Lumigan

Package leaflet: Information for the patient

LUMIGAN 0.1 mg/ml eye drops, solution

bimatoprost
Please read this leaflet carefully before 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 their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What LUMIGAN is and what it is used for

LUMIGAN is an anti-glaucoma medicine. It belongs to a class of medicines called prostamides.
LUMIGAN eye drops are used to reduce elevated intraocular pressure. This medicine may 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, the pressure inside the eye increases. This medicine works by increasing the amount of fluid that is drained, thereby reducing the pressure inside the eye. Elevated intraocular pressure, if left untreated, can lead to a condition called glaucoma and may eventually cause damage to vision.

2. What you need to know before using LUMIGAN

Do not use LUMIGAN

• 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 LUMIGAN 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 "LUMIGAN contains benzalkonium chloride")
• you have or have had 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 (involution of
dermatocalasis), 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 LUMIGAN, these changes may
resolve. LUMIGAN 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
LUMIGAN 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 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, think you might be pregnant, are planning a pregnancy, or are breastfeeding,
please consult your doctor or pharmacist before taking this medicine.
LUMIGAN may pass into breast milk; therefore, breastfeeding is not recommended during treatment
with LUMIGAN.
Driving and use of machinery:
After administration of LUMIGAN, you may experience a mild, transient blurring of vision.
In this case, do not drive or operate machinery until your vision has cleared.
LUMIGAN 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, may be absorbed by soft contact lenses and may cause a change in
their colour. Remove your contact lenses before using this medicine and wait 15 minutes after
administration of the eye drops before reinserting your contact lenses. Benzalkonium chloride may also
cause ocular irritation, especially if you have dry eye or corneal disorders (the outermost transparent layer of the eye). If you experience any unusual sensation, burning, or pain in the eye after using this medicine, speak to your doctor.

3. How to use LUMIGAN

Use this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
LUMIGAN must be applied only in the eyes. The recommended dose is one drop of
LUMIGAN once daily in the evening, in each eye to be treated.
If you use LUMIGAN together with another eye medicine, apply LUMIGAN 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.

3. Wash your hands. Tilt your head backward and look upward.
4. Gently pull down the lower eyelid to form a small pocket.
5. Invert the bottle and gently squeeze to release one drop of eye drops into each eye to be treated.
6. Release the lower eyelid and close the 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 injuries, the tip of the bottle must not touch the eye or any other surface. After using the bottle, close it properly by screwing the cap back on tightly.
If you use more LUMIGAN than you should
If you use more LUMIGAN than recommended, 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 LUMIGAN
If you forget to use LUMIGAN, as soon as you remember, apply a single drop and then return to your regular dosing schedule. Do not use a double dose to make up for the missed dose.
If you stop using LUMIGAN
To work properly, LUMIGAN must be used every day. If you stop using
LUMIGAN, eye pressure may increase; therefore, you must 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 everybody gets them.

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

• Mild redness (in 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 growth
• 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 surface of the eye
• Blurred vision
• Loss of eyelashes

Skin-related

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

General

• Headache
• Feeling unwell

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

• Macular oedema (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 the lung condition known as 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 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):

• Eye burning
• An allergic reaction in the eye
• Inflamed eyelids
• Difficulty seeing clear images
• Worsening of vision
• Swelling of the transparent layer covering the surface of the eye
• Tearing
• Darker eyelashes
• Bleeding of the retina
• Inflammation inside the eye
• Cystoid macular oedema (swelling of the retina inside the eye leading to worsening of vision)
• Eyelid spasms
• Narrowing of the eyelid, pulling away from the eye surface
• Redness of the skin around the eye
• 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 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 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

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle label and on the box after Exp. The expiry date refers to the last day of that month.
The bottle must be discarded no later than 4 weeks after first opening, even if there are still eye drops remaining. This will prevent infections. To help you remember, write the date of first opening in the space provided on the box.
Do not dispose of any medicine 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 LUMIGAN 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, sodium phosphate dibasic 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) (see section 2).

