Latanoprost timolol genoptim

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Latanoprost + Timolol Genoptim,
50 μg/ml + 5 mg/ml, eye drops, solution
Latanoprostum + Timololum
Please read this leaflet carefully before using the medicine, because
it contains important information for the patient.

• Keep this leaflet for possible future reference.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, 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.

Leaflet Contents

1. What Latanoprost + Timolol Genoptim is and what it is 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 pack and other information

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

Latanoprost + Timolol Genoptim contains two active substances: latanoprost and timolol.
Latanoprost belongs to a group of medicines called prostaglandin analogues, and timolol belongs to a group of medicines called beta-blockers. Latanoprost works by increasing the outflow of fluid from the eyeball into the bloodstream. Timolol works by reducing the amount of fluid produced in the eye.
Latanoprost + Timolol Genoptim is used to lower intraocular pressure in patients with open-angle glaucoma or in patients with ocular hypertension. Both conditions are associated with elevated intraocular pressure and may affect vision.
Your doctor will usually recommend using Latanoprost + Timolol Genoptim if other treatments have not been sufficiently effective.

2. Important information before using Latanoprost + Timolol Genoptim

Latanoprost + Timolol Genoptim may be used in adult patients (including elderly individuals), but it is not recommended for use in individuals 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-blockers, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has or has had breathing problems such as asthma, or severe chronic obstructive pulmonary disease (a serious lung condition that may cause wheezing, difficulty breathing, and/or prolonged coughing);
• if the patient has severe heart disease or heart rhythm disorders.

Warnings and precautions

Before starting treatment with Latanoprost + Timolol Genoptim, inform your doctor or pharmacist if the patient has or has had:

• coronary heart disease (symptoms may include chest pain or tightness, shortness of breath, or suffocation), heart failure, or low blood pressure;
• heart rate disorders, such as slow heartbeat;
• breathing difficulties, asthma, or chronic obstructive pulmonary disease (COPD);
• conditions related to poor blood circulation (such as Raynaud's disease or Raynaud's syndrome);
• diabetes, because timolol may mask the subjective and objective symptoms of low blood sugar;
• hyperthyroidism, because timolol may mask the subjective and objective symptoms;
• planned eye surgery (including cataract surgery) or if such surgery has previously been performed;
• eye problems (such as eye pain, eye surface irritation, eye inflammation, or blurred vision);
• dry eyes;
• if the patient wears contact lenses. Latanoprost + Timolol Genoptim may still be used, but follow the instructions regarding contact lens use provided in section 3;
• bronchial asthma (especially Prinzmetal's angina);
• severe allergic reactions requiring hospital treatment;
• a history of herpetic keratitis or herpetic keratitis caused by the Herpes Simplex virus (HSV).

Before undergoing surgery, inform the doctor that the patient is using Latanoprost + Timolol Genoptim, as timolol may affect the action of certain drugs used during anesthesia.

Latanoprost + Timolol Genoptim and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including eye drops, even those obtained without a prescription, as well as any medicines the patient plans to take.

Latanoprost + Timolol Genoptim may interact with, or be affected by, other medicines, including eye drops used in the treatment of glaucoma. Inform your doctor if the patient is using or intends to use medicines that lower blood pressure, heart medications, or medicines used in the treatment of diabetes.

Inform your doctor or pharmacist if you are using a medicine belonging to any of the following groups:

• prostaglandins, analogues and derivatives of prostaglandins;
• beta-blockers;
• epinephrine;
• blood pressure-lowering medicines, such as oral calcium channel blockers, guanethidine, antiarrhythmics, cardiac glycosides, or parasympathomimetics;
• quinidine (used in the treatment of heart disorders and certain types of malaria);
• antidepressants such as fluoxetine, paroxetine.

Latanoprost + Timolol Genoptim with food and drink

Eating regular meals, food, or drinking beverages does not affect when or 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. Inform your doctor immediately if the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant.

Breastfeeding

Latanoprost + Timolol Genoptim should not be used during breastfeeding. Latanoprost and timolol may pass into human milk. Consult your doctor before using any medicine during breastfeeding.

Effect on fertility

Animal studies have shown no effect of latanoprost and timolol on fertility in males or females.

Driving and using machines

After using Latanoprost + Timolol Genoptim, blurred vision may occur for a short time. If the patient experiences such symptoms, they should not drive or operate machinery until these symptoms have resolved.

Latanoprost + Timolol Genoptim contains benzalkonium chloride and phosphate buffers

The medicine contains 0.2 mg of benzalkonium chloride per millilitre.

Benzalkonium chloride may be absorbed by soft contact lenses and may change their colour. Contact lenses should be removed before instillation and at least 15 minutes should elapse before reinsertion.

