BIALVIZ 0.1 mg/ml Глазные капли, раствор

Содержание инструкции

1. What is BROSTIMAB 0.3 mg/ml and what is it used for
2. What you need to know before using BROSTIMAB 0.3 mg/ml
3. How to use BROSTIMAB 0.3 mg/ml
4. Possible side effects
5. How to store BROSTIMAB 0.3 mg/ml
6. Package Contents and Other Information
7. What is BROSTIMAB 0.3 mg/ml single-dose and what is it used for
8. What you need to know before using BROSTIMAB 0,3 mg/ml single-dose
9. How to use BROSTIMAB 0,3 mg/ml single-dose
10. Possible side effects
11. How to store BROSTIMAB 0,3 mg/ml single-dose
12. Package Contents and Other Information
13. What is BROSTIMAB 0.1 mg/ml and what is it used for
14. What you need to know before using BROSTIMAB 0.1 mg/ml
15. How to use BROSTIMAB 0.1 mg/ml
16. Possible side effects
17. How to store BROSTIMAB 0.1 mg/ml
18. Package Contents and Other Information
19. What is BROSTIMAB 0.1 mg/ml single-dose and what is it used for
20. What you need to know before using BROSTIMAB 0.1 mg/ml single-dose
21. How to use BROSTIMAB 0,1 mg/ml single-dose
22. Possible side effects
23. How to store BROSTIMAB 0,1 mg/ml single-dose
24. Contents of the pack and other information

BROSTIMAB 0,3 mg/ml, eye drops, solution
Bimatoprost
Generic medicine

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 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 BROSTIMAB 0,3 mg/ml is and what it is used for
• 2. What you need to know before you use BROSTIMAB 0,3 mg/ml
• 3. How to use BROSTIMAB 0,3 mg/ml
• 4. Possible side effects
• 5. How to store BROSTIMAB 0,3 mg/ml
• 6. Contents of the pack and other information

1. What is BROSTIMAB 0.3 mg/ml and what is it used for

BROSTIMAB eye drops are an antiglaucoma medication. It belongs to a category of drugs called

prostamides.
BROSTIMAB is used to reduce elevated intraocular pressure. This medicine can be used
alone or together with other eye drops called beta-blockers, which also serve to reduce pressure
in the eye.
The eye contains a clear, aqueous liquid that nourishes its interior. This liquid is
constantly drained from the eye and new liquid is produced to replace what is drained. If the
liquid is not drained quickly enough, the pressure inside the eye increases. This medicine helps to increase the amount of liquid that is drained, thus reducing
the pressure inside the eye. Elevated intraocular pressure, if not reduced, can cause
a disease called glaucomaand can eventually cause damage to vision.

2. What you need to know before using BROSTIMAB 0.3 mg/ml

Do not use BROSTIMAB 0.3 mg/ml

• if you are allergic to the active ingredient bimatoprost or to any of the other ingredients of this medicine (listed in section 6).
• if you have had to stop using eye drops in the past due to an undesirable effect caused by the preservative benzalkonium chloride.

Warnings and precautions
Talk to your doctor or pharmacist before using BROSTIMAB 0.3 mg/ml.
Consult your doctor if:

• you suffer from respiratory problems
• you have liver or kidney problems
• you have had cataract surgery in the past
• you suffer from dry eyes
• you have or have had problems with the cornea (the clear front part of the eye)
• you wear contact lenses (see “BROSTIMAB 0.3 mg/ml contains benzalkonium chloride”)
• you suffer or have suffered from hypotension or bradycardia
• you have had a viral infection or inflammation of the eyes.

During treatment, BROSTIMAB may cause loss of fat around the eye, which may lead to
deepening of the eyelid crease, sunken eye (enophthalmos), drooping of the upper eyelid
(ptosis), tightening of the skin around the eye (dermatocalasis involution) and exposure
of the lower white part of the eye (inferior scleral show). The changes are usually mild in degree, but if they are pronounced, they can impair the field of vision. If you stop using
BROSTIMAB, the changes may disappear
BROSTIMAB may also cause darkening and lengthening of the eyelashes, and may also darken the
eyelids. The color of the iris may also darken. These changes may be permanent and are more noticeable if only one eye is treated.

Children and adolescents
Bimatoprost has not been tested in patients under 18 years of age, therefore it should not be used in
patients under 18 years of age.

Other medicines and BROSTIMAB
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning to become pregnant or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
BROSTIMAB may pass into breast milk, so it is advisable not to breastfeed during treatment with
this medicine.

Driving and using machines
After administration of BROSTIMAB 0.3 mg/ml, you may experience mild transient blurred
vision. In this case, do not drive or operate machinery until your vision has returned to normal.

