Latanoprost Timolol Genoptim

LEAFLET INCLUDED IN THE PACKAGING: PATIENT INFORMATION

Latanoprost + Timolol Genoptim,

50 μg/ml + 5 mg/ml, eye drops, solution
Latanoprostum + Timololum

It is essential to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Latanoprost + Timolol Genoptim and what is it used for

Latanoprost + Timolol Genoptim 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.
Latanoprost + Timolol Genoptim is used to reduce intraocular pressure in patients with open-angle glaucoma or patients with increased intraocular pressure. Both conditions are associated with increased intraocular pressure and can affect vision quality.
The doctor will usually recommend using Latanoprost + Timolol Genoptim if the action of other medicines has not been sufficient.

2. Important information before using Latanoprost + Timolol Genoptim

Latanoprost + Timolol Genoptim 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 Latanoprost + Timolol Genoptim

• 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 disorders, 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 diseases or rhythm disorders.

Warnings and precautions

Before starting treatment with Latanoprost + Timolol Genoptim, 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, eye inflammation, or blurred vision;
• dry eyes;
• if the patient uses contact lenses. The patient can continue to use Latanoprost + Timolol Genoptim, but they should follow the instructions for using contact lenses, as stated in section 3;
• variant angina (especially Prinzmetal's angina);
• severe allergic reactions requiring hospital treatment;
• herpetic keratitis in the medical history or herpetic keratitis caused by the Herpes Simplex virus (HSV).

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

Latanoprost + Timolol Genoptim 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.
Latanoprost + Timolol Genoptim may interact with other medicines, including eye drops used to treat glaucoma. The patient should inform their doctor about using 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 that belongs to any of the following groups:

• prostaglandins, analogs, and 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 certain types of malaria),
• antidepressants, such as fluoxetine, paroxetine.

Latanoprost + Timolol Genoptim with food and drink

Consuming standard meals, food, and drinks does not affect when and how to use Latanoprost + Timolol Genoptim.

Pregnancy, breastfeeding, and fertility

Pregnancy
Latanoprost + Timolol Genoptim 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
Latanoprost + Timolol Genoptim should not be used during breastfeeding.
Latanoprost and timolol may pass into breast milk. Before using any medicine during breastfeeding, the patient should consult their doctor.
Fertility
In animal studies, no effect of latanoprost and timolol on fertility in males or females has been found.

Driving and using machines

After using Latanoprost + Timolol Genoptim, blurred vision may occur for a short period. If the patient experiences this type of discomfort, they should not drive or operate machines until it resolves.

Latanoprost + Timolol Genoptim 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 Latanoprost + Timolol Genoptim 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 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 (the total phosphate content is 6.345 mg/ml).
In patients with severely damaged corneas (the transparent layer on the front of the eye), phosphates may rarely cause corneal calcification during treatment.

3. How to use Latanoprost + Timolol Genoptim

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

Using contact lenses

If the patient uses contact lenses, they should remove them before using Latanoprost + Timolol Genoptim. After using Latanoprost + Timolol Genoptim, the patient should wait 15 minutes before putting their contact lenses back on.
Instructions for using Latanoprost + Timolol Genoptim:

• 1. Wash your hands and sit or stand comfortably.
• 2. Remove the protective outer cap from the bottle.
• 3. Gently pull down the lower eyelid of the affected eye.
• 4. Place the tip of the bottle close to the eye, but without touching it. Do not touch the dropper tip to the eye, eyelid, or surrounding areas.This can cause infection. Using infected drops can lead to serious complications, even vision loss.
• 5. Gently squeeze the bottle to release one drop into the eye, then release the lower eyelid.
• 6. After using Latanoprost + Timolol Genoptim, press the corner of the eye where the eye meets the nose with your finger for two minutes. This helps prevent latanoprost and timolol from entering the bloodstream.
• 7. If the doctor recommends it, repeat the procedure in the other eye.
• 8. After use, replace the bottle cap.

Using Latanoprost + Timolol Genoptim with other eye drops

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

Using a higher dose of Latanoprost + Timolol Genoptim than recommended

If a higher dose of the eye drops is administered, it may cause eye irritation, tearing, and redness. These symptoms should resolve on their own, but if the patient is concerned, they should consult their doctor for advice.

Accidental ingestion of Latanoprost + Timolol Genoptim

In case of accidental ingestion of Latanoprost + Timolol Genoptim, the patient should contact their doctor. If a large amount of the eye drops is ingested, it may cause discomfort, abdominal pain, fatigue, flushing, and dizziness.

