Latay

Package leaflet: Information for the user

Latay 0.05 mg/ml eye drops, solution

Latanoprost
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 the doctor treating your child or your pharmacist.
• This medicine has been prescribed for you or your child only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If any side effect occurs, including those not listed in this leaflet, contact your doctor or the doctor treating your child or your pharmacist. See section 4.

Contents of this leaflet:

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

1. What Latay is and what it is used for

Latay contains the active substance latanoprost and belongs to a class of medicines known as "anti-glaucoma agents".
Glaucoma is a condition characterized by increased pressure inside the eye, which may cause irreversible damage to the optic nerve, leading to progressive vision loss, up to partial vision loss and blindness.
Latanoprost is a prostaglandin F2-alpha analogue. It penetrates through the cornea, where it is converted into a biologically active form that enhances the outflow of excess aqueous humour – a saline fluid present within the eye – thereby reducing intraocular pressure.
Latay is indicated for the reduction of elevated intraocular pressure in the following conditions:

• "open-angle glaucoma", the most common type of glaucoma, which occurs when the eye's drainage channels for aqueous humour become gradually blocked over time;
• elevated intraocular pressure above the level considered normal (ocular hypertension).

Latay is indicated for use in adult women and men (including the elderly).
Latay is also used in the treatment of elevated intraocular pressure and glaucoma in children of all ages and in newborns.

2. What you need to know before using Latay

Do not use Latay if:

• you or your child are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• you are pregnant, planning to become pregnant, or breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions

Talk to your doctor or pharmacist before using Latay if:
you or your child have recently undergone or are scheduled to undergo eye surgery (including cataract surgery);
you or your child have risk factors for ocular inflammatory conditions affecting the iris (iritis) or the uvea, the intermediate layer of the eyeball located between the retina and the sclera (uveitis);
you or your child suffer from types of glaucoma other than open-angle glaucoma (e.g., chronic angle-closure glaucoma, pigmentary glaucoma, inflammatory glaucoma, neovascular glaucoma, congenital glaucoma);
you or your child have undergone cataract surgery with implantation of an artificial lens, have an aphakic eye (absence of the lens), or have risk factors (such as diabetic retinopathy and retinal vein occlusion) for a condition affecting the center of the retina characterized by fluid accumulation in small cysts (cystoid macular edema);
you or your child suffer from severe asthma or asthma that is not well controlled;
you or your child have eye problems (such as eye pain, inflammation, irritation, blurred vision);
you or your child suffer from dry eye;
you or your child wear contact lenses (see section “How to use Latay”);
you or your child have had or currently have a viral eye infection caused by the herpes simplex virus (HSV).

It is possible that during treatment with Latay the following may occur:

• gradual change in eye colour due to increased brown pigment in the coloured part of the eye called the iris. This change in eye colour has been observed mainly in individuals with mixed-colour irises, e.g., blue-brown, grey-brown, yellow-brown, and green-brown. In clinical studies with latanoprost, the colour change was usually observed within the first 8 months of treatment, rarely during the second or third year, and not observed after the fourth year of treatment. The change in eye colour may be permanent.
• gradual changes in the eyelashes and fine hair around the treated eye and surrounding area. Changes in eyelashes may be reversible upon discontinuation of treatment. See section “Possible side effects”.

Children and adolescents
Latay can be used in children from birth up to 18 years of age. The use of Latay in preterm newborns (with a gestational age of less than 36 weeks) has not been studied.

Other medicines and Latay
Tell your doctor, your child’s doctor, or pharmacist if you or your child are taking, have recently taken, or might take any other medicines.
Exercise particular caution with Latay if you are using:

• prostaglandins, prostaglandin analogues, or prostaglandin derivatives, as concomitant use of two or more of these medicines may lead to increased intraocular pressure;
• eye drops containing thiomersal as a preservative: in such cases, eye drops should be administered at least 5 minutes apart.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
Do not use Latay if you are pregnant.
Breastfeeding
Do not use Latay while breastfeeding, as latanoprost and its metabolites may be excreted in breast milk.

Driving and using machines
Latay may affect the ability to drive or operate machinery.
As with other ophthalmic preparations, temporary blurred vision may occur after applying Latay.
Therefore, exercise appropriate caution and resume driving or operating machinery only when your vision has cleared.

3. How to use Latay

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

Use in adults and elderly

The recommended dose is 1 drop of Latay, once daily, in the eye to be treated.
Apply Latay preferably in the evening, as optimal effect has been observed when administration occurs in the evening hours.
Do not use Latay more than once a day, as more frequent administration has been shown to reduce its effect in lowering intraocular pressure.
Apply one drop of Latay into the eye by gently pulling down the lower eyelid.
Press with a finger on the inner corner of the affected eye. Keep your eyes closed for one minute. Repeat the procedure in the other eye, if your doctor has instructed you to do so, immediately after instilling each single drop.

If you wear contact lenses

If you or your child wears contact lenses, remove them before using Latay and reinsert them 15 minutes after administration.
If you are using more than one topical eye medicine, administer Latay at least 5 minutes after the other medicine.
Use the single-dose container immediately after opening and discard any unused medicine.

Use in children and adolescents

Same dosage as in adults.

If you use more Latay than you should

In case of accidental ingestion/overdose of Latay, contact your doctor, the doctor treating your child, or go immediately to the nearest hospital.
If you instill too many drops into the eye, you may experience transient effects such as mild irritation, tearing, and eye redness. If this occurs, contact your doctor or the doctor treating your child, who will prescribe appropriate treatment for the symptoms.

If you forget to use Latay

If you have forgotten to apply the drops, continue treatment as usual with the next dose.
Do not apply a double dose to make up for the missed dose.

If you stop using Latay

If you have any doubts about using this medicine, consult your doctor, the doctor treating your child, or the pharmacist.

4. Possible side effects

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

The following side effects have been observed with the use of Latay:

Very common (may affect more than 1 in 10 people):
gradual change in eye colour due to increased amount of brown pigment in the coloured part of the eye called the iris. This change is more likely if your eyes are of mixed colour (blue-brown, grey-brown, yellow-brown or green-brown) rather than uniform colour (blue, grey, green or brown). Any change in eye colour may occur after years, although it generally appears within the first 8 months of treatment. The change in colour may be permanent and may be more noticeable if you use Latay in only one eye. There appear to be no problems associated with the change in eye colour. After stopping treatment with Latay, no further change in eye colour has been observed;
redness of the eyes (mild to moderate conjunctival hyperaemia), eye irritation (burning, sensation of sand, itching, stinging pain and sensation of foreign body in the eyes). If you experience irritation severe enough to cause excessive tearing in your eyes, or if it leads to discontinuation of the medicine, consult your doctor, pharmacist or nurse immediately (within one week). Your therapy may need to be reviewed to ensure adequate treatment of your condition;
gradual change in the eyelashes and fine hair around the treated eye and surrounding area (lengthening, thickening, darkening and increased density, growth of eyelashes with abnormal direction).

Common (may affect up to 1 in 10 people):
irritation or abrasion of the eye surface (transient punctate epithelial erosion), inflammation of the eyelid margin (blepharitis), eye pain, light sensitivity (photophobia), conjunctivitis.

Uncommon (may affect up to 1 in 100 people):
swelling of the eyelids (eyelid oedema), dry eyes, inflammation or irritation of the eye surface (keratitis), blurred vision, inflammation of the coloured part of the eye (uveitis), swelling of the retina (macular oedema);
skin rash;
nausea, vomiting;
chest pain (angina), awareness of heartbeat (palpitations);
asthma, shortness of breath (dyspnoea);
chest pain;
headache, dizziness;
muscle pain, joint pain.

Rare (may affect up to 1 in 1,000 people):
ocular inflammations affecting the coloured part of the eye called the iris (iritis) or the uvea (uveitis) in patients with concomitant predisposing factors, symptoms related to swelling or abrasion/damage of the ocular surface, swelling around the eyes (periorbital oedema), altered eyelash orientation leading to eye irritation, abnormal eyelash growth (distichiasis), scarring of the eye surface, fluid-filled area in the coloured part of the eye (iris cysts);
skin reactions on the eyelids, darkening of the eyelid skin;
worsening of asthma and shortness of breath (dyspnoea);
intense skin itching;
development of a viral eye infection caused by the herpes simplex virus (HSV).

Very rare (may affect up to 1 in 10,000 people):
worsening of angina pectoris (in patients already affected by heart disease);
sunken appearance of the eye (enophthalmos).

Side effects observed more frequently in children than in adults were: runny and itchy nose, fever.

In very rare cases, some patients with severe damage to the transparent layer at the front of the eye (the cornea) developed cloudy-shaped 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, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Latay

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the word "Exp.". The expiry date refers to the last day of that month.
The expiry date applies to the product in its original, undamaged packaging, when stored correctly.
Store in a refrigerator (2-8°C), in the original packaging to protect the medicine from light.
After first opening the aluminium pouch, store at a temperature below 25°C for a maximum of 7 days; after this period, any remaining containers must be discarded.
The single-dose container must be used immediately after opening; any leftover medicine must be discarded.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Latay contains
The active substance is latanoprost.
100 ml of solution contain 0.005 g of latanoprost.
One drop contains approximately 1.5 mcg of latanoprost.
The other components are: sodium chloride, monosodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate anhydrous, water for injections.

Description of the appearance of Latay and contents of the pack
Latay is a clear, colourless liquid solution for eye drops, supplied in single-dose containers made of polyethylene.
A carton contains 30 single-dose containers of 0.2 ml each.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
NEOPHARMED Gentili S.p.A.
Via San Giuseppe Cottolengo, 15
20143 Milano
Manufacturer
Genetic S.p.A.
Contrada Canfora
Fisciano (SA)

Package leaflet: Information for the user

Latay 0.05 mg/ml eye drops, solution

Latanoprost
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, the doctor treating your child, or your pharmacist.
• This medicine has been prescribed for you or your child only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you or your child experience any side effect, including those not listed in this leaflet, talk to your doctor, the doctor treating your child, or your pharmacist. See section 4.

Contents of this leaflet:

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

1. What Latay is and what it is used for

Latay contains the active substance latanoprost and belongs to a class of medicines known as "anti-glaucoma agents".
Glaucoma is a condition characterized by increased pressure inside the eye, which may cause irreversible damage to the optic nerve, leading to progressive vision loss, up to partial vision loss and blindness.
Latanoprost is a prostaglandin F2-alpha analogue. It penetrates through the cornea, where it is converted into a biologically active form that enhances the outflow of excess aqueous humour—a saline fluid present within the eye—thereby reducing intraocular pressure.
Latay is indicated for the reduction of elevated intraocular pressure in the following conditions:

• “open-angle glaucoma”, the most common type of glaucoma, which occurs when the eye's drainage channels for aqueous humour gradually become blocked over time;
• elevated intraocular pressure above the normal range (ocular hypertension).

Latay is indicated in adult women and men (including the elderly).
Latay is also used in the treatment of elevated intraocular pressure and glaucoma in children of all ages and in newborns.

2. What you need to know before using Latay

Do not use Latay if:

• you or your child are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• you are pregnant, planning to become pregnant, or breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions

Talk to your doctor or pharmacist before using Latay if:
you or your child have recently undergone or are scheduled to undergo eye surgery (including cataract surgery);
you or your child have risk factors for ocular inflammatory conditions affecting the iris (iritis) or the uvea, the intermediate layer of the eyeball located between the retina and the sclera (uveitis);
you or your child suffer from other forms of glaucoma different from open-angle glaucoma (e.g. chronic closed-angle glaucoma, pigmentary glaucoma, inflammatory glaucoma, neovascular glau游戏副本, congenital glaucoma);
you or your child have undergone cataract surgery with implantation of an artificial lens, have an aphakic eye (absence of the lens), or have risk factors (such as diabetic retinopathy and retinal vein occlusion) for a condition affecting the center of the retina characterized by fluid accumulation in small cysts (cystoid macular edema);
you or your child suffer from severe asthma or asthma that is not well controlled;
you or your child have eye problems (such as eye pain, inflammation, irritation, blurred vision);
you or your child suffer from dry eye;
you or your child wear contact lenses (see section “How to use Latay”);
you or your child have had or currently have a viral eye infection caused by the herpes simplex virus (HSV).

During treatment with Latay, the following may occur:

• gradual change in eye colour due to increased brown pigment in the coloured part of the eye called the iris. This change in eye colour has been observed mainly in individuals with mixed-colour irises, such as blue-brown, grey-brown, yellow-brown, or green-brown. In clinical studies with latanoprost, the colour change was usually observed within the first 8 months of treatment, rarely during the second or third year, and not observed after the fourth year of treatment. The change in eye colour may be permanent.
• gradual changes in the eyelashes and fine hair around the treated eye and surrounding area. Changes in eyelashes are reversible upon discontinuation of treatment. See section “Possible side effects”.

Children and adolescents
Latay can be used in children from birth to 18 years of age. The use of Latay in premature infants (with a gestational age below 36 weeks) has not been studied.

Other medicines and Latay
Tell your doctor, your child’s doctor, or pharmacist if you or your child are taking, have recently taken, or might take any other medicines.
Exercise particular caution with Latay if you are using:

• prostaglandins, prostaglandin analogues, or prostaglandin derivatives, as concomitant use of two or more of these medicines may lead to increased intraocular pressure;
• eye drops containing thiomersal as a preservative: in such cases, eye drops should be administered at least 5 minutes apart.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
Do not use Latay if you are pregnant.
Breastfeeding
Do not use Latay while breastfeeding, as latanoprost and its metabolites may be excreted in breast milk.

Driving and using machines
Latay may affect the ability to drive or operate machinery.
As with other ophthalmic preparations, temporary blurred vision may occur after applying Latay.
Therefore, exercise appropriate caution and resume driving or operating machinery only when your vision is clear again.

Latay contains benzalkonium chloride
This medicine contains 0.2 mg of benzalkonium chloride per ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may alter their colour. Remove 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 (the transparent outermost layer of the eye). If you experience an unusual sensation, burning, or pain in the eye after using this medicine, consult your doctor.

3. How to use Latay

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

Use in adults and elderly patients
The recommended dose is 1 drop of Latay once daily in the affected eye.
Apply Latay preferably in the evening, as optimal effect has been observed with evening administration.
Do not use Latay more than once a day, as more frequent administration has been shown to reduce its effect in lowering intraocular pressure.
Apply one drop of Latay into the eye by gently pulling down the lower eyelid.
Press with a finger on the inner corner of the treated eye. Keep your eyes closed for one minute.
Repeat the procedure in the other eye if your doctor has instructed you to do so, immediately after instilling each single drop.

If you wear contact lenses
If you or your child wears contact lenses, remove them before using Latay and reinsert them 15 minutes after application.
If you are using more than one topical eye medicine, administer Latay at least 5 minutes after the other medicine.

Use in children and adolescents
Same dosage as in adults.

If you use more Latay than you should
In case of accidental ingestion/overdose of Latay, immediately contact your doctor, the doctor treating your child, or go to the nearest hospital.
If you instill too many drops into the eye, you may experience transient effects such as mild irritation, tearing, and eye redness. If this occurs, contact your doctor or the doctor treating your child, who will prescribe treatment for the symptoms.

If you forget to use Latay
If you forget to apply the drops, continue treatment as usual with the next dose.
Do not apply a double dose to make up for the missed dose.

If you stop using Latay
If you have any questions about the use of this medicine, consult your doctor, the doctor treating your child, or the pharmacist.

4. Possible side effects

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

The following side effects have been observed with the use of Latay:

Very common (may affect more than 1 in 10 people):
gradual change in eye colour due to increased amount of brown pigment in the coloured part of the eye called the iris. This change is more likely if your eyes are of mixed colour (blue-brown, grey-brown, yellow-brown or green-brown) rather than uniformly coloured (blue, grey, green or brown). Any change in eye colour may occur after several years, although it generally appears within the first 8 months of treatment. The change in colour may be permanent and may be more noticeable if you use Latay in only one eye. There appear to be no associated problems with the change in eye colour. After discontinuation of Latay treatment, no further change in eye colour has been observed;
redness of the eyes (mild to moderate conjunctival hyperaemia), eye irritation (burning, sensation of sand in the eyes, itching, stinging pain, and sensation of a foreign body in the eyes). If you experience irritation severe enough to cause excessive tearing or that leads to discontinuation of the medicine, consult your doctor, pharmacist, or nurse immediately (within one week). Therapy may need to be adjusted to ensure adequate treatment of your condition;
gradual change in the eyelashes and surrounding fine hair of the treated eye and surrounding area (lengthening, thickening, darkening, and increased density, and growth of eyelashes with abnormal orientation).

Common (may affect up to 1 in 10 people):
irritation or abrasion of the eye surface (transient punctate epithelial erosion), inflammation of the eyelid margin (blepharitis), eye pain, sensitivity to light (photophobia), conjunctivitis.

Uncommon (may affect up to 1 in 100 people):
swelling of the eyelids (eyelid oedema), dry eyes, inflammation or irritation of the eye surface (keratitis), blurred vision, inflammation of the coloured part of the eye (uveitis), swelling of the retina (macular oedema);
skin rash;
nausea, vomiting;
chest pain (angina), awareness of heartbeat (palpitations);
asthma, shortness of breath (dyspnoea);
chest pain;
headache, dizziness;
muscle pain, joint pain.

Rare (may affect up to 1 in 1,000 people):
ocular inflammations affecting the coloured part of the eye called the iris (iritis) or the uvea (uveitis) in patients with concomitant predisposing factors, symptoms related to swelling or abrasion/damage of the ocular surface, swelling around the eyes (periorbital oedema), altered eyelash orientation leading to eye irritation, abnormal growth of eyelashes (distichiasis), scarring of the eye surface, fluid-filled area in the coloured part of the eye (iris cysts);
skin reactions on the eyelids, darkening of the eyelid skin;
worsening of asthma and shortness of breath (dyspnoea);
intense skin itching;
development of a viral eye infection caused by the herpes simplex virus (HSV).

Very rare (may affect up to 1 in 10,000 people):
worsening of angina pectoris (in patients already affected by heart disease);
sunken appearance of the eye (hollowing of the eye socket).

Side effects observed more frequently in children than in adults were: runny and itchy nose, fever.

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

Reporting of side effects
If you experience any side effect, 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/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Latay

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the word "Exp.".
The expiry date refers to the last day of that month.
The expiry date applies to the product in its original, unopened packaging, when correctly stored.
Store in a refrigerator (2-8°C), in the original packaging to protect the medicine from light.
After first opening the vial, store at a temperature below 25°C for a maximum period of 28 days; after this period, any remaining medicine must be discarded.
Record the date of first opening in the dedicated space provided on the carton.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Latay contains
The active substance is latanoprost.
100 ml of solution contain 0.005 g of latanoprost.
One drop contains approximately 1.5 mcg of latanoprost.
The other components are: benzalkonium chloride 0.2 mg/ml, sodium chloride, sodium dihydrogen
phosphate monohydrate, disodium hydrogen phosphate anhydrous, water for injections.

Description of the appearance of Latay and package contents
Latay is a clear, colourless, liquid eye drop solution supplied in a multidose bottle made of polyethylene.
One package contains one 2.5 ml multidose bottle.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
NEOPHARMED GENTILI S.p.A.
Via San Giuseppe Cottolengo, 15
20143 Milan
Manufacturer
Genetic S.p.A.
Contrada Canfora
Fisciano (SA)