Bimanext

Package leaflet: Information for the user

BIMANEXT 0.3 mg/ml, eye drops, solution

Bimatoprost
Generic 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 others, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What BIMANEXT 0.3 mg/ml is and what it is used for
2. What you need to know before using BIMANEXT 0.3 mg/ml
3. How to use BIMANEXT 0.3 mg/ml
4. Possible side effects
5. How to store BIMANEXT 0.3 mg/ml
6. Contents of the pack and other information

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

BIMANEXT eye drops is an antiglaucoma medicine. It belongs to a group of medicines called prostamides.
BIMANEXT 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 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, 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 left untreated, can lead to a condition called glaucoma and may eventually cause damage to vision.

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

Do not use BIMANEXT 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 BIMANEXT 0.3 mg/ml.
Consult your doctor if:

• you suffer from 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 “BIMANEXT 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, BIMANEXT 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 (lower scleral show). These changes are usually mild in degree, but if pronounced, they may impair the visual field. If you stop using BIMANEXT, these changes may resolve. BIMANEXT may also cause darkening and elongation 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
Bimatoprost has not been studied in patients under 18 years of age and therefore must not be used in patients under 18 years of age.

Other medicines and BIMANEXT
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, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
BIMANEXT may pass into breast milk; therefore, breastfeeding is not recommended during treatment with this medicine.

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

BIMANEXT 0.3 mg/ml contains benzalkonium chloride.
BIMANEXT 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 BIMANEXT 0.3 mg/ml

Take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
BIMANEXT must be applied only in the eyes. The recommended dose is one drop of
BIMANEXT once daily, in the evening, in each eye to be treated.
If you use BIMANEXT together with another eye medicine, wait at least 5 minutes after using BIMANEXT
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. Turn the bottle upside down and apply gentle 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 injuries, 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 BIMANEXT 0.3 mg/ml than you should
If you use more BIMANEXT than recommended, 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 BIMANEXT 0.3 mg/ml
If you forget to use BIMANEXT, as soon as you remember, apply one drop and then return to your
regular dosing schedule. Do not use a double dose to make up for the missed dose.

If you stop using BIMANEXT 0.3 mg/ml
To work properly, BIMANEXT must be used every day. If you stop using
BIMANEXT, your eye pressure may increase; therefore, you must speak with your doctor before stopping this treatment.

If you have any questions about using 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, speak to your doctor or pharmacist.

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

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

Effects on the ocular region

• Loss of fat in the ocular region, which may lead to deepening of the eyelid crease, sunken eye (enophthalmos), drooping eyelid (ptosis), tightness of the skin around the eye (dermatocalasis involution), and exposure of the lower white part of the eye (lower scleral show).

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

• Ocular allergic reaction
• Tired eyes
• Light sensitivity
• Darkening of the skin around the eye
• Darker eyelashes
• Pain
• Foreign body sensation 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 side effects

• Headache
• Increased blood test values related to liver function
• Increased blood pressure values

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

• Cystoid macular edema (swelling of the retina inside the eye leading to worsening vision)
• Inflammation inside the eye
• Retinal bleeding
• Swollen eyelids
• Eyelid spasms
• Narrowing of the eyelid, pulling away from the eye surface
• Redness of the skin around the eye

Systemic side effects

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

Side effects with unknown frequency
Eye-related effects

• Ocular discomfort

Systemic side effects

• Asthma
• Worsening of asthma
• Worsening of the lung disease known as chronic obstructive pulmonary disease (COPD)
• Shortness of breath
• Skin colour changes (periocular)

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 accumulation during treatment.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, speak 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 0.3 mg/ml

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the vial label and on the carton after "Exp". The expiry date refers to the last day of that month.
After first opening the BIMANEXT 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 no longer in use. This will help protect the environment.

6. Package contents and other information

What BIMANEXT 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 BIMANEXT 0.3 mg/ml and contents of the pack
BIMANEXT is a clear, colourless eye drop solution supplied in a pack containing 1 plastic bottle with a screw cap,
containing 3 ml of solution.

