Latanoprost Genoptim

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

Latanoprost Genoptim, 50 µg /ml, eye drops, solution

Latanoprost

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 any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. WHAT IS LATANOPROST GENOPTIM AND WHAT IS IT USED FOR

Latanoprost Genoptim belongs to a group of medicines known as prostaglandin analogs. Its action is to increase the natural outflow of fluid from the inside of the eye into the blood. Latanoprost Genoptim is used to treat open-angle glaucoma and ocular hypertension. Both conditions are associated with increased pressure in the eye, which can eventually affect vision. Latanoprost Genoptim is also used to treat elevated intraocular pressure and glaucoma in children and infants of any age.

2. IMPORTANT INFORMATION BEFORE USING LATANOPROST GENOPTIM

Latanoprost Genoptim can be used in adults, including the elderly, and in children from birth to 18 years. The use of Latanoprost Genoptim has not been studied in premature infants (born before 36 weeks of gestation).

When not to use Latanoprost Genoptim:

• If you are allergic to latanoprost or any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant, think you may be pregnant, or are planning to have a baby.
• If you are breast-feeding.

Warnings and precautions

If any of the following points apply to you, tell your doctor or your child's doctor before using Latanoprost Genoptim.

• If you have recently had or are about to have eye surgery (including cataract surgery).
• If you have symptoms in your eyes such as eye pain, irritation, or inflammation, blurred vision.
• If you have dry eye syndrome.
• If you have severe asthmaor uncontrolled asthma.
• If you wear contact lenses. You can use Latanoprost Genoptim, but follow the instructions for contact lens wearers in section 3.
• If you have had or currently have a viral eye infection caused by the herpes simplex virus (HSV).

Latanoprost Genoptim and other medicines

Latanoprost Genoptim may interact with other medicines. Tell your doctor, your child's doctor, or pharmacist about all medicines (including eye drops) you are taking now or have recently taken, including those obtained without a prescription.

Pregnancy and breast-feeding

If you are pregnant, breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

Latanoprost Genoptim should not be used during pregnancy.

Breast-feeding

Latanoprost Genoptim should not be used during breast-feeding.

Driving and using machines

While using Latanoprost Genoptim, temporary blurred vision may occur. If this happens, do not driveor use any tools or machines until your vision is clear again.

Latanoprost Genoptim contains benzalkonium chloride

Latanoprost Genoptim contains 0.5 mg of benzalkonium chloride per bottle, which corresponds to 0.2 mg/ml. Benzalkonium chloride may be absorbed by contact lenses and cause discoloration of soft contact lenses. If an adult or child wears contact lenses, they should be removed before using this medicine. Contact lenses can be put back 15 minutes after using Latanoprost Genoptim. Instructions for contact lens wearers, see section 3. Benzalkonium chloride can also cause eye irritation, especially if you have dry eyes or corneal disorders (the transparent layer on the front of the eye). If you experience any abnormal sensation in the eye, stinging, or eye pain after using this medicine, you should talk to your doctor.

Latanoprost Genoptim eye drops contain phosphates.

This medicine contains 15.625 mg of phosphates per bottle, which corresponds to 6,250 mg/ml. In the event of severe damage to the transparent layer on the front of the eye (cornea), phosphates may rarely cause corneal clouding due to calcium deposition during treatment.

3. HOW TO USE LATANOPROST GENOPTIM

Always use Latanoprost Genoptim exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. The recommended dose for adults (including the elderly) and children is one drop once daily into the affected eye(s). It is best to use the medicine in the evening. Do not use Latanoprost Genoptim more than once daily, as more frequent administration may reduce the efficacy of the treatment. Use Latanoprost Genoptim as prescribed by your doctor until they tell you to stop.

For contact lens wearers

If you wear contact lenses, remove them before using Latanoprost Genoptim. Wait 15 minutes after using Latanoprost Genoptim before putting your contact lenses back in.

Method of administration

Following the order of actions below will help you use Latanoprost Genoptim correctly:

• 1. Wash your hands and sit or stand in a comfortable position.
• 2. Before opening the bottle for the first time, check that the cap is intact.
• 3. Unscrew the bottle by turning the cap to the left.
• 4. Tilt your head back and gently pull the lower eyelid down to create a "pocket" between your eye and eyelid.
• 5. Turn the bottle upside down and gently squeeze the middle part of the bottle with your thumb and index finger until one drop falls into the conjunctival sac (the space between the conjunctiva of the eyelid and the conjunctiva of the eye) as instructed by your doctor. Do not touch the dropper tip to the eye or eyelid.Then, press the tear duct (the drainage path of tears from the conjunctival sac to the lacrimal sac) for about 1 minute (by pressing the inner corner of the eye with your finger), close your eye (eyes), and keep it (them) closed for the mentioned period. This will help the drop absorb into the eye and reduce the amount of medicine that drains into the nose through the tear duct.
• 6. To administer the drop to the second eye, if prescribed by your doctor, repeat steps 4 and 5.
• 7. Close the bottle with the cap. Do not tighten the cap too much.

Using Latanoprost Genoptim with other eye drops

Wait at least 5 minutes between using Latanoprost Genoptim and using other eye drops.

Using more than the recommended dose of Latanoprost Genoptim

If you accidentally put too many drops in your eye, you may experience mild irritation, tearing, and redness of the eye. These symptoms should go away, but if they bother you, you should contact your doctor. If you accidentally swallow Latanoprost Genoptim, contact your doctor immediately.

