Menezon

Package leaflet: Information for the user

MENEZON 40 micrograms/mL eye drops, solution

Travoprost
Generic medicine
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful to them.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What MENEZON is and what it is used for
2. What you need to know before you use MENEZON
3. How to use MENEZON
4. Possible side effects
5. How to store MENEZON
6. Contents of the pack and other information

1. What MENEZON is and what it is used for

MENEZON contains travoprost, a substance belonging to a group of medicines called prostaglandin analogues. It works by reducing intraocular pressure. It can be used alone or in combination with other eye drops, such as beta-blockers, which also reduce pressure.
MENEZON is used to reduce elevated intraocular pressure in adults, adolescents, and children from 2 months of age onwards. This pressure can lead to a condition called glaucoma.

2. What you need to know before using MENEZON

Do not use MENEZON

• If you are allergic to travoprost or to any of the excipients of this medicine (listed in section 6). In this case, consult your doctor.

Warnings and precautions

• MENEZON may increase the length, thickness, colour and/or number of your eyelashes. Changes to the eyelids or tissues around the eye, including abnormal hair growth, have also been observed.
• MENEZON may change the colour of your iris (the coloured part of the eye). This change may be permanent. A change in the colour of the skin around the eye may also occur.
• If you have undergone cataract surgery, consult your doctor before using MENEZON.
• If you currently have or have previously had ocular inflammation (iritis or uveitis), consult your doctor before using MENEZON.
• MENEZON may rarely cause difficulty breathing or shortness of breath, or worsen symptoms of asthma. Inform your doctor immediately if you notice any changes in your breathing after using MENEZON.
• Travoprost may be absorbed through the skin. If any amount of the medicine comes into contact with the skin, it should be washed off immediately. This is particularly important for women who are pregnant or planning to become pregnant.
• If you wear soft contact lenses, do not use the eye drops while wearing them. Wait 15 minutes after using the eye drops before reinserting your lenses.

Children and adolescents
MENEZON may be used in children from 2 months of age up to less than 18 years of age at the same dose as adults.
The use of MENEZON is not recommended in children under 2 months of age.
Other medicines and MENEZON
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding and fertility
Do not use MENEZON during pregnancy
Speak immediately with your doctor if you think you may be pregnant. If you could become pregnant, use an effective contraceptive method during treatment.
Do not use MENEZON while breastfeeding
MENEZON may be excreted in breast milk.
Ask your doctor for advice before taking any medicine.
Driving and using machines
You may experience blurred vision for a period of time after using MENEZON. Do not drive or operate machinery until these symptoms have resolved.
MENEZON contains:

• Hydrogenated castor oil and propylene glycol, which may cause skin reactions and irritation.
• Benzalkonium chloride 0.15 mg per 1 ml (equivalent to 0.375 mg per 2.5 ml), which may be absorbed by soft contact lenses and may lead to a change in their colour. Remove your contact lenses before using this medicine and wait 15 minutes before reinserting them. Benzalkonium chloride may also cause eye irritation, especially if you have dry eye or corneal disorders (conditions affecting the cornea, the eye's outermost transparent layer). If you experience an unusual sensation, burning, or pain in the eye after using this medicine, speak with your doctor.

3. How to use MENEZON

Use this medicine exactly as directed by your doctor or paediatrician. If you have any doubts, consult your doctor, paediatrician, or pharmacist.

Recommended dose:
One drop in the eye(s) once daily – in the evening.
Use MENEZON in both eyes only if prescribed by your doctor. Use the medicine for the length of time recommended by your doctor or paediatrician.

MENEZON must be used only as an eye drop.

Instructions for use:

