BIMANEXT 0.1 MG/ML Krople do oczu, roztwór

Treść ulotki

1. BIMANEXT 0,3 mg/ml, eye drops, solution
   1. What is BIMANEXT 0.3 mg/ml and what is it 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 0.3 mg/ml
   6. Package contents and other information
2. BIMANEXT 0,3 mg/ml, eye drops, solution in single-dose container
   1. What is BIMANEXT 0.3 mg/ml single-dose and what is it 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
3. BIMANEXT 0,1 mg/ml, eye drops, solution
   1. What is BIMANEXT 0.1 mg/ml and what is it 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. BIMANEXT must be applied only to the eyes. The recommended dose is one drop of
   1. Possible side effects
   2. How to store BIMANEXT 0.1 mg/ml
   3. Package Contents and Other Information
5. BIMANEXT 0,1 mg/ml, eye drops, solution, in single-dose container
   1. What is BIMANEXT 0.1 mg/ml single-dose and what is it 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

BIMANEXT 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 they have the same symptoms as you, 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 BIMANEXT 0,3 mg/ml is and what it is used for
• 2. What you need to know before you use 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 is BIMANEXT 0.3 mg/ml and what is it used for

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

prostamides.
BIMANEXT is used to reduce elevated intraocular pressure. This medicine can be used by
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 what has been eliminated. If the
liquid is not eliminated quickly enough, the pressure inside the eye increases.
This medicine helps to increase the amount of liquid that is eliminated, thereby 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 BIMANEXT 0.3 mg/ml

Do not use BIMANEXT 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 BIMANEXT 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 “BIMANEXT 0.3 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, BIMANEXT 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
BIMANEXT, the changes may disappear. BIMANEXT 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 on patients under 18 years of age and therefore should not be used on
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, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
BIMANEXT may pass into breast milk, so it is advisable not to breastfeed during treatment with
this medicine.

Driving and operating machinery
After administration of BIMANEXT 0.3 mg/ml, you may experience mild, transient blurred
vision. In this case, do not drive or operate machinery until your vision returns to normal.

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

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
BIMANEXT must be applied only to the eyes. The recommended dose is one drop of
BIMANEXT once a day, in the evening, in each eye to be treated.
If you are using BIMANEXT with another ophthalmic medicine, wait at least 5 minutes after using BIMANEXT
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 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 the 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 BIMANEXT 0.3 mg/ml than you should
If you use more BIMANEXT 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 BIMANEXT 0.3 mg/ml
If you forget to use BIMANEXT, 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 BIMANEXT 0.3 mg/ml
For it to work correctly, BIMANEXT must be used every day. If you stop using BIMANEXT, 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 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)

Concerning the eye area

• Loss of fat in the eye area which may lead to deepening of the eyelid crease, hollowed 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 in 100.
Effects on the eye

• Allergic eye reaction
• Tired eyes
• Sensitivity to light
• 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 clearly
• 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
• Increased 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
• Narrowing of the eyelid, which moves away from the surface of the eye
• Redness of the skin around the eye

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 condition called chronic obstructive pulmonary disease (COPD)
• Shortness of breath
• Change in 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, 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 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 bottle and on the packaging
after Exp. The expiry date refers to the last day of that month.
After the first opening of the BIMANEXTbottle, use within 28 days; after this period, any
remaining medicine must be disposed of. 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 BIMANEXT 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 BIMANEXT 0,3 mg/ml and package contents
BIMANEXT is a clear, colorless eye drop, supplied in a package 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)

BIMANEXT 0,3 mg/ml, eye drops, solution in single-dose container

Bimatoprost
Generic medicine

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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell 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 you use 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 is BIMANEXT 0.3 mg/ml single-dose and what is it used for

BIMANEXT 0.3 mg/ml single-dose is an antiglaucoma drug. It belongs to a category of drugs
called prostamides.
BIMANEXT 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 what 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 BIMANEXT 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 BIMANEXT 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, BIMANEXT 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 marked, they may impair the visual field. If you stop using
BIMANEXT, the changes may disappear. BIMANEXT 0.3 mg/ml single-dose 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
BIMANEXT 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 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, suspect you are pregnant, are planning to become pregnant, or are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
BIMANEXT 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 BIMANEXT 0.3 mg/ml single-dose, you may experience slight transient
blurred vision. In this case, do not drive or use machinery until your vision returns to
normal.

3. How to use BIMANEXT 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. BIMANEXT 0,3
mg/ml single-dose must be applied only to the eyes.
If you are using BIMANEXT 0,3 mg/ml single-dose with another ophthalmic medicine, wait at least 5 minutes after
using BIMANEXT 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 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 unscrew the cap.
• 2. Gently pull down 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.

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 reinserting the lenses.

If you use more BIMANEXT 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 BIMANEXT 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 dosing times. Do not take a double dose to make up for a missed dose.

