Bialviz

Patient Information Leaflet: Information for the User

BROSTIMAB 0.3 mg/mL, eye drops, solution
Bimatoprost
Equivalent medicine
Please read this leaflet carefully before 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult 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 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. Contents of the pack and other information

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

BROSTIMAB eye drops is an antiglaucoma medicine. It belongs to a class of medicines called
prostamides.
BROSTIMAB is used to reduce elevated intraocular pressure. This medicine may be used
alone or in combination with other eye drops called beta-blockers, which also help reduce pressure
in the eye.
The eye contains a clear, watery fluid that nourishes its interior. This fluid is constantly drained from the eye, and new fluid is produced to replace the drained fluid. If the fluid is not drained quickly enough, pressure inside the eye increases. This medicine works by increasing the amount of fluid drained, thereby reducing the pressure inside the eye. Elevated intraocular pressure, if not reduced, can lead to a condition called glaucoma and may eventually cause vision damage.

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 substance bimatoprost or to any of the other ingredients of this medicine (listed in section 6).
• if in the past you had to discontinue use of eye drops due to an adverse reaction 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 have respiratory problems
• you have liver or kidney problems
• you have previously undergone cataract surgery
• you suffer from dry eye
• you have or have had corneal problems (the transparent front part of the eye)
• you wear contact lenses (see “BROSTIMAB 0.3 mg/ml contains benzalkonium chloride”)
• you have or have had 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 can lead to
deepening of the eyelid crease, sunken eye (enophthalmos), drooping of the upper eyelid (ptosis), tightness of the skin around the eye (dermatological involution), and exposure of the lower white part of the eye (inferior scleral show). These changes are usually mild in degree, but if pronounced, they may impair the visual field. If you stop using BROSTIMAB, these changes may resolve.
BROSTIMAB may also cause darkening and lengthening of the eyelashes, as well as darkening of the eyelids. The colour 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 studied in patients under 18 years of age and therefore should not be used in patients under 18 years of age.

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

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
BROSTIMAB may pass into breast milk; therefore, breastfeeding is not recommended 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 cleared.

BROSTIMAB 0.3 mg/ml contains benzalkonium chloride.
BROSTIMAB contains a preservative called benzalkonium chloride; it may cause ocular irritation and may 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 reinserting your contact lenses.

3. How to use BROSTIMAB 0.3 mg/ml

Use this medicine exactly as your doctor or pharmacist has told you. If you are
unsure, consult your doctor or pharmacist.
BROSTIMAB should be applied only to the eyes. The recommended dose is one drop of
BROSTIMAB once daily, in the evening, in each eye to be treated.
If you use BROSTIMAB with another eye medicine, wait at least 5 minutes after using
BROSTIMAB before applying the second eye medicine.
Do not use the medicine more than once a day, as the effectiveness of 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 backward and look upward.
2. Gently pull down the lower eyelid to form a small pocket.
3. Invert the bottle and apply slight pressure to release one drop of eye drops into each eye to be treated.
4. Release the lower eyelid and close the eye for 30 seconds.

Wipe away any excess liquid running down the cheek.
If the drop did not enter the eye, repeat the procedure.
To avoid eye infections and injury, the tip of the bottle must not touch the eye or come into
contact with any other surfaces. After using the bottle, close it properly by screwing the cap back on tightly.
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.
Take the next dose at your usual time. If you are concerned, 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, apply one single drop and then return to your
regular dosing schedule. Do not take a double dose to make up for a forgotten dose.
If you stop using BROSTIMAB 0.3 mg/ml
For BROSTIMAB to work properly, it must be used every day. If you stop using
BROSTIMAB, eye pressure may increase; therefore, you must speak with your doctor before
discontinuing this treatment.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Very common side effects
These may affect more than 1 in 10 people.
Eye effects

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

Common side effects
These may affect 1 to 9 in 100 people.
Eye effects

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

Systemic effects

• Headache
• Increased liver function test values in blood tests
• Increased blood pressure values

