BIMADOC 0.1 MG/ML Eye drops, solution

Зміст інструкції

1. BIMADOC 0,1 mg/ml, eye drops, solution
   1. What BIMADOC 0.1 mg/ml is and what it is used for
   2. What you need to know before using BIMADOC 0.1 mg/ml
   3. How to use BIMADOC 0.1 mg/ml
   4. Possible side effects
   5. How to store BIMADOC 0.1 mg/ml
   6. Contents of the pack and other information
2. BIMADOC 0,3 mg/ml, eye drops, solution in single-dose container
   1. What BIMADOC 0.3 mg/ml single-dose is and what it is used for
   2. What you need to know before using BIMADOC 0,3 mg/ml single-dose
   3. How to use BIMADOC 0,3 mg/ml single dose
   4. Possible side effects
   5. How to store BIMADOC 0.3 mg/ml single-dose
   6. Contents of the pack and other information
3. BIMADOC 0,3 mg/ml, eye drops, solution
   1. What is BIMADOC 0.3 mg/ml and what is it used for
4. BIMADOC is an antiglaucoma drug. It belongs to a category of drugs called
5. BIMADOC is used to reduce increased intraocular pressure. This medicine can be
   1. What you need to know before using BIMADOC 0,3 mg/ml
6. BIMADOC may pass into breast milk, therefore it is advisable not to breastfeed during the
   1. How to use BIMADOC 0,3 mg/ml
   2. Possible side effects
   3. How to store BIMADOC 0.3 mg/ml
   4. Contents of the pack and other information

BIMADOC 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 BIMADOC 0,1 mg/ml is and what it is used for
• 2. What you need to know before you use BIMADOC 0,1 mg/ml
• 3. How to use BIMADOC 0,1 mg/ml
• 4. Possible side effects
• 5. How to store BIMADOC 0,1 mg/ml
• 6. Contents of the pack and other information

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

BIMADOC is an antiglaucoma medication. It belongs to a category of drugs called
prostamides.
BIMADOC 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 helps to increase the amount of liquid
that is drained, thus reducing the pressure inside the eye. Elevated intraocular
pressure, if not reduced, can cause a disease called glaucoma and can ultimately
cause damage to vision.

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

Do not use BIMADOC 0.1 mg/ml

• if you are allergic to bimatoprost or 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 BIMADOC 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 “BIMADOC 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.

BIMADOC may cause darkening and lengthening of the eyelashes, and it may also darken the
eyelids. Over time, 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
BIMADOC 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 BIMADOC
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 to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
BIMADOC may pass into breast milk, therefore it is advisable not to breastfeed during
treatment with BIMADOC.

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

BIMADOC 0.1 mg/ml contains benzalkonium chloride.
Do not use the eye drops while wearing contact lenses. After administering the eye drops
wait 15 minutes before putting your contact lenses back in. The preservative in BIMADOC,
called benzalkonium chloride, can cause eye irritation and can discolour soft contact lenses.

3. How to use BIMADOC 0.1 mg/ml

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any
doubts, ask your doctor or pharmacist.
BIMADOC must only be applied to the eyes. The recommended dose is one drop of
BIMADOC once a day, in the evening, in each eye to be treated.
If you are using BIMADOC with another ophthalmic medicine, apply BIMADOC eye drops first and wait 5
minutes 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:
Do not use the bottle if the tamper-evident seal on the cap is not intact before 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 dispense one drop of eye drops into each eye to be treated.
• 4. Release the lower eyelid and close your eye for 30 seconds.

Wipe away any excess that runs down your cheek.
If the drop does not enter 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 BIMADOC 0.1 mg/ml than you should
If you use more BIMADOC 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 BIMADOC 0.1 mg/ml
If you forget to use BIMADOC, as soon as you remember, put one drop and then return
to your normal dosing schedule. Do not take a double dose to make up for a
missed dose.

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

4. Possible side effects

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

Very common side effects
These may affect more than 1 in 10 people.
Effects on the eye

• Mild redness (up to 29% of people)

Common side effects
These may affect up to 1 in 10 people.
Effects on the eye

• Small ulcers on the surface of the eye, with or without inflammation
• Irritation
• Eye itching
• Lengthening of the eyelashes
• Irritation when administering the drops into the eyes
• 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 may affect up to 1 in 1,000 people.
Affecting the eye

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

Affecting the skin

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

Affecting the body

• Headache
• Feeling unwell

Side effects with frequency not known
Affecting 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
• Sunken eyes
• Dry eye
• Sticky eyes
• Feeling of a foreign body in the eye
• Eye swelling
• Increased tearing
• Eye discomfort
• Sensitivity to light