Marketing Authorization Holder
FB Vision S.p.A.
Via San Giovanni Scafa, snc
63074 – San Benedetto del Tronto (AP) - Italy

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

Package leaflet: Information for the user

BIMANEXT 0.3 mg/ml, eye drops, solution in single-dose container

Bimatoprost
Equivalent medicine
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, 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, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What BIMANEXT 0.3 mg/ml single-dose is and what it is used for
2. What you need to know before using BIMANEXT 0.3 mg/ml single-dose
3. How to use BIMANEXT 0.3 mg/ml single-dose
4. Possible side effects
5. How to store BIMANEXT 0.3 mg/ml single-dose
6. Contents of the pack and other information

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

BIMANEXT 0.3 mg/ml single-dose is an antiglaucoma medicine. It belongs to a class of medicines
called prostamides.
BIMANEXT 0.3 mg/ml eye drops solution in single-dose container 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 eye pressure.
The eye contains a clear, watery fluid that nourishes its internal structures. This fluid is continuously drained from the eye, while new fluid is produced to replace what has been drained. 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 intraocular pressure. If left untreated, elevated intraocular pressure 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 BIMANEXT 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 BIMANEXT 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 have or have had low blood pressure or slow heart rate.
• you have had a viral infection or inflammation of the eye.

During treatment, BIMANEXT 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 (lower scleral show). Changes are usually mild in degree, but if pronounced, they may impair the visual field. If you discontinue use of BIMANEXT, these changes may resolve. BIMANEXT 0.3 mg/ml single dose 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
BIMANEXT 0.3 mg/ml single dose has not been studied in patients under 18 years of age and therefore must not be used in patients under 18 years of age.

Other medicines and BIMANEXT 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, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
BIMANEXT 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 BIMANEXT 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 BIMANEXT 0.3 mg/ml single-dose

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose is one drop once daily in the evening, in each eye to be treated. BIMANEXT 0.3 mg/ml single-dose must be applied only in the eyes.
If you use BIMANEXT 0.3 mg/ml single-dose together with another eye medicine, wait at least 5 minutes after using BIMANEXT 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. Make sure 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 surface.

1. Take a single-dose container and hold it in an upright position (with the cap facing upwards), then unscrew the cap.
2. Gently pull down the lower eyelid to form a pouch. Invert the single-dose container 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. Discard the single-dose container immediately after use, even if there is still 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 contact lenses.

If you use more BIMANEXT 0.3 mg/ml single-dose than you should
If you use more of this medicine than you should, it is unlikely to cause serious problems. Take the next dose at your usual time. If you are concerned, consult your doctor or pharmacist.

If you forget to use BIMANEXT 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 forgotten dose.

If you stop using BIMANEXT 0.3 mg/ml single-dose
For BIMANEXT 0.3 mg/ml single-dose to work properly, it must be used every day. If you stop using BIMANEXT 0.3 mg/ml single-dose, your intraocular pressure may increase; therefore, speak with your doctor before stopping this treatment.

If you have any doubts 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, please talk to your doctor or pharmacist.

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

• Mild redness (up to 24% of people)

Effects on the eye area

• Loss of fat around 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 (lower scleral show).

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

• Small ulcers on the surface of the eye, with or without inflammation
• Irritation
• Itching of the eye
• Pain
• Dryness
• Foreign body sensation in the eye
• Longer eyelashes
• Darkening of the skin around the eye
• Redness of the eyelids

Uncommon side effects
These may affect 1 to 9 people 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 chronic obstructive pulmonary disease (COPD)
• Shortness of breath
• Symptoms of allergic reaction (swelling, eye redness, skin rash)
• Dizziness
• Increase in blood pressure values
• Skin colour changes (around the eye)

Eye-related effects

• Sticky eyes
• Eye discomfort

In addition to the side effects of BIMANEXT 0.3 mg/ml single-dose, the following side effects have been observed with the multidose formulation of BIMANEXT 0.3 mg/ml containing a preservative and may occur in patients using BIMANEXT 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
• Eyelid tightening, 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 cloudy 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, please 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 BIMANEXT 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 leftover 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 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. Package contents and other information

What BIMANEXT 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, monohydrate citric acid and water for injections. Small amounts of hydrochloric acid or sodium hydroxide may be added to maintain a normal pH level (pH).