• Immediately before first use of the bottle, open the outer protective pouch, remove the bottle (Figure 1), and write the date of opening on the designated space on the carton.
• Wash your hands.
• Unscrew the cap.
• After removing the cap, if the loose protective ring is loose, remove it before using the medicine.
• Hold the bottle between your thumb and fingers, with the tip pointing downwards.
• Tilt the head backwards or gently tilt the child’s head backwards. Pull down the lower eyelid gently with a clean finger to create a "pocket" between the eyelid and the eye. The drop should be instilled into this pocket (Figure 2).
• Hold the tip of the bottle close to the eye. Using a mirror may be helpful.
• Do not touch the eye, eyelid, surrounding areas, or any other surfaces with the tip of the bottle. This could contaminate the eye drops.
• Gently squeeze the bottle to release one drop of MENEZON at a time (Figure 3).
• After instilling MENEZON, keep the eyes closed and apply gentle pressure with a finger at the inner corner of the eye, near the nose (Figure 4), for at least one minute. This helps prevent MENEZON from being absorbed into the rest of the body.
• If using the eye drops in both eyes, repeat the steps for the other eye.
• Immediately close the cap tightly after use.
• Use only one bottle at a time. Do not open the outer protective pouch until it is time to use the bottle. If a drop misses the eye, try again.

If you or the child are using other ophthalmic preparations such as eye drops or ointments at the same time, wait at least 5 minutes between instilling MENEZON and the other preparations.

If you or the child have used more MENEZON than you should
Rinse all the medicine away with lukewarm water. Do not use the eye drops until the next scheduled dose.

If you forget to use MENEZON
Continue treatment with the next dose as planned. Do not take a double dose to make up for the missed dose. Never use more than one drop per day per affected eye(s).

If you stop using MENEZON
Do not stop treatment with MENEZON without first talking to your doctor or paediatrician, as intraocular pressure will no longer be controlled, which may result in loss of vision.

If you have any further questions about the use of this medicine, consult your doctor, paediatrician, or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You can generally continue using the drops unless the side effects are severe.
If you are concerned, speak to your doctor or pharmacist. Do not stop treatment with MENEZON without first talking to your doctor.

The following side effects have been observed with MENEZON:

Very common side effects: may affect more than 1 in 10 users
Eye disorders: eye redness.

Common side effects: may affect up to 1 in 10 users
Eye disorders: changes in iris colour (the coloured part of the eye), eye pain, eye discomfort, dry eye, itchy eyes, eye irritation.

Uncommon side effects: may affect up to 1 in 100 users
Eye disorders: corneal disorder, eye inflammation, iris inflammation, intraocular inflammation, ocular surface inflammation with or without surface damage, light sensitivity, eye discharge, eyelid inflammation, eyelid redness, swelling around the eye, eyelid itching, reduced vision, blurred vision, increased lacrimation, conjunctival infection or inflammation (conjunctivitis), abnormal outward turning of the lower eyelid, eye cloudiness, eyelid crusting, eyelash growth, change in eyelash colour, tired eyes.
General side effects: worsening of allergy symptoms, headache, dizziness, irregular heartbeat, shortness of breath, asthma, nasal congestion, throat irritation, darkening of the skin around the eye(s), skin darkening, abnormal hair structure, excessive hair growth.

Rare: may affect up to 1 in 1,000 users
Eye disorders: perception of flashing lights, eyelid eczema, eye swelling, seeing halos around lights, decreased eye sensitivity, inflammation of the eyelid glands, pigmentation inside the eye, increased pupil size, changes in eyelash structure.
General side effects: viral eye infection, unpleasant taste, irregular or slow heart rate, increased or decreased blood pressure, cough, voice changes, gastrointestinal disorders or ulcer, constipation, dry mouth, skin redness or itching, rash, hair colour change, eyelash loss, musculoskeletal pain, generalized weakness.

Not known: frequency cannot be estimated from the available data
Eye disorders: inflammation of the back of the eye, eyes appearing more sunken.
General side effects: depression, anxiety, false sensation of movement, ringing in the ears, chest pain, worsening of asthma, diarrhoea, abdominal pain, nausea, itching, abnormal hair growth, joint pain, painful or involuntary urination, increase in prostate cancer marker.

In children and adolescents, the most common side effects observed with MENEZON were eye redness and eyelash growth. Both of these side effects occurred more frequently in children and adolescents compared to adults.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/web/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store MENEZON

Keep this medicine out of the sight and reach of children.
Do not use MENEZON after the expiry date stated on the bottle and carton after “Exp.”.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
To prevent infections, the bottle must be discarded four weeks after first opening, and a new bottle must be started.
Write the date of opening in the space provided on the carton.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What MENEZON contains
The active substance is travoprost 40 micrograms/mL.
The other components are: benzalkonium chloride, mannitol, tromethamine, polyoxyl 40 hydrogenated castor oil (Cremophor RH40), boric acid, edetate disodium, water for injections.