BROSTIMAB 0.3 mg/ml contains benzalkonium chloride.
BROSTIMAB contains a preservative called benzalkonium chloride; it can cause eye irritation
and can discolor soft contact lenses. Avoid contact with soft contact lenses. Do not use the
eye drops while wearing contact lenses. After administering the eye drops, wait 15 minutes before
replacing the contact lenses.

3. How to use BROSTIMAB 0.3 mg/ml

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.
BROSTIMAB must be applied only to the eyes. The recommended dose is one drop of
BROSTIMAB once a day, in the evening, in each eye to be treated.
If you are using BROSTIMAB with another ophthalmic medicine, wait at least 5 minutes after using
BROSTIMAB before applying the second ophthalmic medicine.
Do not use the medicine more than once a day, as the effectiveness of the treatment may be reduced.

Instructions for use:
Do not use the bottle if the tamper-evident seal on the cap is not intact before first use.

• 1. Wash your hands. Tilt your head back and look up.
• 2. Lower the lower eyelid slowly to form a small pocket.
• 3. Invert the bottle and apply gentle pressure to dispense one drop of eye drops into each eye to be treated.
• 4. Release the lower eyelid and close your eye for 30 seconds.

Wipe away any excess that runs down your cheek.
If the drop does not enter your eye, repeat the operation.
To avoid infection and injury to the eye, the tip of the bottle must not touch the eye or come into
contact with other surfaces. After using the bottle, close it tightly by screwing the cap back on.

If you use more BROSTIMAB 0.3 mg/ml than you should
If you use more BROSTIMAB than you should, it is unlikely to cause serious consequences.
Administer the next dose at the usual time. If this causes you concern, consult your doctor or
pharmacist.

If you forget to use BROSTIMAB 0.3 mg/ml
If you forget to use BROSTIMAB, as soon as you remember, put in one drop and then return to
your normal dosing schedule. Do not take a double dose to make up for a missed dose.

If you stop using BROSTIMAB 0.3 mg/ml
For it to work correctly, BROSTIMAB must be used every day. If you stop using BROSTIMAB, your
eye pressure may increase, so you should talk to your doctor before stopping this treatment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you get any side effects, even those not listed in this leaflet, please tell your doctor or pharmacist.

Very common side effects
These effects may occur in 1 or more patients in 10.
Effects on the eye

• Longer eyelashes (up to 45% of people)
• Mild redness (up to 44% of people)
• Itching (up to 14% of people)

Common side effects
These effects may occur in 1-9 patients in 100.
Effects on the eye

• Ocular allergic reaction
• Tired eyes
• Light sensitivity
• Darkening of the skin around the eye
• Darker eyelashes
• Pain
• Feeling of something in the eye
• Sticky eyes
• Darkening of the iris color
• Difficulty seeing sharp images
• Irritation
• Burning
• Inflamed, red and itchy eyelids
• Tearing
• Dryness
• Worsening of vision
• Blurred vision
• Swelling of the clear layer covering the surface of the eye
• Small ulcers on the surface of the eye, with or without inflammation

Side effects on the body

• Headache
• Increase in blood tests of values related to liver function
• Increase in blood pressure values

Uncommon side effects
These effects may occur in 1-9 patients in 1,000.
Concerning the eye

• Cystoid macular edema (swelling of the retina inside the eye that leads to worsening of vision)
• Inflammation inside the eye
• Retinal bleeding
• Swollen eyelids
• Eyelid spasms
• Retraction of the eyelid, which moves away from the surface of the eye
• Redness of the skin around the eye
• Loss of fat in the ocular region which may involve deepening of the eyelid crease, sunken eye (enophthalmos), drooping of the eyelid (ptosis), tension of the skin around the eye

(dermatocalasis involution) and exposure of the lower white part of the eye (inferior scleral show).
Concerning the body

• Nausea
• Dizziness
• Weakness
• Hair growth around the eye

Side effects with frequency not known
Concerning the eye

• Eye discomfort

Concerning the body

• Asthma
• Worsening of asthma
• Worsening of a lung disease called chronic obstructive pulmonary disease (COPD)
• Shortness of breath
• Alteration of skin color (periocular)

Other side effects reported with eye drops containing phosphates
In very rare cases, some patients with severe damage to the clear layer of the front of the eye (the cornea) have developed cloudy areas on the cornea due to calcium accumulation during treatment.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at 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 BROSTIMAB 0.3 mg/ml

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 label of the vial and on the packaging
after Exp. The expiry date refers to the last day of that month.
After the first opening of the BROSTIMAB vial, use within 28 days; after this period, any
remaining medicine must be discarded. This will avoid infections. To help you remember, write the date of
first opening in the space provided 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. Package Contents and Other Information

What BROSTIMAB 0.3 mg/ml contains

• The active ingredient is bimatoprost. One ml of solution contains 0.3 mg of bimatoprost.
• The other ingredients are: benzalkonium chloride(preservative), sodium chloride, disodium phosphate heptahydrate, citric acid monohydrate and water for injections. Small amounts of hydrochloric acid or sodium hydroxide may be added to maintain a normal acidity level (pH).

