Xaloptic Combi

Leaflet attached to the packaging: patient information

Xaloptic Combi, 50 micrograms/ml + 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.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Xaloptic Combi and what is it used for

Xaloptic Combi eye drops contain two different active substances that reduce pressure inside the eye through two different mechanisms of action. Timolol belongs to a group of medicines called beta-blockers and reduces intraocular pressure by reducing the production of aqueous humor. Latanoprost reduces intraocular pressure by increasing the natural outflow of fluid from the eye.
Xaloptic Combi is indicated for the treatment of increased intraocular pressure (glaucoma) and for the treatment of glaucoma.

2. Important information before using Xaloptic Combi

When not to use Xaloptic Combi

• in patients with current or history of respiratory disease, including asthma, severe chronic obstructive pulmonary disease (severe lung disease that can cause wheezing, difficulty breathing, and/or prolonged coughing)
• in patients with heart disease, such as heart failure or arrhythmias
• if the patient is hypersensitive to latanoprost, timolol, beta-blockers, or any of the other ingredients of this medicine (listed in section 6)
• if the patient is under 18 years old.

If any of the above points apply to the patient, Xaloptic Combi should not be used without consulting a doctor.

Warnings and precautions

Before starting treatment with Xaloptic Combi, the patient should discuss with their doctor if they have or have had:

• ischemic heart disease (symptoms may include chest pain or tightness, shortness of breath, or choking), heart failure, decreased blood pressure
• arrhythmias, such as slow heart rate
• breathing difficulties, asthma, or chronic obstructive pulmonary disease
• diseases related to poor blood circulation (e.g., Raynaud's disease or Raynaud's syndrome)
• diabetes, as timolol may mask symptoms of low blood sugar
• hyperthyroidism, as timolol may mask its symptoms
• herpes simplex virus eye infection (HSV)
• planned eye surgery (including cataract surgery) or any surgical procedure performed on the eye in the past
• eye diseases (such as eye pain, eye irritation, eye inflammation, or blurred vision)
• dry eye syndrome
• wearing contact lenses. Xaloptic Combi can still be used, but the patient should follow the instructions for contact lens users
• angina pectoris (especially Prinzmetal's type)
• severe allergic reactions, which usually require hospital treatment.

Before using Xaloptic Combi in patients with heart disease, the doctor should ensure that the heart disease is well-controlled. During treatment with Xaloptic Combi, the doctor may order additional heart and circulation tests.
In patients with mixed-color irises, e.g., blue-brown, gray-brown, green-brown, yellow-brown, the eye color may slowly change due to an increase in the amount of brown pigment in the iris. Changes in iris color in patients with uniform blue, gray, green, or brown eye color have been observed rarely. The change in iris color is usually slow and often not clinically noticeable for several months or years. If the patient uses Xaloptic Combi in only one eye, a difference in iris color may be noticeable. The change in iris color is harmless but likely to be permanent.
If the patient has mixed-color irises or has noticed a change in iris color towards brown, they should contact their doctor.
Before surgical procedures, the doctor should be informed about the use of Xaloptic Combi, as latanoprost and timolol may affect the action of certain anesthetics.

Xaloptic Combi and other medicines

Xaloptic Combi may affect the action of other medicines, and other medicines, including other eye drops used to treat glaucoma, may affect Xaloptic Combi. The patient should tell their doctor if they are taking or plan to take medicines that lower blood pressure, heart medicines, or anti-diabetic medicines.
The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The patient should inform their doctor about the use of one or more of the following medicines:

• calcium channel blockers (e.g., nifedipine, verapamil, or diltiazem), which are used to treat high blood pressure, angina, arrhythmias, or Raynaud's disease
• digoxin, a medicine used to treat heart failure or arrhythmias
• quinidine, a medicine used to treat heart disease and certain types of malaria
• clonidine, a medicine used to treat high blood pressure
• other beta-blockers (e.g., containing timolol used orally and/or in the eye), which belong to the same group as timolol and may enhance its effect
• medicines used to treat diabetes
• medicines that facilitate urination or normalize bowel function
• medicines that reduce swelling of the mucous membrane (e.g., nose)
• medicines used to treat asthma that contain adrenaline
• antidepressants, such as fluoxetine and paroxetine
• prostaglandins, analogs, and derivatives of prostaglandins.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Xaloptic Combi should not be used in pregnant women unless the doctor considers it necessary.
Xaloptic Combi should not be used in breastfeeding women. Latanoprost and timolol may pass into breast milk.

