BIMATOPROST 0.1 MG/ML Eye drops, solution

Зміст інструкції

1. Bimatoprost Pharmathen 0.1 mg/mL, eye drops, solution
   1. What is Bimatoprost Pharmathen and what is it used for
   2. What you need to know before using Bimatoprost Pharmathen
   3. How to use Bimatoprost Pharmathen
   4. Possible side effects
   5. How to store Bimatoprost Pharmathen
   6. Package contents and other information
2. Bimatoprost Pharmathen 0,3 mg/mL, eye drops, solution
   1. What is Bimatoprost Pharmathen and what it is used for
   2. What you need to know before using Bimatoprost Pharmathen
   3. How to use Bimatoprost Pharmathen
   4. Possible side effects
   5. How to store Bimatoprost Pharmathen
   6. Package contents and other information

Bimatoprost Pharmathen 0.1 mg/mL, eye drops, solution

bimatoprost

Medicinal Equivalent
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 any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Bimatoprost Pharmathen and what is it used for

Bimatoprost Pharmathen is a glaucoma medication belonging to a category of drugs
called prostamides.
Bimatoprost Pharmathen eye drops are 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 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 Bimatoprost Pharmathen

Do not use Bimatoprost Pharmathen

• 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 Bimatoprost Pharmathen.
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 section "Bimatoprost Pharmathen contains benzalkonium chloride")
• you suffer from or have suffered from hypotension or bradycardia
• you have had a viral infection or inflammation of the eyes.

Bimatoprost Pharmathen may cause darkening and lengthening of the eyelashes, it may also darken the
skin around 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
This medicine has not been tested in children under 18 years of age, therefore Bimatoprost
Pharmathen should not be used in patients under 18 years of age.

Other medicines and Bimatoprost Pharmathen
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.
Bimatoprost Pharmathen may pass into breast milk, therefore you should not breastfeed during
treatment with Bimatoprost Pharmathen.

Driving and using machines
After administering this medicine, you may experience short-lived blurred vision.
Do not drive or use machines until your vision has returned to normal.

Bimatoprost Pharmathen contains benzalkonium chloride
This medicine contains 0.2 mg of benzalkonium chloride in each mL of solution.
Benzalkonium chloride can be absorbed by soft contact lenses and can change the color of the
contact lenses. You should remove your contact lenses before using this medicine and reinsert them 15 minutes
later.
Benzalkonium chloride can also cause eye irritation, especially if you suffer from dry eyes or
corneal disorders (the transparent layer of the front of the eye). If you feel a strange
sensation in your eye, stinging pain or eye pain after using this medicine, tell your
doctor.

Bimatoprost Pharmathen contains phosphate buffer
This medicine contains 0.95 mg of phosphates in each mL of solution.
If you suffer from severe damage to the transparent layer of the front of the eye (cornea), phosphates
may, in very rare cases, cause opaque areas on the cornea due to calcium accumulation
during treatment.

3. How to use Bimatoprost Pharmathen

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have
any doubts, consult your doctor or pharmacist.
This medicine must be applied only to the eyes. The recommended dose is one drop of
Bimatoprost Pharmathen once a day, in the evening, in each eye to be treated.
If you use Bimatoprost Pharmathen with another ophthalmic medicine, apply Bimatoprost
Pharmathen 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.

• Take the bottle (figure 1)out of the cardboard box.

1

• Wash your hands. Tilt your head back and look up (figure 2).

• Slowly lower the lower eyelid to form a small pocket (figure 3).
• Turn the bottle upside down and apply gentle pressure to dispense one drop of eye drops into each eye to be treated (figure 4).
• Release the lower eyelid and close your eye for 30 seconds (figure 5).

Wipe away any excess that runs down your cheek.
If the drop does not enter the eye, repeat the operation.
To avoid infections 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 Bimatoprost Pharmathen than you should
If you use more Bimatoprost Pharmathen 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 Bimatoprost Pharmathen
If you forget to use Bimatoprost Pharmathen, as soon as you remember, put one drop in
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 Bimatoprost Pharmathen
For it to work correctly, Bimatoprost Pharmathen must be used every day. If you stop
using Bimatoprost Pharmathen, 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.