Description of the appearance of BROSTIMAB 0.3 mg/ml and package contents
BROSTIMAB is a clear, colorless eye drop solution, supplied in a package containing 1 plastic bottle with
a screw cap, containing 3 ml of solution.

Marketing Authorisation Holder
GENETIC S.p.A. - Via Della Monica, 26 – 84083 Castel S. Giorgio (SA)

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

BROSTIMAB 0.3 mg/ml, eye drops, solution in single-dose container
Bimatoprost
Generic medicine

Read this leaflet carefully before you use 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 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 BROSTIMAB 0.3 mg/ml single-dose is and what it is used for
• 2. What you need to know before you use BROSTIMAB 0.3 mg/ml single-dose
• 3. How to use BROSTIMAB 0.3 mg/ml single-dose
• 4. Possible side effects
• 5. How to store BROSTIMAB 0.3 mg/ml single-dose
• 6. Package Contents and Other Information

1. What is BROSTIMAB 0.3 mg/ml single-dose and what is it used for

BROSTIMAB 0.3 mg/ml single-dose is an antiglaucoma drug. It belongs to a category of drugs
called prostamides.
BROSTIMAB 0.3 mg/ml eye drops single-dose solution is used to reduce increased intraocular pressure.
This medicine can be used alone or together with other eye drops called beta-blockers, which
also serve to reduce pressure in the eye.
The eye contains a clear, aqueous liquid that nourishes its interior. This liquid is
constantly eliminated from the eye and new liquid is produced to replace that which is eliminated. If the
liquid is not eliminated quickly enough, the pressure inside the eye increases.
This medicine serves to increase the amount of liquid that is eliminated, thus reducing
the pressure inside the eye. Elevated intraocular pressure, if not reduced, can cause
a disease called glaucomaand can eventually cause damage to vision.
This medicine does not contain preservatives.

2. What you need to know before using BROSTIMAB 0,3 mg/ml single-dose

Do not use this medicine

• if you are allergic to the active ingredient bimatoprost or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using BROSTIMAB 0,3 mg/ml single-dose.

Consult your doctor or pharmacist if:

• you suffer from respiratory problems.
• you have liver or kidney problems.
• you have had cataract surgery in the past.
• you suffer or have suffered from low blood pressure or slowed heartbeat.
• you have had a viral infection or inflammation of the eyes.

During treatment, BROSTIMAB may cause loss of fat around the eye, which may result in
deepening of the eyelid crease, sunken eye (enophthalmos), drooping of the upper eyelid
(ptosis), tightening of the skin around the eye (dermal calasis involution) and exposure
of the lower white part of the eye (inferior scleral show). The changes are usually mild, but if they are
marked, they may impair the field of vision. If you stop using
BROSTIMAB, the changes may disappear
BROSTIMAB 0,3 mg/ml single-dose may also cause darkening and lengthening of the eyelashes, as well as
darkening of the eyelids. The color of the iris may also darken. These changes may be
permanent and are more noticeable if only one eye is treated.

Children and adolescents
BROSTIMAB 0,3 mg/ml single-dose has not been tested on patients under 18 years of age and therefore should not
be used on patients under 18 years of age.

Other medicines and BROSTIMAB 0,3 mg/ml single-dose
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
BROSTIMAB 0,3 mg/ml single-dose may pass into breast milk, so it is advisable not to breastfeed
during treatment with this medicine.

Driving and operating machinery
After administration of BROSTIMAB 0,3 mg/ml single-dose, you may experience mild transient
blurred vision. In this case, do not drive or use machinery until your vision returns to
normal.

3. How to use BROSTIMAB 0,3 mg/ml single-dose

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.
The recommended dose is one drop once a day, in the evening, in each eye to be treated. BROSTIMAB
0,3 mg/ml single-dose must be applied only to the eyes.
If you are using BROSTIMAB 0,3 mg/ml single-dose with another ophthalmic medicine, wait at least 5 minutes after
using BROSTIMAB 0,3 mg/ml single-dose before applying the second ophthalmic medicine.
Do not use it more than once a day, as the effectiveness of the treatment may be reduced.

Instructions for use:
Wash your hands before use. Make sure the single-dose container is intact before use. The
solution must be used immediately after opening. To avoid contamination, be careful
that the open end of the single-dose container does not come into contact with the eye or with other surfaces.