Affecting the body

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

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

• Eye burning
• An allergic reaction to the eye
• Inflamed eyelids
• Difficulty seeing clear images
• Worsening of vision
• Swelling of the clear layer covering the surface of the eye
• Tearing
• Darker eyelashes
• Retinal bleeding
• Inflammation inside the eye
• Cystoid macular edema (swelling of the retina inside the eye 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 relating to liver function

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

Reporting of side effects
If you get any side effect, even if not listed in this leaflet, tell your doctor or pharmacist. You can also
report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store BIMADOC 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 bottle and
on the box after Exp. The expiry date refers to the last day of that month.
The bottle must be discarded no later than 4 weeks after first opening, even if it still contains
some eye drops. This will prevent infections. To help you remember, write the date of first
opening in the space provided on the box.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What BIMADOC 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 injectable preparations. Small amounts of hydrochloric acid or sodium hydroxide may be added to maintain a normal acidity level (pH).

Description of the appearance of BIMADOC 0,1 mg/ml and contents of the pack
BIMADOC is a clear, colorless eye drop, supplied in a pack containing 1 plastic bottle
with a screw cap. The bottle is filled to about halfway and contains 3 milliliters of solution, sufficient for
4 weeks of use.

Marketing authorisation holder
DOC Generici S.r.l
Via Turati 40
20121 Milano

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

BIMADOC 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 their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

BIMADOC 0.3 mg/ml single-dose is a glaucoma medication. It belongs to a category of
drugs called prostamides.
BIMADOC 0.3 mg/ml single-dose eye drops, solution, is used to reduce elevated intraocular
pressure. This medicine can be used alone or together with other eye drops called
beta-blockers, which also 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 works 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 glaucoma and can eventually
cause damage to vision.
This medicine does not contain preservatives.

2. What you need to know before using BIMADOC 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
Consult your doctor or pharmacist before using BIMADOC 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

BIMADOC 0,3 mg/ml single-dose may cause darkening and lengthening of the eyelashes, in addition
it may darken the eyelids. Over time, 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
BIMADOC 0,3 mg/ml single-dose has not been tested on patients under 18 years of age, therefore
it should not be used on patients under 18 years of age.

Other medicines and BIMADOC 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, or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
BIMADOC 0,3 mg/ml single-dose may pass into breast milk, therefore it is advisable not to
breastfeed during treatment with this medicine.

Driving and operating machinery
After the administration of BIMADOC 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 BIMADOC 0,3 mg/ml single dose

Use this medicine following the instructions of your doctor or pharmacist exactly. If you
have any doubts, consult your doctor or pharmacist.
The recommended dose is one drop once a day, in the evening, in each eye to be treated.
BIMADOC 0,3 mg/ml single dose must be applied only to the eyes.
If you are using BIMADOC 0,3 mg/ml single dose with another ophthalmic medicine, wait at least 5 minutes
after using BIMADOC 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 from the position with the number corresponding to the date of the day and hold it in a vertical position (with the cap facing upwards) and unscrew the cap.
• 2. Gently lower the lower eyelid to form a pocket. Turn the single dose container upside down and apply slight pressure to release one drop of eye drops into the eye(s) to be treated. Open and close your eye(s) for a few seconds.
• 3. Discard the single dose container immediately after use, even if there is some solution remaining inside.

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

If you use more BIMADOC 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 BIMADOC 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 the normal times of administration. Do not take a double dose to make up for the
forgotten dose.

If you stop using BIMADOC 0,3 mg/ml single dose
For it to work correctly, BIMADOC 0,3 mg/ml single dose must be used every day. If
you stop using BIMADOC 0,3 mg/ml single dose, 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 everyone will experience them.
If any side effect occurs, including those not listed in this leaflet, please
consult 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 24% of people)

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

• Small ulcers on the surface of the eye, with or without inflammation
• Irritation
• Eye itching
• 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 affect 1-9 patients out of 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
• Hair growth around the eye

Side effects with frequency not known
Affecting the body

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

Affecting the eye

• Sticky eyes
• Eye discomfort In addition to the side effects of BIMADOC 0.3 mg/ml single-dose, the following side effects have been observed with the multi-dose formulation of BIMADOC 0.3 mg/ml containing the preservative and may occur in patients taking BIMADOC 0.3 mg/ml single-dose:
• Burning sensation inside the eye
• Allergic reaction in the eye
• Inflamed eyelids
• Difficulty seeing clear images
• Worsening of vision
• Darkening of the eyelashes
• Retinal bleeding
• Inflammation inside the eye
• Cystoid macular edema (swelling of the retina inside the eye that leads to worsening of vision)
• Inflammation of the iris
• Eyelid spasms
• Narrowing of the eyelid, which moves away from the surface of the eye
• Sunken eyes
• 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 experience any side effect, including those not listed in this leaflet, please
consult your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse By reporting side effects
you can contribute to providing more information on the safety of this medicine.

