Latacom

Package leaflet: Information for the patient

Latacom, (50 µg + 5 mg)/ml, eye drops, solution
Latanoprostum + Timololum
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet to be able to read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Latacom is and what it is 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 pack and other information

1. What Latacom is and what it is used for

Latacom is a medicine used to treat elevated intraocular pressure (pressure inside the eye).
Latacom contains two active substances: latanoprost (a prostaglandin derivative) and timolol maleate (a beta-blocker).

Inside the eye, a fluid called aqueous humor is produced and then drained into the bloodstream, which helps maintain normal intraocular pressure. When drainage is impaired, pressure inside the eye increases.
Among other effects, beta-blockers reduce intraocular pressure by decreasing 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 elevated intraocular pressure);
• to reduce intraocular pressure in patients who do not respond adequately to treatment with either a beta-blocker or a prostaglandin analogue alone.

2. Important information before using Latacom

When not to use Latacom

• If the patient is allergic to latanoprost or timolol, beta-blockers, or any of the other ingredients of this medicine (listed in section 6).
• If the patient has or has ever had respiratory disorders, such as asthma, chronic obstructive pulmonary disease (a severe lung disease that may cause wheezing, difficulty breathing and/or chronic cough).
• If the patient has slow heartbeat, heart failure, or heart rhythm disorders (irregular heartbeat).

Warnings and precautions
Before starting treatment with Latacom, discuss this with your doctor or pharmacist.
Tell your doctor or pharmacist if any of the following conditions apply to the patient:

• If eye surgery (including cataract surgery) is planned or if the patient has previously undergone any eye surgery;
• If the patient suffers from eye disorders (such as eye pain, eye irritation, eye inflammation or blurred vision);
• If the patient has dry eye syndrome;
• If the patient wears contact lenses. Latacom may still be used, but the instructions regarding contact lens use provided under "Important information on some of the ingredients of Latacom" should be followed;
• If the patient has ischaemic heart disease (symptoms include chest pain or tightness, shortness of breath, angina);
• If the patient has heart rhythm disorders, such as slow heartbeat;
• If the patient has poor blood circulation (e.g. Raynaud's disease or Raynaud's syndrome);
• If the patient has breathing problems (asthma, chronic obstructive pulmonary disease);
• If the patient has diabetes, as timolol may mask symptoms associated with low blood sugar;
• If the patient has hyperthyroidism, as Latacom may mask symptoms of this condition;
• If the patient has angina (chest pain at rest) (especially a type called Prinzmetal's angina);
• If the patient has severe allergic reactions, which usually require hospital treatment.

Before any planned surgery, tell the doctor that you are using Latacom, as this medicine may affect the action of certain drugs used during anaesthesia.

Children and adolescents
Latacom is not recommended for use in children and adolescents.

Latacom with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently using or has recently used, as well as any medicines the patient plans to use.
Some medicines may affect the action of Latacom, and Latacom may also affect the action of other medicines, including other eye drops used in glaucoma treatment. Inform your doctor if you are using or plan to use medicines that lower blood pressure, medicines for heart conditions or for diabetes.
Medicines may interact with each other, leading to interactions. The patient should be aware of this if taking or using any of the following medicines:

• Calcium channel blockers (used e.g. in the treatment of ischaemic heart disease or high blood pressure)
  Guanethidine (used in the treatment of high blood pressure)
  Beta-blockers (used in the treatment of high blood pressure)
  Antiarrhythmics (medicines that restore normal heart rhythm)
  Cardiac glycosides (used in the treatment of heart failure)
  Parasympathomimetics (used e.g. in the treatment of glaucoma)
  Quinidine (used in the treatment of heart conditions and certain types of malaria)

Using Latacom together with the above-mentioned medicines may lead to reduced blood pressure and/or slowed heart function.

• Medicines acting similarly to Latacom
  The effect of other medicines with a similar action to Latacom may be increased if used at the same time as Latacom. For this reason, simultaneous administration of two beta-adrenergic blockers or two prostaglandin analogues into the eye is not recommended.
• Clonidine
  If the patient is using the active substance clonidine together with Latacom to reduce intraocular pressure and suddenly stops using clonidine, intraocular pressure may increase. If the patient is also using beta-adrenergic blockers to reduce blood pressure, this may additionally increase due to the opposing effects of both medicines.
• Antidepressants, such as fluoxetine and paroxetine.

Elderly patients
Latacom may also be used in elderly patients.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Latacom should not be used during pregnancy.
Inform your doctor if you are pregnant or planning to become pregnant.

Breastfeeding
Latacom should not be used during breastfeeding. The medicine may pass into breast milk.
Consult your doctor before using any medicine during breastfeeding.
Always consult your doctor or pharmacist before using any medicine.

Driving and operating machinery
Blurred vision may occur temporarily after instilling eye drops. If the patient experiences blurred vision, especially immediately after instilling Latacom, the patient should not:

• drive vehicles,
• operate any equipment or machinery.

Latacom contains benzalkonium chloride
This medicine contains 0.2 mg of benzalkonium chloride per ml of solution.
Benzalkonium chloride may be absorbed by soft contact lenses and may change their colour. Contact lenses should be removed before instilling the drops and at least 15 minutes should elapse before reinserting them. Benzalkonium chloride may also cause eye irritation, particularly in patients with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If any abnormal sensations in the eye, stinging or pain occur after using the medicine, contact your doctor.

3. How to use Latacom

This medicine should always be used as directed by the physician. If in doubt, consult
your doctor or pharmacist.
Unless otherwise instructed by the physician, the usual dose is:
Adults, including elderly patients: one drop into the affected eye or eyes once daily.
If the patient is using other eye drops in addition, they should be administered at least 5 minutes
after administration of Latacom.
Instructions for use:

1. Wash your hands and assume a comfortable standing or sitting position.
2. Unscrew the protective outer cap from the bottle.
3. Gently pull down the lower eyelid of the affected eye with the fingertip.
4. Hold the top of the dropper close to the eye without touching the eye. Gently squeeze the dropper to release only one drop of the medicine into the eye. Be careful not to squeeze too hard, to avoid releasing more than one drop.
5. Release the lower eyelid.
6. Press with a finger at the inner corner of the affected eye near the nose (Figure 1). Maintain pressure for 2 minutes with the eye closed. This prevents the drops from being absorbed into the body. To administer to the second eye, if prescribed by the physician, repeat all steps. If the drop missed the eye, administer a second drop.
7. Close the bottle.

Figure 1.

Use of a higher than recommended dose of Latacom
If more drops than recommended are administered into the eye, irritation and redness of the eye may occur.
In case of accidental ingestion of the medicine by the patient or someone in their environment, or if more than the recommended number of drops is used, seek immediate medical advice from a physician.
Keep the packaging available so the doctor can access further information about the medicine and decide on further management.
Missed dose of Latacom
If a dose is missed, continue treatment with the next scheduled dose. Do not exceed the recommended dose – one drop once daily into the affected eye or eyes.
Do not use a double dose to make up for a missed dose.
Stopping use of Latacom
Do not discontinue use of Latacom without consulting your doctor.
If the patient does not use the medicine regularly or frequently forgets to use it, treatment may be ineffective.
Elevated intraocular pressure (pressure inside the eye) may damage the optic nerve and lead to worsening vision. Blindness may occur. Usually, the patient feels sudden increase in intraocular pressure. The condition can only be confirmed by an examination performed by an ophthalmologist. If the patient has elevated intraocular pressure, regular eye examinations combined with measurement of intraocular pressure are necessary. Eye pressure should be measured at least once every three months. Visual field testing and examination of the optic nerve should be performed at least once a year.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Treatment can usually be continued, provided the adverse effects are not serious.
If you have any further doubts, consult your doctor or pharmacist. Do not stop treatment without
consulting your doctor.
The following adverse effects have been reported with eye drops containing latanoprost and
timolol. One of the most important adverse effects is a permanent change in eye colour, which
occurs gradually. In addition, eye drops containing latanoprost and timol0l may cause significant
changes in heart function. If the patient notices any changes in heart rhythm or heart function, they
should contact their doctor and inform them about using Latacom eye drops.
The following adverse effects have been observed with the use of eye drops containing latanoprost
and timolol.
Very common adverse effects (occur in more than 1 in 10 patients):

• Change in eye colour due to increased amount of brown pigment in the coloured part of the eye called the iris. This change may be more noticeable in patients with mixed-colour eyes (e.g. blue-brown, grey-brown, yellow-brown or green-brown) than in patients with uniformly coloured irises. Any change in eye colour is very slow and may go unnoticed for years. The change in eye colour may be permanent and more noticeable if Latacom is used in only one eye. Change in eye colour is not associated with other adverse effects. After discontinuation of Latacom treatment, no further change in eye pigmentation is observed.