If you stop using BIMANEXT 0,3 mg/ml single-dose
For it to work correctly, BIMANEXT 0,3 mg/ml single-dose must be used every day. If
you stop using BIMANEXT 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 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 effect, including any 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)

Concerning the eye area

• 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 in 100
Effects on the eye

• Small ulcers on the surface of the eye, with or without inflammation
• Irritation
• Eye itching
• Pain
• Dryness
• Foreign body sensation 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
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)

Concerning the eye

• 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 multi-dose formulation of BIMANEXT 0.3 mg/ml containing the preservative and may occur in patients taking BIMANEXT 0.3 mg/ml single dose:

• Burning sensation inside the eye
• Allergic reaction in the eye
• Inflamed eyelids
• Difficulty seeing sharp 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 effect, including any 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 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 unused solution.
After the first opening of the aluminum sachet: 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. Contents of the pack 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, 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 single-dose and contents of the pack
BIMANEXT 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
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)

BIMANEXT 0,1 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 they have the same symptoms as you, 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 BIMANEXT 0,1 mg/ml is and what it is used for
• 2. What you need to know before you use 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 is BIMANEXT 0.1 mg/ml and what is it used for

BIMANEXT is an antiglaucoma medication. It belongs to a category of drugs called prostamides.
BIMANEXT 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 what 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
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 BIMANEXT 0.1 mg/ml

Do not use BIMANEXT 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
Consult your doctor or pharmacist before using BIMANEXT 0.1 mg/ml.
Consult your doctor if:

• you suffer from respiratory 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 wear contact lenses (see “BIMANEXT 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, BIMANEXT 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, but if they are pronounced, they may impair the field of vision. If you stop using
BIMANEXT, the changes may disappear. BIMANEXT 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 on patients under 18 years of age and therefore should not be used on
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, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
BIMANEXT may pass into breast milk, so it is advisable not to breastfeed during treatment with
this medicine.

Driving and operating machinery
After administration of BIMANEXT, you may experience slight transient blurred vision. In
this case, do not drive or operate machinery until your vision returns to normal.

BIMANEXT 0.1 mg/ml contains benzalkonium chloride.
BIMANEXT 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
reinserting the contact lenses.

3. How to use BIMANEXT 0.1 mg/ml

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

BIMANEXT must be applied only to the eyes. The recommended dose is one drop of

BIMANEXT once a day, in the evening, in each eye to be treated.
If you are using BIMANEXT with another ophthalmic medicine, apply BIMANEXT 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. 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 your eye for 30 seconds.

Wipe away any excess that runs down your cheek.
If the drop does not enter the 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
BIMANEXT should 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 consequences.
Administer the next dose at the usual time. If this causes you concern, 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, 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 BIMANEXT 0.1 mg/ml
For it to work correctly, BIMANEXT must be used every day. If you stop using BIMANEXT, 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 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 out of 10.
Effects on the eye

• Mild redness (up to 29% of people)

Concerning the eye area

• 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
• Itchy eyes
• Lengthening of the 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 out of 1,000.
Concerning the eye

• Darkening of the iris color
• Tired eyes
• Swelling of the eye surface
• 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 unknown frequency
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
• Sensitivity to light

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):

• Burning sensation in the eye
• An allergic reaction to the eye
• Inflamed eyelids
• Difficulty seeing sharp 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 leading 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 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, talk to 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 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 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 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 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 BIMANEXT 0.1 mg/ml contains

• The active ingredient 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 quantities 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 package contents
BIMANEXT is a clear, colorless eye drop, supplied in a package 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)

BIMANEXT 0,1 mg/ml, eye drops, solution, in single-dose container

Bimatoprost

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 they have the same symptoms as you, 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 BIMANEXT 0,1 mg/ml single-dose is and what it is used for
• 2. What you need to know before you use 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 is BIMANEXT 0.1 mg/ml single-dose and what is it used for

BIMANEXT 0.1 mg/ml single-dose is an antiglaucoma drug. It belongs to a category of drugs
called prostamides.
BIMANEXT 0.1 mg/ml eye drops solution single-dose is used to reduce high eye 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. High eye 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 BIMANEXT 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
Consult your doctor or pharmacist before using BIMANEXT 0.1 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 from dry eyes
• you have or have had problems with the cornea (the clear front part of the eye)
• 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 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
BIMANEXT, the changes may disappear. BIMANEXT 0.1 mg/ml single dose 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
BIMANEXT 0.1 mg/ml single dose has not been tested on patients under 18 years of age and therefore should 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, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
BIMANEXT 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 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 returns to
normal.

3. How to use BIMANEXT 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.
BIMANEXT 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 use BIMANEXT 0.1 mg/ml single dose with another ophthalmic medicine, apply BIMANEXT
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 pocket. Turn the single dose container upside down and apply slight pressure to release one drop of eye drops into the/into the eye(s) to be treated. Open and close your eye/eyes for a few seconds.
• 3. Discard the single dose container immediately after use, even if there is some solution remaining 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 reinserting the lenses.

Use in children and adolescents
BIMANEXT 0.1 mg/ml single dose should 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 consequences.
Administer the next dose at the usual time. If this causes you concern, 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, 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 BIMANEXT 0.1 mg/ml single dose
For it to work correctly, BIMANEXT 0.1 mg/ml single dose must be used every day. If
you stop using BIMANEXT 0.1 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 29% of people)

Concerning the eye area

• 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 in 100.
Effects on the eye

• Small ulcers on the surface of the eye, with or without inflammation
• Irritation
• Itchy eyes
• 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 hairs around the eye

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

• Darkening of the color of the iris
• 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 unknown frequency
Concerning the eye

• Macular edema (swelling of the retina in the back of the eye which may lead to worsening of vision)
• Darkening of the eyelids
• Dry eye
• Sticky eyes
• Feeling of a foreign body in the eye
• Swelling of the eye
• Increased tearing
• Eye discomfort
• Sensitivity to light

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):

• Burning sensation in the eye
• 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 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 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 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 unused solution.
After the first opening of the aluminium sachet: 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. Contents of the pack and other information

What BIMANEXT 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 BIMANEXT 0,1 mg/ml single-dose and contents of the pack
BIMANEXT 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
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)