What is it and how is it used?

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 high pressure can lead to a disease called glaucoma. If the high pressure is not reduced, it could eventually damage your sight.

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. LUMIGAN works by increasing the amount of liquid that is drained. This reduces the pressure inside the eye.

LUMIGAN may be used on its own or with other drops called beta-blockers which also reduce pressure.

Table of Contents
What do you have to consider before using it?
How is it used?
What are possible side effects?
How should it be stored?
Further information

What do you have to consider before using it?

Do not use LUMIGAN 0.1 mg/ml:

  • if you are allergic (hypersensitive) to bimatoprost or any of the other ingredients of LUMIGAN.
  • if you have had to stop using eye drops in the past because of a side effect of the preservative benzalkonium chloride.

Take special care with 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.

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

Using other medicines:

Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.

If you use LUMIGAN with another eye drop, leave at least five minutes between putting in LUMIGAN and then the other drops.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine. LUMIGAN should not be used during pregnancy unless your doctor still recommends it.

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.

Important information about some of the ingredients of LUMIGAN 0.1 mg/ml 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.

How is it used?

LUMIGAN should only be applied to the eye. Always use LUMIGAN exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual 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, apply the LUMIGAN eye drop first and wait 5 minutes before applying the second eye medicine.

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.

If a drop misses your eye, try again.

To help prevent infections, 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 use 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 product, ask your doctor or pharmacist.

What are possible side effects?

Like all medicines, LUMIGAN 0.1 mg/ml can have side effects, although not everybody gets them. Most of the side effects are not serious.

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

Affecting the skin

  • Inflamed, 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 of on the edge of the eyelid
  • Swelling of the eyelid
  • Itching

Affecting the body

  • Headache
  • Feeling of sickness

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):

An allergic reaction in the eye; sensitivity to light; darker eyelashes; pain; a feeling that something is in your eye; sticky eyes; difficulty in seeing clearly; burning; tears; dryness; an increase in blood-test results that show how your liver is working, increased blood pressure; cystoid macular oedema (swelling of the retina within the eye leading to worsening vision); inflammation within the eye; retinal bleeding.

If any of the side effects get serious, or if you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.

How should it be stored?

Keep out of the reach and sight of children.

Do not use LUMIGAN 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.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further 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 to slightly yellow, 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.

BelgiëBelgiqueBelgien Allergan NVSA Terhulpsesteenweg 6D B-1560 Hoeilaart TélTel 32 02 351 24 24 E-mail ukmedinfoallergan.com LuxembourgLuxemburg Allergan NVSA Terhulpsesteenweg 6D B-1560 Hoeilaart BelgiqueBelgien TélTel 32 02 351 24 24 E-mail ukmedinfoallergan.com

E . 73, . 27, . 8 1164 . 359 2 962 12 00 E-mail ukmedinfoallergan.com Magyarország Ewopharma AG Magyarországi Kereskedelmi Képviselete 1021 Budapest Budakeszi út 73F Hungary Tel 36 1 200 4650 E-mail ukmedinfoallergan.com

eská republika NEOMED s.r.o. Sodomkova 14746, Praha 10 CZ-102 00 Tel. 420 274 008 411 E-mail ukmedinfoallergan.com Malta Allergan Ltd 1st Floor Marlow International The Parkway Marlow Bucks, SL7 1YL-UK United KingdomRenju Unit Tel 44 01628 494026 E-mail ukmedinfoallergan.com

Danmark Allergan Norden AB Nederland Allergan n.v.

Johanneslundsvägen 3-5 S-194 81 Upplands Väsby Sverige Tlf 46 08 594 100 00 E-mail ukmedinfoallergan.com Terhulpsesteenweg 6D B-1560 Hoeilaart België Tel 32 02 351 24 24 E-mail ukmedinfoallergan.com

Deutschland Pharm-Allergan GmbH Pforzheimer Straße 160 D-76275 Ettlingen Tel 49 07243 501 0 E-mail ukmedinfoallergan.com Norge Allergan Norden AB Johanneslundsvägen 3-5 S-194 81 Upplands Väsby Sverige Tlf 46 08 594 100 00 E-mail ukmedinfoallergan.com

Österreich Pharm-Allergan GmbH Pforzheimer Straße 160 D-76275 Ettlingen Deutschland Tel 49 07243 501 0 E-mail ukmedinfoallergan.com Eesti Allergan Ltd 1st Floor Marlow International The Parkway Marlow Bucks, SL7 1YL-UK Ühendkuningriik Tel 44 01628 494026 E-mail ukmedinfoallergan.com

Nexus Medicals S.A. . - GR-190 03 - T 30 22990.41350 E-mail ukmedinfoallergan.com Polska Allergan Sp. z o.o. Aleje Jerozolimskie 94 00-807 Warszawa Tel 48 22 256 37 00 Fax 48 22 256 37 01 E-mail ukmedinfoallergan.com

Portugal Profarin Lda. Rua da Quinta dos Grilos, 30 P-2790-476 Carnaxide Tel 351 21 425 3242 E-mail ukmedinfoallergan.com España Allergan S.A.U Edificio la Encina Plaza de la Encina, 10-11 E-28760 Tres Cantos Madrid Tel 34 91 807 6130 E-mail ukmedinfoallergan.com

France Allergan France SAS 12, Place de la Défense 92400 Courbevoie Tel 33 01 49 07 83 00 E -mail ukmedinfoallergan.com România Ewopharma AG România B-dul Primverii, nr. 19-21, Bucureti 011972-RO Tel. 40 21 260 13 44 E-mail ukmedinfoallergan.com

Slovenija Ewopharma d.o.o. Cesta 24. junija 23 SI-1231 Ljubljana rnue Tel 386 0 590 848 40 E-mail ukmedinfoallergan.com Ireland Allergan Ltd 1st Floor Marlow International The Parkway Marlow Bucks, SL7 1YL-UK United Kingdom Tel 44 01628 494026 E-mail ukmedinfoallergan.com

Ísland Vistor hf. Hörgatún 2 IS-212 Garðabær Sími 354 535 7000 Netfang ukmedinfoallergan.com Slovenská republika NEOMED,s.r.o., poboka Bratislava astná 11 SK-821 05 Bratislava Tel. 421 2 434 150 12 E-mail ukmedinfoallergan.com

Italia Allergan S.p.A Via S.Quasimodo 134138 I-00144 Roma Tel 39 06 509 561 E-mail ukmedinfoallergan.com SuomiFinland Allergan Norden AB Johanneslundsvägen 3-5 S-194 81 Upplands Väsby RuotsiSverige PuhTel 46 08 594 100 00 E-mail ukmedinfoallergan.com

Sverige Allergan Norden AB Johanneslundsvägen 3-5 S-194 81 Upplands Väsby Tel 46 08 594 100 00 E-mail ukmedinfoallergan.com Allergan Ltd 1st Floor Marlow International The Parkway Marlow Bucks, SL7 1YL-UK 44 01628 494026 E-mail ukmedinfoallergan.com

United Kingdom Allergan Ltd 1st Floor Marlow International The Parkway Marlow Bucks, SL7 1YL-UK Tel 44 01628 494026 E-mail ukmedinfoallergan.com Latvija Allergan Ltd 1st Floor Marlow International The Parkway Marlow Bucks, SL7 1YL-UK Lielbritnija Tel 44 01628 494026 E-mail ukmedinfoallergan.com

Lietuva

Allergan Ltd
1st Floor
Marlow International
The Parkway
Marlow
Bucks, SL7 1YL-UK
Jungtin- Karalyst-
Tel. + 44 (0)1628 494026
E-mail: uk_medinfo@allergan.com

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