Description of the appearance of BIMANEXT 0.3 mg/ml single-dose and contents of the pack
BIMANEXT 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 contains 0.4 ml of solution.
Each pack contains 30 single-dose containers.
Marketing Authorization Holder
FB Vision S.p.a
Via San Giovanni Scafa, snc
63074 – San Benedetto del Tronto (AP) - Italy
Manufacturer
Genetic S.p.A.
Contrada Canfora
84084 Fisciano (SA)
Package leaflet: information for the user

BIMANEXT 0.1 mg/ml, eye drops, solution

Bimatoprost
Equivalent medicine
Please read this leaflet carefully before using this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could 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 BIMANEXT 0.1 mg/ml is and what it is used for
2. What you need to know before using BIMANEXT 0.1 mg/ml
3. How to use BIMANEXT 0.1 mg/ml
4. Possible side effects
5. How to store BIMANEXT 0.1 mg/ml
6. Contents of the pack and other information

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

BIMANEXT is an antiglaucoma medicine. It belongs to a class of medicines called prostamides.
BIMANEXT eye drops are used to reduce elevated intraocular pressure. This medicine can be used alone or in combination with other eye drops known as 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 continuously drained from the eye, and new fluid is produced to replace it. If the fluid does not drain quickly enough, pressure inside the eye increases. This medicine works by increasing the amount of fluid drained from the eye, thereby reducing intraocular pressure. If elevated eye pressure is not lowered, it may lead to a condition called glaucoma, which can eventually cause vision damage.

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

Do not use BIMANEXT 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 BIMANEXT 0.1 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 “BIMANEXT 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 eyes.

During treatment, BIMANEXT may cause loss of fat around the eye, which may lead to deepening of the eyelid fold, 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 discontinue use of BIMANEXT, these changes may resolve. BIMANEXT 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
Bimatoprost has not been studied in patients under 18 years of age; therefore, it must not be used in patients under 18 years of age.

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

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

BIMANEXT 0.1 mg/ml contains benzalkonium chloride.
BIMANEXT 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 BIMANEXT 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.
BIMANEXT must be applied only in the eyes. The recommended dose is one drop of
BIMANEXT once daily, in the evening, in each eye to be treated.
If you use BIMANEXT with another eye medicine, apply BIMANEXT 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 backward and look upward.
2. Gently pull down the lower eyelid to form a small pocket.
3. Invert the bottle and gently squeeze to release one drop 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 use, close the bottle tightly by screwing the cap back on.

Use in children and adolescents
BIMANEXT must not be given to children and adolescents under 18 years of age.

If you use more BIMANEXT 0.1 mg/ml than you should
If you use more BIMANEXT than you should, it is unlikely to cause serious problems.
Take the next dose at your usual time. If you are concerned, consult your doctor or pharmacist.

If you forget to use BIMANEXT 0.1 mg/ml
If you forget to use BIMANEXT, as soon as you remember, instill one 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 BIMANEXT 0.1 mg/ml
For BIMANEXT to work properly, it must be used every day. If you stop using
BIMANEXT, intraocular pressure may increase, so you must speak with your doctor before stopping this treatment.

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

4. Possible side effects

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

• Mild redness (up to 29% of people)

Ocular region effects

• Loss of fat in the eye area, which may lead to deepening of the eyelid crease, sunken eye (enophthalmos), drooping eyelid (ptosis), skin tightness around the eye (dermatocalasis), and exposure of the lower white part of the eye (lower scleral show).