Benzalkonium chloride may also cause eye irritation, especially in individuals with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If abnormal sensations in the eye, stinging, or eye pain occur after using the medicine, consult a doctor.

The medicine contains 6.39 mg of monosodium dihydrogen phosphate monohydrate and 2.89 mg of disodium phosphate anhydrous per millilitre (total phosphate content is 6.345 mg/ml).

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

3. How to use Latanoprost + Timolol Genoptim

This medicine should always be used exactly as directed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
The recommended dose for adult patients (including elderly patients) is 1 drop in 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 treatment.
Latanoprost + Timolol Genoptim should be used according to your doctor's instructions, who will decide when treatment should be discontinued.
If you are using Latanoprost + Timolol Genoptim, your doctor may recommend additional tests of the heart and circulatory system.

Contact lens use
If you wear contact lenses, remove them before using Latanoprost + Timolol Genoptim. Wait 15 minutes after using Latanoprost + Timolol Genoptim before reinserting your contact lenses.

Instructions for using Latanoprost + Timolol Genoptim:

1. Wash your hands and sit or stand comfortably.
2. Unscrew the outer protective cap from the bottle.
3. Gently pull down the lower eyelid of the affected eye with your finger.
4. Hold the tip of the bottle close to the eye, but not touching it. Do not touch the eye dropper tip to the eye, eyelid, surrounding areas, or any other surface. This could contaminate the drops. Using contaminated drops may lead to serious eye infections and even loss of vision.
5. Gently squeeze the bottle so that one drop falls into the eye, then release the lower eyelid.
6. After applying Latanoprost + Timolol Genoptim, press gently with your finger on the inner corner of the eye (where the eye meets the nose) for two minutes. This helps prevent latanoprost and timolol from being absorbed into the bloodstream.
7. If directed by your doctor, repeat the procedure in the other eye.
8. Close the bottle tightly after use.

Using Latanoprost + Timolol Genoptim with other eye drops
If you are using other eye drops at the same time, administer them at least 5 minutes apart.

Accidental overdose of Latanoprost + Timolol Genoptim
If more drops than recommended are used, eye irritation, tearing, and redness of the eye may occur. These symptoms should resolve on their own, but if you are concerned, contact your doctor for advice.

Accidental ingestion of Latanoprost + Timolol Genoptim
If Latanoprost + Timolol Genoptim is accidentally swallowed, contact your doctor. Ingestion of a large amount of Latanoprost + Timolol Genoptim eye drops may cause malaise, abdominal pain, fatigue, facial flushing, dizziness, and sweating.

Missed dose of Latanoprost + Timolol Genoptim
If you miss a dose, apply the next dose at the usual scheduled time. Do not use a double dose to make up for a missed dose. 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.
Usually, eye drops can be used until the adverse effects are not serious.
If in doubt, consult a doctor or pharmacist. Do not stop treatment with Latanoprost + Timolol Genoptim without consulting a doctor.
The adverse effects listed below are known to occur after administration of a medicine containing latanoprost and timolol. The most important adverse effect is the possibility of a gradual, permanent change in eye colour. Latanoprost + Timol0l Genoptim may also cause serious heart problems. Inform your doctor if you notice any changes related to normal heart function or heart activity, and inform them about your use of Latanoprost + Timolol Genoptim.

Known adverse effects after use of Latanoprost + Timolol Genoptim:
Very common (may affect more than 1 in 10 people):

• Gradual change in eye colour due to increased amount of brown pigment in the coloured part of the eye called the iris. Changes are observed significantly more frequently in patients whose iris colour is a mixture of colours (e.g. blue-brown, grey-brown, yellow-brown, green-brown) than in those with uniformly coloured eyes (blue, grey, green or brown). Changes in eye colour may develop over several years. The change in eye colour may be permanent and significantly more noticeable if only one eye is treated with Latanoprost + Timolol Genoptim. The eye colour change appears to be harmless. After discontinuation of Latanoprost + Timolol Genoptim, the eye colour change does not progress.

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

• Eye irritation (including burning sensation, grittiness, itching, stinging or sensation 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 levels (hyperglycaemia),
• High blood cholesterol levels,
• Long and thick eyelashes,
• Depression,
• Light sensitivity (photophobia).

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

• Blurred vision,
• Excessive tearing,
• Skin rash,
• Itching (pruritus).