Missing a dose of Latanoprost Genoptim

If you miss a dose, skip the missed dose. Do not use a double dose to make up for the missed dose. Take the next dose at the usual time.

Stopping the use of Latanoprost Genoptim

If you need to stop using Latanoprost Genoptim, consult your doctor.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them. Known side effects that may occur after using Latanoprost Genoptim:
Very common (more than 1 in 10 people):

• Gradual change in the color of the treated eye due to an increase in the amount of brown pigment in the iris (the part of the eye responsible for its color). In patients with mixed eye color (blue-brown, gray-brown, yellow-brown, or green-brown eyes), there is a greater likelihood of this change occurring than in patients with single-color eyes (blue, gray, green, or brown eyes). The change in eye color may appear only after many years, although it is usually observed within the first 8 months of treatment. The change in eye color may be permanent and more noticeable if Latanoprost Genoptim is used in only one eye. It has not been shown that the change in eye color is associated with any health problems. The change in eye color after stopping Latanoprost Genoptim will stop;
• redness of the eye;
• eye irritation (feeling of burning, grittiness, itching, stinging, or foreign body sensation in the eye). If eye irritation occurs that is severe enough to cause excessive tearing of the eyes or a desire to stop using the medicine, you should contact your doctor, pharmacist, or nurse within a week. It may be necessary to change the medicine to ensure proper treatment.
• Gradual changes in the eyelashes of the treated eye and the eyelashes around the treated eye, which in most cases occur in people of Japanese origin. These changes include darkening, lengthening, thickening, and increasing the number of eyelashes.

Common (less than 1 in 10 people):

• irritation or damage to the surface of the eye, eyelid inflammation, and eye pain, sensitivity to light (photophobia), conjunctivitis.

Uncommon (less than 1 in 100 people):

• swelling of the eyelids, dryness of the eye, inflammation or irritation of the surface of the eye (keratitis), blurred vision, inflammation of the colored part of the eye (uveitis), swelling of the macula (macular edema),
• skin rash,
• chest pain (angina), feeling of palpitations (palpitations),
• asthma, shortness of breath (dyspnea),
• chest pain,
• headache, dizziness,
• muscle pain, joint pain,
• nausea,
• vomiting.

Rare (less than 1 in 1,000 people):

• inflammation of the iris (the colored part of the eye) (iritis and/or uveitis); swelling of the macula (macular edema), symptoms of swelling or scratching or damage to the surface of the eye, swelling around the eye (periorbital edema), change in the direction of eyelash growth or an additional row of eyelashes, scarring on the surface of the eye, formation of fluid-filled spaces in the colored part of the eye (uveoscleral vesicles),
• skin reactions on the eyelids, darkening of the eyelid skin,
• worsening of asthma,
• severe itching of the skin,
• eye infections caused by the herpes simplex virus (HSV).

Very rare (less than 1 in 10,000 people):

• worsening of angina symptoms in patients with heart disease, feeling of sunken eyes. Cold and fever are side effects that occur more frequently in the pediatric and adolescent population than in the adult population.
• In very rare cases, in some patients with significantly damaged cornea (the transparent layer on the front of the eye), cloudy spots on the cornea have occurred during treatment due to calcium deposition.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist, or nurse. You can also report side effects 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, tel.: 22 49-21-301, fax: 22 49-21-309. Website: https://smz.ezdrowie.gov.pl You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE LATANOPROST GENOPTIM

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and bottle. The expiry date refers to the last day of that month. Store in a refrigerator (2-8°C). Do not freeze. Store the bottle in the outer carton in order to protect from light. After opening the bottle: do not store above 25°C. The product should be discarded 4 weeks after the bottle is first opened, even if there is still some solution left. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Latanoprost Genoptim contains

One bottle of Latanoprost Genoptim contains 2.5 ml of eye drop solution, which corresponds to approximately 80 drops of solution. The active substance is latanoprost. 1 ml of eye drop solution contains 50 micrograms of latanoprost. One drop contains approximately 1.5 micrograms of latanoprost. The other ingredients are: benzalkonium chloride, sodium dihydrogen phosphate monohydrate, disodium phosphate anhydrous, sodium chloride, sodium hydroxide or hydrochloric acid to adjust pH, water for injections.

What Latanoprost Genoptim looks like and contents of the pack

Latanoprost Genoptim is a clear, colorless solution for eye drops. One bottle contains 2.5 ml of eye drop solution, which corresponds to approximately 80 drops of solution. Latanoprost Genoptim is available in the following pack sizes: 1 bottle with a dropper containing 2.5 ml of eye drop solution, 3 bottles with a dropper containing 2.5 ml of eye drop solution each, 6 bottles with a dropper containing 2.5 ml of eye drop solution each. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Synoptis Pharma Sp. z o.o. ul. Krakowiaków 65 02-255 Warsaw

Manufacturer:

Rafarm S.A. Thesi Pousi-Hatzi Agiou Louka P.O. Box 37 19002 Paiania Attika, Athens Greece

This medicinal product has been authorized in the EEA member states under the following names:

ES: Latanoprost Combix 50 micrograms/ml eye drops, solution PL: Latanoprost Genoptim

Date of last revision of the leaflet: 03.2022