OCUSYNT 50 MICROGRAMMI/ML Eye drops, solution

Зміст інструкції

1. OCUSYNT 50 micrograms/ml eye drops, solution
   1. What is OCUSYNT and what is it used for
   2. What you need to know before using OCUSYNT
   3. How to use OCUSYNT
   4. Possible side effects
   5. How to store OCUSYNT
   6. Contents of the pack and other information
2. OCUSYNT 50 micrograms/ml eye drops, solution
   1. What is OCUSYNT and what is it used for
   2. What you need to know before using OCUSYNT
   3. How to use OCUSYNT
   4. Possible side effects
   5. How to store OCUSYNT
   6. Contents of the pack and other information

OCUSYNT 50 micrograms/ml eye drops, solution

Latanoprost

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

1. What is OCUSYNT and what is it used for

OCUSYNT contains the active substance Latanoprost which belongs to the category of medicines known as
prostaglandin analogues. Latanoprost works by increasing the natural outflow of fluid
from inside the eye to the blood (blood flow).
OCUSYNT is used to decrease the pressure inside the eye if you have a disease known as
open-angle glaucoma (damage to the optic nerve caused by a high increase in pressure inside
the eye) or if you suffer from increased internal eye pressure (ocular hypertension).

2. What you need to know before using OCUSYNT

Do not use OCUSYNT

• if you are allergic to the active ingredient or any of the other ingredients of this medicine (listed in section 6).
• if you are a pregnant woman, planning a pregnancy or breastfeeding (see “Pregnancy and breastfeeding”).

Warnings and precautions
Consult your doctor or pharmacist before using OCUSYNT.
OCUSYNT can be used in adult women and men (including the elderly). The use of
OCUSYNT is not recommended for patients under 18 years of age.
Use OCUSYNT with caution:

• if you have undergone or are going to undergo eye surgery (including cataract surgery, a condition due to the progressive loss of transparency of the lens located inside the eye, the crystalline lens);
• if you have eye pain, irritation or inflammation, blurred vision;
• if you suffer from dry eyes;
• if you suffer from severe or poorly controlled asthma;
• if you are a contact lens wearer. In this case, you can continue to use OCUSYNT following the instructions in the “How to use OCUSYNT” section;
• if you have suffered or are currently suffering from an eye viral infection caused by the herpes simplex virus (HSV);
• if you have risk factors for eye inflammation such as iritis and uveitis, or for a condition called cystoid macular edema.

OCUSYNTcan cause a gradual change in eye color, which may be permanent, due to
increased amounts of brown pigment in the colored part of the eye called the iris (See
“Possible side effects”).
A gradual change in the eyelashes of the eye treated with OCUSYNT and a change in the
hair around the treated eye have been observed (see “Possible side effects”).

Children and adolescents
OCUSYNT is not recommended for children and adolescents under 18 years of age.

Other medicines and OCUSYNT
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, including medicines (or eye drops) available without a prescription.
The use of OCUSYNT together with other eye drops containing active ingredients similar to
latanoprost (prostaglandins, prostaglandin analogues or prostaglandin derivatives) is not recommended.
If you use OCUSYNT together with eye drops containing the active ingredient thiomersal, the two eye drops must be
administered with an interval of at least 5 minutes between them.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Do not use OCUSYNT during pregnancy.

Breastfeeding
Do not use OCUSYNT during breastfeeding.

Driving and using machines
When using OCUSYNT, you may experience temporary (transient) blurred vision. If this
happens, do not drive or use equipment or machinery until your vision is clear again.

OCUSYNT contains benzalkonium chloride
Benzalkonium chloride can cause eye irritation. Avoid contact of the medicine with soft
contact lenses. Remove contact lenses before application and wait at least 15 minutes before
reapplying them.
The decolorizing action on soft contact lenses is known.

3. How to use OCUSYNT

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts
consult your doctor or pharmacist.
Recommended dose in adults (including elderly patients)
The recommended dose is one drop of OCUSYNT once a day in the eye(s) to be treated.
The optimal effect is achieved by administering OCUSYNT in the evening.
Do not instill OCUSYNTmore than once a day, as it has been shown that more
frequent administrations decrease the effect of lowering eye pressure (hypotensive effect on intraocular
pressure).
As with other eye drops, instill one drop into the eye and press with a finger on the inner corner of the
affected eye. Wait one minute keeping your eyes closed, continuing to press with your finger. This must
be done immediately after instillation of each single drop.

