LUMIGAN 3 ML Глазные капли, раствор

Содержание инструкции

1. LUMIGAN 0,1 mg/ml, eye drops, solution
   1. What is LUMIGAN 0.1 mg/ml and what is it used for
   2. What you need to know before using LUMIGAN 0.1 mg/ml
   3. How to use LUMIGAN 0.1 mg/ml
   4. Possible side effects
   5. How to store LUMIGAN 0.1 mg/ml
   6. Package contents and other information
2. LUMIGAN 0,3 mg/ml, eye drops, solution
   1. What is LUMIGAN 0.3 mg/ml and what is it used for
   2. What you need to know before using LUMIGAN 0.3 mg/ml
   3. How to use LUMIGAN 0.3 mg/ml
   4. Possible side effects
   5. How to store LUMIGAN 0.3 mg/ml
   6. Package contents and other information
3. LUMIGAN 0,3 mg/mL, eye drops, solution, in single-dose container
   1. What is LUMIGAN 0.3 mg/mL single dose and what is it used for
   2. What you need to know before using LUMIGAN 0.3 mg/mL single dose
   3. How to use LUMIGAN 0.3 mg/mL single dose
   4. Possible side effects
   5. How to store LUMIGAN 0.3 mg/mL single dose
   6. Package contents and other information

LUMIGAN 0,1 mg/ml, eye drops, solution

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

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

LUMIGAN is an antiglaucoma medication. It belongs to a category of drugs called
prostamides.
LUMIGAN 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 glaucoma and can eventually cause damage to vision.

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

Do not use LUMIGAN 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 unwanted effect caused by the preservative benzalkonium chloride.

Warnings and precautions
Talk to your doctor or pharmacist before using LUMIGAN 0.1 mg/ml.

• Consult your doctor if:
• you suffer from breathing 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 "LUMIGAN 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, LUMIGAN 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 (dermalcalasis 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 can
compromise the field of vision. If you stop using LUMIGAN, the changes may
disappear. LUMIGAN 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
LUMIGAN 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 LUMIGAN
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.
LUMIGAN may pass into breast milk, so it is advisable not to breastfeed during treatment
with LUMIGAN.

Driving and using machines:
After administering LUMIGAN, you may experience slight transient blurred vision.
In this case, do not drive or operate machinery until your vision returns to normal.

LUMIGAN 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 LUMIGAN, benzalkonium chloride, can be absorbed by soft contact lenses and can lead to a change
in their color. Remove your contact lenses before using this medicine and wait 15 minutes after administering
the eye drops before putting your contact lenses back in. Benzalkonium chloride can also
cause eye irritation, especially if you have dry eyes or corneal disorders (the outermost transparent layer of the eye). If you experience an abnormal sensation in your eye, burning or
pain after using this medicine, talk to your doctor.

3. How to use LUMIGAN 0.1 mg/ml

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

If you use more LUMIGAN 0.1 mg/ml than you should
If you use more LUMIGAN 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 LUMIGAN 0.1 mg/ml
If you forget to use LUMIGAN, as soon as you remember, put in 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 LUMIGAN 0.1 mg/ml
For it to work correctly, LUMIGAN must be used every day. If you stop using LUMIGAN, the
intraocular pressure may increase, so you should talk to your doctor before stopping this
treatment.
If you have any further questions 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 side effects
These effects may occur in 1 or more patients in 10.
Related to the eye

• Mild 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 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.
Related to the eye

• Small ulcers on the surface of the eye, with or without inflammation
• Irritation
• Eye itching
• Lengthening of eyelashes
• Irritation when administering drops into the eyes
• Eye pain

Related to 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 in 1,000.
Related to the eye

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

Related to the skin

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

Related to the body

• Headache
• Feeling unwell

Side effects with unknown frequency
Related to the eye

• Macular edema (swelling of the retina in the back of the eye that 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

Related to 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
• Change in skin color (around the eye)

In addition to the side effects of LUMIGAN 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
• 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. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system indicated in Annex V.
By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store LUMIGAN 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
package after Exp. The expiry date refers to the last day of the 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. Package contents and other information

What LUMIGAN 0.1 mg/ml 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 purified water. Small amounts of hydrochloric acid or sodium hydroxide may be added to maintain a normal acidity level (pH).