Driving and using machines

Certain side effects, such as blurred vision, may affect the ability to drive and/or operate machinery. If the patient experiences such an effect, they should consult their doctor.

Xaloptic Combi contains benzalkonium chloride and phosphates

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 administering the drops and wait at least 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially in people with dry eye syndrome or disorders affecting the cornea (the transparent layer on the front of the eye). If the patient experiences any abnormal sensations in the eye, stinging, or eye pain after using the medicine, they should contact their doctor.
The medicine contains 6.39 mg of sodium dihydrogen phosphate monohydrate and 2.89 mg of disodium phosphate anhydrous per milliliter (total phosphate content is 6.345 mg/ml). In patients with severe damage to the transparent, front part of the eye (cornea), phosphates may rarely cause corneal clouding due to calcium deposits during treatment.

3. How to use Xaloptic Combi

This medicine should always be used exactly as the doctor has instructed. If the patient is unsure, they should ask their doctor or pharmacist.

Dosage

The recommended dose is: 1 drop into the affected eye(s) once a day.
If Xaloptic Combi is used with other eye drops, the patient should wait at least 5 minutes before administering them.
If a dose is missed, the patient should wait until the next dose is due. They should not use a double dose to make up for the missed dose.

Instructions for using the drops

The patient should follow these instructions to ensure proper use of Xaloptic Combi.

• 1. Wash their hands before using the drops.
• 2. Remove the protective cap with "wings" from the bottle.
• 3. Remove the screw cap.
• 4. Gently pull down the lower eyelid of the affected eye.

Figure 1

• 5. Bring the tip of the dropper close to the eye without touching it, gently squeeze the bottle so that only one dropgets into the eye.
• 6. Replace the bottle cap.
• 7. After using Xaloptic Combi, the patient should press the corner of their eye near the nose with their finger for 2 minutes to prevent latanoprost and timolol from being absorbed into the body.

Figure 2

If the patient accidentally uses more Xaloptic Combi than recommended, they should contact their doctor or hospital.
Children
There is limited data on the use of eye drops containing timolol and latanoprost in children and adolescents.

Using more Xaloptic Combi than recommended

If the patient uses more Xaloptic Combi than recommended or accidentally swallows it, they should contact their doctor immediately.
If more drops get into the eye, the patient may experience mild eye irritation. There may be tearing and redness of the eye.

Missing a dose of Xaloptic Combi

If the patient misses a dose at the usual time, they should wait until the next dose is due. They should not use a double dose to make up for the missed dose.
If the patient has any further questions about using this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

Like all medicines, Xaloptic Combi can cause side effects, although not everybody gets them.
Eye drops can usually be used until the side effects are not serious.
If the patient is unsure, they should contact their doctor or pharmacist. They should not stop using Xaloptic Combi without consulting their doctor.
The following are known side effects of Xaloptic Combi.
The most important side effect is the possibility of a gradual, permanent change in eye color. Xaloptic Combi may cause serious changes in heart function. The patient should tell their doctor if they notice changes related to normal heart function or heart function and inform them about using this medicine.
Known side effects that occur after using this medicine:

• Very common(may affect more than 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 with mixed-color irises (such as blue-brown, gray-brown, green-brown, or yellow-brown), these changes can be noticed much more often than in people with uniform blue, gray, green, or brown eye color. The change in eye color may develop over several years. The change in eye color may be permanent and more noticeable if Xaloptic Combi is used in only one eye. The change in eye color appears to be harmless. After stopping the use of this medicine, the change in eye color does not progress.

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

• eye irritation (including feelings of burning, grittiness, itching, stinging, or the 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, excessive tearing, eyelid inflammation, irritation, or disruption of the eye surface
• skin rash and/or itching.