Contact lens wearers
If you wear contact lenses, you must remove them before instilling the eye drops and you can reapply them after
15 minutes.
If you are using more than one medicine for the eyes for local use, administer them with an interval of at least
five minutes from each other.

If you use more OCUSYNT than you should
In case of ingestion/accidental intake of an excessive dose of OCUSYNT, immediately inform
your doctor or go to the nearest hospital.
If you put too many drops in your eyes, you may experience mild irritation, tearing and redness of the
eyes. These effects are transient, but contact your doctor for advice anyway.

If you forget to use OCUSYNT
Do not use a double dose to make up for a missed dose.
If you forgot to use OCUSYNT, continue to take the usual dose at the usual time.

If you stop using OCUSYNT
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest.

Very common side effects(may affect more than 1 in 10 people):

• gradual alteration of the eye color due to an increase in the amount of brown pigment in the colored part of the eye called the iris. This change will be more likely if your eyes are of mixed color (blue - brown, gray-brown, yellow-brown or green-brown) rather than a uniform color (blue, gray, green or brown). Any change in eye color may occur even after years, although it generally appears within the first 8 months of treatment. The color change may be permanent and may be more noticeable if you use OCUSYNT in only one eye. No problems have been found associated with the change in eye color. After stopping treatment with OCUSYNT, no further change in eye color has been observed;
• red eyes;
• eye irritation (burning sensation, feeling of grit, itching, stinging sensation or foreign body sensation in the eyes);
• gradual alteration of the eyelashes of the treated eye and alteration of the vellus hair around the treated eye, observed mostly in people of Japanese origin. These changes include an increase in eyelash lengthening, thickening, darkening and densification, and the growth of eyelashes with abnormal orientation. Eyelash changes are reversible with discontinuation of treatment.

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

• irritation or abrasion of the eye surface;
• inflammation of the eyelid margin (blepharitis);
• eye pain;
• sensitivity to light (photophobia).

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

• swelling of the eyelids;
• dry eye;
• inflammation or irritation of the eye surface (keratitis);
• blurred vision;
• conjunctivitis;
• skin rash;
• nausea;
• vomiting.

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

• inflammation of the eye (iritis/uveitis);
• retinal swelling (macular edema);
• symptoms related to swelling or abrasion/damage to the eye surface, swelling of the area around the eyes (periorbital edema), altered eyelash orientation or abnormal eyelash growth;
• skin reactions on the eyelids;
• darkening of the skin of the eyelids;
• asthma, worsening of asthma and shortness of breath (dyspnea).

Very rare side effects(may affect up to 1 in 10,000 people):

• worsening of angina (chest pain due to lack of oxygen to the heart) if you suffer from heart disease;
• chest pain;
• sunken appearance of the eye (hollowing of the eye socket).

The following have also been reported:

• fluid-filled area in the colored part of the eye (iris cyst);
• headache and dizziness;
• increased perception of heartbeats (palpitations);
• myalgia (muscle pain) and arthralgia (joint pain);
• development of a viral eye infection caused by the herpes simplex virus (HSV).

In very rare cases, some patients with severe damage to the transparent layer in the front of the eye (the
cornea) have developed cloud-like spots on the cornea due to calcium accumulation during
treatment.

Reporting of side effects
If you get any side effects, talk to your
doctor or pharmacist. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-
reazione-avversa. By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store OCUSYNT

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 pack after Scad..
The expiry date refers to the last day of that month.
Store in a refrigerator (2-8°C), in the original package to protect the medicine from light.
After the first opening of the vial, store it at a temperature not exceeding 25°C and the medicine must
be used within 28 days; after this period, any remaining medicine must be discarded.
Record the date of first opening in the designated space on the pack.
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 OCUSYNT contains

• The active ingredient is latanoprost. 1 ml of solution contains 50 micrograms of latanoprost.
• The other ingredients are: Benzalkonium chloride, Sodium chloride, Sodium dihydrogen phosphate monohydrate, Disodium hydrogen phosphate anhydrous, Water for injections.