• 1. Take a single-dose container and hold it in a vertical position (with the cap facing upwards) and rotate the cap.
• 2. Gently lower the lower eyelid to form a pocket. Turn the single-dose container upside down and apply slight pressure to release one drop of eye drops into the eye(s) to be treated. Open and close your eye(s) for a few seconds.
• 3. Dispose of the single-dose container immediately after use, even if there is some solution left inside.

Wipe away any excess that runs down your cheek.
If you wear contact lenses, remove them before using this medicine. Wait 15 minutes after
using the eye drops before inserting the lenses again.

If you use more BROSTIMAB 0,3 mg/ml single-dose than you should
If you use this medicine more than you should, it is unlikely to cause serious consequences.
Administer the next dose at the usual time. If this causes you concern, consult your doctor or
pharmacist.

If you forget to use BROSTIMAB 0,3 mg/ml single-dose
If you forget to use this medicine, as soon as you remember, put one drop and then return to
normal administration times. Do not take a double dose to make up for a missed dose.

If you stop using BROSTIMAB 0,3 mg/ml single-dose
For it to work correctly, BROSTIMAB 0,3 mg/ml single-dose must be used every day. If
you stop using BROSTIMAB 0,3 mg/ml single-dose, the eye pressure may increase, so you must
talk to your doctor before stopping this treatment.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist.

Very common side effects
These effects may occur in 1 or more patients in 10
Effects on the eye

• Mild redness (up to 24% of people)
• Loss of fat in the eye area which may lead to deepening of the eyelid crease, sunken eye (enophthalmos), drooping of the eyelid (ptosis), tightening of the skin around the eye (dermatochalasis involution) and exposure of the lower white part of the eye (inferior scleral show).

Common side effects
These effects may occur in 1-9 patients in 100
Effects on the eye

• Small ulcers on the surface of the eye, with or without inflammation
• Irritation
• Eye itching
• Pain
• Dryness
• Feeling of a foreign body in the eye
• Longer eyelashes
• Darkening of the skin around the eye
• Reddened eyelids

Uncommon side effects
These effects may occur in 1-9 patients in 1000
Effects on the eye

• Tired eyes
• Sensitivity to light
• Darkening of the iris color
• Itchy and swollen eyelids
• Tearing
• Swelling of the transparent layer covering the surface of the eye
• Blurred vision

Side effects on the body

• Headache
• Growth of hair around the eye

Side effects with frequency not known
Affecting the body

• Asthma
• Worsening of asthma
• Worsening of a lung condition called chronic obstructive pulmonary disease (COPD)
• Shortness of breath
• Symptoms of an allergic reaction (swelling, redness of the eye and skin rash)
• Dizziness
• Increased blood pressure values
• Change in skin color (around the eye)

Affecting the eye

• Sticky eyes
• Eye discomfort

In addition to the side effects of BROSTIMAB 0.3 mg/ml single-dose, the following side effects have been observed with the multi-dose formulation of BROSTIMAB 0.3 mg/ml containing the preservative and may occur in patients taking BROSTIMAB 0.3 mg/ml single-dose:

• Burning sensation inside the eye
• Allergic reaction in the eye
• Inflamed eyelids
• Difficulty seeing clear images
• Worsening of vision
• Darkening of eyelashes
• Retinal bleeding
• Inflammation inside the eye
• Cystoid macular edema (swelling of the retina inside the eye leading to worsening of vision)
• Inflammation of the iris
• Eyelid spasms
• Narrowing of the eyelid, which moves away from the surface of the eye
• Nausea
• Redness of the skin around the eyes
• Weakness
• Increased blood test values related to liver function

Other side effects reported with eye drops containing phosphates
In very rare cases, some patients with severe damage to the transparent layer of the front of the eye (the cornea) have developed opaque areas on the cornea due to calcium accumulation during treatment.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at 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 BROSTIMAB 0,3 mg/ml single-dose

Keep this medicine out of the sight and reach of children.
This medicine is for single use only and does not contain preservatives. Do not store unused solution.
After the first opening of the aluminum pouch: use the single-dose containers 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 use this medicine after the expiry date which is stated on the single-dose container, on the sachet and on the carton after EXP. The expiry date refers to the last day of that month.
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. Package Contents and Other Information

What BROSTIMAB 0.3 mg/ml single-dose contains

• The active ingredient is bimatoprost. One ml of solution contains 0.3 mg of bimatoprost.
• The other ingredients are: sodium chloride, disodium phosphate heptahydrate, citric acid monohydrate and water for injections. Small amounts of hydrochloric acid or sodium hydroxide may be added to maintain a normal acidity level (pH).

Description of the appearance of BROSTIMAB 0.3 mg/ml single-dose and package contents
BROSTIMAB 0.3 mg/ml single-dose is a clear, colorless solution, supplied in single-dose plastic containers,
divided into 6 strips of 5 containers each placed in a sachet.
Each single-dose container contains 0.4 ml of solution.
Each pack contains 30 single-dose containers.

