MENEZON 40 MCG/ML Eye drops, solution

Зміст інструкції

1. MENEZON 40 micrograms/mL eye drops, solution
   1. What is MENEZON and what is it 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
2. MENEZON 40 micrograms/mL eye drops, solution
   1. What is MENEZON 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

MENEZON 40 micrograms/mL eye drops, solution

Travoprost

Generic medicine
Read 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even 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 is MENEZON and what is it used for

MENEZON contains travoprost,a substance belonging to the group of drugs called prostaglandin analogues. It works by lowering intraocular pressure. It can be used alone or in addition to other eye drops such as beta-blockers, which are also able to reduce pressure.

MENEZON is used to reduce high 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 allergicto travoprost or any of the excipients of this medicine (listed in section 6). In this case, consult your doctor.

Warnings and precautions

• MENEZON may increasethe 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.
• MENEZONcan 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 had in the past, eye inflammation (iritis and uveitis), consult your doctor before using MENEZON.
• MENEZON can rarely cause difficulty breathingor shortness of breathor worsen the symptoms of asthma. Inform your doctor immediately if you notice that using MENEZON causes changes in your breathing.
• Travoprost can be absorbed through the skin. If anyof the medicine comes into contact with the skin,it should be washed offimmediately.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 the lenses. Wait 15 minutes after using the eye drops before putting the lenses back in.

Children and adolescents
MENEZON can be used in children from 2 months of age to under 18 years at the same dose as adults.
The use of MENEZON is not recommended for children under 2 months of age.

Other medicines and MENEZON
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.

Pregnancy, breastfeeding and fertility
Do not use MENEZON if you are pregnant
Tell your doctor immediately if you think you may be pregnant. If you could become pregnant, use effective contraception during treatment.

Do not use MENEZON if you are breastfeeding
MENEZON may be excreted in breast milk.
Ask your doctor for advice before taking any medicine.

Driving and operating machinery
You may experience blurred vision for a certain period after using MENEZON. Do not drive or use
machinery until these symptoms have disappeared.
MENEZON contains:

• hydrogenated castor oiland propylene glycolwhich can cause skin reactions and irritation.
• benzalkonium chloride0.15 mg per 1 ml equivalent to 0.375 mg per 2.5 ml which can be absorbed by soft contact lenses and may lead to a change in their colour. Remove contact lenses before using this medicine and wait 15 minutes before re-applying them. Benzalkonium chloride can also cause eye irritation, especially if you have dry eyes or corneal disorders (the transparent outermost layer of the eye). If you experience any abnormal eye sensation, burning or pain after using this medicine, talk to your doctor.

3. How to use MENEZON

Use this medicine following exactly the instructions of your doctor or pediatrician. If you have doubts
consult your doctor, pediatrician or pharmacist.

The recommended dose is
One drop in the eye(s), once a day - in the evening.
Use MENEZON in both eyes only as prescribed by your doctor. Use the medicine for the
period of time that your doctor or pediatrician recommends.
MENEZON can only be used as an eye drop.
Instructions for use:

• Immediately before using the bottle for the first time, open the outer protective packaging, remove the bottle (figure 1)and write the date of opening the bottle in the appropriate space on the box.
• Wash your hands.
• Unscrew the cap.
• After removing the cap, if the mobile protective ring is loose, remove it before using the medicine.
• Hold the bottle in your hand, between your thumb and other fingers, and hold it downwards.
• Tilt your head back or gently tilt the child's head back. Lower the lower eyelid with a clean finger, so as to form a “pocket” between the eyelid and the eye. The drop should be inserted there (figure 2).
• Hold the tip of the bottle close to the eye. A mirror may be helpful.
• Do not touch the eye or eyelid, the surrounding areas or other surfaces with the tip of the bottle.This could infect the eye drops.
• Gently press the bottle to release one drop of MENEZON at a time. (figure 3)
• After using MENEZON, keep your eyes closed, apply gentle pressure with a finger to the corner of the eye, near the nose (figure 4)for at least one minute. This helps to prevent MENEZON from spreading throughout the body.
• If you are using the eye drops in both eyes, repeat the steps for the other eye.
• Close the cap tightly immediately after use.
• Use only one bottle at a time. Do not open the outer protective packaging until you are ready to use the bottle. If a drop does not enter the eye, try again. If you or the child are using other ophthalmic preparations at the same timesuch as eye drops or ointments, allow at least 5 minutes between instilling MENEZON and instilling other preparations. If you or the child use more MENEZON than you shouldWash all the medicine away with lukewarm water. Do not use the eye drops until the time of the next dose. If you forget to use MENEZONContinue treatment with the next dose as scheduled. Do not take a double doseto make up for a missed dose. Do not use more than one drop per day per affected eye(s). If you stop treatment with MENEZONDo not stop treatment with MENEZON without first talking to your doctor or pediatrician, as intraocular pressure will not be controlled with possible loss of vision. If you have any further questions about the use of this medicine, ask your doctor, pediatrician or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
You can generally continue to use the drops unless the side effects are serious.
If you are concerned, contact your doctor or pharmacist. Do not stop treatment with MENEZON without
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
Effects on the eye: eye redness.