Description of the appearance of OCUSYNT and contents of the pack
Pack containing 1 bottle of 2.5 ml - Eye drops, solution.

Marketing Authorisation Holder
Genetic S.p.A., Via Della Monica n. 26, 84083 Castel San Giorgio (SA)

Manufacturer
Genetic S.p.A. – Contrada Canfora – 84084 Fisciano (SA)

This leaflet was last updated on

OCUSYNT 50 micrograms/ml eye drops, solution

Latanoprost

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

1. What is OCUSYNT and what is it used for

OCUSYNT contains the active ingredient Latanoprost which belongs to the category of medicines known as
prostaglandin analogues. Latanoprost works by increasing the natural outflow of fluid
from inside the eye to the blood (blood flow).
OCUSYNT is used to decrease the pressure inside the eye if you have a disease known as
open-angle glaucoma (damage to the optic nerve caused by a high increase in pressure inside
the eye) or if you suffer from increased internal eye pressure (ocular hypertension).

2. What you need to know before using OCUSYNT

Do not use OCUSYNT

• if you are allergic to the active ingredient or any of the other ingredients of this medicine (listed in section 6).
• if you are a pregnant woman, planning a pregnancy or breastfeeding (see “Pregnancy and breastfeeding”).

Warnings and precautions
Consult your doctor or pharmacist before using OCUSYNT.
OCUSYNT can be used in adult women and men (including the elderly). The use of
OCUSYNT is not recommended for patients under 18 years of age.
Use OCUSYNT with caution:

• if you have undergone or are going to undergo eye surgery (including cataract surgery, a condition due to the progressive loss of transparency of the lens located inside the eye, the crystalline lens);
• if you have eye pain, irritation or inflammation, blurred vision;
• if you suffer from dry eye;
• if you suffer from severe or poorly controlled asthma;
• if you are a contact lens wearer. In this case, you can continue to use OCUSYNT following the instructions in the “How to use OCUSYNT” section.
• if you have suffered or are currently suffering from a viral eye infection caused by the herpes simplex virus (HSV).
• if you have risk factors for eye inflammation such as iritis and uveitis, or for a condition called cystoid macular edema.

OCUSYNTmay cause a gradual change in eye color, which may be permanent, due to
increased amounts of brown pigment in the colored part of the eye called the iris (See
“Possible side effects”).
A gradual change in the eyelashes of the eye treated with OCUSYNT and a change in the
hair around the treated eye have been observed (see “Possible side effects”).

Children and adolescents
OCUSYNT is not recommended for children and adolescents under 18 years of age.

Other medicines and OCUSYNT
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, including medicines (or eye drops) without a prescription.
The use of OCUSYNT together with other eye drops containing active ingredients similar to
latanoprost (prostaglandins, prostaglandin analogues or prostaglandin derivatives) is not recommended.
If you use OCUSYNT together with eye drops containing the active ingredient thiomersal, the two eye drops must be
administered with an interval of at least 5 minutes between them.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Do not use OCUSYNT during pregnancy.

Breastfeeding
Do not use OCUSYNT during breastfeeding.

Driving and using machines
When using OCUSYNT, you may experience temporary (transient) blurred vision. If this
happens, do not drive or use equipment or machinery until your vision is clear again.

3. How to use OCUSYNT

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts
consult your doctor or pharmacist.
Recommended dose in adults (including elderly patients)
The recommended dose is one drop of OCUSYNT once a day in the eye(s) to be treated.
The single-dose container must be used immediately after opening; the remaining medicine
must be discarded.
The optimal effect is achieved by administering OCUSYNT in the evening.
Do not instill OCUSYNTmore than once a day, as it has been shown that more frequent administrations decrease the effect of lowering eye pressure (hypotensive effect on intraocular pressure).
As with other eye drops, instill one drop into the eye and press with a finger on the inner corner of the affected eye. Wait one minute keeping your eyes closed, continuing to press with your finger. This must
be done immediately after instillation of each single drop.

Contact lens wearers
If you wear contact lenses, you must remove them before instilling the eye drops and you can reapply them after
15 minutes.
If you are using more than one medicine for the eyes for local use, administer them with an interval of at least
five minutes from each other.

