LATAY 0.005 % Krople do oczu, roztwór

Treść ulotki

1. Latay 0.05 mg/ml eye drops, solution
   1. What is Latay and what is it used for
2. Latay is also used in the treatment of elevated intraocular pressure and
   1. How to use Latay
   2. Possible side effects
   3. How to store Latay
   4. Contents of the pack and other information
3. Latay 0.05 mg/ml eye drops, solution
   1. What is Latay and what is it used for
4. Latay is also used in the treatment of elevated intraocular pressure and
   1. How to use Latay
   2. Possible side effects
   3. How to store Latay
   4. Contents of the pack and other information

Latay 0.05 mg/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 the doctor treating your child, or your pharmacist.
• This medicine has been prescribed for you or your child only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you use 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 is Latay and what is it used for

Latay contains the active substance latanoprost and belongs to a class of medicines
called “antiglaucoma”.
Glaucoma is a condition characterized by increased pressure inside the eye
which can cause irreversible damage to the optic nerve, with progressive decrease in
vision, up to loss of part of vision and blindness.
Latanoprost is an analog of prostaglandin F2-alpha. It penetrates through the cornea
where it is modified into a biologically active form, which promotes the elimination
of excess aqueous humor, a saline liquid present inside the eye, thereby decreasing its
internal pressure.
Latay is indicated for the reduction of elevated intraocular pressure, in the presence of:

• “open-angle glaucoma”, which is the most frequent type of glaucoma that manifests when the ocular outflow channels of the aqueous humor become obstructed over time;
• increased internal eye pressure above the considered normal limit (ocular hypertension).

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

Warnings and precautions
Talk to your doctor or pharmacist before using Latay if:
you or your child has recently had or is about to have eye surgery
(including cataract surgery);
you or your child has risk factors for eye conditions due to inflammatory processes affecting a part of the eye called the iris (iritis) or the uvea, the middle layer of the eyeball located between the retina and the sclera (uveitis);
you or your child suffers from other forms of glaucoma other than open-angle glaucoma (e.g., chronic closed-angle glaucoma, pigmentary glaucoma, inflammatory and neovascular glaucoma, congenital glaucoma);
you or your child has undergone cataract surgery with implantation of an artificial lens, if you have an eye without a lens or if you have risk factors (such as diabetic retinopathy and retinal vein occlusion) for a condition affecting the center of the retina characterized by the accumulation of fluid in small cysts (cystoid macular edema);
you or your child suffers from severe asthma or if asthma is not well controlled;
you or your child has eye problems (such as eye pain, inflammation, irritation, blurred vision);
you or your child suffers from dry eyes;
you or your child wears contact lenses (see section “How to use Latay”);
you or your child has suffered or is currently suffering from a viral eye infection caused by the herpes simplex virus (HSV).

It is possible that during treatment with Latay you may experience:

• a gradual change in the color of the eye due to an increase in the amount of brown pigment in the colored part of the eye called the iris. This change in eye color has been noticed especially in irises of mixed color, e.g. blue-brown, gray-brown, yellow-brown and green-brown. In studies conducted with latanoprost, the color change was usually observed within the first 8 months of treatment, rarely during the second or third year and was not found after the fourth year of treatment. It is possible that the change in eye color is permanent.
• a gradual change in the eyelashes of the eye and the fluff around the treated eye and surrounding area. Changes in eyelashes are reversible with discontinuation of treatment. See section “Possible side effects”.

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

Other medicines and Latay
Tell your doctor or the doctor caring for your child or your pharmacist if you or your child is taking, has recently taken or might take any other medicine.
Take particular care with Latay if you are taking:

• prostaglandins, prostaglandin analogs and prostaglandin derivatives, as the concomitant use of two or more of these medicines may cause an increase in intraocular pressure;
• eye drops containing thimerosal as a preservative: in such cases, the eye drops must be administered at an interval of at least 5 minutes from each other.

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

Pregnancy
Do not use Latay if you are pregnant.

Breastfeeding
Do not use Latay during breastfeeding, as latanoprost and its derivatives may be excreted in breast milk.

