Travoprost Genoptim

PATIENT INFORMATION LEAFLET

Enclosed leaflet: information for the user

Travoprost Genoptim, 40 micrograms/ml, eye drops, solution

Travoprost

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.

Contents of the leaflet

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

1. What is Travoprost Genoptim and what is it used for

Travoprost Genoptim eye drops are used to treat high pressure in the eye in adults, adolescents, and children from 2 months of age. This pressure can lead to the development of a disease called glaucoma. High pressure in the eye.The eyes contain a clear, watery fluid that nourishes the inside of the eye. This fluid is constantly being drained from the eye and produced. If the eye fills up faster than it drains, the pressure inside the eyeball increases. If it is too high, vision may be damaged. Travoprost Genoptim contains travoprost, a medicine belonging to a group called prostaglandin analogues. It works by reducing the pressure in the eye. Travoprost Genoptim can be used alone or in combination with other eye drops, such as beta-adrenergic receptor blockers, which also reduce the pressure inside the eye.

2. Important information before using Travoprost Genoptim

When not to use Travoprost Genoptim

• If you are allergic to travoprost or any of the other ingredients of this medicine (listed in section 6).

In this case, consult your doctor for advice.

Warnings and precautions

Before starting treatment with Travoprost Genoptim, discuss it with your doctor or pharmacist.

• Travoprost Genoptim may increase the length, thickness, color, and/or number of eyelashes. Changes in the eyelids, including excessive hair growth and tissue changes around the eye, have also been observed.
• Travoprost Genoptim may change the color of the iris (the colored part of the eye). The change may be permanent. It is also possible to change the color of the skin around the eye.

If you have had cataract surgery, consult your doctor before starting treatment with Travoprost Genoptim.

• If you currently have or have had eye inflammation (inflammation of the iris and/or inflammation of the vascular layer of the eye), consult your doctor before starting treatment with Travoprost Genoptim.
• Travoprost Genoptim may rarely cause shortness of breath, wheezing, or worsening of asthma symptoms. If you notice changes in your breathing while using Travoprost Genoptim, inform your doctor immediately.
• Travoprost Genoptim may be absorbed through the skin. If any amount of the medicine comes into contact with the skin, it should be rinsed off with water immediately. This is especially important in pregnant or breastfeeding women.
• If you wear soft contact lenses, do not use the medicine with the lenses in place. Wait 15 minutes after using the medicine before putting the lenses back in.

Children and adolescents

Travoprost Genoptim can be used in children from 2 months to less than 18 years of age at the same doses as in adults. The use of Travoprost Genoptim in children under 2 months of age is not recommended.

Travoprost Genoptim and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and about any medicines you plan to take.

Pregnancy and breastfeeding

Pregnant women should not use Travoprost Genoptim.If you suspect you may be pregnant, inform your doctor. If you could become pregnant during treatment with Travoprost Genoptim, you must use appropriate contraceptive methods. Do not use Travoprost Genoptim during breastfeeding.Travoprost Genoptim may pass into breast milk. If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.

Driving and using machines

After using Travoprost Genoptim, vision may be blurred for a while. Do not drive or operate machinery until the symptoms have resolved.

Travoprost Genoptim contains benzalkonium chloride

Travoprost Genoptim contains 150 mg of benzalkonium chloride per ml of solution. Benzalkonium chloride may be absorbed by soft contact lenses and change their color. Remove contact lensesbefore using the medicine and wait at least 15 minutes before putting them back in. 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 you experience any abnormal sensations in the eye, stinging, or pain in the eye after using the medicine, consult your doctor.

Travoprost Genoptim contains macrogolglycerol hydroxystearate 40

Travoprost Genoptim contains macrogolglycerol hydroxystearate 40, which may cause skin reactions.

3. How to use Travoprost Genoptim

This medicine should always be used exactly as your doctor or the doctor treating your child has told you. If you are not sure, ask your doctor or pharmacist.

Travoprost Genoptim is for use in the eye only.

Recommended dose

One drop into the affected eye or eyes, once a day- in the evening. Travoprost Genoptim can be used in both eyes only if your doctor has told you to do so. Use the medicine for as long as your doctor or the doctor treating your child has told you to.

1	Immediately before the first use of the bottle, tear off the protective bag, remove the bottle (figure 1), and write the opening date in the space provided on the label. Take the bottle with the medicine and a mirror. Wash your hands. Remove the cap.
2	Hold the bottle with the tip down, between your thumb and fingers. Tilt your head back. With a clean finger, pull down the lower eyelid to create a 'pocket' between the eye and the eyelid. The drop should fall into this 'pocket' (figure 2). Bring the tip of the bottle close to the eye. To make it easier, use a mirror.
3	Do not touch the dropper tip to the eye, eyelid, or surrounding areas, as this may cause infection. To release a single drop of Travoprost Genoptim, gently squeeze the bottle (figure 3). After using the medicine, press the corner of your eye near your nose (figure 4) for a few seconds. This will help prevent the medicine from spreading to the rest of your body.
4	If you are using drops in both eyes, repeat the steps for the other eye. Immediately after use, replace the cap on the bottle. Only use one bottle at a time. Do not open the bag until you need to use the bottle. Discard the bottle 4 weeks after first opening and use a new one.

If the drop does not get into the eye, try again.

Accidental ingestion of Travoprost Genoptim

Flush the entire contents of the bottle from the eye with warm water. Do not administer the next dose until it is time for the next dose.