Description of the appearance of MENEZON and contents of the pack
MENEZON is a liquid (a clear, colourless solution) supplied in a pack containing one polyethylene bottle of 2.5 mL.
Pack size: 1 bottle.

Marketing Authorization Holder:
Visufarma S.p.A.
Via Alberto Cadlolo, 21
00136 Rome, Italy

Manufacturer and batch release:
Genetic S.p.A., Contrada Canfora, 84084 Fisciano (SA)

This leaflet was last approved on

Package leaflet: Information for the user

MENEZON 40 micrograms/mL eye drops, solution

Travoprost
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What MENEZON is and what it is used for
2. What you need to know before using MENEZON
3. How to use MENEZON
4. Possible side effects
5. How to store MENEZON
6. Contents of the pack and other information

1. What MENEZON is and what it is used for

MENEZON contains travoprost, a substance belonging to a group of medicines called prostaglandin analogues. It works by reducing intraocular pressure. It can be used alone or in addition to other eye drops such as beta-blockers, which also help lower pressure.
MENEZON is used to reduce elevated intraocular pressure in adults, adolescents, and children from 2 months of age onwards. This pressure can lead to a condition called glaucoma.

2. What you should know before using MENEZON

Do not use MENEZON

• If you are allergic to travoprost or to any of the excipients of this medicine (listed in section 6). In this case, consult your doctor.

Warnings and precautions

• MENEZON may increase the length, thickness, colour, and/or number of your eyelashes. Changes in the eyelids or tissues around the eye, including abnormal hair growth, have also been observed.
• MENEZON may change the colour of your iris (the coloured part of the eye). This change may be permanent. A change in the colour of the skin around the eye may also occur.
• If you have undergone cataract surgery, consult your doctor before using MENEZON.
• If you currently have or have previously had ocular inflammation (iritis or uveitis), consult your doctor before using MENEZON.
• MENEZON may rarely cause breathing difficulties, shortness of breath, or worsen symptoms of asthma. Inform your doctor immediately if you notice that using MENEZON causes changes in your breathing.
• Travoprost may be absorbed through the skin. If any amount of the medicine comes into contact with the skin, it should be washed off immediately. This is particularly important for women who are pregnant or planning to become pregnant.
• If you wear soft contact lenses, do not use the eye drops while wearing them. Wait 15 minutes after using the eye drops before reinserting your lenses.

Children and adolescents
MENEZON may be used in children from 2 months of age up to less than 18 years of age at the same dose as adults.
The use of MENEZON is not recommended in children under 2 months of age.
Other medicines and MENEZON
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding and fertility
Do not use MENEZON during pregnancy
Speak immediately with your doctor if you think you may be pregnant. If you could become pregnant, use an effective contraceptive method during treatment.
Do not use MENEZON while breastfeeding
MENEZON may be excreted in breast milk.
Ask your doctor for advice before taking any medicine.
Driving and use of machines
You may experience blurred vision for a period of time after using MENEZON. Do not drive or operate machinery until these symptoms have resolved.
MENEZON contains:

• hydrogenated castor oil and propylene glycol, which may cause skin reactions and irritation.

3. How to use MENEZON

Use this medicine exactly as instructed by your doctor or paediatrician. If you have any doubts, consult your doctor, paediatrician or pharmacist.

The recommended dose is
One drop in the eye(s) once daily – in the evening.
Use MENEZON in both eyes only if prescribed by your doctor. Use the medicine for as long as advised by your doctor or paediatrician.
MENEZON may only be used as eye drops.

• Wash your hands.
• Remove one vial from the strip and unscrew the cap with a gentle twist.
• Hold the vial between your thumb and other fingers, with the tip pointing downwards.
• Tilt your head backwards. Pull down the lower eyelid with a clean finger to create a "pocket" between the eyelid and the eye. The drop should be placed here.
• Hold the tip of the vial close to the eye. Using a mirror may be helpful.
• Do not touch the eye, eyelid, surrounding areas or any other surfaces with the tip of the vial.
• Gently squeeze the vial to release one drop of MENEZON at a time.
• After using MENEZON, keep your eyes closed and apply gentle pressure with one finger at the inner corner of the eye, near the nose, for at least one minute. This helps prevent MENEZON from spreading into the rest of the body.
• If using the eye drops in both eyes, repeat the steps for the other eye.
• Discard the vial and any remaining contents. If a drop does not enter the eye, try again.