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

3. How to use Latay

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

Use in adults and the elderly
The recommended dose is 1 drop of Latay, once a day, in the eye to be treated.
Apply Latay preferably in the evening, as the optimal effect of Latay has been observed with
evening administration.
Do not use Latay more than once a day, as more frequent administrations have been shown to
decrease the effect of reducing intraocular pressure.
Apply one drop of Latay to the eye, gently lowering the lower eyelid.
Press with a finger on the inner corner of the affected eye. Wait a minute keeping your
eyes closed. Repeat the operation in the other eye, if your doctor has told you to do so, immediately
after the introduction of each single drop.

If you use contact lenses
If you or your child uses contact lenses, remove them before using Latay and reapply them after 15 minutes.
If you use more than one medicine for topical use for the eyes, administer Latay at least 5
minutes after the other medicine.
Use the single-dose container immediately after opening and discard the unused medicine.

Use in children and adolescents
Same dosage as adults.

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

If you forget to use Latay
If you have forgotten to apply the drops, continue the treatment normally with the next
dose.
Do not apply a double dose to compensate for the forgotten dose.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The following side effects have been observed with the use of Latay:

Very common (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 a 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 after years, although it
usually appears within the first 8 months of treatment. The color change may
be permanent and may be more noticeable if you use Latay in only one eye. It seems that
there are no problems associated with the change in eye color. After stopping
treatment with Latay, no further alteration of eye color has been found;
redness of the eyes (conjunctival hyperemia from mild to moderate), eye irritation (burning, gritty sensation, itching, stinging pain and foreign body sensation in the eyes). If you experience irritation severe enough to produce excessive
tearing in your eyes, or to induce discontinuation of the medicine, contact
immediately (within one week) your doctor, pharmacist or nurse. A
therapy update may be necessary to ensure adequate
treatment for your condition;
gradual alteration of the eyelashes of the eye and the vellus hair around the treated eye
and in the surrounding area (lengthening, thickening, coloring and densification, growth of
eyelashes with abnormal orientation).

Common (may affect up to 1 in 10 people):
irritation or erosion 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 (palpebral edema), dry eye, inflammation or
irritation of the eye surface (keratitis), blurred vision,
inflammation of the colored part of the eye (uveitis), retinal swelling (macular
edema);
skin rash;
nausea, vomiting;
chest pain (angina), awareness of heartbeat (palpitations);
asthma, shortness of breath (dyspnea);
chest pain;
headache, dizziness;
muscle pain, joint pain.

Rare(may affect up to 1 in 1,000 people):
eye inflammations affecting the colored part of the eye called the iris (iritis) or
the uvea (uveitis) in patients with concomitant predisposing factors, symptoms related to
swelling or erosion/damage to the ocular surface, swelling of the
area around the eyes (periorbital edema), altered orientation of the eyelashes and
consequent eye irritation, abnormal eyelash growth (distichiasis), scarring
of the eye surface, fluid-filled area in the colored part of the eye (iris
cyst);
skin reactions on the eyelids, darkening of the skin of the eyelids;
worsening of asthma and shortness of breath (dyspnea);
severe 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 suffering from heart disease);
sunken appearance of the eye (hollowing of the eye socket).
The side effects observed more frequently in children compared to adults were:
runny and itchy nose, fever.
In very rare cases, some patients with severe damage to the transparent layer in the front
part 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. This includes any 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/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 sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after the
words “Exp.”. The expiry date refers to the last day of that month.
The expiry date refers to the product in intact packaging, correctly
stored.
Store in a refrigerator (2-8°C), in the original packaging to protect the medicine
from light.
After the first opening of the aluminium pouch, store at a temperature below
25°C 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 residual 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 Latay contains
The active ingredient is latanoprost.
100 ml of solution contains 0.005 g of latanoprost.
One drop contains approximately 1.5 mcg of latanoprost.
The other ingredients are: sodium chloride, sodium dihydrogen phosphate monohydrate, disodium
hydrogen phosphate anhydrous, water for injections.