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

• 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
• Increased hair growth 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

General 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
• Foreign body sensation in the eye
• Eye swelling
• Increased tearing
• Eye discomfort
• Light sensitivity

General 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
• Increase in 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
• 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 at the front 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, please consult 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 BIMANEXT 0.1 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 vial label and on the carton after "Exp". The expiry date refers to the last day of that month.
After first opening the BIMANEXT 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. Contents of the pack and other information

What BIMANEXT 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 BIMANEXT 0.1 mg/ml and contents of the pack
BIMANEXT is a clear, colourless eye drop solution supplied in a pack containing 1 plastic bottle with a screw cap containing 3 ml of solution.
Marketing Authorisation Holder
FB Vision S.p.a
Via San Giovanni Scafa, snc
63074 – San Benedetto del Tronto (AP) - Italy
Manufacturer
Genetic S.p.A.
Contrada Canfora
84084 Fisciano (SA)
Package leaflet: information for the user

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

Bimatoprost
Please read this entire 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, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What BIMANEXT 0.1 mg/ml single-dose is and what it is used for
2. What you need to know before using BIMANEXT 0.1 mg/ml single-dose
3. How to use BIMANEXT 0.1 mg/ml single-dose
4. Possible side effects
5. How to store BIMANEXT 0.1 mg/ml single-dose
6. Contents of the pack and other information

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

BIMANEXT 0.1 mg/ml single-dose is an antiglaucoma medicine. It belongs to a class of medicines
called prostamides.
BIMANEXT 0.1 mg/ml eye drops solution in single-dose containers is 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 continuously 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 intraocular pressure. If elevated intraocular pressure is not reduced, it may 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 BIMANEXT 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 BIMANEXT 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 eye
• 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, BIMANEXT may cause loss of fat around the eye, which can lead to
deepening of the eyelid fold, 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 (lower scleral show). These changes are usually mild in degree, but if pronounced, they may impair the visual field. If you discontinue the use of BIMANEXT, these changes may resolve. BIMANEXT 0.1 mg/ml single-dose 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

BIMANEXT 0.1 mg/ml single-dose has not been studied in patients under 18 years of age and therefore must not be used in patients under 18 years of age.

Other medicines and BIMANEXT 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, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
BIMANEXT 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 BIMANEXT 0.1 mg/ml single-dose, you may experience mild, transient blurred vision. In this case, do not drive or operate machinery until your vision has cleared.

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

Use this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.

BIMANEXT 0.1 mg/ml single-dose must be used only in the eyes. The recommended dose is one drop once daily in the evening, in each eye to be treated.

If you are using BIMANEXT 0.1 mg/ml single-dose together with another eye medicine, apply BIMANEXT 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. Make sure 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 surface.

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) several times.
3. Discard the single-dose container immediately after use, even if there is some solution left 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

BIMANEXT 0.1 mg/ml single-dose must not be given to children and adolescents under 18 years of age.

If you use more BIMANEXT 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 problems. Take the next dose at the usual time. If you are concerned, consult your doctor or pharmacist.

If you forget to use BIMANEXT 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 normal dosing schedule. Do not use a double dose to make up for a forgotten dose.

If you stop using BIMANEXT 0.1 mg/ml single-dose

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

If you have any doubts 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, talk to your doctor or pharmacist.

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

Eye effects

• Mild eye redness (up to 29% of people)

Effects on the eye area

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

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

Eye effects

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

Skin effects

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

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

Eye effects

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

Skin effects

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

General effects

• Headache
• Feeling unwell

Side effects with unknown frequency

Eye 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
• Foreign body sensation in the eye
• Eye swelling
• Increased tearing
• Eye discomfort
• Light sensitivity

General 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, skin rash)
• Dizziness
• Increase in blood pressure values
• Skin pigmentation 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
• Allergic reaction in the eye
• Inflamed eyelids
• Difficulty seeing clear images
• Worsening of vision
• Swelling of the transparent 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 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 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 BIMANEXT 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; any remaining containers must be discarded after this period.
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 box after "Exp". The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What BIMANEXT 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, sodium phosphate dibasic 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 BIMANEXT 0.1 mg/ml single-dose and contents of the pack
BIMANEXT 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
FB Vision S.p.A.
Via San Giovanni Scafa, snc
63074 – San Benedetto del Tronto (AP) - Italy
Manufacturer
Genetic S.p.A.
Contrada Canfora
84084 Fisciano (SA)