Marketing Authorisation Holder
GENETIC S.p.A. - Via Della Monica, 26 – 84083 Castel S. Giorgio (SA)

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

BROSTIMAB 0.1 mg/ml, eye drops, solution
Bimatoprost
Generic medicine

Read this leaflet carefully before you use 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 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 BROSTIMAB 0.1 mg/ml is and what it is used for
• 2. What you need to know before you use BROSTIMAB 0.1 mg/ml
• 3. How to use BROSTIMAB 0.1 mg/ml
• 4. Possible side effects
• 5. How to store BROSTIMAB 0.1 mg/ml
• 6. Contents of the pack and other information

1. What is BROSTIMAB 0.1 mg/ml and what is it used for

BROSTIMAB is an antiglaucoma medication. It belongs to a category of drugs called prostamides.
BROSTIMAB eye drops are used to reduce elevated intraocular pressure. This medicine can be
used alone or together with other eye drops called beta-blockers, which also serve to reduce
pressure in the eye.
The eye contains a clear, aqueous liquid that nourishes its interior. This liquid is
constantly drained from the eye and new liquid is produced to replace that which is drained. If the
liquid is not drained quickly enough, the pressure inside the eye increases. This medicine serves to increase the amount of liquid that is drained, thus reducing
pressure inside the eye. Elevated intraocular pressure, if not reduced, can cause
a disease called glaucomaand can eventually cause damage to vision.

2. What you need to know before using BROSTIMAB 0.1 mg/ml

Do not use BROSTIMAB 0.1 mg/ml

• if you are allergic to the active ingredient bimatoprost or to any of the other ingredients of this medicine (listed in section 6).
• if you have had to stop using eye drops in the past due to an undesirable effect caused by the preservative benzalkonium chloride.

Warnings and precautions
Talk to your doctor or pharmacist before using BROSTIMAB 0.1 mg/ml.
Consult your doctor if:

• you suffer from respiratory problems
• you have liver or kidney problems
• you have had cataract surgery in the past
• you suffer from dry eyes
• you have or have had problems with the cornea (the clear front part of the eye)
• you wear contact lenses (see “BROSTIMAB 0.1 mg/ml contains benzalkonium chloride”)
• you suffer from or have suffered from hypotension or bradycardia
• you have had a viral infection or inflammation of the eyes. During treatment, BROSTIMAB may cause loss of fat around the eye, which may lead to deepening of the eyelid crease, sunken eye (enophthalmos), drooping of the upper eyelid (ptosis), tightening of the skin around the eye (dermal calasis involution) and exposure of the lower white part of the eye (inferior scleral show). The changes are usually mild, but if they are pronounced, they may impair the field of vision. If you stop using BROSTIMAB, the changes may disappear.

BROSTIMAB may also cause darkening and lengthening of the eyelashes, and may also darken the
eyelids. The color of the iris may also darken. These changes may be permanent and are more noticeable
if only one eye is treated.

Children and adolescents
Bimatoprost has not been tested in patients under 18 years of age, therefore it should not be used in
patients under 18 years of age.

Other medicines and BROSTIMAB
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
BROSTIMAB may pass into breast milk, therefore it is advisable not to breastfeed during treatment with
this medicine.

Driving and using machines
After administration of BROSTIMAB, you may experience slight transient blurred vision. In
this case, do not drive or operate machinery until your vision has returned to normal.

BROSTIMAB 0.1 mg/ml contains benzalkonium chloride.
BROSTIMAB contains a preservative called benzalkonium chloride; it may cause eye irritation
and may discolor soft contact lenses. Avoid contact with soft contact lenses. Do not use the
eye drops while wearing contact lenses. Wait 15 minutes after administering the eye drops before
reinserting the contact lenses.

3. How to use BROSTIMAB 0.1 mg/ml

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.
BROSTIMAB must be applied only to the eyes. The recommended dose is one drop of
BROSTIMAB once a day, in the evening, in each eye to be treated.
If you are using BROSTIMAB with another ophthalmic medicine, apply BROSTIMAB eye drops first and wait 5
minutes before applying the second ophthalmic medicine.
Do not use the medicine more than once a day, as the effectiveness of the treatment may be reduced.

Instructions for use:
Do not use the bottle if the tamper-evident seal on the cap is not intact before first use.

• 1. Wash your hands. Tilt your head back and look up.
• 2. Gently lower the lower eyelid to form a small pocket.
• 3. Invert the bottle and apply gentle pressure to release one drop of eye drops for each eye to be treated.
• 4. Release the lower eyelid and close your eye for 30 seconds.

