Travoprost genoptim

Package leaflet: Information for the user

Travoprost Genoptim, 40 micrograms/ml, eye drops, solution
Travoprost
Read the entire leaflet carefully before starting to use the medicine, because 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 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 effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

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

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

2. Important information before using Travoprost Genoptim

When not to use Travoprost Genoptim

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

In such a case, consult a doctor for advice.
Warnings and precautions
Before starting to use Travoprost Genoptim, discuss it with your doctor or
pharmacist.

• Travoprost Genoptim may increase the length, thickness, pigmentation, and/or number of eyelashes. Changes in the eyelids have also been observed, including excessive hair growth and changes in the tissues around the eye.
• Travoprost Genoptim may change the color of the iris (the colored part of the eye). The change may be permanent. A change in the skin color around the eye is also possible.
• If the patient has undergone cataract surgery, consult a doctor before starting treatment with Travoprost Genoptim.
• If the patient currently has or has previously had eye inflammation (iritis or uveitis), consult a doctor before starting treatment with Travoprost Genoptim.
• Travoprost Genoptim may rarely cause shortness of breath, wheezing, or worsening of asthma symptoms. If any breathing changes occur during treatment with Travoprost Genoptim, inform the doctor immediately.
• Travoprost Genoptim may be absorbed through the skin. If any amount of the medicine comes into contact with the skin, wash it off immediately with water. This is particularly important for women who are pregnant or planning to become pregnant.
• If the patient wears soft contact lenses – do not use the medicine while wearing them. After instilling the drops, wait 15 minutes before reinserting the lenses.

Children and adolescents
Travoprost Genoptim may be used in children from 2 months up to below 18 years of age at the same dosage as in adults. Use of Travoprost Genoptim in children below 2 months of age is not recommended.
Travoprost Genoptim with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Pregnancy and breastfeeding
Women who are pregnant must not use Travoprost Genoptim. If the patient suspects she may be pregnant, she should inform her doctor. If pregnancy could occur during treatment with Travoprost Genoptim, effective contraceptive methods must be used.
Do not use Travoprost Genoptim during breastfeeding. Travoprost Genoptim may pass into breast milk.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Driving and operating machinery
After instilling Travoprost Genoptim, vision may be blurred for a short time. Until this effect subsides, the patient should not drive or operate machinery.
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 may change their color. Contact lenses must be removed before instillation and reinserted at least 15 minutes afterwards.
Benzalkonium chloride may also cause eye irritation, especially in patients with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If abnormal sensations, stinging, or eye pain occur after using the medicine, contact a 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 prescribed by the doctor or the child's treating doctor.
If in doubt, consult the doctor, the child's treating doctor, or pharmacist.
Travoprost Genoptim is intended for ocular instillation only.
Recommended dose
One drop into the affected eye or eyes once daily – in the evening.
Travoprost Genoptim may be used in both eyes only if specifically instructed by the doctor. The medicine should be used for as long as directed by the doctor or the child's treating doctor.

1	Immediately before first use of the bottle, tear open the protective pouch, remove the bottle (Figure 1), and record the date of opening in the space provided on the label. Take the bottle with medicine and a mirror. Wash your hands. Unscrew the cap.
2	Hold the bottle with the tip pointing downwards, gripping it between your thumb and fingers. Tilt your head backwards. Gently pull down the lower eyelid with a clean finger to create a "pocket" between the eyeball and the eyelid. The drop should be instilled into this "pocket" (Figure 2). Bring the tip of the bottle close to the eye. Use the mirror to assist.
3	Do not let the dropper touch the eye, eyelid, surrounding areas or any other surface, as this may lead to contamination of the drops. To release a single drop of Travoprost Genoptim, gently squeeze the bottle (Figure 3). After instilling Travoprost Genoptim, press with a finger on the inner corner of the eye near the nose (Figure 4). This helps prevent the medicine from draining into the rest of the body.
4	If treating both eyes, repeat these steps for the second eye. Immediately after using the medicine, tightly replace the cap on the bottle. Only use one bottle at a time. Do not open the pouch until you need to use the bottle. Dispose of the bottle 4 weeks after first opening to prevent infection, and use a new bottle.

If a drop does not enter the eye, repeat the instillation attempt.
Accidental overdose of Travoprost Genoptim eye drops
Rinse the eye thoroughly with lukewarm water. Do not instill further drops until it is time for the next scheduled dose.
If you miss a dose of Travoprost Genoptim
Apply the next dose at the usual scheduled time. Do not use a double dose to make up for the missed dose. Never use more than one drop in the affected eye(s) once daily.
Stopping treatment with Travoprost Genoptim
Do not stop using Travoprost Genoptim without first consulting your doctor or your child's doctor, as intraocular pressure in adult or pediatric patients will no longer be controlled, which may lead to vision loss.
If you are using other ophthalmic medicines, such as eye drops or eye ointments, maintain at least a 5-minute interval between instillation of Travoprost Genoptim and the use of other ophthalmic products.
If you have any doubts concerning the use of the medicine, consult your doctor, your child's doctor, or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You can usually continue using the drops unless the adverse reactions are severe. If you have any concerns,
contact your doctor or pharmacist. Do not stop using Travoprost Genoptim without first consulting your doctor.

