Bimadoc

Package leaflet: Information for the user

BIMADOC 0.1 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 other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact 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 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

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

BIMADOC is an antiglaucoma medicine. It belongs to a class of medicines called prostamides.
BIMADOC eye drops are used to reduce elevated intraocular pressure. This medicine may 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 constantly drained from the eye, and new fluid is produced to replace what is drained. 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 intraocular pressure. Elevated intraocular pressure, if left untreated, can lead to a condition called glaucoma and may eventually cause vision damage.

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 to any of the other ingredients of this medicine (listed in section 6).
• if in the past you had to stop using eye drops due to an adverse reaction 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 have breathing problems
• you have liver or kidney problems
• you have previously undergone cataract surgery
• you suffer from dry eye
• you have or have had corneal problems (the transparent front part of the eye)
• you wear contact lenses (see “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.

During treatment, BIMADOC 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), tightness of the skin around the eye (dermatochalasis involution), and exposure
of the lower white part of the eye (inferior scleral show). Changes are usually mild,
but if pronounced, they may impair the visual field. If you discontinue use of
BIMADOC, these changes may resolve. BIMADOC 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
BIMADOC has not been tested in patients under 18 years of age and therefore should not be used in
patients under 18 years of age.
Other medicines and BIMADOC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicines.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding,
please consult your doctor or pharmacist before taking this medicine.
BIMADOC may pass into breast milk; therefore, breastfeeding is not recommended during treatment with
BIMADOC.
Driving and using machines
After administration of BIMADOC, you may experience mild, 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.
This medicine contains 0.6 mg of benzalkonium chloride in 3 ml of solution, equivalent to 0.2 mg/ml.
Do not use the eye drops while wearing contact lenses. The preservative in BIMADOC,
benzalkonium chloride, may be absorbed by soft contact lenses and may cause a change in their colour. Remove contact lenses before using this medicine and wait 15 minutes after administering the eye drops before reinserting the contact lenses. Benzalkonium chloride may cause ocular irritation, especially if you have dry eye or corneal disorders (the transparent outermost layer of the eye). If you experience any abnormal sensation, burning, or pain in the eye after using this medicine, speak with your doctor.

3. How to use BIMADOC 0.1 mg/ml

Use this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
BIMADOC must be used only in the eyes. The recommended dose is one drop of BIMADOC once daily in the evening, in each eye to be treated.
If you are using BIMADOC together with another eye medicine, apply BIMADOC eye drops first and wait 5 minutes 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:
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 backwards and look upwards.
2. Gently pull down the lower eyelid to form a small pocket.
3. Invert the bottle and gently squeeze to release one drop of eye drops into each eye to be treated.
4. Release the lower eyelid and close your eye for 30 seconds.

Wipe away any excess liquid running down the cheek.
If the drop did not enter the eye, repeat the procedure.
To avoid eye infections or injury, the tip of the bottle must not touch the eye or any other surface. After use, close the bottle tightly by replacing the cap.

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

If you forget to use BIMADOC 0.1 mg/ml
If you forget to use BIMADOC, as soon as you remember, apply one drop and then continue with your regular dosing schedule. Do not use a double dose to make up for the missed dose.

If you stop using BIMADOC 0.1 mg/ml
To work properly, BIMADOC must be used every day. If you stop using BIMADOC, your intraocular pressure may increase. Therefore, you should speak with your doctor before stopping this treatment.

If you have further 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 everyone experiences them.
Very common (may affect more than 1 in 10 people)
Eye-related

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

Common (may affect up to 1 in 10 people)
Eye-related

• 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

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

Uncommon (may affect up to 1 in 100 people)
Eye-related

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

Skin-related

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

General

• Headache
• Feeling unwell

Not known (frequency cannot be estimated from available data)
Eye-related

• 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

• 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)

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 narrowing, 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 of the front part of the eye (the cornea) have developed opaque areas on the cornea due to calcium accumulation during treatment.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 stated on the bottle label and on the carton 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 there are still eye drops remaining. This will prevent the risk of infection. To help you remember, write the date of first opening in the space provided on the carton.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What BIMADOC 0.1 mg/ml contains

• The active substance is bimatoprost. One ml of solution contains 0.1 mg of bimatoprost.
• The other ingredients are benzalkonium chloride (preservative), sodium chloride, disodium phosphate heptahydrate, citric acid monohydrate and water for injections. Small amounts of hydrochloric acid or sodium hydroxide may be added to adjust and 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, colourless eye drop solution supplied in a pack containing 1 plastic bottle with a screw cap. The bottle is approximately half full and contains 3 millilitres 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)