Description of the appearance of Latay and contents of the pack
Latay is presented as eye drops, in a clear, colorless liquid solution, inside
a single-dose container 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)

Latay 0.05 mg/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 the doctor treating your child or your pharmacist.
• This medicine has been prescribed only for you or your child. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including any not listed in this leaflet, tell 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 you use 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 is Latay and what is it used for

Latay contains the active ingredient latanoprost and belongs to a class of medicines
called “antiglaucoma”.
Glaucoma is a condition characterized by increased pressure inside the eye
which can cause irreversible damage to the optic nerve, with progressive decrease in
vision, up to loss of part of the vision and blindness.
Latanoprost is an analog of prostaglandin F2-alpha. It penetrates through the cornea
where it is modified into a biologically active form, which promotes the elimination
of excess aqueous humor, a saline fluid present inside the eye, thereby reducing its
internal pressure.
Latay is indicated for the reduction of elevated intraocular pressure, in the presence of:

• “open-angle glaucoma” which is the most common type of glaucoma that manifests when the ocular outflow channels of the aqueous humor become obstructed over time;
• increased internal eye pressure above the considered normal limit (ocular hypertension).

Latay is indicated in women and adult 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 you use Latay
Do not use Latay if:

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

Warnings and precautions
Talk to your doctor or pharmacist before using Latay if:
you or your child has recently had or is about to have eye surgery
(including cataract surgery);
you or your child has risk factors for eye diseases due to inflammatory processes affecting a part of the eye called the iris (iritis) or the uvea, the middle layer of the eyeball located between the retina and the sclera (uveitis);
you or your child suffers from other forms of glaucoma other than open-angle glaucoma (e.g. chronic closed-angle glaucoma, pigmentary glaucoma, inflammatory and neovascular glaucoma, congenital glaucoma);
you or your child has undergone cataract surgery with implantation of an artificial lens, if you have an eye without a lens or if you have risk factors (such as diabetic retinopathy and retinal vein occlusion) for a condition affecting the center of the retina characterized by the accumulation of fluid in small cysts (cystoid macular edema);
you or your child suffers from severe asthma or if asthma is not well controlled;
you or your child has eye problems (such as eye pain, inflammation, irritation, blurred vision);
you or your child suffers from dry eyes;
you or your child wears contact lenses (see section “How to use Latay”);
you or your child has suffered from or currently suffers from a viral eye infection caused by the herpes simplex virus (HSV).

It is possible that during treatment with Latay you may experience:

• a gradual change in the color of the eye due to an increase in the amount of brown pigment in the colored part of the eye called the iris. This change in eye color has been noticed especially in irises of mixed color, e.g. blue-brown, gray-brown, yellow-brown and green-brown. In studies conducted with latanoprost, the color change was usually observed within the first 8 months of treatment, rarely during the second or third year and was not found after the fourth year of treatment. It is possible that the change in eye color is permanent.
• a gradual change in the eyelashes of the eye and the fluff around the eye and in the surrounding area. Changes in eyelashes are reversible with discontinuation of treatment. See section “Possible side effects”.

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

Other medicines and Latay
Tell your doctor or the doctor caring for your child or your pharmacist if you or your child is taking, has recently taken or might take any other medicine.
Take special care with Latay if you are taking:

• prostaglandins, prostaglandin analogues and prostaglandin derivatives, as the simultaneous use of two or more of these medicines can cause an increase in intraocular pressure;
• eye drops containing thiomersal as a preservative: in such cases, the eye drops must be administered at an interval of at least 5 minutes from each other.

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

Pregnancy
Do not use Latay if you are pregnant.

Breastfeeding
Do not use Latay during breastfeeding, as latanoprost and its derivatives may be excreted in breast milk.

Driving and using machines
Latay may affect your ability to drive and use machines.
As with other ophthalmic preparations, it is possible that temporary blurred vision may occur with the application of Latay.
Therefore, exercise due caution and resume driving or using machines only when vision is clear again.

Latay containsbenzalkonium chloride
This medicine contains 0.2 mg of benzalkonium chloride per ml.
Benzalkonium chloride can be absorbed by soft contact lenses and can lead to a change in their color. Remove contact lenses before using this medicine and wait 15 minutes before re-applying them.
Benzalkonium chloride can also cause irritation to the eyes, especially if you have dry eyes or corneal disorders (the most superficial transparent layer of the eye). If you experience an abnormal sensation in the eye, burning or pain after using this medicine, talk to your doctor.

3. How to use Latay

Use this medicine following the instructions of your doctor or the doctor caring for your child or your pharmacist exactly as prescribed. If you have any doubts, consult your doctor or the doctor caring for your child or your pharmacist.

