LATACOM (50 mcg + 5 mg)/ml Drops

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Latacom, (50 µg + 5 mg)/ml, eye drops, solution
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Latacom and what is it used for
4. Important information before using Latacom
   1. When not to use Latacom
   2. Warnings and precautions
   3. Children and adolescents
   4. Latacom and other medicines
   5. Medicines with a similar effect to Latacom
   6. Clonidine
   7. Pregnancy and breastfeeding
   8. Driving and using machines
   9. Latacom contains benzalkonium chloride
5. How to use Latacom
   1. Using a higher dose of Latacom than recommended
   2. Missing a dose of Latacom
   3. Stopping the use of Latacom
6. Possible side effects
   1. Other side effects
   2. Reporting side effects
7. How to store Latacom
   1. Follow these storage instructions:
8. Contents of the packaging and other information
   1. What Latacom contains
   2. What Latacom looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer
   6. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   7. Date of last revision of the leaflet:

Leaflet accompanying the packaging: patient information

Latacom, (50 µg + 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, so you can read it again if you need to.
• If you have any doubts, consult your 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 as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Latacom and what is it used for

Latacom is a medicine used to treat increased intraocular pressure (pressure inside the eye).
Latacom is a combination of two active substances: latanoprost (a prostaglandin derivative) and timolol maleate (a beta-adrenergic blocker).
A fluid called aqueous humor is produced inside the eye. This fluid is then drained into the bloodstream, which helps maintain normal pressure inside the eyeball. If the outflow is narrowed, the pressure inside the eyeball increases.
Among other effects, beta-adrenergic blockers reduce intraocular pressure by reducing the production of aqueous humor. Prostaglandins, on the other hand, facilitate the outflow of aqueous humor.
Latacom is used:

• to reduce intraocular pressure in patients with open-angle glaucoma (optic nerve damage caused by increased intraocular pressure);
• to reduce intraocular pressure in patients who have an insufficient response to beta-adrenergic blockers or prostaglandin derivatives used as a single medication.

2. Important information before using Latacom

When not to use Latacom

• If the patient is allergicto latanoprost or timolol, beta-blockers, or any of the other ingredients of this medicine (listed in section 6).
• If the patient has respiratory diseasessuch as asthma, chronic obstructive pulmonary disease (a serious lung disease that can cause wheezing, difficulty breathing, and/or chronic cough).
• If the patient has a slow heart rate, heart failure, or irregular heart rhythm.

Warnings and precautions

Before starting to use Latacom, discuss it with your doctor or pharmacist.
Tell your doctor or pharmacist before using Latacom if any of the following conditions/disorders apply to the patient:

• If the patient is planning to have any eye surgery (including cataract surgery) or if the patient has had any eye surgery in the past;
• If the patient has eye diseases (such as eye pain, eye irritation, conjunctivitis, or blurred vision);
• If the patient has dry eye syndrome;
• If the patient wears contact lenses. Latacom can still be used, but the patient should read the instructions for using contact lenses, found in the section "Important information about some ingredients of Latacom";
• If the patient has coronary heart disease (symptoms include chest pain or tightness, shortness of breath, choking), heart failure, low blood pressure;
• If the patient has irregular heart rhythms, such as a slow heart rate;
• If the patient has poor blood circulation (e.g., Raynaud's disease or syndrome);
• If the patient has breathing problems (asthma, chronic obstructive pulmonary disease);
• If the patient has diabetes, as timolol may mask symptoms related to low blood sugar levels;
• If the patient has hyperthyroidism, as Latacom may mask symptoms of this disease;
• If the patient has angina (chest pain at rest) (especially the type called Prinzmetal's angina);
• If the patient has severe allergic reactions that usually require hospital treatment.

Before planned surgery, tell your doctor that you are using Latacom, as this medicine may affect the action of some medicines used during anesthesia.

Children and adolescents

Latacom is not recommended for use in children and adolescents.

Latacom and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take.
Some medicines may affect the action of Latacom, and Latacom may affect the action of other medicines, including other eye drops used to treat glaucoma. Tell your doctor about using or planning to use blood pressure-lowering medicines, heart disease medicines, or diabetes medicines.
Medicines can interact with each other and cause interactions. The patient should keep this in mind if they are taking or using the following medicines:

• Calcium channel blockers(used, for example, to treat coronary heart disease or high blood pressure) Guanethidine(used to treat high blood pressure) Beta-blockers(used to treat high blood pressure) Antiarrhythmic drugs(drugs that restore a normal heart rhythm) Digitalis glycosides(used to treat heart failure) Parasympathomimetics(used, for example, to treat glaucoma) Quinidine(used to treat heart diseases and some types of malaria)

Using Latacom with the above-mentioned medicines may cause a decrease in blood pressure and/or a slowing of the heart rate.