Package leaflet: Information for the user

BIMADOC 0.3 mg/ml, eye drops, solution

Bimatoprost
Equivalent medicine
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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact 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 using 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. Package contents and other information

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

BIMADOC is an antiglaucoma medicine. It belongs to a group of medicines called prostamides.
BIMADOC 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 constantly drained from the eye, and new fluid is produced to replace the drained fluid. If the fluid is not drained quickly enough, pressure inside the eye increases. This medicine works by increasing the amount of fluid drained, thereby reducing the pressure inside the eye. Elevated intraocular pressure, if not reduced, may lead to a condition called glaucoma and may 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 to any of the other ingredients of this medicine (listed in section 6).
• if you have previously had to stop using eye drops due to an adverse reaction to 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 have breathing problems.
• you have liver or kidney problems.
• you have previously undergone cataract surgery.
• you suffer from dry eye.
• you have or have had corneal problems (the transparent front part of the eye).
• you wear contact lenses (see "BIMADOC 0.3 mg/ml contains benzalkonium chloride").
• you have or have had hypotension or bradycardia.
• you have had a viral infection or inflammation of the eyes.

During treatment, BIMADOC 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), tightness of the skin around the eye (dermatocalasis involution), and exposure of the lower white part of the eye (inferior scleral show). These changes are usually mild in degree, but if pronounced, they may impair the visual field. If you stop using BIMADOC, these changes may resolve. BIMADOC 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 and therefore should not be used in patients under 18 years of age.

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

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

Driving and using machines
After administration of BIMADOC, you may experience a slight, temporary blurring of vision. If this occurs, do not drive or operate machinery until your vision has cleared.

BIMADOC 0.3 mg/ml contains benzalkonium chloride.
This medicine contains 0.15 mg of benzalkonium chloride in 3 ml of solution, equivalent to 0.05 mg/ml.
Do not use the eye drops while wearing contact lenses. The preservative in BIMADOC, benzalkonium chloride, may be absorbed by soft contact lenses and may cause a change in their colour. Remove contact lenses before using this medicine and wait 15 minutes after administering the eye drops before reinserting the contact lenses. Benzalkonium chloride may cause ocular irritation, especially if you have dry eye or corneal disorders (the transparent outer layer of the eye). If you experience an abnormal sensation, burning, or pain in the eye after using this medicine, speak with your doctor.

3. How to use BIMADOC 0.3 mg/ml

Use this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
BIMADOC must be applied only to the eyes. The recommended dose is one drop of BIMADOC once daily in the evening, in each eye to be treated.
If you are using BIMADOC together with another eye medicine, wait at least 5 minutes after using BIMADOC 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:

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 pouch.
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 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.

If you use more BIMADOC 0.3 mg/ml than you should
If you use more BIMADOC than recommended, it is unlikely to cause serious problems. Take your next dose at the usual time. If you are concerned, 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, apply one drop only, then continue with your regular dosing schedule. Do not use a double dose to make up for the missed dose.

If you stop using BIMADOC 0.3 mg/ml
To work properly, BIMADOC must be used every day. If you stop using BIMADOC, your eye pressure may increase. Therefore, you should speak to your doctor before stopping this treatment.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Very common (may affect more than 1 in 10 people)
Eye-related:

• Longer eyelashes (up to 45% of people)
• Mild redness (up to 44% of people)
• Itching (up to 14% of people)
• Loss of fat around 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 (inferior scleral show).

Common (may affect up to 1 in 10 people)
Eye-related:

• Allergic eye reaction
• Tired eyes
• Sensitivity to light
• Darkening of the skin around the eye
• Darker eyelashes
• Pain
• Foreign body sensation in the eye
• Sticky eyes
• Darkening of iris color
• 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 surface of the eye
• Small ulcers on the surface of the eye, with or without inflammation

General side effects:

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

Uncommon (may affect up to 1 in 100 people)
Eye-related:

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

General side effects:

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

Not known (frequency cannot be estimated from available data)
Eye-related:

• Eye discomfort

General side effects:

• Asthma
• Worsening of asthma
• Worsening of the lung condition known as chronic obstructive pulmonary disease (COPD)
• Shortness of breath
• Symptoms of allergic reaction (swelling, eye redness, and skin rash)
• Darkening of the skin around the eye
• Change in skin color (around the eye)