Common side effects: may affect up to 1 in 10 users
Effects on the eye: changes in the color of the iris (colored 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
Effects on the eye: corneal pathology, eye inflammation, iritis, inflammation
inside the eye, inflammation of the ocular surface with or without damage to the surface, sensitivity
to light, eye discharge, eyelid inflammation, redness of the eyelids, swelling around
the eye, itchy eyelids, reduced vision, blurred vision, increased tearing, infection or
inflammation of the conjunctiva (conjunctivitis), abnormal outward rotation of the lower eyelid,
blurred vision, crusting on the eyelid, eyelash growth, altered eyelash color, tired eyes.

General side effects: increased allergy symptoms, headache, dizziness, irregular heartbeat,
shortness of breath, asthma, nasal congestion, sore throat, 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
Effects on the eye: perception of flashing lights, eczema of the eyelids, eye swelling, vision with
halo, decreased eye sensitivity, inflammation of the eyelid glands, pigmentation
inside the eye, increased pupil size, change in eyelash structure.

General side effects:viral eye infection, unpleasant taste, irregular or
reduced heart rate, increased or decreased blood pressure, cough, voice changes, gastrointestinal
disorders or ulcer, constipation, dry mouth, skin redness or itching, rash,
change in hair color, eyelash loss, musculoskeletal pain, generalized weakness.

Not known: frequency cannot be estimated based on available data
Effects on the eye:inflammation of the back of the eye, eyes appear more sunken.

General side effects:depression, anxiety, false sensation of movement, ringing in the ears, chest pain,
worsening of asthma, diarrhea, abdominal pain, nausea, itching, abnormal hair growth,
joint pain, painful or involuntary urination, increased prostate cancer marker.
In children and adolescents, the most common side effects observed with MENEZON were
eye redness and eyelash growth. Both side effects were observed with a
higher incidence in children and adolescents compared to adults.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through 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 which is stated on the vial and the packaging 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 vial must be discarded four weeks after first openingand a
new vial should be started. Write the date of opening the vial in the space on the packaging.
Do not dispose of any medicine in 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 ingredient is travoprost 40 micrograms/mL
The other ingredients are: benzalkonium chloride, mannitol, trometamol, hydrogenated castor oil polyoxyl 40 (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, colorless solution) supplied in a pack containing a
2.5 ml polyethylene bottle.
Pack of 1 bottle.

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

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

This leaflet was last approved on

MENEZON 40 micrograms/mL eye drops, solution

Travoprost

Read this leaflet carefully before you start using this medicine as 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 others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even 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 is MENEZON and what it is used for

MENEZON contains travoprost,a substance belonging to the group of drugs called prostaglandin analogues. It works by lowering intraocular pressure. It can be used alone or in addition to other
eye drops such as beta-blockers, which are also able to reduce pressure.

MENEZON is used to reduce high 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 allergicto 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 increasethe length, thickness, colour and/or number of your eyelashes.Changes in the eyelids or the 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 had in the past, eye inflammation (iritis and uveitis), consult your doctor before using MENEZON.
• MENEZON can rarely cause difficulty breathingor shortness of breathor worsen the symptoms of asthma. Inform your doctor immediately if you notice that using MENEZON causes changes in your breathing.
• Travoprost can be absorbed through the skin. If any amountof medicine comes into contact with the skin,it should be washed offimmediately.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 the lenses. Wait 15 minutes after using the eye drops before putting the lenses back in.

Children and adolescents
MENEZON can be used in children from 2 months of age to under 18 years at the same dose as adults.
The use of MENEZON is not recommended for children under 2 months of age.

Other medicines and MENEZON
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.

Pregnancy, breastfeeding and fertility
Do not use MENEZON if you are pregnant
Tell your doctor immediately if you think you may be pregnant. If you could become pregnant, use effective contraception during treatment.

Do not use MENEZON if you are breastfeeding
MENEZON may be excreted in breast milk.
Ask your doctor for advice before taking any medicine.