Common adverse effects (occur in less than 1 in 10 patients):

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

Uncommon adverse effects (occur in less than 1 in 100 patients):

• Headache.
• Eye redness, eye inflammation (conjunctivitis), blurred vision, watery eyes, eyelid inflammation, eye surface irritation or disruption.

Other adverse effects
Immune system disorders:

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

Psychiatric disorders:

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

Nervous system disorders:

• Dizziness, tingling, skin numbness, changes in cerebral blood flow, worsening of muscle fatigue symptoms (if the patient suffers from this condition), sudden fainting or feeling faint.

Eye disorders:

• Changes in the appearance of eyelashes and fine hairs around the eye (increased number, length, thickness and darkening), change in the direction of eyelash growth, swelling around the eye, swelling of the coloured part of the eye (iritis, uveitis), swelling of the back of the eye (macular oedema), inflammation/irritation of the eye surface (keratitis), dry eyes, changes/worsening of vision, double vision, drooping eyelids and injury to the back layer of the eye (a condition known as choroidal detachment, occurring after eye surgery), cyst within the coloured part of the eye (iris cyst).

Ear disorders:

• Ringing or buzzing in the ears (tinnitus).

Cardiac disorders:

• Worsening of angina, awareness of heartbeat (palpitations), changes in heart rate, slowed heart rate, heart failure (cardiac arrest, heart block, congestive heart failure – a heart condition causing breathlessness and swelling of the feet and legs due to fluid retention in the body).

Vascular disorders:

• Low blood pressure, pale/discoloured or cold feeling in fingers and toes (Raynaud's phenomenon), cold hands and feet.

Respiratory disorders:

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

Gastrointestinal disorders:

• Nausea, diarrhoea, indigestion, dry mouth sensation.

Skin disorders:

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

Musculoskeletal disorders:

• Joint pain, muscle pain.

General disorders:

• Chest pain, fatigue, swelling (oedema).

As with other eye medications, timolol may be absorbed into the bloodstream. This may lead to adverse effects similar to those observed with intravenous and/or oral administration of beta-blockers. The frequency of adverse effects with locally administered eye drops is lower than, for example, with oral or injectable administration.
The listed adverse effects include additional effects generally associated with the class of beta-blocker products used in eye disease treatment:

• General allergic reactions including subcutaneous oedema (which may occur on the face and limbs and may obstruct airways, making swallowing and breathing difficult), urticaria, localised or generalised rash, sudden severe, life-threatening allergic reactions.
• Low blood glucose levels.
• Stroke, reduced blood flow to the brain.
• Corneal inflammation, retinal detachment from the underlying choroid following filtration surgery, which may cause visual disturbances, reduced corneal sensitivity, dry eyes, corneal erosion (damage to the front layer of the eyeball), drooping of the upper eyelid (causing the eye to be partially open), double vision.
• Changes in heart rate, heart rhythm disorders, heart attack.
• Airway constriction (mainly in patients previously diagnosed with lung disease).
• Taste disturbances, abdominal pain, vomiting.
• Skin rash with silvery-white appearance (psoriasiform changes) or worsening of psoriasis.
• Sexual dysfunction.
• Muscle weakness/fatigue.

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration 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
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Latacom
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and carton, after EXP. The expiry date refers to the last day of the stated month.
Please observe the following storage instructions:
Unopened bottles: Store in a refrigerator (2°C - 8°C).
After first opening of the bottle: Do not store above 25°C.
After 4 weeks from first opening, the bottle must be discarded, even if drops remain unused. Otherwise, there is a risk of eye infection.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Latacom contains

• The active substances are latanoprost and timolol maleate. Each 1 ml of eye drops contains 50 µg of latanoprost and 6.8 mg of timolol maleate, equivalent to 5 mg of timolol.
• The other ingredients are: Sodium chloride, benzalkonium chloride, disodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, water for injections, sodium hydroxide - to adjust pH, and hydrochloric acid 1 M - to adjust pH.

What Latacom looks like and contents of the pack
Latacom is a clear, colourless solution packaged in a transparent bottle with a dropper and cap.
Latacom is available in the following pack sizes:
1 bottle with dropper containing 2.5 ml of eye drops.
3 bottles with dropper, each containing 2.5 ml of eye drops.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland

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

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Poland: Latacom
04.2025