Description of the appearance of LUMIGAN and contents of the pack
LUMIGAN is a clear, colourless eye drop solution supplied in a pack containing 1 plastic bottle
or 3 plastic bottles, each with a screw cap. Each bottle is approximately half full and contains 3
millilitres 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, please contact the local representative of the Marketing
Authorisation Holder.
België/Belgique/Belgien Lietuva
AbbVie SA AbbVie UAB
Tél/Tel: +32 10 477811 Tel: + 370 5 205 3023
България Luxembourg/Luxemburg
АбВи ЕООД AbbVie SA
Тел:+359 2 90 30 430 Belgique/Belgien
Tél/Tel: +32 10 477811
Česká republika Magyarország
AbbVie s.r.o. AbbVie Kft.
Tel.: +420 233 098 111 Tel:+36 1 455 8600
Danmark Malta
AbbVie A/S Vivian Corporation Ltd.
Tlf: +45 72 30 20 28 Tel: +356 27780331
Deutschland Nederland
AbbVie Deutschland GmbH & Co. KG AbbVie B.V.
Tel.: 00800 222843 33 (toll-free) Tel: +31 (0)88 322 2843
Tel.: +49 (0) 611 / 1720-0
Eesti Norge
AbbVie OÜ AbbVie AS
Tel. +372 6231011 Tlf: +47 67 81 80 00
Ελλάδα Österreich
AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε. AbbVie GmbH
Τηλ: +30 214 4165 555 Tel: +43 1 20589-0
España Polska
AbbVie Spain, S.L.U. AbbVie Sp. z o.o.
Tel: +34 913840910 Tel.: +48 22 372 78 00
France Portugal
AbbVie AbbVie, Lda.
Tél: +33 (0) 1 45 60 13 00 Tel.: +351 (0)21 1908400
Hrvatska România
AbbVie d.o.o. AbbVie S.R.L.
Tel: + 385 (0)1 5625 501 Tel: +40 21 529 30 35
Ireland Slovenija
AbbVie Limited AbbVie Biofarmacevtska družba d.o.o.
Tel: +353 (0)1 4287900 Tel: +386 (1)32 08 060
Ísland Slovenská republika
Vistor hf. AbbVie s.r.o.
Sími: +354 535 7000 Tel: +421 2 5050 0777
Italia Suomi/Finland
AbbVie S.r.l. AbbVie Oy
Tel: +39 06 928921 Puh/Tel: +358 (0)10 2411 200
Κύπρος Sverige
Lifepharma (Z.A.M.) Ltd AbbVie AB
Τηλ: +357 22 34 74 40 Tel: +46 (0)8 684 44 600
Latvija
AbbVie SIA
Tel: +371 67605000
More detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu .
To listen to or request a copy of this package leaflet in an alternative format (e.g. large print or audio), please contact the local representative of the Marketing Authorisation Holder.

Package leaflet: Information for the patient

LUMIGAN 0.3 mg/ml eye drops, solution

bimatoprost
Please read this leaflet carefully before 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, 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 side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What LUMIGAN is and what it is used for

LUMIGAN is an anti-glaucoma medicine. It belongs to a group of medicines called
prostamides.
LUMIGAN is used to reduce elevated intraocular pressure. This medicine may 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 interior. 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, the pressure inside the eye increases. This medicine works by increasing the amount of fluid that is drained, thereby reducing the pressure inside the eye. Elevated intraocular pressure, if not reduced,
can lead to a condition called glaucoma and may eventually cause damage to vision.

2. What you need to know before using LUMIGAN

Do not use LUMIGAN

• if you are allergic to bimatoprost or to any of the other ingredients of this medicine (listed in section 6).
• if you have previously stopped using eye drops due to an adverse reaction to the preservative benzalkonium chloride.

Warnings and precautions
Talk to your doctor or pharmacist before using LUMIGAN 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 "LUMIGAN 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, 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), 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 compromise the visual field. If you discontinue use of LUMIGAN, these changes may resolve. LUMIGAN 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
LUMIGAN 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 LUMIGAN
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 may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
LUMIGAN may pass into breast milk; therefore, breastfeeding is not recommended during treatment with LUMIGAN.