Medicines with a similar effect to Latacom

The effect of other medicines with a similar effect to Latacom may be increased if they are used at the same time as Latacom. Therefore, it is not recommended to administer two beta-adrenergic blockers or two prostaglandin derivatives to the eye at the same time.

Clonidine

If the patient is using clonidine concomitantly with Latacom to reduce intraocular pressure and suddenly stops using clonidine, the intraocular pressure may increase. If the patient is using beta-adrenergic blockers to reduce blood pressure, it may also increase due to the opposing effects of the two medicines.

• Antidepressants, such as fluoxetine and paroxetine.

Elderly patients
Latacom can also be used in elderly patients.

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.
Pregnancy
Do not use Latacom during pregnancy.
Tell your doctor if the patient is pregnant or plans to become pregnant.
Breastfeeding
Do not use Latacom during breastfeeding. The medicine may pass into breast milk.
Before using any medicine during breastfeeding, consult your doctor.
Before using any medicine, consult your doctor or pharmacist.

Driving and using machines

After administering the eye drops, temporary vision disturbances may occur. If the patient experiences blurred vision, especially immediately after administering Latacom, they should not:

• drive vehicles,
• operate any devices or machines.

Latacom contains benzalkonium chloride

The medicine contains 0.2 mg of benzalkonium chloride per 1 ml of solution.
Benzalkonium chloride may be absorbed by soft contact lenses and change their color. Remove contact lenses before administering the drops and wait at least 15 minutes before putting them back on. 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 abnormal sensations in the eye, stinging, or eye pain occur after using the medicine, consult a doctor.

3. How to use Latacom

Always use this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
Unless your doctor has told you otherwise, the usual doseis:
Adults, including elderly patients: one drop into the affected eye or eyes once a day.
If the patient is using other eye drops, they should be administered at least 5 minutes apart from Latacom.
Method of administration:

• 1. Wash your hands and take a comfortable standing or sitting position.
• 2. Remove the protective outer cap from the bottle.
• 3. Gently pull the lower eyelid of the affected eye down.
• 4. Hold the upper part of the dropper close to the eye, without touching the eye. Gently squeeze the dropper to release one drop of medicine into the eye. Make sure not to squeeze the dropper too hard, so as not to release more than one drop of medicine into the eye.
• 5. Release the lower eyelid.
• 6. Press the corner of the affected eye near the nose (diagram 1) for 2 minutes, keeping the eye closed. This will prevent the drop from being absorbed into the body. To administer a drop to the second eye, if prescribed by the doctor, repeat all the steps. If the drop does not get into the eye, administer a second drop.
• 7. Close the bottle.

Diagram 1.

Using a higher dose of Latacom than recommended

If more drops than recommended are administered to the eye, irritation and rednessof the eye may occur.
In case of accidental ingestion of the medicine by the patient or someone else, or if more drops than recommended are used, contact a doctor immediately.
Keep the packaging so that the doctor can get more information about the medicine and decide on further action.

Missing a dose of Latacom

If a dose of Latacom is missed, continue treatment by administering the next scheduled dose. Do not exceed the recommended dose - one drop once a day into the affected eye or eyes.
Do not use a double doseto make up for a missed dose.

Stopping the use of Latacom

Do not stop using Latacom without consulting your doctor.
If the patient does not use the medicine regularly or often forgets to use it, treatment may be ineffective.
Increased intraocular pressure (pressure inside the eye) can cause damage to the optic nerve and worsen vision. Blindness may occur. Usually, the patient feels a sudden increase in intraocular pressure. The disease can only be confirmed by an eye examination performed by an ophthalmologist. If the patient has increased intraocular pressure, regular eye exams, combined with intraocular pressure measurement, are necessary. The intraocular pressure should be measured at least once every three months. Visual field tests and optic nerve exams should be performed at least once a year.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Latacom can cause side effects, although not everybody gets them.
It is usually possible to continue treatment, provided that the side effects are not serious.
Consult your doctor or pharmacist if you have any further doubts.
Do not stop treatment without consulting your doctor.
The following side effects are related to the use of eye drops containing latanoprost and timolol. One of the most important side effects is a permanent change in eye color that occurs gradually. In addition, eye drops containing latanoprost and timolol may cause significant changes in heart function. If the patient notices changes in heart rhythm or heart function, they should contact their doctor and inform them about the use of Latacom.
The following side effects have been observed after using eye drops containing latanoprost and timolol.
Very common side effects(occurring in more than 1 in 10 patients):

• Change in eye color due to an increase in the amount of brown pigment in the part of the eye called the iris. In patients with mixed eye color (e.g., blue-brown, gray-brown, yellow-brown, or green-brown), this change may be more noticeable than in patients with single-colored irises. Any change in eye color is very slow and may not be noticed for years. The change in eye color may be permanent and more noticeable when Latacom is used in only one eye. The change in eye color is not associated with the development of other side effects. After stopping treatment with Latacom, no further change in eye color is observed.