Very common:may affect more than 1 in 10 people
Effects on the eye:

• Mild redness (up to 29% of people)

Commonmay affect up to 1 in 10 people
Effects on the eye

• Small damage to the surface of the eye, with or without inflammation
• Irritation
• Eye itching
• Eyelash lengthening
• Irritation when administering the drops into the eyes
• Eye pain

Effects on the skin

• Red and itchy eyelids
• Darkening of the skin around the eye
• Hair growth around the eye

Uncommonmay affect up to 1 in 100 people
Effects on the eye

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

Effects on the skin

• dry skin
• Formation of crusts on the edge of the eyelid
• Swelling of the eyelid
• Itching

Effects on the body

• headache
• Feeling unwell

Not knownfrequency cannot be estimated based on available data
Effects on the eye

• Macular edema (swelling of the retina in the back of the eye)
• Darkening of the eyelids
• Sunken eyes
• Dry eye
• Sticky eyes
• Foreign body sensation in the eye
• Eye swelling
• Increased tearing
• Eye discomfort
• Sensitivity to light

Effects on 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 Pharmathen 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
• Increase in blood tests of values related to liver function

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet. 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 Bimatoprost Pharmathen

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
pack after “Exp”. The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
After opening the container, the product can be stored for 4 weeks. It is necessary to
dispose of the bottle at the latest 4 weeks after first opening, even if it still contains some
eye drops. This will avoid infections. To help you remember, write the date of first opening in the
space provided on the pack and on the bottle.
Do not dispose of any medicine in waste water 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 Bimatoprost Pharmathen contains

• The active ingredient is bimatoprost. One mL of solution contains 0.1 mg of bimatoprost.
• The excipients 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 Bimatoprost Pharmathen and package contents
Bimatoprost Pharmathen is a clear, colorless eye drop, free from visible particles supplied in a white
opaque low-density polyethylene dropper bottle containing 3 mL of the ophthalmic solution
sealed with a white opaque LDPE applicator and white HDPE / LDPE cap with a seal of
guarantee.
The following packs are available: carton containing 1 or 3 bottles of 3 mL solution.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Pharmathen S.A.
6 Dervenakion Street
Pallini 15351
Athens, Greece
Tel: 0030 210 66 04 300
Fax: 0030 210 66 66 749

Manufacturer
BALKANPHARMA-RAZGRAD AD
68 Aprilsko vastanie Blvd.,
Razgrad,
7200
Bulgaria
Telephone: +359 84 613 318
Fax: +359 84 634 272
E-Mail: [email protected]
Ο
Pharmathen S.A.
6 Dervenakion Street
Pallini 15351
Atene, Greece
Tel: 0030 210 66 04 300
Fax: 0030 210 66 66 749

This medicinal product is authorised in the Member States of the European Economic Area with the
following names:
Denmark Bimatoprost Pharmathen
Germany Bimatoprost Pharmathen 0.1 mg/mL eye drops, solution
United Kingdom Bimatoprost Aspire
Italy Bimatoprost Pharmathen
Spain Bimatoprost AMG Labs 0.1 mg/mL eye drops in solution
Romania Bimatoprost Pharmathen 0.1 mg/mL ophthalmic drops, solution
Cyprus Bimatoprost Pharmathen
Greece Bimatoprost Pharmathen

Bimatoprost Pharmathen 0,3 mg/mL, eye drops, solution

bimatoprost
Equivalent 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 Bimatoprost Pharmathen is and what it is used for
• 2. What you need to know before you use Bimatoprost Pharmathen
• 3. How to use Bimatoprost Pharmathen
• 4. Possible side effects
• 5. How to store Bimatoprost Pharmathen
• 6. Contents of the pack and other information

1. What is Bimatoprost Pharmathen and what it is used for

Bimatoprost Pharmathen is a glaucoma medication. It belongs to a category of drugs called
prostamides.
Bimatoprost Pharmathen eye drops are used to reduce increased 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 that which 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 eye 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 Bimatoprost Pharmathen

Do not use Bimatoprost Pharmathen

• 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 Bimatoprost Pharmathen.
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 section "Bimatoprost Pharmathen contains benzalkonium chloride")
• you suffer from or have suffered from hypotension or bradycardia
• you have had a viral infection or inflammation of the eyes.

Bimatoprost Pharmathen may cause darkening and lengthening of the eyelashes, and it may also darken the
skin around 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
This medicine has not been tested in children under 18 years of age, therefore Bimatoprost
Pharmathen should not be used in patients under 18 years of age.

Other medicines and Bimatoprost Pharmathen
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.
Bimatoprost Pharmathen may pass into breast milk, therefore you should not breastfeed during
treatment with Bimatoprost Pharmathen.

Driving and using machines
After administering this medicine, you may experience blurred vision of short duration.
In this case, do not drive or use machines until your vision returns to normal.

Bimatoprost Pharmathen contains benzalkonium chloride
This medicine contains 0.05 mg of benzalkonium chloride in each mL of solution.
Benzalkonium chloride can be absorbed by soft contact lenses and can change the color of
contact lenses. You should remove your contact lenses before using this medicine and replace them 15 minutes
later.
Benzalkonium chloride can also cause eye irritation, especially if you suffer from dry eyes or
corneal disorders (the transparent layer of the front of the eye). If you feel a strange
sensation in your eye, stinging pain or eye pain after using this medicine, tell your
doctor.