Other side effects

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

• herpes simplex virus eye infection (HSV)
• general allergic reactions, including swelling under the skin, which can occur on the face, limbs, and can make it difficult to breathe, swallowing difficulties, and breathing difficulties, hives, or itchy rash, localized and generalized rash, itching, severe life-threatening allergic reactions
• low blood sugar
• dizziness
• sleep disturbances (insomnia), depression, nightmares, memory loss, hallucinations
• fainting, stroke, decreased blood flow to the brain, worsening of myasthenia symptoms (muscle disease), sensory disturbances (such as tingling, burning), and headache
• fluid accumulation in the back of the eye (macular edema), formation of fluid-filled spaces in the iris (iris cysts), increased sensitivity to light (photophobia), changes in the eye socket and eyelids resulting in deepening of the eyelid fold
• eye irritation symptoms (burning, stinging, itching, tearing, redness), eyelid inflammation, corneal inflammation, blurred vision, and retinal detachment following filtering surgery, which can cause vision disturbances, decreased corneal sensitivity, dry eye, corneal erosion (loss of the outer surface of the eye), eyelid drooping (causing the eyes to be half-closed), double vision
• darkening of the skin around the eyes, changes in eyelashes and primary hair (increased number, length, thickness, and darkening), changes in the direction of eyelash growth, swelling around the eyes, swelling of the iris - the colored part of the eye (iritis and/or uveitis)

kidney problems, including nephritis (inflammation of the kidneys), kidney failure, and worsening of existing kidney disease, fluid accumulation in the lungs, heart failure, and changes in liver function, including liver failure and abnormal liver function tests

• tinnitus (ringing or buzzing in the ears)
• angina pectoris, worsening of existing angina pectoris in people with existing heart disease
• slow heart rate, chest pain, palpitations, fluid accumulation (edema), changes in heart rhythm or accelerated heart rate, congestive heart failure (heart disease characterized by shortness of breath and fluid accumulation in the feet and legs), a certain type of heart rhythm disorder, heart attack, heart failure
• low blood pressure, decreased blood pressure, poor blood circulation characterized by numbness and paleness of fingers and toes, symptoms of cold hands and feet
• shallow breathing, bronchospasm (mainly in patients with existing respiratory diseases), breathing difficulties, cough, asthma, asthma exacerbation
• nausea (uncommon), vomiting (uncommon), taste disturbances, digestive disturbances, diarrhea, dryness of the mucous membranes, abdominal pain
• hair loss, skin rash with a white-silvery appearance (psoriasis-like rash) or exacerbation of psoriasis, skin rash
• joint and muscle pain, not caused by physical exertion, muscle weakness, fatigue
• sexual disturbances, decreased libido.

In patients with severe damage to the transparent, front part of the eye (cornea), phosphates may rarely cause corneal clouding due to calcium deposits during treatment.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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.
By reporting side effects, more information can be collected on the safety of this medicine.

5. How to store Xaloptic Combi

Keep out of sight and reach of children.
Before the first opening, Xaloptic Combi should be stored and transported in a refrigerator (at a temperature between 2°C and 8°C).
After the first opening, the bottle can be stored for 28 days at room temperature (below 25°C).
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the carton and bottle with the dropper. The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number.
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 pack and other information

What Xaloptic Combi contains

• The active substances of Xaloptic Combi are latanoprost and timolol. Each milliliter (1 ml) of Xaloptic Combi eye drop solution contains 50 micrograms of latanoprost and timolol maleate, equivalent to 5 mg of timolol.
• The other ingredients are sodium dihydrogen phosphate monohydrate, sodium chloride, disodium phosphate anhydrous, benzalkonium chloride (preservative), and purified water.

Each bottle contains 2.5 ml of solution.

What Xaloptic Combi looks like and contents of the pack

Xaloptic Combi eye drops are a clear, colorless solution. The drops are available in a bottle with a dropper containing 2.5 ml of solution.
Pack sizes:
1, 3, or 6 bottles of 2.5 ml
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
Jadran - Galenski Laboratorij d.d.
Svilno 20, 51000 Rijeka
Croatia
Date of last revision of the leaflet:February 2023