Missing a dose of Travoprost Genoptim

Apply the next dose at the scheduled time. Do not use a double doseto make up for a missed dose. Never use more than one drop into the affected eye or eyes, once a day.

Stopping treatment with Travoprost Genoptim

Do not stop using Travoprost Genoptim without consulting your doctor or the doctor treating your child first, as the pressure inside the eye of the adult or child patient will not be controlled, which may lead to loss of vision. If you are using other eye drops or eye ointments, wait at least 5 minutes between using Travoprost Genoptim and using other eye drops or ointments.

In case of doubts about the use of the medicine, consult your doctor, the doctor treating your child, or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. You can usually continue to use the drops as long as the side effects are not serious. If you are concerned, talk to your doctor or pharmacist. Do not stop using Travoprost Genoptim without talking to your doctor. The following side effects have been observed during treatment with travoprost: Very common side effects(may affect more than 1 in 10 people):

• eye redness.

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

• changes in iris color (the colored part of the eye),
• eye pain,
• eye discomfort,
• eye dryness,
• eye itching,
• eye irritation.

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

• corneal disorders,
• eye inflammation,
• iritis,
• inflammation inside the eye,
• inflammation of the eye surface with or without damage to the eye surface,
• photophobia,
• eye discharge,
• blepharitis,
• eyelid redness,
• swelling around the eye,
• eyelid itching,
• blurred vision,
• increased tear production,
• conjunctivitis,
• ectropion,
• eye clouding,
• eyelid margin crusting,
• excessive eyelash growth.

General disorders:

• allergic reactions,
• headache,
• palpitations,
• cough,
• nasal congestion,
• throat irritation,
• skin darkening around the eye (eyes),
• abnormal hair growth,
• excessive hair growth.

Rare side effects(may affect up to 1 in 1,000 people):

• flashing lights,
• blepharospasm,
• abnormal eyelash growth, which grows towards the eye,
• eye swelling,
• limited vision,
• halo vision,
• decreased sensation in the eye,
• meibomian gland inflammation,
• eye discoloration,
• pupil dilation,
• eyelash thickening,
• eyelash color change,
• eye fatigue.

General disorders:

• eye viral infection,
• dizziness,
• unpleasant taste in the mouth,
• irregular or slow heartbeat,
• increased or decreased blood pressure,
• shortness of breath (dyspnea),
• asthma,
• allergy or rhinitis,
• nasal dryness,
• voice changes,
• gastrointestinal discomfort or stomach ulcer,
• constipation,
• dry mouth,
• skin redness or itching,
• rash,
• hair color changes,
• eyelash loss,
• joint pain,
• musculoskeletal pain,
• general weakness.

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

• posterior segment inflammation,
• enophthalmos.

General disorders:

• depression,
• anxiety,
• insomnia,
• abnormal sensation,
• tinnitus,
• chest pain,
• arrhythmias,
• tachycardia,
• asthma exacerbation,
• diarrhea,
• epistaxis,
• abdominal pain,
• nausea,
• vomiting,
• pruritus,
• abnormal hair growth,
• painful or involuntary urination,
• increased prostate-specific antigen.

The most common side effects in children and adolescents using travoprost were eye redness and excessive eyelash growth. Both of these side effects were more common in children and adolescents than in adults.

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, phone: +48 22 49 21 301, fax: +48 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 Travoprost Genoptim

Keep the medicine out of the sight and reach of children.

Do not use Travoprost Genoptim after the expiry date stated on the label and carton after "EXP". The expiry date refers to the last day of that month. Do not use the medicine if the packaging is damaged or broken before first opening. Store the bottle in the pouch to protect it from moisture. After opening, the product does not require any special storage conditions. To prevent infections, discard the bottle 4 weeks after first openingand start using a new one. Write the opening date on the label of each bottle and on the box. 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 Travoprost Genoptim contains

The active substance is travoprost. This medicine contains 40 micrograms of travoprost per ml. The other ingredients are benzalkonium chloride (50% solution), macrogolglycerol hydroxystearate 40, trometamol, disodium edetate, boric acid (E 284), mannitol (E 421), sodium hydroxide, water for injections, or purified water.

What Travoprost Genoptim looks like and contents of the pack

Travoprost Genoptim is a clear, colorless solution supplied in packs containing one or more 5 ml bottles with a dropper made of LDPE and a cap made of HDPE with a tamper-evident seal, placed in a pouch made of PET/Aluminum/PE. The product is available in the following packs: cardboard boxes containing 1 or 3 bottles. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

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

Manufacturer

Pharmathen S.A. Dervenakion 6 Pallini Attiki, 153 51 Greece BALKANPHARMA-RAZGRAD AD 68 Aprilsko vastanie Blvd., Razgrad, 7200 Bulgaria JADRAN-GALENSKI LABORATORIJ d.d. Svilno 20, Rijeka 51000 Croatia

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

Denmark, United Kingdom, Netherlands, Bulgaria, Greece Travoprost Pharmathen France Travoprost BGR Germany Travoprost OmniVision 40 micrograms/ml eye drops, solution Italy Travoprost Doc Generici Spain Travoprost Vir Poland Travoprost Genoptim Iceland Travoprost Alvogen Sweden Travoprost Medical Valley 40 micrograms/ml eye drops, solution

Date of last revision of the leaflet: