. After stopping Xalacom, the change in eye color does not progress.

• Common(may occur in up to 1 in 10 people):

eye irritation (including burning, grittiness, itching, stinging, or feeling of a foreign body in the eye),
eye pain,
headache,
eye redness,
eye infection (conjunctivitis),
blepharitis (inflammation of the eyelids),
inflammation or irritation of the eye surface (cornea),
high blood sugar (diabetes),
high cholesterol,
long and thick eyelashes,
depression,
photosensitivity (sensitivity to light).

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

• blurred vision,
• increased tearing,
• skin rash,
• itching (pruritus).

Other side effects

Like other eye medicines, Xalacom (latanoprost with timolol) is absorbed into the bloodstream. The frequency of side effects with eye drops is lower than with oral or intravenous medicines.
The following are side effects that have not occurred with Xalacom but have occurred with the individual ingredients of this medicine (latanoprost and timolol), and may also occur with Xalacom. These include side effects observed during the use of beta-adrenergic blockers (e.g., timolol) in the treatment of eye diseases.

• Very common(may occur more often than in 1 in 10 people):

changes in eyelashes and vellus hair (increased amount, length, thickness, and darkening).

• Common(may occur in up to 1 in 10 people):

irritation or damage to the eye surface, dry eyes, eyelid swelling.

• Uncommon(may occur in up to 1 in 100 people):

angina pectoris, worsening of angina pectoris in patients with existing heart disease, chest pain, nausea, vomiting.

• Frequency not known(cannot be estimated from the available data):

development of herpetic keratitis (inflammation of the cornea caused by the herpes simplex virus).
Generalized allergic reactions, including angioedema (swelling under the skin that can occur on the face, limbs, and may make it difficult to breathe and swallow), urticaria (hives) or pruritus (itching), localized and generalized rash, itching, severe life-threatening allergic reactions.
Low blood sugar.
Dizziness, shortness of breath.
Difficulty sleeping (insomnia), depression, nightmares, memory loss, hallucinations.
Feeling of confusion, delusions, anxiety, disorientation, agitation.
Sudden fainting or feeling of impending fainting, stroke, decreased blood flow to the brain, worsening of myasthenia symptoms (muscle weakness and pain in patients with this disease), feeling of tingling or numbness and headache.
Macular edema (swelling of the back of the eye), formation of fluid-filled spaces in the iris (iris cysts), photosensitivity (sensitivity to light), changes in the eye socket and eyelids resulting in deepening of the eyelid fold.

• symptoms of eye irritation (burning, stinging, itching, tearing, redness), blepharitis, keratitis, blurred vision, and retinal detachment following filtering surgery, which can cause vision disturbances, decreased corneal sensitivity, corneal ulcers (defects in the outer surface of the eyeball), ptosis (drooping eyelid), double vision.

darkening of the skin around the eyes, misdirected eyelashes, swelling around the eyes, swelling of the iris - the colored part of the eye (iritis and/or uveitis), scleritis (inflammation of the white part of the eye).
Tinnitus (ringing in the ears).

• bradycardia (slow heart rate), palpitations (awareness of heartbeat), edema (fluid accumulation), arrhythmias, heart failure, arrhythmias, cardiac arrest, heart failure.

formation of tissue around the kidneys and other internal organs, decreased blood pressure, poor circulation (manifested as numbness and pallor of fingers and toes), symptoms of cold hands and feet.

• shallow breathing, bronchospasm (especially in patients with pre-existing lung disease), shortness of breath, fluid in the lungs (pulmonary edema), cough, stuffy nose, asthma, worsening of asthma.

taste disturbances, nausea, diarrhea, dry mouth, stomach pain.

• hair loss, rash with white-silvery lesions (psoriasis-like) or exacerbation of psoriasis symptoms, skin rash.

joint pain, muscle pain not caused by physical exertion, muscle weakness, fatigue.

• sexual dysfunction, decreased libido.

Very rarely, in some patients with significantly damaged corneas (the transparent layer covering the front of the eye), calcium deposits in the cornea may occur during treatment, resulting in corneal clouding.

Reporting side effects

If side effects occur, including those not listed in this leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or its representative.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Xalacom

The medicine should be stored out of sight and reach of children.
Xalacom should not be used after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the month stated.
Before opening the packaging, the medicine should be stored in a refrigerator (2°C - 8°C). Protect from light. After the first opening of the bottle, Xalacom can be stored for 4 weeks at a temperature below 25°C. After this time, the medicine should be discarded. The bottle should be stored in the outer packaging to protect it from light.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Xalacom contains

• The active substances of Xalacom are latanoprost and timolol. 1 ml of eye drops contains 0.05 mg of latanoprost and 5 mg of timolol (as timolol maleate).
• The other ingredients are: benzalkonium chloride, disodium phosphate anhydrous, sodium dihydrogen phosphate monohydrate, sodium chloride, hydrochloric acid 10% (to adjust pH 6.0), sodium hydroxide 10% (to adjust pH 6.0), water for injections.

One drop of solution contains approximately 1.5 micrograms of latanoprost and 150 micrograms of timolol.

What Xalacom looks like and contents of the packaging

The packaging contains one or 3 bottles containing 2.5 ml of Xalacom eye drop solution.
Xalacom is a clear, colorless solution.

Marketing authorization 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

To obtain more detailed information, please contact the representative of the marketing authorization holder:

Viatris Healthcare Sp. z o.o.

tel. 22 546 64 00

Date of last revision of the leaflet:

Other sources of information

Detailed information about this medicine can be found on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products http://urpl.gov.pl