Common side effects(occurring in less than 1 in 10 patients):

• Eye irritation (feeling of burning, grittiness, itching, stinging, or foreign body sensation in the eye) and eye pain.

Uncommon side effects(occurring in less than 1 in 100 patients):

• Headache.
• Eye redness, eye inflammation (conjunctivitis), blurred vision, eye discharge, eyelid inflammation, irritation, or disruption of the eye surface.
• Skin rash or itching (pruritus).
• Nausea.
• Vomiting.

Other side effects

Immune system disorders:

• Symptoms of an allergic reaction (swelling and redness of the skin and rash).

Psychiatric disorders:

• Depression, memory loss, hallucination, decreased libido, insomnia, nightmares.

Nervous system disorders:

• Dizziness, tingling, numbness of the skin, changes in blood flow to the brain, worsening of myasthenia gravis symptoms (if the patient has this disease), sudden fainting or feeling of fainting.

Eye disorders:

• Changes in the appearance of eyelashes and fine hairs around the eye (increased number, length, density, and darkening), change in the direction of eyelash growth, swelling around the eye, swelling of the colored part of the eye (uveitis), swelling of the back of the eye (macular edema), inflammation/irritation of the eye surface (keratitis), dry eye, changes/worsening of vision, double vision, drooping eyelids, and injury to the back of the eye (a condition known as retinal detachment, which can occur after eye surgery).

Hearing disorders:

• Ringing in the ears (tinnitus).

Heart disorders:

• Worsening of angina, feeling of heart rhythm (palpitations), changes in heart rate, slowing of heart rate, heart failure (cardiac arrest, heart block, congestive heart failure - a heart disease characterized by shortness of breath and swelling of the feet and legs due to fluid retention in the body).

Vascular disorders:

• Low blood pressure, discoloration/feeling of cold fingers and toes (Raynaud's phenomenon), cold hands and feet.

Respiratory disorders:

• Asthma, worsening of asthma, shortness of breath, sudden difficulty breathing (bronchospasm), cough.

Gastrointestinal disorders:

• Nausea, diarrhea, indigestion, dry mouth feeling.

Skin disorders:

• Darkening of the skin around the eyes, hair loss (alopecia), itchy rash or worsening of itching skin.

Musculoskeletal disorders:

• Joint pain, muscle pain.

General disorders:

• Chest pain, fatigue, swelling (edema).

Like other eye medicines, timolol is absorbed into the bloodstream. This can cause side effects similar to those that occur with intravenous and/or oral administration of beta-adrenergic blockers. The frequency of side effects with eye medicines is lower than with oral medicines or injections.
The listed side effects include additionalside effects attributed to the class of beta-adrenergic blockers used to treat eye diseases:

• General allergic reactions, including angioedema (may occur on the face and limbs, may limit airway patency, making swallowing and breathing difficult), urticaria, local and generalized rash, sudden severe life-threatening allergic reactions.
• Low blood sugar levels.
• Stroke, restricted blood flow to the brain.
• Keratitis, retinal detachment after filtration surgery, which can cause vision disturbances, decreased corneal sensitivity, dry eye, corneal erosion (damage to the front layer of the eyeball), drooping eyelid (which causes the eye to be half-open), double vision.
• Changes in heart rate, arrhythmias, heart attack.
• Constriction of airways (mainly in patients with previously diagnosed lung disease).
• Taste disorders, abdominal pain, vomiting.
• Skin rash with a white-silvery appearance (psoriasis-like changes) or worsening of psoriasis.
• Sexual disorders.
• Muscle weakness/fatigue.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Latacom

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton, after the expiry date (EXP). The expiry date refers to the last day of the month stated.

Follow these storage instructions:

Unopened bottles: Store in a refrigerator (2°C - 8°C).
After opening the bottle: Do not store above 25°C.
After 4 weeks from opening the bottle, discard it, even if the drops have not been used. Otherwise, there is a risk of eye infection.
Medicines should not be disposed of via wastewater or household waste. Ask your 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 Latacom contains

• The active substancesof Latacom are latanoprost and timolol maleate. 1 ml of eye drops contains 50 µg of latanoprost and 6.8 mg of timolol maleate, which corresponds to 5 mg of timolol.
• The other ingredients are: sodium chloride, benzalkonium chloride, sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, purified water, sodium hydroxide - to adjust the pH, and hydrochloric acid 1M - to adjust the pH.

What Latacom looks like and contents of the pack

Latacom is a clear colorless solution, packaged in a transparent bottle with a dropper and cap.
Latacom is available in the following packaging:
1 bottle with a dropper, containing 2.5 ml of eye drops.
3 bottles with a dropper, containing 2.5 ml of eye drops.

Marketing authorization holder and manufacturer

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Manufacturer

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
ROMPHARM COMPANY S.R.L.
Eroilor Street, no. 1A
Otopeni 075100, Ilfov District
Romania

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Poland: Latacom

Date of last revision of the leaflet:

• 04.2025