Driving and operating machinery
You may experience blurred vision for a certain period after using MENEZON. Do not drive or use
machinery until these symptoms have disappeared.
MENEZON contains:

• Hydrogenated castor oiland propylene glycol, which can cause skin reactions and irritation.

3. How to use MENEZON

Use this medicine following exactly the instructions of your doctor or pediatrician. If you have any doubts
consult your doctor, pediatrician or pharmacist.

The recommended dose is
One drop in the eye(s), once a day - in the evening.
Use MENEZON in both eyes only on your doctor's prescription. Use the medicine for the
period of time that your doctor or pediatrician advises you.
MENEZON can only be used as an eye drop.

• Wash your hands.
• Remove a vial from the strip and unscrew the cap with a slight rotation.
• Hold the vial in your hand, between your thumb and other fingers, and hold it pointing downwards.
• Tilt your head back. Lower the lower eyelid with a clean finger, so as to form a “pocket” between the eyelid and the eye. The drop should be inserted there.
• Hold the tip of the vial close to the eye. It may be helpful to use a mirror.
• Do not touch the eye or eyelid, the surrounding areas or other surfaces with the tip of the vial.
• Apply slight pressure on the vial so as to release one drop of MENEZON at a time.
• After using MENEZON, keep your eyes closed, apply slight pressure with a finger to the corner of the eye, near the nose for at least one minute. This helps to prevent MENEZON from spreading throughout the body.
• If you use the eye drops in both eyes, repeat the steps for the other eye.
• Throw away 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 at the same timesuch as eye drops or ointments, allow
at least 5 minutes to pass between the instillation of MENEZON and the instillation of other preparations.

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

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

If you stop treatment with MENEZON
Do not stop treatment with MENEZON without first talking to your doctor or pediatrician, the
intraocular pressure will not be controlled with possible loss of vision.
If you have any further questions about the use of the medicine, ask your doctor, pediatrician or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You can generally continue to use the drops unless the side effects are serious.
If you are concerned, contact your doctor or pharmacist. Do not stop treatment with MENEZON without
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
Effects on the eye: eye redness.

Common side effects: may affect up to 1 in 10 users
Effects on the eye: changes in the color of the iris (colored 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
Effects on the eye: corneal pathology, eye inflammation, iriditis, inflammation
inside the eye, inflammation of the ocular surface with or without damage to the surface, sensitivity
to light, eye discharge, eyelid inflammation, redness of the eyelids, swelling around
the eye, itchy eyelids, reduced vision, blurred vision, increased tearing, infection or
inflammation of the conjunctiva (conjunctivitis), abnormal outward rotation of the lower eyelid,
eye clouding, crusting on the eyelid, eyelash growth, change in eyelash color, tired eyes.

General side effects: increased 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
Effects on the eye:perception of flashing lights, eczema of the eyelids, eye swelling, vision with
halo, decreased eye sensitivity, inflammation of the eyelid glands, pigmentation
inside the eye, increased pupil size, change in eyelash structure.

General side effects:viral eye infection, unpleasant taste, irregular or
slowed heart rate, increased or decreased blood pressure, cough, voice changes, gastrointestinal
disorders or ulcer, constipation, dry mouth, skin redness or itching, rash,
change in hair color, eyelash loss, musculoskeletal pain, generalized weakness.

Not known: frequency cannot be estimated from available data.
Effects on the eye:inflammation of the back of the eye, eyes appear more sunken.

General side effects:depression, anxiety, false sensation of movement, ringing in the ears, chest pain,
worsening of asthma, diarrhea, abdominal pain, nausea, itching, abnormal hair growth,
joint pain, painful or involuntary urination, increased prostate cancer marker.
In children and adolescents, the most common side effects observed with MENEZON have been
eye redness and eyelash growth. Both side effects have been observed with a
higher incidence in children and adolescents compared to adults.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through 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 which is stated on the pack after “Exp.”
The expiry date refers to the last day of that month.
Store at a temperature not exceeding 25°C. After the first opening of 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 any medicine in 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 ingredient is travoprost 40 micrograms/mL
The other ingredients are: mannitol, trometamol, hydrogenated castor oil polyoxyl 40 (Cremophor
RH40), boric acid, disodium edetate, water for injections.

Description of MENEZON and contents of the pack
MENEZON is a liquid (a clear, colorless solution) supplied in a single-dose polyethylene container.
One pack contains 30 single-dose containers of 0.1 ml.

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

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

This leaflet was last approved on