Driving and using machines
After administration of LUMIGAN, you may experience a mild, transient blurring of vision.
In this case, do not drive or operate machinery until your vision has cleared.

LUMIGAN 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, may be absorbed by soft contact lenses and may cause discoloration. Remove contact lenses before using this medicine and wait 15 minutes after administering the eye drops before reinserting the contact lenses. Benzalkonium chloride may also 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 LUMIGAN

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
LUMIGAN must be used only in the eyes. The recommended dose is one drop of
LUMIGAN once daily, in the evening, in each eye to be treated.
If you are using LUMIGAN with another eye medicine, wait at least 5 minutes after using
LUMIGAN 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.

3. Wash your hands. Tilt your head backward and look upward.
4. Gently pull down the lower eyelid to form a small pocket.
5. Invert the bottle and gently squeeze to release one drop of eye drops into each eye to be treated.
6. 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 using the bottle, close it tightly by screwing the cap back on.
If you use more LUMIGAN than you should
If you use more LUMIGAN than recommended, it 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 LUMIGAN
If you forget to use LUMIGAN, as soon as you remember, apply one single drop and then return to your regular dosing schedule. Do not use a double dose to make up for the missed dose.
If you stop using LUMIGAN
For LUMIGAN to work properly, it must be used every day. If you stop using
LUMIGAN, your intraocular pressure may increase, so you should speak with your doctor before stopping this treatment.
If you have any 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 everybody 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 in the eye region, which may lead to deepening of the eyelid crease, sunken eye (enophthalmos), drooping eyelid (ptosis), tightness of the skin around the eye (dermatological 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

• Ocular allergic reaction
• Tired eyes
• Light sensitivity
• Darkening of the skin around the eye
• Darker eyelashes
• Pain
• Foreign body sensation in the eye
• Sticky eyes
• Darkening of iris colour
• Difficulty seeing clear images
• Irritation
• Burning
• Inflamed, red, and itchy eyelids
• Tearing
• Dryness
• Worsening of vision
• Blurred vision
• Swelling of the transparent layer covering the eye surface
• Small ulcers on the eye surface, with or without inflammation

General side effects

• Headache
• Increased blood test values indicating liver function
• 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
• Bleeding of the retina
• Swollen eyelids
• Eyelid spasms
• Narrowing of the eyelid, pulling 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 disease 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 colour (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) 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 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

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle label and on the box after Exp. The expiry date refers to the last day of that month.
The bottle must be discarded no later than 4 weeks after first opening, even if there are still eye drops remaining. This will prevent infection. To help you remember, write the date of first opening in the space provided on the box.
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 LUMIGAN 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 purified water. Small amounts of hydrochloric acid or sodium hydroxide may be added to maintain a normal acidity level (pH) (see section 2).

Description of the appearance of LUMIGAN and pack contents
LUMIGAN is a clear, colourless eye drop solution supplied in a pack containing either 1 plastic bottle or 3 plastic bottles, each with a screw cap. Each bottle is half-filled and contains 3 millilitres 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 about LUMIGAN, please contact the local representative of the Marketing Authorisation Holder.

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

България Luxembourg/Luxemburg
АбВи ЕООД AbbVie SA
Тел:+359 2 90 30 430 Belgique/Belgien
Tél/Tel: +32 10 477811

Česká republika Magyarország
AbbVie s.r.o. AbbVie Kft.
Tel.: +420 233 098 111 Tel:+36 1 455 8600

Danmark Malta
AbbVie A/S Vivian Corporation Ltd.
Tlf: +45 72 30 20 28 Tel: +356 27780331

Deutschland Nederland
AbbVie Deutschland GmbH & Co. KG AbbVie B.V.
Tel.: 00800 222843 33 (toll-free) Tel: +31 (0)88 322 2843
Tel.: +49 (0) 611 / 1720-0

Eesti Norge
AbbVie OÜ AbbVie AS
Tel. +372 6231011 Tlf: +47 67 81 80 00

Ελλάδα Österreich
AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε. AbbVie GmbH
Τηλ: +30 214 4165 555 Tel: +43 1 20589-0