Uncommon side effects
These may affect 1 to 9 in 1,000 people.
Eye-related effects

• Cystoid macular edema (swelling of the retina inside the eye leading to worsening of vision)
• Inflammation inside the eye
• Retinal bleeding
• Swollen eyelids
• Eyelid spasms
• Eyelid tightening pulling away from the eye surface
• Redness of the skin around the eye
• Loss of fat in the eye area which may lead to deepening of the eyelid crease, sunken eye (enophthalmos), drooping eyelid (ptosis), tightness of the skin around the eye (involution of dermatochalasis), and exposure of the lower white part of the eye (inferior scleral show)

Systemic effects

• Nausea
• Dizziness
• Weakness
• Growth of hair around the eye

Side effects with unknown frequency
Eye-related effects

• Eye discomfort

Systemic effects

• Asthma
• Worsening of asthma
• Worsening of chronic obstructive pulmonary disease (COPD)
• Shortness of breath
• Skin colour changes (periorbital)

Other side effects reported with eye drops containing phosphates
In very rare cases, some patients with severe damage to the transparent layer at the front of the eye (the cornea) have developed cloudy areas on the cornea due to calcium buildup 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 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 stated on the label of the vial and on the carton after Exp. The expiry date refers to the last day of that month.
After first opening 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 carton.
Do not dispose of medicines via 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 0.3 mg/ml contains

• The active substance is bimatoprost. One ml of solution contains 0.3 mg of bimatoprost.
• The other components 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 contents of the pack
BROSTIMAB is a clear, colourless ophthalmic solution supplied in a pack 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)

Package leaflet: Information for the user

BROSTIMAB 0.3 mg/ml, eye drops, solution in single-dose container
Bimatoprost
Equivalent medicine
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 pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult 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 using 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. Contents of the pack and other information

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

BROSTIMAB 0.3 mg/ml single-dose is an antiglaucoma medicine. It belongs to a group of medicines
called prostamides.
BROSTIMAB 0.3 mg/ml eye drops solution in single-dose containers is used to reduce elevated intraocular pressure.
This medicine can be used alone or together with other eye drops called beta-blockers, which also help reduce eye pressure.
The eye contains a clear, watery fluid that nourishes its internal structures. This fluid is constantly drained from the eye, and new fluid is produced to replace the drained fluid. If the fluid is not drained quickly enough, the pressure inside the eye increases. This medicine works by increasing the amount of fluid that is drained, thereby reducing the pressure inside the eye. If elevated intraocular pressure is not reduced, it can lead to a condition called glaucoma and may eventually cause vision damage.
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 substance 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 have breathing problems.
• you have liver or kidney problems.
• you have previously undergone cataract surgery.
• you suffer or have suffered from low blood pressure or slow heart rate.
• you have had a viral infection or inflammation of the eye.

During treatment, BROSTIMAB may cause loss of fat around the eye, which can lead to
deepening of the eyelid crease, sunken eye (enophthalmos), drooping of the upper eyelid (ptosis), tightness of the skin around the eye (dermatocalasis involution), and exposure of the lower white part of the eye (inferior scleral show). These changes are usually mild in degree, but if pronounced, they may impair the visual field. If you discontinue use of BROSTIMAB, these changes may resolve.

BROSTIMAB 0.3 mg/ml single-dose may also cause darkening and lengthening of the eyelashes, and may 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
BROSTIMAB 0.3 mg/ml single-dose has not been tested in patients under 18 years of age and therefore must not be used in patients under 18 years of age.

Other medicines and BROSTIMAB 0.3 mg/ml single-dose
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
BROSTIMAB 0.3 mg/ml single-dose may pass into breast milk; therefore, breastfeeding is not recommended during treatment with this medicine.

Driving and using machines
After administration of BROSTIMAB 0.3 mg/ml single-dose, you may experience a mild, transient blurring of vision. In this case, do not drive or operate machinery until your vision has cleared.

