bimatoprost: package leaflet

treatment.

Wipe off any excess that runs down the cheek.

If a drop misses your eye, try again.

To help prevent infections and avoid eye injury, do not let the tip of the bottle touch your eye or anything else. Put the cap back on and close the bottle straight after you have used it.

If you use more LUMIGAN than you should
If you use more LUMIGAN than you should, it is unlikely to cause you any serious harm. Put your next dose in at the usual time. If you are worried, talk to your doctor or pharmacist.

If you forget to use LUMIGAN
If you forget to use LUMIGAN, use a single drop as soon as you remember, and then go back to your regular routine. Do not take a double dose to make up for a forgotten dose.

If you stop using LUMIGAN
LUMIGAN should be used every day to work properly. If you stop using LUMIGAN the pressure inside your eye may go up, therefore 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)
Affecting the eye
- Slight redness (up to 29 % of people)
- Loss of fat in the eye region which can lead to deepening of your eyelid crease, sunken eye (enophthalmos), drooping eyelid (ptosis), tightening of the skin around your eye (involution of dermatochalasis), and the lower white part of your eye to become more visible (inferior scleral show)

Common (may affect up to 1 in 10 people)
Affecting the eye
- Small breaks in the surface of the eye, with or without inflammation
- Irritation
- Itchy eyes
- Longer eyelashes
- Irritation, when drop is put in the eye
- Eye pain

Affecting the skin
- Red and itchy eyelids
- Darker skin colour around the eye
- Hair growth around the eye

Uncommon (may affect up to 1 in 100 people)
Affecting the eye
- Darker Iris colour
- Tired eye
- Swelling of the surface of the eye
- Blurred vision
- Loss of eye lashes

Affecting the skin
- Dry skin
- Crusting on the edge of the eyelid
- Swelling of the eyelid
- Itching

Affecting the body
- Headache
- Feeling of sickness

Not known (frequency cannot be estimated from the available data)
Affecting the eye
- Macular oedema (swelling of the retina at the back of the eye which may lead to worsening vision)
- Darker eyelid colour
- Dryness
- Sticky eyes
- A feeling that something is in your eye
- Swelling of the eye
- Increasing tears
- Ocular discomfort
- Sensitivity to light

Affecting the body
- Asthma
- Worsening of asthma
- Worsening of the lung disease called chronic obstructive pulmonary disease (COPD)
- Shortness of breath
- Symptoms of allergic reaction (swelling, redness of the eye and rash of the skin)
- Dizziness
- Increased blood pressure
- Skin discoloration (periocular)

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

• Ocular burning
• An allergic reaction in the eye
• Inflamed eyelids
• Difficulty in seeing clearly
• Worsening of vision
• Swelling of the see-through layer that covers the eye
• Tears
• Darker eyelashes
• Retinal bleeding
• Inflammation within the eye
• Cystoid macular oedema (swelling of the retina within the eye leading to worsening vision)

• Eyelid twitching
• Eyelid shrinking, moving away from surface of the eye
• Skin redness around the eye
• Weakness
• An increase in blood-test results that show how your liver is working

Other side effects reported with eye drops containing phosphates
In very rare cases, some patients with severe damage to the clear layer at the front of the eye (the cornea) have developed cloudy patches on the cornea due to calcium build-up 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 via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of the medicine.

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 bottle label and the carton after EXP. The expiry date refers to the last day of that month.

You must throw away the bottle at the latest four weeks after you first opened it, even if there are still some drops left. This will prevent infections. To help you remember, write down the date you opened it in the space on the box.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

What LUMIGAN contains

• The active substance is bimatoprost. One ml of solution contains 0.1 mg 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 keep the level of acid (pH levels) normal (see section 2).

What LUMIGAN looks like and contents of the pack
LUMIGAN is a colourless clear eye drop solution in a pack containing either 1 plastic bottle or 3 plastic bottles each with a screw cap. Each bottle is approximately half full and contains 3 millilitres of solution. This is enough for 4 weeks’ usage. 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 any information about this medicine, please contact the local representative of the marketing authorisation holder.

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

Lietuva
AbbVie UAB
Tel: + 370 5 205 3023

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

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

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

Malta
Vivian Corporation Ltd.
Tel: +356 27780331
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 6231011

Norge
AbbVie AS
Tlf: +47 67 81 80 00

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

España
AbbVie Spain, S.L.U.
Tel: +34 913840910

Polska
AbbVie Sp. Z o.o.
Tel.: +48 22 372 78 00
France
AbbVie
Tél: +33 (0) 1 45 60 13 00
Portugal
AbbVie, Lda.
Tel.: +351 (0)21 1908400

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

România
AbbVie S.R.L.
Tel: +40 21 529 30 35

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
AbbVie s.r.o.
Tel: +421 2 5050 0777

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

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

Latvija
AbbVie SIA
Tel: +371 67605000

This leaflet was last revised in

Detailed information on this medicinal product is available on the European Medicines Agency web site: https://www.ema.europa.eu.

To listen to or request a copy of this leaflet in <Braille>, <large print> or <audio>, please contact the local representative of the Marketing Authorisation Holder.

treatment.

Wipe off any excess that runs down the cheek.

If a drop misses your eye, try again.

To help prevent infections and avoid eye injury, do not let the tip of the bottle touch your eye or anything else. Put the cap back on and close the bottle straight after you have used it.

If you use more LUMIGAN than you should
If you use more LUMIGAN than you should, it is unlikely to cause you any serious harm. Put your next dose in at the usual time. If you are worried, talk to your doctor or pharmacist.

If you forget to use LUMIGAN
If you forget to use LUMIGAN, use a single drop as soon as you remember, and then go back to your regular routine. Do not take a double dose to make up for a forgotten dose.

If you stop using LUMIGAN
LUMIGAN should be used every day to work properly. If you stop using LUMIGAN the pressure inside your eye may go up, therefore 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)
Affecting the eye
- Longer eyelashes (up to 45% of people)
- Slight redness (up to 44% of people)
- Itchiness (up to 14% of people)
- Loss of fat in the eye region which can lead to deepening of your eyelid crease, sunken eye (enophthalmos), drooping eyelid (ptosis), tightening of the skin around your eye (involution of dermatochalasis), and the lower white part of your eye to become more visible (inferior scleral show)

Common (may affect up to 1 in 10 people)
Affecting the eye
- An allergic reaction in the eye
- Tired eyes
- Sensitivity to light
- Darker skin colour around the eye

• Darker eyelashes
• Pain
• A feeling that something is in your eye
• Sticky eyes
• Darker iris colour
• Difficulty in seeing clearly
• Irritation
• Burning
• Inflamed, red and itchy eyelids
• Tears
• Dryness
• Worsening of vision
• Blurred vision
• Swelling of the see-through layer which covers the surface of the eye
• Small breaks in the surface of the eye, with or without inflammation

Affecting the body
- Headaches
- An increase in blood-test results that show how your liver is working
- Increased blood pressure

Uncommon (may affect up to 1 in 100 people)
Affecting the eye
- Cystoid macular oedema (swelling of the retina within the eye leading to worsening vision)
- Inflammation within the eye
- Retinal bleeding
- Swollen eyelids
- Eyelid twitching
- Eyelid shrinking, moving away from surface of the eye
- Skin redness around the eye

Affecting the body
- Nausea
- Dizziness
- Weakness
- Hair growth around the eye

Not known (frequency cannot be estimated from the available data)
Affecting the eye
- Ocular discomfort

Affecting the body
- Asthma
- Worsening of asthma
- Worsening of the lung disease called chronic obstructive pulmonary disease (COPD)
- Shortness of breath
- Symptoms of allergic reaction (swelling, redness of the eye and rash of the skin)
- Skin discoloration (periocular)

Other side effects reported with eye drops containing phosphates.
In very rare cases, some patients with severe damage to the clear layer at the front of the eye (the cornea) have developed cloudy patches on the cornea due to calcium build-up 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 via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of the medicine.

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 bottle label and the carton after EXP. The expiry date refers to the last day of that month.

You must throw away the bottle, at the latest, four weeks after you first opened it, even if there are still some drops left. This will prevent infections. To help you remember, write down the date you opened it in the space on the box.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

What LUMIGAN contains
- The active substance is bimatoprost. One ml of solution contains 0.3 mg 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 keep the level of acid (pH levels) normal (see section 2).

What LUMIGAN looks like and contents of the pack
LUMIGAN is a colourless clear eye drop solution in a pack containing either 1 plastic bottle or 3 plastic bottles each with a screw cap. Each bottle is approximately half full and contains 3 millilitres of solution. This is enough for 4 weeks’ usage. 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 any information about this medicine, please contact the local representative of the marketing authorisation holder.

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

Lietuva
AbbVie UAB
Tel: + 370 5 205 3023

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

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

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

Malta
Vivian Corporation Ltd.
Tel: +356 27780331
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 6231011

Norge
AbbVie AS
Tlf: +47 67 81 80 00

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

España
AbbVie Spain, S.L.U.
Tel: +34 913840910

Polska
AbbVie Sp. z o.o.
Tel.: +48 22 372 78 00
France
AbbVie
Tél: +33 (0) 1 45 60 13 00
Portugal
AbbVie, Lda.
Tel.: +351 (0)21 1908400

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

România
AbbVie S.R.L.
Tel: +40 21 529 30 35

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
AbbVie s.r.o.
Tel: +421 2 5050 0777
Italia
AbbVie S.r.l.
Tel: +39 06 928921
Suomi/Finland
AbbVie Oy
Puh/Tel: +358 (0)10 2411 200

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

Latvija
AbbVie SIA
Tel: +371 67605000

This leaflet was last revised in

Detailed information on this medicinal product is available on the European Medicines Agency web site:
https://www.ema.europa.eu/

To listen to or request a copy of this leaflet in <Braille>, <large print> or <audio>, please contact the local representative of the Marketing Authorisation Holder.

upwards) and twist-off the cap.

and squeeze it to release 1 drop into the affected eye(s).

Wipe off any excess that runs down the cheek.

If you wear contact lenses, take your lenses out before using this medicine. Wait 15 minutes after using the drops, and before you put your lenses back in.

If you use more LUMIGAN than you should
If you use more of this medicine than you should, it is unlikely to cause you any serious harm. Put your next dose in at the usual time. If you are worried, talk to your doctor or pharmacist.

If you forget to use LUMIGAN
If you forget to use this medicine, use a single drop as soon as you remember, and then go back to your regular routine. Do not take a double dose to make up for a forgotten dose.

If you stop using LUMIGAN
LUMIGAN single-dose should be used every day to work properly. If you stop using LUMIGAN single-dose the pressure inside your eye may go up, therefore talk to your doctor before stopping this treatment.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

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

Very common (may affect more than 1 in 10 people)
Affecting the eye
- Slight redness (up to 24% of people)
- Loss of fat in the eye region which can lead to deepening of your eyelid crease, sunken eye (enophthalmos), drooping eyelid (ptosis), tightening of the skin around your eye (involution of dermatochalasis), and the lower white part of your eye to become more visible (inferior scleral show)

Common side (may affect up to 1 in 10 people)
Affecting the eye
- Small breaks in the surface of the eye, with or without inflammation
- Irritation
- Itchy eyes
- Pain
- Dryness
- A feeling that something is in your eye
- Longer eyelashes
- Darker skin colour around the eye
- Red eyelids

Uncommon (may affect up to 1 in 100 people)
These may affect 1 to 9 users in 1000
Affecting the eye
- Tired eyes
- Sensitivity to light
- Darker iris colour
- Itchy and swollen eyelids
- Tears
- Swelling of the see-through layer which covers the surface of the eye
- Blurred vision

Affecting the body
- Headaches
- Hair growth around the eye

Not known (frequency cannot be estimated from the available data)
Affecting the eye
- Sticky eyes
- Ocular discomfort

Affecting the body
- Asthma
- Worsening of asthma
- Worsening of the lung disease called chronic obstructive pulmonary disease (COPD)
- Shortness of breath
- Symptoms of allergic reaction (swelling, redness of the eye and rash of the skin)
- Dizziness
- Increased blood pressure
- Skin discoloration (periocular)

In addition to the side effects for LUMIGAN 0.3 mg/mL single-dose, the following side effects have been seen with the preserved multi-dose formulation of LUMIGAN 0.3 mg/mL and may occur in patients taking LUMIGAN 0.3 mg/mL single-dose:

• Burning sensation in the eye
• An allergic reaction in the eye
• Inflamed eyelids
• Difficulty in seeing clearly
• Worsening vision
• Darker eyelashes
• Retinal bleeding
• Inflammation within the eye
• Cystoid macular oedema (swelling of the retina within the eye leading to worsening vision)
• Iris inflammation
• Eyelid twitching
• Eyelid shrinking, moving away from surface of the eye
• Nausea
• Skin redness around the eye
• Weakness
• An increase in blood-test results that show how your liver is working

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

Reporting of side effects
If you get any of the 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 via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of the medicine.

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 keep any unused solution.

Do not use this medicine after the expiry date which is stated on the single-dose container and the carton after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage condition. However, once the pouch is opened use within 30 days.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

What LUMIGAN single-dose contains
- The active substance is bimatoprost. One ml of solution contains 0.3 mg bimatoprost.
- The other ingredients are sodium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate and purified water. Small amounts of hydrochloric acid or sodium hydroxide may be added to keep the level of acid (pH levels) normal.

What LUMIGAN single-dose looks like 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.

Pack contains 5-single-dose containers in a carton.

Pack contains 3 or 9 aluminium foil 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 Authorisation Holder
AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany

Manufacturer
Allergan Pharmaceuticals Ireland
Castlebar Road
Westport
Co. Mayo
Ireland

For any information about this medicine, please contact the local representative of the marketing authorisation holder.

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

Lietuva
AbbVie UAB
Tel: + 370 5 205 3023

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

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

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

Malta
Vivian Corporation Ltd.
Tel: +356 27780331
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 6231011

Norge
AbbVie AS
Tlf: +47 67 81 80 00

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

España
AbbVie Spain, S.L.U.
Tel: +34 913840910

Polska
AbbVie Sp. z o.o.
Tel.: +48 22 372 78 00
France
AbbVie
Tél: +33 (0) 1 45 60 13 00
Portugal
AbbVie, Lda.
Tel.: +351 (0)21 1908400

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

România
AbbVie S.R.L.
Tel: +40 21 529 30 35

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
AbbVie s.r.o.
Tel: +421 2 5050 0777
Italia
AbbVie S.r.l.
Tel: +39 06 928921
Suomi/Finland
AbbVie Oy
Puh/Tel: +358 (0)10 2411 200

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

Latvija
AbbVie SIA
Tel: +371 67605000

This leaflet was last revised in

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 leaflet in <Braille>, <large print> or <audio>, please contact the local representative of the Marketing Authorisation Holder.