5. How to store BIMADOC 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 the
unused solution.
Do not use this medicine after the expiry date 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.
This medicine does not require special storage conditions. However, use it within 7
days of opening each sachet.
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 BIMADOC 0,3 mg/ml single-dose contains

• The active ingredient 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 BIMADOC 0,3 mg/ml single-dose and contents of the pack
BIMADOC 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
DOC Generici S.r.l
Via Turati 40
20121 Milano

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

BIMADOC 0,3 mg/ml, eye drops, solution

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 their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What BIMADOC 0,3 mg/ml is and what it is used for
• 2. What you need to know before you use BIMADOC 0,3 mg/ml
• 3. How to use BIMADOC 0,3 mg/ml
• 4. Possible side effects
• 5. How to store BIMADOC 0,3 mg/ml

• 6. Contents of the pack and other information

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

BIMADOC is an antiglaucoma drug. It belongs to a category of drugs called

prostamides.

BIMADOC 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 it.
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, thus reducing the pressure inside the eye. Elevated intraocular
pressure, if not reduced, can cause a disease called glaucoma and can eventually
cause damage to vision.

2. What you need to know before using BIMADOC 0,3 mg/ml

Do not use BIMADOC 0,3 mg/ml

• if you are allergic to bimatoprost or 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 BIMADOC 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 “BIMADOC 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

BIMADOC may cause darkening and lengthening of the eyelashes, it may also darken the
eyelids. Over time, 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 BIMADOC
Tell your doctor or pharmacist if you are taking, have recently taken, or might
take any other medicines.

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

BIMADOC may pass into breast milk, therefore it is advisable not to breastfeed during the

treatment with BIMADOC.

Driving and operating machinery
After the administration of BIMADOC, you may experience slight, transient visual blurring.
If this occurs, do not drive or operate machinery until your vision has returned to
normal.

BIMADOC 0.3 mg/ml contains benzalkonium chloride.
Do not use the eye drops while wearing contact lenses. After administration of the eye drops
wait 15 minutes before reinserting the contact lenses. The preservative present in BIMADOC,
called benzalkonium chloride, may cause eye irritation and may discolor soft contact
lenses.

3. How to use BIMADOC 0,3 mg/ml

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any
doubts, ask your doctor or pharmacist.
BIMADOC must only be applied to the eyes. The recommended dose is one drop of
BIMADOC once a day, in the evening, in each eye to be treated.
If you are using BIMADOC with another ophthalmic medicine, wait at least 5 minutes after using
BIMADOC 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:
Do not use the bottle if the tamper-evident seal on the cap is not intact before 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 dispense one drop of eye drops for each eye to be treated.
• 4. Release the lower eyelid and close your eye for 30 seconds.

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

If you use more BIMADOC 0,3 mg/ml than you should
If you use more BIMADOC 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 BIMADOC 0,3 mg/ml
If you forget to use BIMADOC, as soon as you remember, put one drop and then return
to the normal times of administration. Do not take a double dose to make up for the
forgotten dose.

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

4. Possible side effects

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

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

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

Common side effects
These may affect 1 to 9 in 100 people.
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 colour
• 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
• Increased blood tests values related to liver function
• Increased blood pressure values

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

• Cystoid macular edema (swelling of the retina inside the eye that leads to worsening of vision)
• Inflammation inside the eye
• Retinal bleeding
• Swollen eyelids
• Eyelid spasms
• Retraction of the eyelid, which moves away from the surface of the eye
• Redness of the skin around the eye

Affecting the body

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

Side effects with unknown frequency
Affecting the eye

• Sunken eyes
• Eye discomfort

Affecting the body

• Asthma
• Worsening of asthma
• Worsening of a lung condition called chronic obstructive pulmonary disease (COPD)
• Shortness of breath
• Change in skin colour (around the eye)

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at
https:// www.aifa.gov.it/content/segnalazioni-reazioni-avverse By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store BIMADOC 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 package after Exp. The expiry date refers to the last day of that month.
The bottle must be discarded no later than 4 weeks after first opening, even if it still contains
some eye drops. This will prevent infections. To help you remember, write the date of first
opening in the space provided on the package.
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 BIMADOC 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 BIMADOC 0,3 mg/ml and contents of the pack
BIMADOC is a clear, colorless eye drop, supplied in a pack containing 1 plastic bottle
with a screw cap. The bottle is filled to about halfway and contains 3 milliliters of solution, sufficient for
4 weeks of use.

Marketing Authorisation Holder
DOC Generici S.r.l
Via Turati 40
20121 Milano

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