Use in adults and the elderly
The recommended dose is 1 drop of Latay, once a day, in the eye to be treated.
Apply Latay preferably in the evening, as the optimal effect of Latay has been observed with evening administration.
Do not use Latay more than once a day, as more frequent administrations have been shown to decrease the effect of reducing intraocular pressure.
Apply one drop of Latay to the eye, gently lowering the lower eyelid.
Press with a finger on the inner corner of the affected eye. Wait one minute keeping your
eyes closed. Repeat the operation in the other eye, if your doctor has told you to do so, immediately
after introducing each single drop.

If you use contact lenses
If you or your child use contact lenses, remove them before using Latay and
reapply them after 15 minutes.
If you use more than one medicine for topical use for the eyes, administer Latay after at least 5
minutes from the other medicine.

Use in children and adolescents
Same dosage as adults.

If you use more Latay than you should
In case of ingestion/accidental intake of an excessive dose of Latay, immediately notify
your doctor or the doctor caring for your child or go to the nearest
hospital.
If you introduce too many drops into the eye, you may experience transient effects such as mild irritation,
tearing and redness of the eyes. If this should happen, contact your doctor or the
doctor caring for your child who will prescribe you treatment for the care of the symptoms.

If you forget to use Latay
If you forgot to apply the drops, continue the treatment normally with the next
dose.
Do not apply a double dose to compensate for the forgotten dose.

If you stop using Latay
If you have any doubts about the use of this medicine, consult your doctor or the doctor caring for
your child or your 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 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, grey-brown, yellow-brown or green-brown) rather than a uniform color
(blue, grey, green or brown). Any change in eye color may occur 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 Latay in only one eye. There do not appear to be any
problems associated with the change in eye color. After stopping treatment with Latay, no
further alteration of eye color has been observed;
redness of the eyes (mild to moderate conjunctival hyperemia), eye irritation (burning,
sandy feeling, itching, stinging pain and foreign body sensation in the eyes). If you experience
irritation severe enough to produce excessive tearing in your eyes, or to induce suspension of
the medicine, immediately (within one week) contact your doctor, pharmacist or nurse. A
therapy update may be necessary to ensure adequate treatment for your condition;
gradual alteration of the eyelashes of the treated eye and of the hair around the eye and in the
surrounding area (lengthening, thickening, coloring and densification, growth of eyelashes
with abnormal orientation).

Common (may affect up to 1 in 10 people):
irritation or erosion 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 (palpebral edema), dry eye, inflammation or irritation of the eye
surface (keratitis), blurred vision, inflammation of the colored part of the eye (uveitis), retinal
swelling (macular edema);
skin rash;
nausea, vomiting;
chest pain (angina), awareness of heartbeat (palpitations);
asthma, shortness of breath (dyspnea);
chest pain;
headache, dizziness;
muscle pain, joint pain.

Rare (may affect up to 1 in 1,000 people):
eye inflammations affecting the colored part of the eye called the iris (iritis) or the uvea
(uveitis) in patients with concomitant predisposing factors, symptoms related to swelling or
erosion/damage to the eye surface, swelling of the area around the eyes (periorbital edema),
altered orientation of the eyelashes and consequent eye irritation, abnormal eyelash growth
(distichiasis), scarring of the eye surface, fluid-filled area in the colored part of the eye (iris
cyst);
skin reactions on the eyelids, darkening of the skin of the eyelids;
worsening of asthma and shortness of breath (dyspnea);
severe 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 suffering from heart disease);
sunken appearance of the eye (hollowing of the eye socket).
The side effects observed more frequently in children compared to adults have been: runny and
itchy nose, fever.
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. This includes any 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/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 which is stated on the packaging after the
wording “Exp.”. The expiry date refers to the last day of that month.
The expiry date refers to the product in intact packaging, correctly
stored.
Store in a refrigerator (2-8°C), in the original packaging to protect the medicine
from light.
After the first opening of 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 designated space on the box.
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 Latay contains
The active ingredient is latanoprost.
100 ml of solution contains 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 contents of the pack
Latay is presented as eye drops, in a colorless, clear liquid solution, inside a
multidose polyethylene bottle.
One pack contains 1 multidose bottle of 2.5 ml.

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)