Description of the appearance of LUMIGAN 0.1 mg/ml and contents of the pack
LUMIGAN is a clear, colorless eye drop solution, supplied in a pack containing 1 plastic bottle
or 3 plastic bottles, each with a screw cap. Each bottle is filled to approximately halfway and contains 3
milliliters of solution, sufficient for 4 weeks of use. Not all pack sizes may be marketed.

Marketing authorisation holder
AbbVie Deutschland GmbH & Co. KG
Knollstraße
67061 Ludwigshafen
Germany

Manufacturer
Allergan Pharmaceuticals Ireland
Castlebar Road
Westport
Co. Mayo
Ireland
For further information on LUMIGAN, contact the local representative of the marketing authorisation holder.

België/Belgique/BelgienLietuva
AbbVie UAB
AbbVie SA Tel: +370 5 205 3023
Tél/Tel: +32 10 477811

България
Allergan България ЕООД
Тел.: +359 (0) 800 20 280

Luxembourg/Luxemburg
AbbVie SA
Belgique/Belgien
Tél/Tel: +32 10 477811

Česká republika
Allergan CZ s.r.o.
Tel: +420 800 188 818

Magyarország
Allergan Hungary Kft.
Tel: +36 80 100 101

Malta
Allergan Pharmaceuticals Ireland
+356 27780331

Danmark
AbbVie A/S
Tlf: +45 72 30 20 28

Deutschland
AbbVie Deutschland GmbH & Co. KG
Tel.: 00800 222843 33 (gebührenfrei)
Tel.: +49 (0) 611 / 1720-0

Nederland
AbbVie B.V.
Tel: +31 (0)88 322 2843

Eesti
AbbVie OÜ
Tel: + 372 623 1011

Norge
AbbVie AS
Tlf: +47 67 81 80 00

Ελλάδα/Κύπρος
Allergan Hellas Pharmaceuticals S.A.
Τηλ: +30 210 74 73 300
Österreich
AbbVie GmbH
Tel: +43 1 20589-0

España
AbbVie Spain, S.L.U.
Tel: +34 913840910
Polska
Allergan Sp. z o.o.
Tel: +48 22 256 37 00

France
Allergan France SAS
Tel: +33 (0)1 49 07 83 00

Portugal
AbbVie, Lda.
Tel.: +351 (0)21 1908400

Hrvatska
AbbVie d.o.o
Tel: +385 (0)1 5625 501

România
Allergan S.R.L.
Tel.: +40 21 301 53 02

Ireland
AbbVie Limited
Tel: +353 (0)1 4287900

Slovenija
AbbVie biofarmacevtska družba d.o.o
Tel: + 386 (1)32 08 060

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Allergan SK s.r.o.
Tel: +421 800 221 223

Italia
Allergan S.p.A
Tel: +39 06 509 562 90

Suomi/Finland
AbbVie Oy
Puh/Tel: +358 (0)10 2411 200

Latvija
AbbVie SIA
Tel: +371 676 05000

Sverige
AbbVie AB
Tel: +46 (0)8 684 44 600

United Kingdom (Northern Ireland)
AbbVie Deutschland GmbH & Co. KG
Tel: +44 (0)1628 561090
More detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu .

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

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

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

LUMIGAN is an antiglaucoma medication. It belongs to a category of drugs called
prostamides.
LUMIGAN 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 fluid that nourishes its interior. 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, the pressure inside the eye increases. This medicine serves to increase the amount of fluid 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.

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

Do not use LUMIGAN 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 of the preservative benzalkonium chloride.

Warnings and precautions
Talk to your doctor or pharmacist before using LUMIGAN 0.3 mg/ml.

• Consult your doctor if:
• you suffer from breathing 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 "LUMIGAN 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, LUMIGAN 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), thickening tension 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
compromise the visual field. If you stop using LUMIGAN, the changes may
disappear. LUMIGAN 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
LUMIGAN has not been tested in patients under 18 years of age, therefore LUMIGAN should not
be used in patients under 18 years of age.

Other medicines and LUMIGAN
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.
LUMIGAN may pass into breast milk, therefore it is advisable not to breastfeed during treatment
with LUMIGAN.