España Polska
AbbVie Spain, S.L.U. AbbVie Sp. z o.o.
Tel: +34 913840910 Tel.: +48 22 372 78 00

France Portugal
AbbVie AbbVie, Lda.
Tél: +33 (0) 1 45 60 13 00 Tel.: +351 (0)21 1908400

Hrvatska România
AbbVie d.o.o. AbbVie S.R.L.
Tel: + 385 (0)1 5625 501 Tel: +40 21 529 30 35

Ireland Slovenija
AbbVie Limited AbbVie Biofarmacevtska družba d.o.o.
Tel: +353 (0)1 4287900 Tel: +386 (1)32 08 060

Ísland Slovenská republika
Vistor hf. AbbVie s.r.o.
Sími: +354 535 7000 Tel: +421 2 5050 0777

Italia Suomi/Finland
AbbVie S.r.l. AbbVie Oy
Tel: +39 06 928921 Puh/Tel: +358 (0)10 2411 200

Κύπρος Sverige
Lifepharma (Z.A.M.) Ltd AbbVie AB
Τηλ: +357 22 34 74 40 Tel: +46 (0)8 684 44 600

Latvija
AbbVie SIA
Tel: +371 67605000

More detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu

To listen to or request a copy of this patient information leaflet in an alternative format (e.g. large print), please contact the local representative of the Marketing Authorisation Holder.

Patient Information Leaflet: Information for the patient

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

bimatoprost
Please read this leaflet carefully before 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 their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What LUMIGAN single-dose is and what it is used for
2. What you need to know before using LUMIGAN single-dose
3. How to use LUMIGAN single-dose
4. Possible side effects
5. How to store LUMIGAN single-dose
6. Package contents and other information

1. What LUMIGAN single-dose is and what it is used for

LUMIGAN single-dose is an antiglaucoma medicine. It belongs to a class of medicines
called prostamides.
LUMIGAN eye drops solution in single-dose containers is used to reduce elevated intraocular pressure. This
medicinal product 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 amount. 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 intraocular pressure. If left untreated, elevated intraocular pressure
can lead to a condition called glaucoma and may eventually cause vision damage.
This medicinal product does not contain preservatives.

2. What you need to know before using LUMIGAN monodose

Do not use LUMIGAN

• 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 LUMIGAN monodose if:

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

During treatment, LUMIGAN may cause loss of fat around the eye, which can lead to deepening of the eyelid crease, sunken eye (enophthalmos), drooping of the upper eyelid (ptosis), tightening of the skin around the eye (dermatocalasis involution), and exposure of the lower white part of the eye (inferior scleral show). These changes are usually mild in degree, but if pronounced, they may impair the visual field. If you stop using LUMIGAN, these changes may resolve. LUMIGAN monodose may also cause darkening and lengthening of eyelashes, and may 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 monodose has not been studied in patients under 18 years of age and therefore must 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, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
LUMIGAN monodose may pass into breast milk; therefore, breastfeeding is not recommended during treatment with this medicine.

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

3. How to use LUMIGAN 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.
LUMIGAN single-dose must be applied only in the eyes.
If you use LUMIGAN single-dose together with another eye medicine, wait at least 5 minutes after using
LUMIGAN 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.
Wash your hands before use. Ensure 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 come into contact with the eye or
with other surfaces.

1. Take a single-dose container from the pouch and hold it in an upright position (with the cap facing upwards) and twist the cap.
2. Gently pull down the lower eyelid to form a pouch. Invert the single-dose container and gently squeeze to release one drop of eye drops into the eye(s) to be treated.
3. Dispose of the single-dose container immediately after use, even if there is some solution remaining inside.

Wipe away any excess that runs 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 lenses.
If you use more LUMIGAN than you should
If you use more of this medicine than recommended, it is unlikely to cause serious
consequences. Take the next dose at your usual time. If you are concerned, consult your
doctor or pharmacist.
If you forget to use LUMIGAN
If you forget to use this medicine, as soon as you remember, apply one single drop and then
resume your regular dosing schedule. Do not take a double dose to make up for a
missed dose.
If you stop using LUMIGAN
For LUMIGAN single-dose to work properly, it must be used every day. If you stop
using LUMIGAN single-dose, eye pressure may increase, so you should speak with your
doctor before stopping this treatment.
If you have any doubts about how to use this medicine, consult 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 eye 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), 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 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 the iris colour
• Itchy and swollen eyelids
• Tearing
• Swelling of the transparent layer covering the eye surface
• Blurred vision

General disorders

• Headache
• Growth of hair 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 chronic obstructive pulmonary disease (COPD)
• Shortness of breath
• Symptoms of allergic reaction (swelling, eye redness, skin rash)
• Dizziness
• Increase in blood pressure values
• Change in skin colour (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 using 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
• 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 tests

Other side effects reported with eye drops containing phosphates
In very rare cases, some patients with severe damage to the transparent front layer 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, talk to your doctor or pharmacist. You can also report side effects directly via 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 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 after EXP and on the carton after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions. However, it must be used within 30 days of opening the pouch.
Do not dispose of medicines 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 LUMIGAN single-dose contains

• The active substance is bimatoprost. One ml of solution contains 0.3 mg of bimatoprost.
• The excipients are sodium chloride, sodium dibasic 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 single-dose and contents of the pack
LUMIGAN 0.3 mg/ml single-dose is a clear, colourless solution supplied in single-dose plastic containers, each containing 0.4 ml of solution.
The pack contains 5 single-dose containers in a cardboard box.
The pack contains 3 or 9 aluminium pouches, each containing 10 single-dose containers, for a total of 30 or 90 single-dose containers in a cardboard box, respectively.
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 about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

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

България Luxembourg/Luxemburg
АбВи ЕООД AbbVie SA
Тел:+359 2 90 30 430 Belgique/Belgien
Tél/Tel: +32 10 477811

Česká republika Magyarország
AbbVie s.r.o. AbbVie Kft.
Tel.: +420 233 098 111 Tel:+36 1 455 8600

Danmark Malta
AbbVie A/S Vivian Corporation Ltd.
Tlf: +45 72 30 20 28 Tel: +356 27780331

Deutschland Nederland
AbbVie Deutschland GmbH & Co. KG AbbVie B.V.
Tel.: 00800 222843 33 (toll-free) Tel: +31 (0)88 322 2843
Tel.: +49 (0) 611 / 1720-0

Eesti Norge
AbbVie OÜ AbbVie AS
Tel. +372 6231011 Tlf: +47 67 81 80 00

Ελλάδα Österreich
AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε. AbbVie GmbH
Τηλ: +30 214 4165 555 Tel: +43 1 20589-0

España Polska
AbbVie Spain, S.L.U. AbbVie Sp. z o.o.
Tel: +34 913840910 Tel.: +48 22 372 78 00

France Portugal
AbbVie AbbVie, Lda.
Tél: +33 (0) 1 45 60 13 00 Tel.: +351 (0)21 1908400

Hrvatska România
AbbVie d.o.o. AbbVie S.R.L.
Tel: + 385 (0)1 5625 501 Tel: +40 21 529 30 35

Ireland Slovenija
AbbVie Limited AbbVie Biofarmacevtska družba d.o.o.
Tel: +353 (0)1 4287900 Tel: +386 (1)32 08 060

Ísland Slovenská republika
Vistor hf. AbbVie s.r.o.
Sími: +354 535 7000 Tel: +421 2 5050 0777

Italia Suomi/Finland
AbbVie S.r.l. AbbVie Oy
Tel: +39 06 928921 Puh/Tel: +358 (0)10 2411 200

Κύπρος Sverige
Lifepharma (Z.A.M.) Ltd AbbVie AB
Τηλ: +357 22 34 74 40 Tel: +46 (0)8 684 44 600

Latvija
AbbVie SIA
Tel: +371 67605000

More detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu

To listen to or request a copy of this package leaflet in an alternative format, such as enlarged print, please contact the local representative of the Marketing Authorisation Holder.