The following adverse reactions have been observed during treatment with travoprost.

Very common adverse reactions (may occur in more than 1 in 10 people):
Eye-related reactions:

• eye redness.

Common adverse reactions (may occur in less than 1 in 10 people):
Eye-related reactions:

• changes in iris colour (coloured part of the eye),
• eye pain,
• eye discomfort,
• dry eye,
• eye itching,
• eye irritation.

Uncommon adverse reactions (may occur in less than 1 in 100 people):
Eye-related reactions:

• corneal disorders,
• eye inflammation,
• uveitis (inflammation of the uvea),
• intraocular inflammation,
• ocular surface inflammation with or without damage to the ocular surface,
• light sensitivity,
• eye discharge,
• eyelid inflammation (blepharitis),
• eyelid redness,
• swelling around the eye,
• eyelid itching,
• blurred vision,
• increased tear production,
• conjunctival infection or inflammation,
• abnormal lower eyelid eversion,
• eye cloudiness,
• eyelid nodules,
• excessive eyelash growth.

General reactions:

• worsening of allergic symptoms,
• headache,
• irregular heartbeat,
• cough,
• nasal congestion,
• throat irritation,
• darkening of the skin around the eyes,
• abnormal hair appearance,
• excessive hair growth.

Rare adverse reactions (may occur in less than 1 in 1,000 people):
Eye-related reactions:

• perception of flickering light,
• eyelid rash,
• abnormal eyelash orientation (eyelashes growing toward the eye),
• eye swelling,
• reduced vision,
• seeing halos around lights,
• decreased sensation in the eye,
• inflammation of eyelid glands (meibomian glands),
• pigmentation of the inner eye,
• pupil dilation,
• eyelash thickening,
• change in eyelash pigmentation,
• eye fatigue.

General reactions:

• viral eye infection,
• dizziness,
• unpleasant taste in the mouth,
• irregular or slow heartbeat,
• increased or decreased blood pressure,
• shortness of breath,
• asthma,
• allergy or nasal inflammation,
• dry nose,
• voice changes,
• gastrointestinal discomfort or peptic ulcer,
• constipation,
• dry mouth,
• skin redness or itching,
• rash,
• changes in hair pigmentation,
• eyelash loss,
• joint pain,
• musculoskeletal pain,
• generalised weakness.

Frequency not known (frequency cannot be estimated from available data):
Eye-related reactions:

• posterior segment inflammation of the eye,
• enophthalmos (sunken eyeballs).

General reactions:

• depression,
• anxiety,
• insomnia,
• sensation of abnormal movement,
• tinnitus (ringing in the ears),
• chest pain,
• cardiac rhythm disorders,
• rapid heartbeat,
• worsening of asthma,
• diarrhoea,
• nosebleeds,
• abdominal pain,
• nausea,
• vomiting,
• itching,
• abnormal hair growth,
• painful or involuntary urination,
• increased prostate-specific antigen (PSA) levels.

The most common adverse reactions observed in children and adolescents treated with travoprost are eye redness and excessive eyelash growth. Both of these adverse reactions have been reported more frequently in children and adolescents than in adults.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse reactions 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 4921 301, fax: +48 22 4921 309,
website: https://smz.ezdrowie.gov.pl.
Adverse reactions may also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Travoprost Genoptim

Keep this medicine out of the sight and reach of children.
Do not use Travoprost Genoptim after the expiry date stated on the label and carton under "EXP". The expiry date refers to the last day of the specified month.
Do not use the medicine if there is obvious tampering or any damage to the packaging before first opening.
Store the bottle in its sachet to protect it from moisture.
After opening, no special storage conditions are required.
To prevent infection, discard the bottle 4 weeks after first opening and start using a new one. The date of opening should be recorded in the designated space on the label of each bottle and on the box.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This helps 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/ml of travoprost.
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, colourless solution supplied in packs containing a 5 ml bottle made of PP with a dropper made of LDPE and a cap made of HDPE with a tamper-evident seal, placed in a pouch made of PET/Aluminium/PE foil.
The product is available in the following pack sizes: cardboard boxes containing 1 or 3 bottles.
Not all pack sizes may be marketed.

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

Manufacturers
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 authorised in the European Economic Area countries under the following names:
Denmark, United Kingdom, Netherlands,
Bulgaria, Greece Travoprost Pharmathen
France Travoprost BGR
Germany Travoprost OmniVision 40 Microgram/ml Eye Drops,
Solution
Italy Travoprost Doc Generici
Spain Travoprost Vir
Poland Travoprost Genoptim
Iceland Travoprost Alvogen
Sweden Travoprost Medical Valley 40 microgram/ml Eye Drops,
Solution