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

LUMIGAN 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 LUMIGAN, benzalkonium
chloride, can be absorbed by soft contact lenses and can lead to a change
in their color. Remove contact lenses before using this medicine and after administration
of the eye drops, wait 15 minutes before putting the contact lenses back in. Benzalkonium chloride can also
cause eye irritation, especially if you have dry eyes or corneal disorders (the outermost transparent layer of the eye). If you experience any abnormal sensation in the eye, burning or
pain after using this medicine, talk to your doctor.

3. How to use LUMIGAN 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.
LUMIGAN must be applied only to the eyes. The recommended dose is one drop of
LUMIGAN once a day, in the evening, in each eye to be treated.
If you are using LUMIGAN with another ophthalmic medicine, wait at least 5 minutes after using
LUMIGAN 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 pull down your 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 your 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 the cap back on.

If you use more LUMIGAN 0.3 mg/ml than you should
If you use more LUMIGAN 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 LUMIGAN 0.3 mg/ml
If you forget to use LUMIGAN, as soon as you remember, put in 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 LUMIGAN 0.3 mg/ml
For it to work correctly, LUMIGAN must be used every day. If you stop using
LUMIGAN, your eye pressure may increase, so you should talk to your doctor before
stopping this treatment.
If you have any further questions 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 side effects
These effects may occur in 1 or more patients out of 10.
Related to the eye

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

• Eye allergic 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 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

Related to the body

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

Uncommon side effects
These effects may occur in 1-9 patients out of 1,000.
Related to 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
• Tightening of the eyelid, which moves away from the surface of the eye
• Redness of the skin around the eye

Related to the body

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

Side effects with unknown frequency
Related to the eye

• Eye discomfort

Related to 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 rash)
• Darkening of the skin around the eye
• Changes 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 clear layer of 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, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store LUMIGAN 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
pack after Exp. The expiry date refers to the last day of the month.
The bottle must be discarded no later than 4 weeks after first opening, even if it still contains
eye drops. This will prevent infections. To help you remember, write the date of first
opening in the space provided on the pack.
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 LUMIGAN 0.3 mg/ml 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 purified water. Small amounts of hydrochloric acid or sodium hydroxide may be added to maintain a normal acidity level (pH).

Description of the appearance of LUMIGAN 0.3 mg/ml and package contents
LUMIGAN is a clear, colorless eye drop, supplied in a package containing 1 plastic bottle
or 3 plastic bottles, each with a screw cap. Each bottle is filled to about halfway and contains 3
milliliters of solution, sufficient for 4 weeks of use. Not all pack sizes may be marketed.

Marketing authorisation holder
AbbVie Deutschland GmbH & Co. KG
Knollstraße
67061 Ludwigshafen
Germany

Manufacturer
Allergan Pharmaceuticals Ireland
Castlebar Road
Westport
Co. Mayo
Ireland
For further information on LUMIGAN, contact the local representative of the marketing authorisation holder.

België/Belgique/BelgienLietuva
AbbVie UAB
AbbVie SA Tel: +370 5 205 3023
Tél/Tel: +32 10 477811

България
Allergan Bulgaria EOOD
Тел.: +359 (0) 800 20 280

Luxembourg/Luxemburg
AbbVie SA
Belgique/Belgien
Tél/Tel: +32 10 477811

Česká republika
Allergan CZ s.r.o.
Tel: +420 800 188 818

Magyarország
Allergan Hungary Kft.
Tel: +36 80 100 101

Malta
Allergan Pharmaceuticals Ireland
+356 27780331

Danmark
AbbVie A/S
Tlf: +45 72 30 20 28

Deutschland
AbbVie Deutschland GmbH & Co. KG
Tel.: 00800 222843 33 (gebührenfrei)
Tel.: +49 (0) 611 / 1720-0

Nederland
AbbVie B.V.
Tel: +31 (0)88 322 2843

Eesti
AbbVie OÜ
Tel: + 372 623 1011

Norge
AbbVie AS
Tlf: +47 67 81 80 00

Ελλάδα/Κύπρος
Allergan Hellas Pharmaceuticals S.A.
Τηλ: +30 210 74 73 300
Österreich
AbbVie GmbH
Tel: +43 1 20589-0