Bimatoprost Pharmathen contains phosphate buffer
This medicine contains 0.95 mg of phosphates in each mL of solution.
If you suffer from severe damage to the transparent layer of the front of the eye (cornea), phosphates
may, in very rare cases, cause opaque areas on the cornea due to calcium accumulation
during treatment.

3. How to use Bimatoprost Pharmathen

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
This medicine must be applied only to the eyes. The recommended dose is one drop of
Bimatoprost Pharmathen once a day, in the evening, in each eye to be treated.
If you are using Bimatoprost Pharmathen with another ophthalmic medicine, apply Bimatoprost
Pharmathen 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:

• Take the bottle (figure 1), out of the cardboard box.

1

• Wash your hands. Tilt your head back and look up (figure 2).

• Gently lower the lower eyelid to form a small pocket (figure 3).
• Turn the bottle upside down and apply slight pressure to dispense one drop of eye drops for each eye to be treated (figure 4).
• Release the lower eyelid and close your eye for 30 seconds (figure 5).

Wipe away any excess that runs down your cheek.
If the drop does not enter the eye, repeat the operation.
To avoid infections and eye injuries, 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 Bimatoprost Pharmathen than you should
If you use more Bimatoprost Pharmathen 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 Bimatoprost Pharmathen
If you forget to use Bimatoprost Pharmathen, as soon as you remember, put one drop
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 Bimatoprost Pharmathen
For it to work correctly, Bimatoprost Pharmathen must be used every day. If you stop
using Bimatoprost Pharmathen, 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.

Very common:may affect more than 1 in 10 people
Effects on the eye

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

Common:may affect up to 1 in 10 people
Effects on the eye

• Ocular allergic reaction
• Tired eyes
• Sensitivity to light
• Darkening of the skin around the eye
• Darker eyelashes
• Pain
• Feeling of a foreign body in the eye
• Sticky eyes
• Darkening of the color of the iris
• Difficulty seeing images clearly
• 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

Effects on the body

• Headache
• Increase in blood tests of values related to liver function
• Increase in blood pressure values

Uncommon:may affect up to 1 in 100 people
Effects on 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

Effects on the body

• Nausea
• Dizziness
• Weakness
• Hair growth around the eye

Not known:frequency cannot be estimated from available data
Effects on the eye

• Sunken eyes
• Eye discomfort

Effects on the body

• Asthma
• Worsening of asthma
• Worsening of a lung condition called chronic obstructive pulmonary disease (COPD)
• Shortness of breath
• Symptoms of allergic reaction (swelling, redness of the eye and skin rash)
• Alteration of skin color (periocular)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national 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 Bimatoprost Pharmathen

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
pack after “Exp”. The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
After opening the container, the product can be stored for 4 weeks. It is necessary to
dispose of the bottle at the latest 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 pack and on the bottle.
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 Bimatoprost Pharmathen contains

• The active ingredient is bimatoprost. One mL of solution contains 0.3 mg of bimatoprost.
• The excipients 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 Bimatoprost Pharmathen and package contents
Bimatoprost Pharmathen is a clear, colorless eye drop, free from visible particles, supplied in a white
opaque low-density polyethylene dropper bottle containing 3 mL of the ophthalmic solution
sealed with a white opaque LDPE applicator and white HDPE/LDPE cap with a seal of
guarantee.
The following pack sizes are available: carton containing 1 or 3 bottles of 3 mL solution.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Pharmathen S.A.
6 Dervenakion Street
Pallini 15351
Athens, Greece
Tel: 0030 210 66 04 300
Fax: 0030 210 66 66 749

ManufacturerBALKANPHARMA-RAZGRAD AD
68 Aprilsko vastanie Blvd.,
Razgrad,
7200
Bulgaria
Telephone: +359 84 613 318
Fax: +359 84 634 272
E-Mail: [email protected]
Ο
Pharmathen S.A.
6 Dervenakion Street
Pallini 15351
Atene, Greece
Tel: 0030 210 66 04 300
Fax: 0030 210 66 66 749

This medicinal product is authorised in the Member States of the European Economic Area with the
following names:
Danmark Bimatoprost Pharmathen
Deutschland Bimatoprost Pharmathen 0.3 mg/mL Augentropfen, Lösung
United Kingdom Bimatoprost Aspire
Italia Bimatoprost Pharmathen
España Bimatoprost AMG Labs 0.3 mg/mL colirio en solucion
România Bimatoprost Pharmathen 0.3 mg/mL picaturi oftalmice, solutie
Κύπρος Bimatoprost Pharmathen
Eλλάδα Bimatoprost Pharmathen