Wipe away any excess that runs down your cheek.
If the drop does not enter your eye, repeat the operation.
To avoid infection and injury to the eye, the tip of the bottle must not touch the eye or come into
contact with other surfaces. After using the bottle, close it tightly by screwing the cap back on.

Use in children and adolescents
BROSTIMAB should not be given to children and adolescents under 18 years of age.

If you use more BROSTIMAB 0.1 mg/ml than you should
If you use more BROSTIMAB than you should, it is unlikely to cause serious consequences.
Administer the next dose at the usual time. If this causes you concern, consult your doctor or
pharmacist.

If you forget to use BROSTIMAB 0.1 mg/ml
If you forget to use BROSTIMAB, as soon as you remember, put one drop and then return to
normal dosing times. Do not take a double dose to make up for a missed dose.

If you stop using BROSTIMAB 0.1 mg/ml
For it to work correctly, BROSTIMAB must be used every day. If you stop using BROSTIMAB, the eye pressure may increase, so you should talk to your doctor before
stopping this treatment.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist.

Very common side effects
These effects may occur in 1 or more patients out of 10.
Effects on the eye

• Mild redness (up to 29% of people)
• Loss of fat in the eye area which may lead to deepening of the eyelid crease, sunken eye (enophthalmos), drooping of the eyelid (ptosis), tightening of the skin around the eye (dermatocalasis involution) and exposure of the lower white part of the eye (inferior scleral show).

Common side effects
These effects may occur in 1-9 patients out of 100.
Effects on the eye

• Small ulcers on the surface of the eye, with or without inflammation
• Irritation
• Eye itching
• Lengthening of eyelashes
• Irritation when administering drops into the eyes
• Eye pain

Side effects on the skin

• Red and itchy eyelids
• Darkening of the skin around the eye
• Growth of hairs around the eye

Uncommon side effects
These effects may occur in 1-9 patients out of 1,000.
Concerning the eye

• Darkening of the iris color
• Tired eyes
• Swelling of the surface of the eye
• Blurred vision
• Loss of eyelashes

Concerning the skin

• Dryness
• Formation of crusts on the edge of the eyelid
• Swelling of the eyelid
• Itching

Concerning the body

• Headache
• Feeling unwell

Side effects with frequency not known
Concerning the eye

• Macular edema (swelling of the retina in the back of the eye which can lead to worsening of vision)
• Darkening of the eyelids
• Dry eye
• Sticky eyes
• Foreign body sensation in the eye
• Eye swelling
• Increased tearing
• Eye discomfort
• Light sensitivity

Concerning the body

• Asthma
• Worsening of asthma
• Worsening of a lung condition called chronic obstructive pulmonary disease (COPD)
• Shortness of breath
• Symptoms of an allergic reaction (swelling, redness of the eye and skin rash)
• Dizziness
• Increased blood pressure values
• Alteration of skin color (around the eye)

In addition to the side effects of bimatoprost 0.1 mg/ml, the following side effects have been observed with another medicine containing a
higher concentration of bimatoprost (0.3 mg/ml):

• Eye burning
• An allergic reaction to the eye
• Inflamed eyelids
• Difficulty seeing clear images
• Worsening of vision
• Swelling of the clear layer covering the surface of the eye
• Tearing
• Darker eyelashes
• Retinal bleeding
• Inflammation inside the eye
• Cystoid macular edema (swelling of the retina inside the eye that leads to worsening of vision)
• Eyelid spasms
• Narrowing of the eyelid, which moves away from the surface of the eye
• Redness of the skin around the eye
• Weakness
• Increase in blood tests of values related to liver function

Other side effects reported with eye drops containing phosphates
In very rare cases, some patients with severe damage to the clear layer of the front of the eye (the
cornea) have developed opaque areas on the cornea due to calcium accumulation during treatment.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at 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 BROSTIMAB 0.1 mg/ml

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 label of the vial and the packaging
after Exp. The expiry date refers to the last day of that month.
After the first opening of the BROSTIMAB vial, use within 28 days; after this period, any
remaining medicine must be discarded. This will prevent infections. To help you remember, write the date of
first opening in the space provided 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. Package Contents and Other Information

What BROSTIMAB 0.1 mg/ml contains

• The active ingredient is bimatoprost. One ml of solution contains 0.1 mg of bimatoprost.
• The other ingredients are: benzalkonium chloride(preservative), sodium chloride, disodium phosphate heptahydrate, citric acid monohydrate and water for injections. Small amounts of hydrochloric acid or sodium hydroxide may be added to maintain a normal acidity level (pH).

Description of the appearance of BROSTIMAB 0.1 mg/ml and package contents
BROSTIMAB is a clear, colorless eye drop, supplied in a package containing 1 plastic bottle with
a screw cap, containing 3 ml of solution.