España
AbbVie Spain, S.L.U.
Tel: +34 913840910
Polska
Allergan Sp. z o.o.
Tel: +48 22 256 37 00

France
Allergan France SAS
Tel: +33 (0)1 49 07 83 00

Portugal
AbbVie, Lda.
Tel.: +351 (0)21 1908400

Hrvatska
AbbVie d.o.o
Tel: +385 (0)1 5625 501

România
Allergan S.R.L.
Tel.: +40 21 301 53 02

Ireland
AbbVie Limited
Tel: +353 (0)1 4287900

Slovenija
AbbVie biofarmacevtska družba d.o.o
Tel: + 386 (1)32 08 060

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Allergan SK s.r.o.
Tel: +421 800 221 223

Italia
Allergan S.p.A
Tel: +39 06 509 562 90

Suomi/Finland
AbbVie Oy
Puh/Tel: +358 (0)10 2411 200

Latvija
AbbVie SIA
Tel: +371 676 05000

Sverige
AbbVie AB
Tel: +46 (0)8 684 44 600

United Kingdom (Northern Ireland)
AbbVie Deutschland GmbH & Co. KG
Tel: +44 (0)1628 561090
More detailed information on this medicine is available on the website of the European Medicines Agency:
http://www.ema.europa.eu

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

1. What is LUMIGAN 0.3 mg/mL single dose and what is it used for

LUMIGAN 0.3 mg/mL single dose is a glaucoma medication. It belongs to a category of
drugs called prostamides.
LUMIGAN 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 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 glaucoma and can ultimately cause damage to vision.
This medicine does not contain preservatives.

2. What you need to know before using LUMIGAN 0.3 mg/mL single dose

Do not use this medicine

• if you are allergic to bimatoprost or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using LUMIGAN 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 from or have suffered from low blood pressure or slowed heartbeat
• you have had a viral infection or inflammation of the eyes

During treatment, LUMIGAN 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), thickening tension of the periorbital skin (dermatocalasis
inversion) 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
compromise the visual field. If you stop using LUMIGAN, the changes may
disappear. LUMIGAN 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
LUMIGAN 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 LUMIGAN 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, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
LUMIGAN 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 administration of LUMIGAN 0.3 mg/mL single dose, you may experience mild transient
blurred vision. In this case, do not drive or use machinery until your vision is
clear.

3. How to use LUMIGAN 0.3 mg/mL single dose

Use this medicine following the instructions of your doctor or pharmacist exactly. 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.
LUMIGAN 0.3 mg/mL single dose must be applied only to the eyes.
If you are using LUMIGAN 0.3 mg/mL single dose with another ophthalmic medicine, wait at least 5 minutes
after using LUMIGAN 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.
Wash your hands before use. Make sure the single dose container is intact before use. The
solution must be used immediately after opening. To avoid contamination, be careful
to ensure 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 sachet 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 a drop of eye drops into the/into the eye(s) to be treated.
• 3. Discard the single dose container immediately after use, even if some solution remains 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 LUMIGAN 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 LUMIGAN 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 LUMIGAN 0.3 mg/mL single dose
For it to work correctly, LUMIGAN 0.3 mg/mL single dose must be used every day. If
you stop using LUMIGAN 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 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 everyone will experience them.

Very common side effects
These effects may occur in 1 or more patients out of 10.
Related to the eye

• Mild redness (up to 24% of people)
• 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 (dermalchalasis 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.
Related to 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 users out of 1000
Related to 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

Related to the body

• Headache
• Growth of hair around the eye

Side effects with frequency not known
Related to the eye

• Sticky eyes
• Eye discomfort

Related to 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 LUMIGAN 0.3 mg/mL single dose, the following
side effects have been observed with the multidose formulation of LUMIGAN 0.3 mg/mL containing the preservative
and may occur in patients taking LUMIGAN 0.3 mg/mL single dose:

• Burning sensation inside the eye
• Allergic reaction in the eye
• Inflamed eyelids
• Difficulty seeing clear images
• Worsening of vision
• Darkening of eyelashes
• Retinal bleeding
• Inflammation inside the eye
• Cystoid macular edema (swelling of the retina inside the eye leading to worsening of vision)
• Inflammation of the iris
• Eyelid spasms
• Narrowing of the eyelid, which moves away from the surface of the eye
• Nausea
• Redness of the skin around the eyes
• Weakness
• Increased liver function 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
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 effects, including those not listed in this leaflet, please inform
your doctor or pharmacist. You can also report side effects directly through the national reporting system
as reported in Annex V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. How to store LUMIGAN 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 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 30
days of opening the 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. Package contents and other information

What LUMIGAN 0,3 mg/mL single-dose contains

• The active ingredient is bimatoprost. One ml of solution contains 0.3 mg of bimatoprost.
• The excipients are sodium chloride, disodium phosphate heptahydrate, citric acid monohydrate and purified water. Small amounts of hydrochloric acid or sodium hydroxide may be added to maintain a normal acidity level (pH).

Description of the appearance of LUMIGAN 0,3 mg/mL single-dose and package contents
LUMIGAN 0,3 mg/mL single-dose is a clear, colorless solution, supplied in single-dose plastic containers, each containing 0.4 ml of solution.
The package contains 5 single-dose containers in a carton.
The package contains 3 or 9 aluminum pouches, each containing 10 single-dose containers, for
a total of 30 or 90 single-dose containers in a carton, respectively.
Not all pack sizes may be marketed.

Marketing authorization holder
AbbVie Deutschland GmbH & Co. KG
Knollstraße
67061 Ludwigshafen
Germany

Manufacturer
Allergan Pharmaceuticals Ireland
Castlebar Road
Westport
Co. Mayo
Ireland
For further information on this medicinal product, contact the local representative of the marketing authorization holder.

België/Belgique/BelgienLietuva
AbbVie UAB
AbbVie SA Tel: +370 5 205 3023
Tél/Tel: +32 10 477811

България
Allergan България ЕООД
Тел.: +359 (0) 800 20 280

Luxembourg/Luxemburg
AbbVie SA
Belgique/Belgien
Tél/Tel: +32 10 477811

Česká republika
Allergan CZ s.r.o.
Tel: +420 800 188 818

Magyarország
Allergan Hungary Kft.
Tel: +36 80 100 101

Malta
Allergan Pharmaceuticals Ireland
+356 27780331

Danmark
AbbVie A/S
Tlf: +45 72 30 20 28

Deutschland
AbbVie Deutschland GmbH & Co. KG
Tel.: 00800 222843 33 (gebührenfrei)
Tel.: +49 (0) 611 / 1720-0

Nederland
AbbVie B.V.
Tel: +31 (0)88 322 2843

Eesti
AbbVie OÜ
Tel: + 372 623 1011

Norge
AbbVie AS
Tlf: +47 67 81 80 00

Ελλάδα/Κύπρος
Allergan Hellas Pharmaceuticals S.A.
Τηλ: +30 210 74 73 300
Österreich
AbbVie GmbH
Tel: +43 1 20589-0

España
AbbVie Spain, S.L.U.
Tel: +34 913840910
Polska
Allergan Sp. z o.o.
Tel: +48 22 256 37 00

France
Allergan France SAS
Tel: +33 (0)1 49 07 83 00

Portugal
AbbVie, Lda.
Tel.: +351 (0)21 1908400

Hrvatska
AbbVie d.o.o
Tel: +385 (0)1 5625 501

România
Allergan S.R.L.
Tel.: +40 21 301 53 02

Ireland
AbbVie Limited
Tel: +353 (0)1 4287900

Slovenija
AbbVie biofarmacevtska družba d.o.o
Tel: + 386 (1)32 08 060

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Allergan SK s.r.o.
Tel: +421 800 221 223

Italia
Allergan S.p.A
Tel: +39 06 509 562 90

Suomi/Finland
AbbVie Oy
Puh/Tel: +358 (0)10 2411 200

Latvija
AbbVie SIA
Tel: +371 676 05000

Sverige
AbbVie AB
Tel: +46 (0)8 684 44 600

United Kingdom (Northern Ireland)
AbbVie Deutschland GmbH & Co. KG
Tel: +44 (0)1628 561090
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu
This leaflet is available in all official languages of the European Union/European Economic Area on the
website of the European Medicines Agency.