Other side effects reported with eye drops containing phosphates
In very rare cases, some patients with severe damage to the transparent layer of the front part of the eye (the cornea) have developed opaque areas on the cornea due to calcium 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 the following website: 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 stated on the bottle label and on the carton 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 carton.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What BIMADOC 0.3 mg/ml contains

• The active substance 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, colourless eye drop solution supplied in a pack containing 1 plastic bottle with a screw cap. The bottle is half-filled and contains 3 millilitres of solution, sufficient for 4 weeks of use.
Marketing Authorization Holder
DOC Generici S.r.l
Via Turati 40
20121 Milan
Manufacturer
Genetic S.p.A.
Nucleo Industriale, Contrada Canfora
84084 Fisciano (SA)

Package leaflet: information for the user

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

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, 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 may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What 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

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

BIMADOC 0.3 mg/ml single-dose is an antiglaucoma medicine. It belongs to a class of medicines
called prostamides.
BIMADOC 0.3 mg/ml ophthalmic solution single-dose 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, aqueous 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 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 BIMADOC 0.3 mg/ml single-dose

Do not use BIMADOC

• if you are allergic to 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 BIMADOC 0.3 mg/ml single-dose if:

• you have breathing problems
• you have liver or kidney problems
• you have previously undergone cataract surgery
• you suffer or have suffered from low blood pressure or slow heart rate
• you have had a viral infection or inflammation of the eye

During treatment, BIMADOC 0.3 mg/ml single-dose 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), tightness of the skin around the eye (dermatochalasis 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 BIMADOC 0.3 mg/ml single-dose, these changes may resolve. BIMADOC 0.3 mg/ml
single-dose may also cause darkening and lengthening of the eyelashes, as well as darkening of the eyelids.
The iris colour 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 in patients under 18 years of age and therefore must not
be used in patients under 18 years of age.

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

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding,
consult your doctor or pharmacist before taking this medicine.
BIMADOC 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 BIMADOC 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 BIMADOC 0.3 mg/ml single-dose

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
The recommended dose is one drop once daily, in the evening, in each eye to be treated. BIMADOC 0.3
mg/ml single-dose must be applied only in the eyes.
If you are using BIMADOC 0.3 mg/ml single-dose together with another eye medicine, wait at least 5 minutes after using BIMADOC 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 surfaces.

1. Take a single-dose container out of the sachet and hold it upright (with the cap facing upwards), then twist the cap.
2. Gently pull down the lower eyelid to form a pouch. Turn the single-dose container upside down and apply slight pressure to release one drop of eye drops into the eye(s) to be treated.
3. Discard the single-dose container immediately after use, even if there is some solution remaining inside.

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

If you use more BIMADOC 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 BIMADOC 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 BIMADOC 0.3 mg/ml single-dose
To work properly, BIMADOC 0.3 mg/ml single-dose must be used every day. If you stop using BIMADOC 0.3 mg/ml single-dose, your intraocular pressure may increase; therefore, you should speak with your doctor before stopping this treatment.

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

4. Possible side effects

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

Very common (may affect more than 1 in 10 people)
Eye disorders

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

Common (may affect up to 1 in 10 people)
Eye disorders

• 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
• Red eyelids

Uncommon (may affect up to 1 in 100 people)
Eye disorders

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

General disorders

• Headache
• Growth of hairs around the eye

Not known (frequency cannot be estimated from the available data)
Eye disorders

• Sticky eyes
• Eye discomfort

General disorders

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

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 a preservative, and may also occur in patients using 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 eyelashes
• Bleeding of the retina
• Inflammation inside the eye
• Cystoid macular edema (swelling of the retina inside the eye leading to worsening of vision)
• Inflammation of the iris
• Eyelid spasms
• Narrowing of the eyelid, pulling away from the eye surface
• Nausea
• Redness of the skin around the eyes
• Weakness
• Increased liver function test values in blood 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 cloudy areas on the cornea due to calcium deposits during treatment.

Reporting of side effects
If you experience any side effects, 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 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 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.
Do not use this medicine after the expiry date stated on the single-dose container, the pouch, and the outer carton after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions. However, use it within 7 days of opening each pouch.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What BIMADOC 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 BIMADOC 0.3 mg/ml single-dose and contents of the pack
BIMADOC 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, packed in a sachet.
Each single-dose container holds 0.4 ml of solution.
Each package contains 30 single-dose containers.
Marketing Authorisation Holder
DOC Generici S.r.l
Via Turati 40
20121 Milan
Manufacturer
Genetic S.p.A.
Nucleo Industriale, Contrada Canfora
84084 Fisciano (SA)