Marketing Authorisation Holder
GENETIC S.p.A. - Via Della Monica, 26 – 84083 Castel S. Giorgio (SA)

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

BROSTIMAB 0.1 mg/ml, eye drops, solution, in single-dose container
Bimatoprost

Read this leaflet carefully before you use 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 their symptoms are the same as yours, 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 BROSTIMAB 0.1 mg/ml single-dose is and what it is used for
• 2. What you need to know before you use BROSTIMAB 0.1 mg/ml single-dose
• 3. How to use BROSTIMAB 0.1 mg/ml single-dose
• 4. Possible side effects
• 5. How to store BROSTIMAB 0.1 mg/ml single-dose
• 6. Package Contents and Other Information

1. What is BROSTIMAB 0.1 mg/ml single-dose and what is it used for

BROSTIMAB 0.1 mg/ml single-dose is an antiglaucoma drug. It belongs to a category of drugs
called prostamides.
BROSTIMAB 0.1 mg/ml single-dose eye solution is used to reduce increased intraocular pressure.
This medicine can be used alone or together with other eye drops called beta-blockers, which
also serve to reduce pressure in the eye.
The eye contains a clear, aqueous liquid that nourishes its interior. This liquid is
constantly drained from the eye and new liquid is produced to replace it. If the
liquid is not drained quickly enough, the pressure inside the eye increases.
This medicine helps to increase the amount of fluid that is drained, thus reducing
the pressure inside the eye. Elevated intraocular pressure, if not reduced, can cause
a disease called glaucomaand can eventually cause damage to vision.
This medicine does not contain preservatives.

2. What you need to know before using BROSTIMAB 0.1 mg/ml single-dose

Do not use this medicine

• if you are allergic to the active ingredient bimatoprost or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using BROSTIMAB 0.1 mg/ml single-dose.

Consult your doctor or pharmacist if:

• you suffer from breathing problems
• you have problems with your liver or kidneys
• you have had cataract surgery in the past
• you suffer from dry eyes
• you have or have had problems with the cornea (the clear front part of the eye)
• you suffer from or have suffered from hypotension or bradycardia
• you have had a viral infection or inflammation of the eyes.

During treatment, BROSTIMAB may cause loss of fat around the eye, which may result in
deepening of the eyelid crease, sunken eye (enophthalmos), drooping of the upper eyelid
(ptosis), tightening of the skin around the eye (dermal calasis involution) and exposure of
the lower white part of the eye (inferior scleral show). The changes are usually mild in degree,
but if they are pronounced, they may impair the field of vision. If you stop using
BROSTIMAB, the changes may disappear
BROSTIMAB 0.1 mg/ml single-dose may also cause darkening and lengthening of the eyelashes, as well as
darkening of the eyelids. The color of the iris may also darken. These changes may be
permanent and are more noticeable if only one eye is treated.

Children and adolescents
BROSTIMAB 0.1 mg/ml single-dose has not been tested on patients under 18 years of age and therefore should not
be used on patients under 18 years of age.

Other medicines and BROSTIMAB 0.1 mg/ml single-dose
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
BROSTIMAB 0.1 mg/ml single-dose may pass into breast milk, so it is advisable not to breastfeed
during treatment with this medicine.

Driving and operating machinery
After administration of BROSTIMAB 0.1 mg/ml single-dose, you may experience slight transient
blurred vision. In this case, do not drive or operate machinery until your vision has returned
to normal.

3. How to use BROSTIMAB 0,1 mg/ml single-dose

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.
BROSTIMAB 0,1 mg/ml single-dose must be applied only to the eyes. The recommended dose is
one drop once a day, in the evening, in each eye to be treated.
If you are using BROSTIMAB 0,1 mg/ml single-dose with another ophthalmic medicine, apply BROSTIMAB
eye drops first and wait 5 minutes before applying the second ophthalmic medicine.
Do not use the medicine more than once a day, as the effectiveness of the treatment may be reduced.

Instructions for use:
Wash your hands before use. Make sure that the single-dose container is intact before use. The
solution must be used immediately after opening. To avoid contamination, be careful
that the open end of the single-dose container does not come into contact with the eye or with other surfaces.

• 1. Take a single-dose container and hold it in a vertical position (with the cap facing upwards) and rotate the cap.
• 2. Gently lower the lower eyelid to form a pouch. Turn the single-dose container upside down and apply slight pressure to release one drop of eye drops into the eye(s) to be treated. Open and close your eye(s) for a few seconds.
• 3. Dispose of the single-dose container immediately after use, even if some solution remains inside.

Dry any excess that runs down your cheek.
If you wear contact lenses, remove them before using this medicine. Wait 15 minutes after
using the eye drops before inserting the lenses again.

Use in children and adolescents
BROSTIMAB 0,1 mg/ml single-dose should not be given to children and adolescents under 18 years of
age.

If you use more BROSTIMAB 0,1 mg/ml single-dose than you should
If you use more of this medicine than you should, it is unlikely to cause serious consequences.
Administer the next dose at the usual time. If this causes you concern, consult your doctor or
pharmacist.

If you forget to use BROSTIMAB 0,1 mg/ml single-dose
If you forget to use this medicine, as soon as you remember, put one drop and then return to
normal administration times. Do not take a double dose to make up for a missed dose.

If you stop using BROSTIMAB 0,1 mg/ml single-dose
For it to work correctly, BROSTIMAB 0,1 mg/ml single-dose must be used every day. If
you stop using BROSTIMAB 0,1 mg/ml single-dose, the eye pressure may increase, so you should
talk to your doctor before stopping this treatment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any side effects, including those not listed in this leaflet, please tell your
doctor or pharmacist.

Very common side effects
These effects may occur in 1 or more patients in 10.
Effects on the eye

• Mild redness (up to 29% of people)
• Loss of fat in the eye area which may lead to deepening of the eyelid crease, sunken eye (enophthalmos), drooping eyelid (ptosis), tightening of the skin around the eye (dermalchalasis involution) and exposure of the lower white part of the eye (inferior scleral show).

Common side effects
These effects may occur in 1-9 patients in 100.
Effects on the eye

• Small ulcers on the surface of the eye, with or without inflammation
• Irritation
• Eye itching
• Lengthening of eyelashes
• Irritation when administering eye drops
• Eye pain

Side effects on the skin

• Red and itchy eyelids
• Darkening of the skin around the eye
• Growth of hair around the eye

Uncommon side effects
These effects may occur in 1-9 patients in 1,000.
Affecting the eye

• Darkening of the color of the iris
• Tired eyes
• Swelling of the surface of the eye
• Blurred vision
• Loss of eyelashes

Affecting the skin

• Dryness
• Formation of crusts on the edge of the eyelid
• Swelling of the eyelid
• Itching

Affecting the body

• Headache
• Feeling unwell

Side effects with unknown frequency
Affecting the eye

• Macular edema (swelling of the retina in the back of the eye that can lead to worsening of vision)
• Darkening of the eyelids
• Dry eye
• Sticky eyes
• Foreign body sensation in the eye
• Eye swelling
• Increased tearing
• Eye discomfort
• Sensitivity to light

Affecting the body

• Asthma
• Worsening of asthma
• Worsening of a lung condition called chronic obstructive pulmonary disease (COPD)
• Shortness of breath
• Symptoms of an allergic reaction (swelling, redness of the eye and skin rash)
• Dizziness
• Increased blood pressure values
• Change in skin color (around the eye)

In addition to the side effects of bimatoprost 0.1 mg/ml, the following side effects have been observed with another medicine containing a
higher concentration of bimatoprost (0.3 mg/ml):

• Eye burning
• An allergic reaction to the eye
• Inflamed eyelids
• Difficulty seeing clear images
• Worsening of vision
• Swelling of the clear layer covering the surface of the eye
• Tearing
• Darker eyelashes
• Retinal bleeding
• Inflammation inside the eye
• Cystoid macular edema (swelling of the retina inside the eye that leads to worsening of vision)
• Eyelid spasms
• Narrowing of the eyelid, which moves away from the surface of the eye
• Redness of the skin around the eye
• Weakness
• Increased values in blood tests relating to liver function

Other side effects reported with eye drops containing phosphates
In very rare cases, some patients with severe damage to the clear layer of the front of the eye (the
cornea) have developed opaque areas 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 possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at 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 BROSTIMAB 0,1 mg/ml single-dose

Keep this medicine out of the sight and reach of children.
Store in the original packaging to protect the medicine from light.
This medicine is for single use only and does not contain preservatives. Do not store unused solution.
After the first opening of the aluminum pouch: use the single-dose containers 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 use this medicine after the expiry date stated on the single-dose container, the sachet and the carton after Exp. The expiry date refers to the last day of that month.
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 BROSTIMAB 0,1 mg/ml single-dose contains

• The active ingredient is bimatoprost. One ml of solution contains 0.1 mg of bimatoprost.
• The other components are: sodium chloride, disodium phosphate heptahydrate, citric acid monohydrate and water for injections. Small amounts of hydrochloric acid or sodium hydroxide may be added to maintain a normal acidity level (pH).

Description of the appearance of BROSTIMAB 0,1 mg/ml single-dose and contents of the pack
BROSTIMAB 0,1 mg/ml single-dose is a clear and colourless solution, supplied in a pack containing
30 single-dose containers of 0.15 ml.

Marketing Authorisation Holder
GENETIC S.p.A. - Via Della Monica, 26 – 84083 Castel S. Giorgio (SA)

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