If you or the child are using other ophthalmic preparations such as drops or ointments at the same time, wait at least 5 minutes between instilling MENEZON and the other preparations.

If you or the child use more MENEZON than you should
Rinse all the medicine away with lukewarm water. Do not use the eye drops until the next scheduled dose.

If you forget to use MENEZON
Continue treatment with the next dose as planned. Do not take a double dose to make up for a forgotten dose. Never use more than one drop per day in each affected eye.

If you stop using MENEZON
Do not stop treatment with MENEZON without first talking to your doctor or paediatrician, as intraocular pressure will not be controlled, possibly resulting in loss of vision.

If you have any further questions about the use of this medicine, consult your doctor, paediatrician or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
You can generally continue using the drops unless the side effects are severe.
If you are concerned, speak to your doctor or pharmacist. Do not stop treatment with MENEZON without first talking to your doctor.

The following side effects have been observed with MENEZON:

Very common side effects: may affect more than 1 in 10 users
Eye effects: ocular redness.

Common side effects: may affect up to 1 in 10 users
Eye effects: changes in iris colour (the coloured part of the eye), eye pain, eye discomfort, dry eyes, itchy eyes, eye irritation.

Uncommon side effects: may affect up to 1 in 100 users
Eye effects: corneal disorder, eye inflammation, iris inflammation, intraocular inflammation, inflammation of the eye surface with or without surface damage, light sensitivity, eye discharge, eye infection or inflammation of the conjunctiva (conjunctivitis), abnormal outward turning of the lower eyelid, eye cloudiness, crusting on the eyelid, eyelash growth, change in eyelash colour, tired eyes.
General side effects: worsening of allergy symptoms, headache, dizziness, irregular heartbeat, shortness of breath, asthma, nasal congestion, throat irritation, darkening of the skin around the eye(s), generalised skin darkening, abnormal hair structure, excessive hair growth.

Rare: may affect up to 1 in 1,000 users
Eye effects: perception of flashing lights, eyelid eczema, eye swelling, seeing halos around lights, decreased eye sensitivity, inflammation of the eyelid glands, pigmentation inside the eye, increased pupil size, changes in eyelash structure.
General side effects: viral eye infection, unpleasant taste, irregular or slow heart rate, increased or decreased blood pressure, cough, voice changes, gastrointestinal disorders or ulcer, constipation, dry mouth, skin redness or itching, skin rash, hair colour change, eyelash loss, musculoskeletal pain, generalised weakness.

Not known: frequency cannot be estimated from the available data
Eye effects: inflammation of the back of the eye, eyes appearing sunken.
General side effects: depression, anxiety, false sensation of movement, ringing in the ears, chest pain, worsening of asthma, diarrhoea, abdominal pain, nausea, itching, abnormal hair growth, joint pain, painful or involuntary urination, increase in prostate cancer marker.

In children and adolescents, the most commonly observed side effects with MENEZON were ocular redness and eyelash growth. Both of these side effects occurred more frequently in children and adolescents compared to adults.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/web/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store MENEZON

Keep this medicine out of the sight and reach of children.
Do not use MENEZON after the expiry date stated on the packaging after “Exp.”
The expiry date refers to the last day of that month.
Store below 25°C. After first opening the aluminium sachet,
use within 7 days; after this period, any remaining containers must be discarded.
The single-dose container must be used immediately after opening; any remaining medicine must be discarded.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What MENEZON contains
The active substance is travoprost 40 micrograms/mL.
The other components are: mannitol, trometamol, polyoxyl 40 hydrogenated castor oil (Cremophor RH40), boric acid, disodium edetate, water for injections.

Description of the appearance of MENEZON and contents of the pack
MENEZON is a liquid (a clear, colourless solution) supplied in single-dose containers made of polyethylene.
One pack contains 30 single-dose containers of 0.1 mL each.

Marketing Authorization Holder
Visufarma S.p.A.
Via Alberto Cadlolo, 21
00136 Rome, Italy

Manufacturer and batch release
Genetic S.p.A., Contrada Canfora, 84084 Fisciano (SA), Italy

This leaflet was last approved on