Lumigan 0.3 mg / ml eye drops solution in single-dose Container – patient leaflet, side effects, dosage

1. What LUMIGAN 0.3 mg/mL used for

LUMIGAN 0.3 mg/mL single-dos It belongs to a group of medicine LUMIGAN 0.3 mg/mL single-dos high pressure in the eye. This me with other drops called beta-bloc Your eye contains a clear, watery l eye. Liquid is constantly being dra made to replace this. If the liquid c pressure inside the eye builds up. the amount of liquid that is drained

ngle-dose is and what it is used for e you use LUMIGAN 0.3 mg/mL

/mL single-dose g/mL single-dose r information single-dose is and what it is e is an antiglaucoma preparation. s called prostamides.

e eye drops are used to reduce dicine may be used on its own or kers which also reduce pressure. iquid that feeds the inside of the ined out of the eye and new liquid is annot drain out quickly enough, the This medicine works by increasing . This reduces the pressure inside the eye. If the high pressure is not called glaucoma and eventually d This medicine does not contain a

2. What you need to know bef

LUMIGAN 0.3 mg/mL single Do not use this medicine:

• If you are allergic to bimatopro

  of this medicine (listed in sect Warnings and precautions

Talk to you doctor or pharmacist LUMIGAN 0.3 mg/mL single-dos Please tell your doctor or pha

• You have any breathing pro
• You have liver or kidney pro
• You have had a cataract su
• You have or have had low b

• You have had a viral infecti During treatment, LUMIGAN may which may cause your eyelid crea

  reduced, it could lead to a disease amage your sight.

  preservative.

  ore you use

  -dose st or any of the other ingredients ion 6).

  before you use e.

  rmacist, if:

  blems blems rgery in the past lood pressure or low heart rate on or inflammation of the eye cause a loss of fat around the eye, se to deepen, your eye to appear sunken (enophthalmos), your upp around your eye to tighten (involuti white part of your eye to become The changes are typically mild, but field of vision. The changes may di LUMIGAN 0.3 mg/mL single-dos to darken and grow, and cause th too. The colour of your iris may al be permanent. The changes may treating one eye.

Children and adolescents

LUMIGAN 0.3 mg/mL single-dose the age of 18 and therefore should n Other medicines and LUMIGA

Tell your doctor or pharmacist if y or might take any other medicine Pregnancy, breast-feeding an

If you are pregnant or breast-fee or are planning to have a baby, a advice before taking this medicin

er eyelid to droop (ptosis), the skin on of dermatochalasis) and the lower more visible (inferior scleral show). if pronounced, they can affect your sappear if you stop taking LUMIGAN. e may also cause your eyelashes e skin around the eyelid to darken so go darker. These changes may be more noticeable if you are only has not been tested in children under ot be used by patients under 18 years. N 0.3 mg/mL single-dose ou are taking, have recently taken, s.

d fertility ding, think you might be pregnant sk your doctor or pharmacist for e.

LUMIGAN 0.3 mg/mL single-dose should not breast-feed while you Driving and using machines

Your sight may become blurred fo LUMIGAN 0.3 mg/mL single-dose machines until your sight is clear

3. How to use LUMIGAN 0.3 m

Always use this medicine exactly told you. Check with your doctor o The recommended dose is one dro daily in each eye that needs treatm dose should only be applied to the If you use LUMIGAN 0.3 mg/mL si medicine, wait at least 5 minutes b 0.3 mg/mL single-dose and the ot Do not use more than once a day may be reduced.

may get into breast milk so you are taking this medicine.

r a short time just after using . You should not drive or use again.

g/mL single-dose as your doctor or pharmacist has r pharmacist if you are not sure. p once daily, in the evening, once ent. LUMIGAN 0.3 mg/mL single-eye ngle-dose with another eye etween using LUMIGAN her eye medicine.

as the effectiveness of treatment

Wash your hands before use. Make is intact before use. The solution sh opening. To avoid contamination, do single-dose container touch your ey

1. 1. 2.
2. 1. Take one single-dose container upright (with the cap pointing u
3. 2. Gently pull down the lower eye single-dose container upside d 1 drop into the affected eye(s).
4. 3.

   Throw away the single-dose co even if there is some solution l Wipe off any excess that runs dow If you wear contact lenses, take y medicine. Wait 15 minutes after u

   sure that the single-dose container ould be used immediately after not let the open-end of the e or anything else.

   3.

   from the pouch and hold it pwards) and twist off the cap. lid to form a pocket. Turn the own and squeeze it to release ntainer after you have used it, eft.

   n the cheek.

   our lenses out before using this sing the drops, and before you put your lenses back in.

If you use more LUMIGAN 0.3 you should

If you use more of this medicine than you any serious harm. Put your next worried, talk to your doctor or pharm If you forget to use LUMIGAN 0

If you forget to use this medicine, us remember, and then go back to you a double dose to make up for a for If you stop using LUMIGAN 0.3

LUMIGAN 0.3 mg/mL single-dose work properly. If you stop using LU the pressure inside your eye may doctor before stopping this treatm If you have any further questions on doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine ca

mg/mL single-dose than you should, it is unlikely to cause dose in at the usual time. If you are acist.

.3 mg/mL single-dose e a single drop as soon as you r regular routine. Do not take gotten dose.

mg/mL single-dose should be used every day to MIGAN 0.3 mg/mL single-dose go up, therefore talk to your ent.

the use of this product, ask your n cause side effects, although not everybody gets them.

Very common side effects

These may affect one or more use Affecting the eye

• Slight redness (up to 24% of p
• Loss of fat in the eye region wh your eyelid crease, sunken eye eyelid (ptosis), tightening of the of dermatochalasis), and the lo become more visible (inferior s Common side effects

These may affect 1 to 9 users in 1 Affecting the eye

• Small breaks in the surface of t inflammation
• Irritation
• Itchy eyes
• Pain
• Dryness

• A feeling that something is in y

  rs in 10 eople)

  ich can lead to deepening of (enophthalmos), drooping skin around your eye (involution wer white part of your eye to cleral show)

  00 he eye, with or without our eye

  • Longer eyelashes
  • Darker skin colour around the e
  • Red eyelids

Uncommon side effects

These may affect 1 to 9 users in 10 Affecting the eye

• Tired eyes
• Sensitivity to light
• Darker iris colour
• Itchy and swollen eyelids
• Tears
• Swelling of the see-through laye of the eye
• Blurred vision

Affecting the body

• Headaches
• Hair growth around the eye Side effects where the frequenc

Affecting the eye

ye

00 r which covers the surface y is not known

• Sticky eyes
• Ocular discomfort

Affecting the body

• Asthma
• Worsening of asthma
• Worsening of the lung disease c pulmonary disease (COPD)
• Shortness of breath
• Symptoms of allergic reaction (s rash of the skin)
• Dizziness
• Increased blood pressure
• Skin discoloration (periocular) In addition to the side effects for LU dose, the following side effects hav multi-dose formulation of LUMIGA patients taking LUMIGAN 0.3 mg/
• Burning sensation in the eye
• An allergic reaction in the eye

• Inflamed eyelids

  alled chronic obstructive welling, redness of the eye and

  MIGAN 0.3 mg/mL single-e been seen with the preserved N 0.3 mg/mL and may occur in mL single-dose:

• Difficulty in seeing clearly
• Worsening vision
• Darker eyelashes
• Retinal bleeding
• Inflammation within the eye
• Cystoid macular oedema (swelli leading to worsening vision)
• Iris inflammation
• Eyelid twitching
• Eyelid shrinking, moving away fr
• Nausea
• Skin redness around the eye
• Weakness
• An increase in blood-test results is working

Other side effects reported with ey In very rare cases, some patients w layer at the front of the eye (the cor patches on the cornea due to calci

ng of the retina within the eye om surface of the eye that show how your liver e drops containing phosphates ith severe damage to the clear nea) have developed cloudy um build-up during treatment.

eye drops, solution, in single-dose container

Bimatoprost

0.3 mg/mL,

73567GB14

Reporting side effects

If you get any of the side effects, This includes any possible side e can also report side effects direct

UK

Yellow Card Scheme

Website: www.mhra.gov.uk/yello

By reporting side effects you can h safety of the medicine.

5. How to store LUMIGAN 0.3

Keep this medicine out of the sig

This medicine is for single use o preservatives. Do not keep any u

Do not use this medicine after th the single-dose container and th

talk to your doctor or pharmacist. ffects not listed in this leaflet. You ly via:

wcard elp provide more information on the mg/mL single-dose ht and reach of children.

nly and does not contain nused solution.

e expiry date which is stated on e carton after the expiry date

(EXP):. The expiry date refers to

This medicinal product does not condition. However, once the po

Do not throw away any medicine waste. Ask your pharmacist how longer use. These measures will

6. Contents of the pack and o What LUMIGAN 0.3 mg/mL si

• The active substance is bimato

  0.3 mg bimatoprost.

• The other ingredients are sodi

  dibasic heptahydrate, citric ac Small amounts of hydrochloric added to keep the level of acid

What LUMIGAN 0.3 mg/mL si contents of the pack

LUMIGAN 0.3 mg/mL single-dos supplied in single-dose plastic co

the last day of that month.

require any special storage uch is opened use within 30 days.

s via wastewater or household to throw away medicines you no help to protect the environment.

ther information ngle-dose contains prost. One ml of solution contains um chloride, sodium phosphate id monohydrate and purified water. acid or sodium hydroxide may be (pH levels) normal.

ngle-dose looks like and e is a clear, colourless solution ntainers, each containing 0.4 ml of solution.

Pack contains 5-single-dose con

Pack contains 3 or 9 aluminium f 10 single-dose containers, for a containers in a carton, respectiv Not all pack sizes may be marke

Marketing Authorisation Hold

AbbVie Ltd.

Maidenhead

SL6 4UB

UK

Manufacturer

Allergan Pharmaceuticals Irelan Castlebar Road

Westport

Co. Mayo

Ireland

tainers in a carton.

oil pouches, each containing total of 30 or 90 single-dose ely.

ted.

er d

For any information about this me representative of the marketing a United Kingdom

AbbVie Ltd.

+44 (0)1628 561090 uk_medinfo@abbvie.com

This leaflet was last revised in

dicine, please contact the local uthorisation holder.

02/2022