3. How to use BROSTIMAB 0.3 mg/ml single-dose

Take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is one drop once daily in the evening in each eye to be treated. BROSTIMAB
0.3 mg/ml single-dose must be applied only in the eyes.
If you are using BROSTIMAB 0.3 mg/ml single-dose together with another eye medicine, wait at least 5 minutes after using BROSTIMAB 0.3 mg/ml single-dose before applying the second eye medicine.
Do not use it more than once a day, as the effectiveness of treatment may be reduced.

Instructions for use:
Wash your hands before use. Ensure the single-dose container is intact before use. The solution should be used immediately after opening. To avoid contamination, take care that the open end of the single-dose container does not touch the eye or any other surfaces.

1. Take a single-dose container and hold it in an upright position (with the cap facing upwards) and twist the cap.
2. Gently pull down the lower eyelid to form a pouch. Invert the single-dose container and gently squeeze to release one drop of eye drops into the eye(s) to be treated. Open and close the eye(s) for a few seconds.
3. Discard the single-dose container immediately after use, even if there is some solution remaining inside.

Wipe away any excess liquid running down the cheek.
If you wear contact lenses, remove them before using this medicine. Wait 15 minutes after using the eye drops before reinserting your lenses.

If you use more BROSTIMAB 0.3 mg/ml single-dose than you should
If you use more of this medicine than recommended, it is unlikely to cause serious harm. Take the next dose at your usual time. If you are concerned, 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, apply one single drop and then continue with your regular dosing schedule. 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 BROSTIMAB 0.3 mg/ml single-dose to work properly, it must be used every day. If you stop using BROSTIMAB 0.3 mg/ml single-dose, eye pressure may increase; therefore, speak with your doctor before stopping this treatment.

If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Very common side effects
These may affect 1 or more patients in 10
Eye-related effects

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

Common side effects
These may affect 1 to 9 patients in 100
Eye-related effects

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

Uncommon side effects
These may affect 1 to 9 patients in 1000
Eye-related effects

• Tired eyes
• Light sensitivity
• Darkening of the iris colour
• Itchy and swollen eyelids
• Tearing
• Swelling of the transparent layer covering the eye surface
• Blurred vision

Systemic side effects

• Headache
• Growth of hair around the eye

Side effects with unknown frequency
Systemic effects

• Asthma
• Worsening of asthma
• Worsening of the lung disease known as chronic obstructive pulmonary disease (COPD)
• Shortness of breath
• Symptoms of allergic reaction (swelling, eye redness, and skin rash)
• Dizziness
• Increase in blood pressure values
• Change in skin colour (around the eye)

Eye-related effects

• 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 the 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, pulling away from the eye surface
• Nausea
• Redness of the skin around the eyes
• Weakness
• Increased liver function test values in blood tests

Other side effects reported with eye drops containing phosphates
In very rare cases, some patients with severe damage to the transparent layer at the front of the eye (the cornea) have developed opaque areas on the cornea due to calcium buildup 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 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 any unused solution.
After first opening the aluminium 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 residual medicine must be discarded.
Do not use this medicine after the expiry date stated on the single-dose container, sachet, and carton after EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine via 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 0.3 mg/ml single-dose contains

• The active substance is bimatoprost. One ml of solution contains 0.3 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 level of acidity (pH).

Description of the appearance of BROSTIMAB 0.3 mg/ml single-dose and contents of the pack
BROSTIMAB 0.3 mg/ml single-dose is a clear, colourless solution supplied in single-dose plastic containers, divided into 6 strips of 5 containers each, placed in a pouch.
Each single-dose container holds 0.4 ml of solution.
Each pack contains 30 single-dose containers.
Marketing Authorization Holder
GENETIC S.p.A. - Via Della Monica, 26 – 84083 Castel S. Giorgio (SA)
Manufacturer
Genetic S.p.A.
Contrada Canfora
84084 Fisciano (SA)

Package leaflet: Information for the user

BROSTIMAB 0.1 mg/ml, eye drops, solution
Bimatoprost
Equivalent medicine
Please read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact 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 using 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 BROSTIMAB 0.1 mg/ml is and what it is used for