Other adverse effects
Like other eye medicines, Latanoprost + Timolol Genoptim (latanoprost with timolol) is absorbed into the bloodstream. The frequency of systemic adverse effects after administration of eye drops is lower than with oral or intravenous medicines.
The adverse effects listed below have not been reported with Latanoprost + Timolol Genoptim, but have occurred with the individual components of this medicine (latanoprost and timolol) and therefore may also occur with Latanoprost + Timolol Genoptim. Among these adverse effects are also those observed during use of beta-blocking agents (e.g. timolol) in the treatment of eye diseases.
Very common (may affect more than 1 in 10 people):

• Changes in eyelashes and vellus hair (increased number, length, thickness and darkening).

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

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

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

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

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

• Development of eye inflammation caused by infection with herpes simplex virus.
• General allergic reactions including swelling beneath the skin which may occur in the face, limbs and may obstruct airflow, causing difficulty in swallowing and breathing, urticaria or itchy rash, localised and generalised rash, pruritus, severe cases of sudden life-threatening allergic reactions.
• Low blood sugar levels.
• Dizziness, shortness of breath.
• Difficulty sleeping (insomnia), depression, nightmares, memory loss, hallucinations.
• Confusion, delusions, anxiety, disorientation, restlessness.
• Sudden fainting or feeling faint, stroke, reduced blood flow to the brain, worsening of symptoms of myasthenia (muscle weakness and pain in patients with this disease), tingling or numbness, headache.
• Swelling at the back of the eye (macular oedema), formation of fluid-filled pockets in the iris (iris cysts), light sensitivity (photophobia), changes in the eye socket and eyelids leading to deepening of the eyelid crease.
• Eye irritation symptoms (burning, stinging, itching, tearing, redness), blepharitis, keratitis, blurred vision and choroidal detachment following filtration surgery which may lead to visual disturbances, reduced corneal sensitivity, corneal erosion (defects of the outer surface of the eyeball), eyelid drooping (causing eyes to be half-closed), double vision.
• Darkening of the skin around the eyes, misdirected eyelashes, swelling around the eyes, iris swelling – the coloured part of the eye (iritis and/or uveitis), cicatrizing conjunctivitis.
• Ringing in the ears (tinnitus).
• Slowed heart rate, palpitations (awareness of heartbeat), oedema (fluid accumulation), disturbances in heart rhythm and rate, congestive heart failure (a condition characterised by shortness of breath and swelling of feet and legs due to fluid accumulation), cardiac arrhythmias, cardiac arrest, heart failure.
• Formation of tissue around the kidneys and other internal organs, decreased blood pressure, poor circulation causing numbness and paleness of fingers and toes, sensation of cold hands and feet.
• Shallow breathing, bronchospasm (mainly in patients with pre-existing conditions), breathing difficulties, fluid in the lungs (pulmonary oedema), cough, nasal congestion, asthma, worsening of asthma.
• Taste disturbances, indigestion, diarrhoea, dry mouth sensation, abdominal pain.
• Hair loss, rash with white-silvery lesions (psoriasiform) or worsening 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 membrane covering the front part of the eyeball), corneal spots due to calcium deposits have occurred during treatment.

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

5. How to store Latanoprost + Timolol Genoptim

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and
packaging after: expiry date (EXP). The expiry date refers to the last day of the stated
month.
Before first opening, store the medicine in the refrigerator (2°C - 8°C).
Keep in the original packaging to protect from light.
After first opening, the medicine may be stored for up to 4 weeks at a temperature
below 25°C. After this period, the medicine must be discarded. The bottle should be
kept in the outer packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the package and other information

What Latanoprost + Timolol Genoptim contains
The active substances in this medicine are: latanoprost and timolol (as timolol maleate).
1 ml of eye drops contains 50 μg of latanoprost and 6.8 mg of timolol maleate, equivalent to 5 mg of timolol.
2.5 ml of eye drop solution (the contents of one package) contains 125 μg of latanoprost and 17 mg of timolol maleate, equivalent to 12.5 mg of timolol.
1 ml of solution contains 0.2 mg of benzalkonium chloride.
2.5 ml of solution (the contents of one package) contains 0.5 mg of benzalkonium chloride.
Other ingredients include: benzalkonium chloride, sodium chloride, monosodium dihydrogen phosphate monohydrate, disodium phosphate anhydrous, hydrochloric acid 10% (to adjust pH to 6.0), sodium hydroxide 10% (to adjust pH to 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 contents of the pack
The pack contains a bottle made of LDPE with a white dropper made of LDPE and a white screw cap made of HDPE with a tamper-evident seal, containing 2.5 ml of Latanoprost + Timolol Genoptim eye drops.
Latanoprost + Timolol Genoptim is a clear, colourless 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 pack sizes:
1 bottle with dropper containing 2.5 ml of eye drops.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warszawa
tel. 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