If you use more OCUSYNT than you should
In case of ingestion/accidental intake of an excessive dose of OCUSYNT, immediately inform your
doctor or go to the nearest hospital.
If you put too many drops in your eyes, you may experience mild irritation, tearing and redness of the
eyes. These effects are transient, but still contact your doctor for advice.

If you forget to use OCUSYNT
Do not use a double dose to make up for the missed dose.
If you have forgotten to use OCUSYNT, continue to take the usual dose at the usual time.

If you stop using OCUSYNT
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Very common side effects(may affect more than 1 in 10 people):

• gradual alteration of the eye color due to an increase in the amount of brown pigment in the colored part of the eye called the iris. This change is more likely if your eyes are of mixed color (blue-brown, gray-brown, yellow-brown, or green-brown) rather than a uniform color (blue, gray, green, or brown). Any change in eye color may occur even after years, although it generally appears within the first 8 months of treatment. The color change may be permanent and may be more noticeable if you use OCUSYNT in only one eye. No problems have been found associated with the change in eye color. After stopping treatment with OCUSYNT, no further alteration of eye color has been observed;
• red eyes;
• eye irritation (burning sensation, feeling of grit, itching, stinging sensation or foreign body sensation in the eyes);
• gradual alteration of the eyelashes of the treated eye and alteration of the vellus hair around the treated eye, observed mostly in people of Japanese origin. These changes include an increase in the lengthening, thickening, darkening and thickening of the eyelashes or vellus hair and the growth of eyelashes with abnormal orientation. Changes in eyelashes are reversible with discontinuation of treatment.

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

• irritation or abrasion of the eye surface;
• inflammation of the eyelid margin (blepharitis);
• eye pain;
• sensitivity to light (photophobia).

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

• swelling of the eyelids;
• dry eye;
• inflammation or irritation of the eye surface (keratitis);
• blurred vision;
• conjunctivitis;
• skin rash;
• nausea;
• vomiting.

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

• inflammation of the eye (iritis/uveitis);
• retinal swelling (macular edema);
• symptoms related to swelling or abrasion/damage to the eye surface, swelling around the eyes (periorbital edema), altered orientation of the eyelashes or abnormal eyelash growth;
• skin reactions on the eyelids;
• darkening of the skin of the eyelids;
• asthma, worsening of asthma and shortness of breath (dyspnea).

Very rare side effects(may affect up to 1 in 10,000 people):

• worsening of angina (chest pain due to lack of oxygen to the heart) if you suffer from heart disease;
• chest pain;
• sunken appearance of the eye (hollowing of the eye socket).

The following have also been reported:

• fluid-filled area in the colored part of the eye (iris cyst);
• headache and dizziness;
• increased perception of heartbeats (palpitations);
• myalgia (muscle pain) and arthralgia (joint pain);
• development of a viral eye infection caused by the herpes simplex virus (HSV).

In very rare cases, some patients with severe damage to the transparent layer in the front of the eye (the
cornea) have developed cloud-like spots on the cornea due to calcium accumulation during
treatment.

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
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-
reazione-avversa. By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store OCUSYNT

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 pack after Exp..
The expiry date refers to the last day of that month.
Store in a refrigerator (2-8°C), in the original package to protect the medicine from light.
After the first opening of the aluminium pouch, store it at a temperature not exceeding 25°C and for a
maximum period of 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 OCUSYNT contains

• The active ingredient is: latanoprost. 1 ml of solution contains 50 micrograms of latanoprost.
• The other ingredients are: Sodium chloride, Sodium dihydrogen phosphate monohydrate, Disodium hydrogen phosphate anhydrous, Water for injections.

Description of the appearance of OCUSYNT and contents of the pack
Pack containing 30 single-dose containers of 0.2 ml - Eye drops, solution.

Marketing Authorisation Holder
Genetic S.p.A., Via Della Monica n. 26, 84083 Castel San Giorgio (SA)

Manufacturer
Genetic S.p.A. – Contrada Canfora – 84084 Fisciano (SA)

Exclusive distributor for sales
Bausch & Lomb IOM S.p.A., Viale Martesana, 12 – 20090 Vimodrone (MI)

This leaflet was last updated on