BROSTIMAB is an anti-glaucoma medicine. It belongs to a class of medicines called prostamides.
BROSTIMAB eye drops are used to reduce elevated intraocular pressure. This medicine can be used alone or in combination with other eye drops called beta-blockers, which also help reduce pressure in the eye.
The eye contains a clear, watery fluid that nourishes its internal structures. This fluid is constantly drained from the eye, and new fluid is produced to replace what is drained. If the fluid does not drain quickly enough, pressure inside the eye increases. This medicine works by increasing the amount of fluid drained, thereby reducing intraocular pressure. If elevated intraocular pressure is not reduced, it can lead to a condition called glaucoma, which may eventually cause vision damage.

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 substance bimatoprost or to any of the other ingredients of this medicine (listed in section 6).
• if in the past you had to discontinue use of eye drops due to an adverse reaction 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 have breathing problems
• you have liver or kidney problems
• you have previously undergone cataract surgery
• you suffer from dry eye
• you have or have had corneal problems (the transparent front part of the eye)
• you wear contact lenses (see “BROSTIMAB 0.1 mg/ml contains benzalkonium chloride”)
• you suffer or have suffered from hypotension or bradycardia
• you have had a viral infection or inflammation of the eye. 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). These changes are usually mild in degree, but if pronounced, they may impair the visual field. If you stop using BROSTIMAB, these changes may resolve.

BROSTIMAB may also cause darkening and elongation of the eyelashes, as well as darkening of the eyelids. The colour 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 studied in patients under 18 years of age and therefore should not be used in patients under 18 years of age.

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

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
BROSTIMAB may pass into breast milk; therefore, breastfeeding is not recommended during treatment with this medicine.

Driving and using machines
After administration of BROSTIMAB, you may experience a mild, transient blurring of vision. In this case, do not drive or operate machinery until your vision has cleared.

BROSTIMAB 0.1 mg/ml contains benzalkonium chloride.
BROSTIMAB contains a preservative called benzalkonium chloride; it may cause ocular irritation and may discolour 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 reinserting your contact lenses.

3. How to use BROSTIMAB 0.1 mg/ml

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
BROSTIMAB must be applied only to the eyes. The recommended dose is one drop of
BROSTIMAB once daily in the evening, in each eye to be treated.
If you use BROSTIMAB together with another eye medicine, apply BROSTIMAB eye drops first and wait 5
minutes before applying the second eye medicine.
Do not use the medicine more than once a day, as the effectiveness of 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 backwards and look upwards.
2. Gently pull down the lower eyelid to form a small pocket.
3. Invert the bottle and gently squeeze to release 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 liquid running down the cheek.
If the drop did not enter the eye, repeat the procedure.
To avoid eye infections and injury, the tip of the bottle must not touch the eye or come into
contact with any other surfaces. After using the bottle, close it tightly by screwing the cap back on.
Use in children and adolescents
BROSTIMAB must 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 harm.
Take your next dose at the usual time. If you are concerned, 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, apply one single drop and then return to your
regular dosing schedule. Do not take a double dose to make up for a missed dose.
If you stop using BROSTIMAB 0.1 mg/ml
For BROSTIMAB to work properly, it must be used every day. If you stop using
BROSTIMAB, eye pressure may increase; therefore, you must speak with your doctor before
stopping this treatment.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist.

Very common side effects
These may occur in 1 or more out of 10 patients.
Eye-related effects

• 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 (dermatocalasis), and exposure of the lower white part of the eye (inferior scleral show).