Missing a dose of Latanoprost + Timolol Genoptim

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, Latanoprost + Timolol Genoptim 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 Latanoprost + Timolol Genoptim without consulting their doctor.
The following are known side effects that have occurred with the use of latanoprost with timolol. The most significant side effect is the possibility of gradual, permanent change in eye color. Latanoprost + Timolol Genoptim may cause serious changes in heart function. The patient should inform their doctor if they notice any changes related to normal heart function or heart rhythm and inform them about using Latanoprost + Timolol Genoptim.
Known side effects that have occurred with the use of Latanoprost + Timolol Genoptim:

• Very common(may occur in 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 eye color (such as blue-brown, gray-brown, yellow-brown, or green-brown), these changes can be noticed much more often than in people with uniform eye color (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 Latanoprost + Timolol Genoptim. The change in eye color appears to be harmless. After stopping the use of Latanoprost + Timolol Genoptim, 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 or irritation of the eye surface (cornea),
• high blood sugar (diabetes),
• high cholesterol,
• long and thick eyelashes,
• depression,
• photophobia (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, Latanoprost + Timolol Genoptim (latanoprost with timolol) is absorbed into the bloodstream. The frequency of side effects with eye drops is lower than with medicines taken orally or intravenously.
The following are side effects that have not occurred with Latanoprost + Timolol Genoptim but have occurred with the individual ingredients of this medicine (latanoprost and timolol) and may also occur with Latanoprost + Timolol Genoptim. Among these side effects are those observed with the use of beta-adrenergic blockers (such as timolol) in the treatment of eye diseases.
Very common(may occur in more than 1 in 10 people):

• Changes in eyelashes and vellus hair (increased number, 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):

• Chest pain, worsening of chest pain in patients with existing heart disease, nausea, vomiting.

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

• Development of herpetic keratitis caused by the herpes simplex virus.
• Generalized allergic reactions, including angioedema (swelling under the skin that can occur on the face, limbs, and can make it difficult to breathe and swallow), which can be life-threatening.
• Low blood sugar.
• Dizziness, shortness of breath.
• Difficulty sleeping (insomnia), depression, nightmares, memory loss, hallucinations.
• Feeling confused, 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.
• Swelling of the back of the eye (macular edema), formation of fluid-filled spaces in the iris (iris cysts), photophobia (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 eye), ptosis (drooping eyelid, which can cause the eyes to be half-closed), double vision.
• Darkening of the skin around the eyes, misdirected eyelashes, swelling around the eyes, swelling of the iris (iritis and/or uveitis), scleritis (inflammation of the white part of the eye).
• Ringing in the ears (tinnitus).
• Slow heart rate, palpitations (awareness of heartbeat), swelling (fluid accumulation), arrhythmias, congestive heart failure (a disease characterized by shortness of breath and swelling of the feet and legs due to fluid accumulation), arrhythmias, cardiac arrest, heart failure.
• Formation of tissue around the kidneys and other internal organs, decreased blood pressure, poor blood circulation characterized by numbness and paleness of the fingers and toes, symptoms of cold hands and feet.
• Shallow breathing, bronchospasm (especially in patients with pre-existing diseases), difficulty breathing, fluid in the lungs (pulmonary edema), cough, stuffy nose, asthma, exacerbation of asthma.
• Taste disorders, nausea, diarrhea, dry mouth, abdominal pain.
• Hair loss, skin rash with white-silver scales (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 severely damaged corneas (the transparent layer on the front of the eye), calcium deposits on the cornea have occurred during treatment.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor or pharmacist. 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, 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 Latanoprost + Timolol Genoptim

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiration date stated on the bottle and packaging after: expiration date (EXP). The expiration date refers to the last day of the specified month.
Before the first opening of the bottle, the medicine should be stored in the refrigerator (2°C - 8°C).
The medicine should be stored in the original packaging to protect it from light.
After the first opening of the bottle, the medicine 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 in 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 Latanoprost + Timolol Genoptim contains

The active substances of the medicine are latanoprost and timolol (in the form of 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. 2.5 ml of eye drop solution (the content of one package) contains 125 μg of latanoprost and 17 mg of timolol maleate, which corresponds to 12.5 mg of timolol. 1 ml of solution contains 0.2 mg of benzalkonium chloride.
2.5 ml of solution (the content of one package) contains 0.5 mg of benzalkonium chloride.
The other ingredients are benzalkonium chloride, sodium chloride, sodium dihydrogen phosphate monohydrate, disodium phosphate anhydrous, 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 Latanoprost + Timolol Genoptim looks like and what the packaging contains

The packaging contains a LDPE bottle with a white dropper made of LDPE and a white HDPE cap with a tamper-evident seal, containing 2.5 ml of Latanoprost + Timolol Genoptim.
Latanoprost + Timolol Genoptim is a clear, colorless solution free from visible particles, with a pH between 5.7 and 6.3 and an osmolality between 240 and 325 mOsmol/kg.
Latanoprost + Timolol Genoptim is available in the following packaging:

1 bottle with a dropper containing 2.5 ml of eye drops.

Marketing authorization holder and manufacturer

Marketing authorization holder

Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw
phone: 607 696 231
e-mail: [email protected]

Manufacturer

RAFARM S.A.
Thesi Pousi-Xatzi
Agiou Louka
P.O. Box 37
19002, Paiania Attiki, Athens
Greece

Date of the last update of the leaflet: