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Lumigan (bimatoprost) – Package leaflet - S01EE03

Updated on site: 08-Oct-2017

Medication nameLumigan
ATC CodeS01EE03
Substancebimatoprost
ManufacturerAllergan Pharmaceuticals Ireland

Package leaflet: Information for the user

LUMIGAN 0.1 mg/ml, eye drops, solution

Bimatoprost

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

-Keep this leaflet. You may need to read it again.

-If you have further questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

LUMIGAN is an antiglaucoma preparation. It belongs to a group of medicines called prostamides.

LUMIGAN eye drops are used to reduce high pressure in the eye. This medicine may be used on its own or with other drops called beta-blockers which also reduce pressure.

Your eye contains a clear, watery liquid that feeds the inside of the eye. Liquid is constantly being drained out of the eye and new liquid is made to replace this. If the liquid cannot drain out quickly enough, the pressure inside the eye builds up. This medicine works by increasing the amount of liquid that is drained. This reduces the pressure inside the eye. If the high pressure is not reduced, it could lead to a disease called glaucoma and eventually damage your sight.

2. What you need to know before you use 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 because of a side effect of the preservative benzalkonium chloride.

Warnings and precautions:

Talk to your doctor or pharmacist before you use LUMIGAN 0.1 mg/ml

Talk to your doctor, if:

-You have any breathing problems

-You have liver or kidney problems

-You have had a cataract surgery in the past

-You have dry eye

-You have or have had any problems with your cornea (front transparent part of the eye)

-You wear contact lenses (see “Important information about some of the ingredients of

LUMIGAN 0.1 mg/ml”)

-You have or have had low blood pressure or low heart rate

-You have had a viral infection or inflammation of the eye

LUMIGAN may cause your eyelashes to darken and grow, and cause the skin around the eyelid to darken too. The colour of your iris may also go darker over time. These changes may be permanent. The change may be more noticeable if you are only treating one eye.

Children and adolescents

LUMIGAN has not been tested in children under the age of 18 and therefore should not be used by patients under 18 years.

Other medicines and LUMIGAN

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breast-feeding

If you are pregnant or breast feeding, think you might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking any medicine.

LUMIGAN may get into breast milk so you should not breast-feed while you are taking LUMIGAN.

Driving and using machines

Your sight may become blurred for a short time just after using LUMIGAN. You should not drive or use machines until your sight is clear again.

LUMIGAN 0.1 mg/ml contains benzalkonium chloride

Do not use the drops when you are wearing your lenses. Wait 15 minutes after using the drops before you put your lenses back in. A preservative in LUMIGAN called benzalkonium chloride may cause eye irritation and can discolour soft contact lenses.

3.How to use LUMIGAN 0.1 mg/ml

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

LUMIGAN should only be applied to the eye. The recommended dose is one drop of LUMIGAN in the evening, once daily in each eye that needs treatment.

If you use LUMIGAN with another eye medicine, wait at least five minutes between using LUMIGAN and the other eye medicine.

Do not use more than once a day as the effectiveness of treatment may be reduced.

Instructions for use:

You must not use the bottle if the tamper-proof seal on the bottle neck is broken before you first use it.

1.Wash your hands. Tilt your head back and look at the ceiling.

2.Gently pull down the lower eyelid until there is a small pocket.

3.Turn the bottle upside down and squeeze it to release one drop into each eye that needs treatment.

4.Let go of the lower lid, and close your eye for 30 seconds.

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 0.1 mg/ml 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 0.1 mg/ml

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 0.1 mg/ml

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 side effects

These may affect one or more users in 10

Affecting the eye

Slight redness (up to 29 % of people)

Common side effects

These may affect 1 to 9 users in 100

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 side effects

These may affect 1 to 9 users in 1000

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

Side effects where the frequency is not known

Affecting the eye

Macular oedema (swelling of the retina at the back of the eye which may lead to worsening vision)

Darker eyelid colour

Eyes appear sunken

Dryness

Sticky eyes

A feeling that something is in your eye

Swelling of the eye

Increasing tears

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)

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):

Dizziness

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

Sensitivity to light

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

Increased blood pressure

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 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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of the 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 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.

6. Contents of the pack and other information

What LUMIGAN 0.1 mg/ml 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.

What LUMIGAN 0.1 mg/ml 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 and 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

Ísland

Luxembourg/Luxemburg/Nederland

Actavis ehf.

Allergan n.v.

Sími: +354 550 3300

Tél/Tel: +32 (0)2 351 24 24

 

България

Italia

Алерган България ЕООД

Allergan S.p.A

Тел.: +359 (0) 800 20 280

Tel: +39 06 509 561

Česká republika

Latvija

Allergan CZ s.r.o.

Allergan Baltics UAB

Tel: +420 800 188 818

Tel: +371 27331152

Danmark/Norge/Suomi/Finland/Sverige

Lietuva

Allergan Norden AB

Allergan Baltics UAB

Tlf/Puh/Tel: +46 (0)8 594 100 00

Tel: +370 62660247

Deutschland

Magyarország

Pharm-Allergan GmbH

Allergan Hungary Kft.

Tel: +49 69 92038 10

Tel: +36 80 100 101

Eesti

Österreich

Allergan Baltics UAB

Pharm-Allergan GmbH

Tel: + 372 56955144

Tel: +43 1 99460 6355

Ελλάδα/Κύπρος

Polska

Allergan Hellas Pharmaceuticals S.A.

Allergan Sp. z o.o.

Τηλ: +30 210 74 73 300

Tel: +48 22 256 37 00

España

Portugal

Allergan S.A.

Profarin Lda.

Tel: +34 91 807 6130

Tel: +351 21 425 3242

France

România

Allergan France SAS

Allergan S.R.L.

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

Tel.: +40 21 301 53 02

Hrvatska

Slovenija

Ewopharma d.o.o.

Ewopharma d.o.o.

Tel: +385 1 6646 563

Tel: +386 (0) 590 848 40

Ireland/Malta/United Kingdom

Slovenská republika

Allergan Ltd

Allergan SK s.r.o.

Tel: +44 (0)1628 494026

Tel: +421 800 221 223

This leaflet was last revised in

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

Package leaflet: Information for the user

LUMIGAN 0.3 mg/ml, eye drops, solution

Bimatoprost

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

-Keep this leaflet. You may need to read it again.

-If you have further questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

LUMIGAN is an antiglaucoma preparation. It belongs to a group of medicines called prostamides.

LUMIGAN is used to reduce high pressure in the eye. This medicine may be used on its own or with other drops called beta-blockers which also reduce pressure.

Your eye contains a clear, watery liquid that feeds the inside of the eye. Liquid is constantly being drained out of the eye and new liquid is made to replace this. If the liquid cannot drain out quickly enough, the pressure inside the eye builds up. This medicine works by increasing the amount of liquid that is drained. This reduces the pressure inside the eye. If the high pressure is not reduced, it could lead to a disease called glaucoma and eventually damage your sight.

2. What you need to know before you use 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 because of a side effect of the preservative benzalkonium chloride.

Warnings and precautions:

Talk to your doctor or pharmacist before you use LUMIGAN 0.3 mg/ml:

-Talk to your doctor, if:

-You have any breathing problems

-You have liver or kidney problems

-You have had a cataract surgery in the past

-You have dry eye

-You have or have had any problems with your cornea (front transparent part of the eye)

-You wear contact lenses (see “Important information about some of the ingredients of

LUMIGAN 0.3 mg/ml”)

-You have or have had low blood pressure or low heart rate

-You have had a viral infection or inflammation of the eye

LUMIGAN may cause your eyelashes to darken and grow, and cause the skin around the eyelid to darken too. The colour of your iris may also go darker over time. These changes may be permanent. The change may be more noticeable if you are only treating one eye.

Children and adolescents

LUMIGAN has not been tested in children under the age of 18 and therefore LUMIGAN should not be used by patients under 18 years.

Other medicines and LUMIGAN

Tell your doctor or pharmacist if you are taking, or have recently taken, or might take any other medicines.

Pregnancy and breast-feeding

If you are pregnant or breast feeding, think you might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking any medicine.

LUMIGAN may get into breast milk so you should not breast-feed while you are taking LUMIGAN.

Driving and using machines

Your sight may become blurred for a short time just after using LUMIGAN. You should not drive or use machines until your sight is clear again.

LUMIGAN 0.3 mg/ml contains benzalkonium chloride

Do not use the drops when you are wearing your lenses. Wait 15 minutes after using the drops before you put your lenses back in. A preservative in LUMIGAN called benzalkonium chloride may cause eye irritation and can discolour soft contact lenses.

3.How to use LUMIGAN 0.3 mg/ml

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

LUMIGAN should only be applied to the eye. The recommended dose is one drop of LUMIGAN in the evening, once daily in each eye that needs treatment.

If you use LUMIGAN with another eye medicine, wait at least five minutes between using LUMIGAN and the other eye medicine.

Do not use more than once a day as the effectiveness of treatment may be reduced.

Instructions for use:

You must not use the bottle if the tamper-proof seal on the bottle neck is broken before you first use it.

1. Wash your hands. Tilt your head back and look at the ceiling.

2.Gently pull down the lower eyelid until there is a small pocket.

3.Turn the bottle upside down and squeeze it to release one drop into each eye that needs treatment.

4.Let go of the lower lid, and close your eye for 30 seconds.

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 0.3 mg/ml 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 0.3 mg/ml

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 0.3 mg/ml

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 side effects

These may affect one or more users in 10

Affecting the eye

Longer eyelashes (up to 45% of people)

Slight redness (up to 44% of people)

Itchiness (up to 14% of people)

Common side effects

These may affect 1 to 9 users in 100

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 side effects

These may affect 1 to 9 users in 1000

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

Side effects where the frequency is not known

Affecting the eye

Eyes appear sunken

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)

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 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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of the 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 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.

6. Contents of the pack and other information

What LUMIGAN 0.3 mg/ml 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.

What LUMIGAN 0.3 mg/ml 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 and 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

Ísland

Luxembourg/Luxemburg/Nederland

Actavis ehf.

Allergan n.v.

Sími: +354 550 3300

Tél/Tel: +32 (0)2 351 24 24

 

България

Italia

Алерган България ЕООД

Allergan S.p.A

Тел.: +359 (0) 800 20 280

Tel: +39 06 509 561

Česká republika

Latvija

Allergan CZ s.r.o.

Allergan Baltics UAB

Tel: +420 800 188 818

Tel: +371 27331152

Danmark/Norge/Suomi/Finland/Sverige

Lietuva

Allergan Norden AB

Allergan Baltics UAB

Tlf/Puh/Tel: +46 (0)8 594 100 00

Tel: +370 62660247

Deutschland

Magyarország

Pharm-Allergan GmbH

Allergan Hungary Kft.

Tel: +49 69 92038 10

Tel: +36 80 100 101

Eesti

Österreich

Allergan Baltics UAB

Pharm-Allergan GmbH

Tel: + 372 56955144

Tel: +43 1 99460 6355

Ελλάδα/Κύπρος

Polska

Allergan Hellas Pharmaceuticals S.A.

Allergan Sp. z o.o.

Τηλ: +30 210 74 73 300

Tel: +48 22 256 37 00

España

Portugal

Allergan S.A.

Profarin Lda.

Tel: +34 91 807 6130

Tel: +351 21 425 3242

France

România

Allergan France SAS

Allergan S.R.L.

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

Tel.: +40 21 301 53 02

Hrvatska

Slovenija

Ewopharma d.o.o.

Ewopharma d.o.o.

Tel: +385 1 6646 563

Tel: +386 (0) 590 848 40

Ireland/Malta/United Kingdom

Slovenská republika

Allergan Ltd

Allergan SK s.r.o.

Tel: +44 (0)1628 494026

Tel: +421 800 221 223

This leaflet was last revised in

Detailed information on this medicinal product is available on the European Medicines Agency web site:

http://www.ema.europa.eu/

Package Leaflet: Information for the user

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

Bimatoprost

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

-Keep this leaflet. You may need to read it again.

-If you have further questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in 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 LUMIGAN 0.3 mg/mL single-dose is and what it is used for

LUMIGAN 0.3 mg/mL single-dose is an antiglaucoma preparation. It belongs to a group of medicines called prostamides.

LUMIGAN 0.3 mg/mL single-dose eye drops are used to reduce high pressure in the eye. This medicine may be used on its own or with other drops called beta-blockers which also reduce pressure.

Your eye contains a clear, watery liquid that feeds the inside of the eye. Liquid is constantly being drained out of the eye and new liquid is made to replace this. If the liquid cannot drain out quickly enough, the pressure inside the eye builds up. This medicine works by increasing the amount of liquid that is drained. This reduces the pressure inside the eye. If the high pressure is not reduced, it could lead to a disease called glaucoma and eventually damage your sight.

This medicine does not contain a preservative.

2.What you need to know before you use 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 you doctor or pharmacist before you use LUMIGAN 0.3 mg/mL single-dose.

Please tell your doctor or pharmacist, if:

-You have any breathing problems

-You have liver or kidney problems

-You have had a cataract surgery in the past

-You have or have had low blood pressure or low heart rate

-You have had a viral infection or inflammation of the eye

LUMIGAN 0.3 mg/mL single-dose may cause your eyelashes to darken and grow, and cause the skin around the eyelid to darken too. The colour of your iris may also go darker over time. These changes may be permanent. The change may be more noticeable if you are only treating one eye.

Children and adolescents

LUMIGAN 0.3 mg/mL single-dose has not been tested in children under the age of 18 and therefore should not be used by patients under 18 years.

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, breast-feeding and fertility

If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

LUMIGAN 0.3 mg/mL single-dose may get into breast milk so you should not breast-feed while you are taking this medicine.

Driving and using machines

Your sight may become blurred for a short time just after using LUMIGAN 0.3 mg/mL single-dose. You should not drive or use machines until your sight is clear again.

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

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is one drop once daily, in the evening, once daily in each eye that needs treatment. LUMIGAN 0.3 mg/mL single-dose should only be applied to the eye

If you use LUMIGAN 0.3 mg/mL single-dose with another eye medicine, wait at least 5 minutes between using LUMIGAN 0.3 mg/mL single-dose and the other eye medicine.

Do not use more than once a day as the effectiveness of treatment may be reduced.

A calendar card is provided in the pack, numbered 1-31 for each day of the month. Place the calendar card on the top of the plastic tub and push down to snap it into place. The 30 vials in the pack should be separated from each other and fitted into the numbered spaces starting with the space that is numbered with today’s date. If you have any remaining vials, start over with the spot labelled “1” which will take you into the next month. Each day, the vial should be taken from the numbered spot that matches the calendar day to make sure a daily dose is not missed.

65

Wash your hands before use. Make sure that the single-dose container is intact before use. The solution should be used immediately after opening. To avoid contamination, do not let the open-end of the single-dose container touch your eye or anything else.

1.Take one single-dose container from the numbered spot that matches the calendar day and hold it upright (with the cap pointing upwards) and twist off the cap.

2.Gently pull down the lower eyelid to form a pocket. Turn the single-dose container upside down and squeeze it to release 1 drop into the affected eye(s).

3.Throw away the single-dose container after you have used it, even if there is some solution left.

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 0.3 mg/mL single-dose 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 0.3 mg/mL single-dose

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 0.3 mg/mL single-dose

LUMIGAN 0.3 mg/mL single-dose should be used every day to work properly. If you stop using LUMIGAN 0.3 mg/mL 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.

4. Possible side effects

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

Very common side effects

These may affect one or more users in 10

Affecting the eye

Slight redness (up to 24% of people)

Common side effects

These may affect 1 to 9 users in 100

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 side effects

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

Side effects where the frequency is not known

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)

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:

Dizziness

Burning sensation in the eye

An allergic reaction in the eye

Inflamed eyelids

Difficulty in seeing clearly

Sticky eyes

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

Eyes appear sunken

Increased blood pressure

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 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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of the 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 keep any unused solution.

Do not use this medicine after the expiry date which is stated on the single-dose container and the tray after the expiry date (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 pack 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.

6. Contents of the pack and other information

What LUMIGAN 0.3 mg/mL 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 0.3 mg/mL 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.

Each pack contains 5,30 or 90 single-dose containers. Not all pack sizes may be marketed.

Marketing Authorisation Holder and 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

Ísland

Luxembourg/Luxemburg/Nederland

Actavis ehf.

Allergan n.v.

Sími: +354 550 3300

Tél/Tel: +32 (0)2 351 24 24

 

България

Italia

Алерган България ЕООД

Allergan S.p.A

Тел.: +359 (0) 800 20 280

Tel: +39 06 509 561

Česká republika

Latvija

Allergan CZ s.r.o.

Allergan Baltics UAB

Tel: +420 800 188 818

Tel: +371 27331152

Danmark/Norge/Suomi/Finland/Sverige

Lietuva

Allergan Norden AB

Allergan Baltics UAB

Tlf/Puh/Tel: +46 (0)8 594 100 00

Tel: +370 62660247

Deutschland

Magyarország

Pharm-Allergan GmbH

Allergan Hungary Kft.

Tel: +49 69 92038 10

Tel: +36 80 100 101

Eesti

Österreich

Allergan Baltics UAB

Pharm-Allergan GmbH

Tel: + 372 56955144

Tel: +43 1 99460 6355

Ελλάδα/Κύπρος

Polska

Allergan Hellas Pharmaceuticals S.A.

Allergan Sp. z o.o.

Τηλ: +30 210 74 73 300

Tel: +48 22 256 37 00

España

Portugal

Allergan S.A.

Profarin Lda.

Tel: +34 91 807 6130

Tel: +351 21 425 3242

France

România

Allergan France SAS

Allergan S.R.L.

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

Tel.: +40 21 301 53 02

Hrvatska

Slovenija

Ewopharma d.o.o.

Ewopharma d.o.o.

Tel: +385 1 6646 563

Tel: +386 (0) 590 848 40

Ireland/Malta/United Kingdom

Slovenská republika

Allergan Ltd

Allergan SK s.r.o.

Tel: +44 (0)1628 494026

Tel: +421 800 221 223

This leaflet was last revised in

 

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

This leaflet is available in all EU/EEA languages on the European Medicines Agency website.

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