Common side effects
These may occur in 1 to 9 out of 100 patients.
Eye-related effects

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

Skin-related side effects

• Red, itchy eyelids
• Darkening of the skin around the eye
• Increased hair growth around the eye

Uncommon side effects
These may occur in 1 to 9 out of 1,000 patients.
Eye-related effects

• Darkening of the iris color
• Tired eyes
• Swelling of the eye surface
• Blurred vision
• Eyelash loss

Skin-related effects

• Dryness
• Crusting at the edge of the eyelid
• Eyelid swelling
• Itching

Systemic effects

• Headache
• Feeling unwell

Side effects with unknown frequency
Eye-related effects

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

Systemic effects

• Asthma
• Worsening of asthma
• Worsening of the lung condition known as chronic obstructive pulmonary disease (COPD)
• Shortness of breath
• Symptoms of allergic reaction (swelling, eye redness, skin rash)
• Dizziness
• Increase in blood pressure values
• Change in skin pigmentation (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
• Allergic reaction in the eye
• Inflamed eyelids
• Difficulty seeing clear images
• Worsening of vision
• Swelling of the transparent layer covering the eye surface
• Tearing
• Darker eyelashes
• Retinal bleeding
• Inflammation inside the eye
• Cystoid macular edema (swelling of the retina inside the eye leading to worsening vision)
• Eyelid spasms
• Narrowing of the eyelid, pulling away from the eye surface
• Redness of the skin around the eye
• Weakness
• Increased liver function test values in blood analyses

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly via 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 on the carton
after Exp. The expiry date refers to the last day of that month.
After first opening 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 carton.
Do not dispose of any medicine via 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 substance is bimatoprost. One ml of solution contains 0.1 mg of bimatoprost.
• The other components 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, colourless ophthalmic 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)

Package leaflet: Information for the user

BROSTIMAB 0.1 mg/ml, eye drops, solution, in single-dose container
Bimatoprost
Please read this leaflet carefully before 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult 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 using 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. Contents of the pack and other information

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

BROSTIMAB 0.1 mg/ml single-dose is an antiglaucoma medicine. It belongs to a group of medicines
called prostamides.
BROSTIMAB 0.1 mg/ml single-dose eye drop solution is used to reduce elevated intraocular pressure.
This medicine can be used alone or together with other eye drops called beta-blockers, which also help
reduce pressure in the eye.
The eye contains a clear, watery fluid that nourishes its interior. This fluid is constantly drained from the eye, and new fluid is produced to replace the drained fluid. If the fluid is not drained quickly enough, the pressure inside the eye increases. This medicine works by increasing the amount of fluid that is drained, thereby reducing the pressure inside the eye. Elevated intraocular pressure, if not reduced, can lead to a condition called glaucoma and may eventually cause damage to vision.
This medicine does not contain preservatives.

2. What you should know before using BROSTIMAB 0.1 mg/ml single dose

Do not use this medicine

• if you are allergic to the active substance 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 have breathing problems
• you have liver or kidney problems
• you have previously undergone cataract surgery
• you suffer from dry eyes
• you have or have had corneal problems (the transparent front part of the eye)
• you have or have had 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 can lead to
deepening of the eyelid crease, sunken eye (enophthalmos), drooping of the upper eyelid
(ptosis), tightness of the skin around the eye (involution of dermatochalasis), and exposure
of the lower white part of the eye (inferior scleral show). Changes are usually mild in degree,
but if pronounced, they may impair the visual field. If you stop using
BROSTIMAB, these changes may resolve.
BROSTIMAB 0.1 mg/ml single dose may also cause darkening and lengthening of the eyelashes, and may darken the eyelids. The colour 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 in patients under 18 years of age and therefore must not be used in patients under 18 years of age.

Other medicines and BROSTIMAB 0.1 mg/ml single dose
Inform 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 may be pregnant, are planning a pregnancy, or 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; therefore, breastfeeding is not recommended during treatment with this medicine.

Driving and using machines
After administration of BROSTIMAB 0.1 mg/ml single dose, you may experience a mild, transient blurring of vision. In this case, do not drive or operate machinery until your vision has cleared.

3. How to use BROSTIMAB 0.1 mg/ml single-dose

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult 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 daily in the evening, in each eye to be treated.
If you are using BROSTIMAB 0.1 mg/ml single-dose together with another eye medicine, apply BROSTIMAB
eye drops first and wait 5 minutes before applying the second eye medicine.
Do not use the medicine more than once a day, as the effectiveness of treatment may be reduced.

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

1. Take a single-dose container and hold it upright (with the cap facing upwards), then twist the cap.
2. Gently pull down 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 the eye(s) for a few seconds.
3. Dispose of the single-dose container immediately after use, even if some solution remains inside.

Wipe away any excess liquid running down the cheek.
If you wear contact lenses, remove them before using this medicine. Wait 15 minutes after using the eye drops before reinserting your lenses.

Use in children and adolescents
BROSTIMAB 0.1 mg/ml single-dose must 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 harm.
Take the next dose at your usual time. If you are concerned, 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, apply one drop and then continue with your
regular dosing schedule. Do not use a double dose to make up for a forgotten dose.

If you stop using BROSTIMAB 0.1 mg/ml single-dose
For BROSTIMAB 0.1 mg/ml single-dose to work properly, it must be used every day. If
you stop using BROSTIMAB 0.1 mg/ml single-dose, eye pressure may increase; therefore, you should
talk to your doctor before stopping this treatment.

If you have any questions about how to use 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 effect, including those not listed in this leaflet, please consult your doctor or pharmacist.

Very common side effects
These may occur in 1 or more patients out of 10.
Eye-related effects

• 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), tightness of the skin around the eye (dermatocalasis), and exposure of the lower white part of the eye (inferior scleral show).

Common side effects
These may occur in 1 to 9 patients out of 100.
Eye-related effects

• Small ulcers on the surface of the eye, with or without inflammation
• Irritation
• Itching of the eyes
• Eyelash elongation
• Irritation when administering the eye drops
• Eye pain

Skin-related side effects

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

Uncommon side effects
These may occur in 1 to 9 patients out of 1,000.
Eye-related effects

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

Skin-related effects

• Dryness
• Crusting at the edge of the eyelid
• Swelling of the eyelid
• Itching

Systemic effects

• Headache
• Feeling unwell

Side effects with unknown frequency
Eye-related effects

• Macular edema (swelling of the retina at the back of the eye, which may lead to worsening of vision)
• Darkening of the eyelids
• Dry eye
• Sticky eyes
• Sensation of a foreign body in the eye
• Eye swelling
• Increased tearing
  • Eye discomfort
  • Light sensitivity

Systemic effects

• Asthma
• Worsening of asthma
• Worsening of chronic obstructive pulmonary disease (COPD)
• Shortness of breath
• Symptoms of allergic reaction (swelling, eye redness, skin rash)
  • Dizziness
  • Increased blood pressure values
  • Skin colour changes (discoloration 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 in the eye
• Inflamed eyelids
• Difficulty seeing clear images
• Worsening of vision
• Swelling of the transparent layer covering the eye surface
• Tearing
• Darker eyelashes
• Retinal bleeding
• Inflammation inside the eye
• Cystoid macular edema (swelling of the retina inside the eye leading to worsening of vision)
• Eyelid spasms
• Eyelid tightening, pulling away from the eye surface
• Redness of the skin around the eye
• Weakness
• Increased liver function test values in blood analyses

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 part of the eye (the cornea) have developed opaque areas 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, please consult your doctor or pharmacist. You may also report side effects directly via 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 any unused solution.
After first opening the aluminium 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 residual medicine must be discarded.
Do not use this medicine after the expiry date stated on the single-dose container, on the sachet, and on the outer carton after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Pack contents and other information

What BROSTIMAB 0.1 mg/ml single-dose contains

• The active substance 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 pH level (acidity).

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, colourless solution supplied in a pack containing
30 single-dose containers of 0.15 ml each.
Marketing Authorization Holder
GENETIC S.p.A. - Via Della Monica, 26 – 84083 Castel S. Giorgio (SA)
Manufacturer
Genetic S.p.A.
Contrada Canfora
84084 Fisciano (SA)