Lumigan

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 



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1. NAME OF THE MEDICINAL PRODUCT 
 
LUMIGAN 0.1 mg/ml eye drops, solution 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
One ml of solution contains 0.1 mg bimatoprost. 
 
Excipient with known effect:  
One ml of solution contains 0.2 mg benzalkonium chloride.  
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Eye drops, solution. 
 
Colourless solution. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Reduction of elevated intraocular pressure in chronic open-angle glaucoma and ocular hypertension in 
adults (as monotherapy or as adjunctive therapy to beta-blockers). 
 
4.2 Posology and method of administration 
 
Posology 
The recommended dose is one drop in the affected eye(s) once daily, administered in the evening. The 
dose should not exceed once daily, as more frequent administration may lessen the intraocular pressure 
lowering effect.  
 
Paediatric population:  
The safety and efficacy of LUMIGAN in children aged 0 to 18 years has not yet been established. 
 
Patients with hepatic and renal impairment: 
LUMIGAN has not been studied in patients with renal or moderate to severe hepatic impairment and 
should therefore be used with caution in such patients. In patients with a history of mild liver disease 
or abnormal alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or bilirubin at 
baseline, bimatoprost 0.3 mg/ml eye drops, solution had no adverse effect on liver function over 24 
months. 
 
Method of administration 
If more than one topical ophthalmic medicinal product is being used, each one should be administered 
at least 5 minutes apart. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.  
 
LUMIGAN 0.1 mg/ml is contraindicated in patients who have had a suspected previous adverse 
reaction to benzalkonium chloride that has led to discontinuation. 
 



3 

4.4 Special warnings and precautions for use 
 
Ocular 
Before treatment is initiated, patients should be informed of the possibility of eyelash growth, 
darkening of the eyelid skin and increased iris pigmentation, since these have been observed during 
treatment with LUMIGAN. Some of these changes may be permanent, and may lead to differences in 
appearance between the eyes when only one eye is treated. Increased iris pigmentation is likely to be 
permanent. The pigmentation change is due to increased melanin content in the melanocytes rather 
than to an increase in the number of melanocytes. The long term effects of increased iris pigmentation 
are not known. Iris colour changes seen with ophthalmic administration of bimatoprost may not be 
noticeable for several months to years. Typically, the brown pigmentation around the pupil spreads 
concentrically towards the periphery of the iris and the entire iris or parts become more brownish. 
Neither naevi nor freckles of the iris appear to be affected by the treatment. At 12 months, the 
incidence of iris hyperpigmentation with bimatoprost 0.1 mg/ml eye drops, solution was 0.5%. At 
12 months, the incidence with bimatoprost 0.3 mg/ml eye drops, solution was 1.5% (see section 4.8 
Table 2) and did not increase following 3 years treatment. Periorbital tissue pigmentation has been 
reported to be reversible in some patients.  
 
Cystoid macular oedema has been uncommonly reported (≥1/1,000 to <1/100) following treatment 
with bimatoprost 0.3 mg/ml eye drops, solution. Therefore, LUMIGAN should be used with caution in 
patients with known risk factors for macular oedema (e.g. aphakic patients, pseudophakic patients with 
a torn posterior lens capsule). 
 
There have been rare spontaneous reports of reactivation of previous corneal infiltrates or ocular 
infections with bimatoprost 0.3 mg/ml eye drops, solution. LUMIGAN should be used with caution in 
patients with a prior history of significant ocular viral infections (e.g. herpes simplex) or uveitis/iritis. 
 
LUMIGAN has not been studied in patients with inflammatory ocular conditions, neovascular, 
inflammatory, angle-closure glaucoma, congenital glaucoma or narrow-angle glaucoma.  
 
Skin  
There is a potential for hair growth to occur in areas where LUMIGAN solution comes repeatedly in 
contact with the skin surface. Thus, it is important to apply LUMIGAN as instructed and avoid it 
running onto the cheek or other skin areas.  
 
Respiratory 
LUMIGAN has not been studied in patients with compromised respiratory function.  While there is 
limited information available on patients with a history of asthma or COPD, there have been reports of 
exacerbation of asthma, dyspnoea and COPD, as well as reports of asthma, in post marketing 
experience. The frequency of these symptoms is not known. Patients with COPD, asthma or 
compromised respiratory function due to other conditions should be treated with caution. 
 
Cardiovascular 
LUMIGAN has not been studied in patients with heart block more severe than first degree or 
uncontrolled congestive heart failure. There have been a limited number of spontaneous reports of 
bradycardia or hypotension with bimatoprost 0.3 mg/ml eye drops, solution. LUMIGAN should be 
used with caution in patients predisposed to low heart rate or low blood pressure. 
 
Other Information 
In studies of bimatoprost 0.3 mg/ml in patients with glaucoma or ocular hypertension, it has been 
shown that the more frequent exposure of the eye to more than one dose of bimatoprost daily may 
decrease the IOP-lowering effect (see section 4.5). Patients using LUMIGAN with other prostaglandin 
analogues should be monitored for changes to their intraocular pressure.  
 
LUMIGAN 0.1 mg/ml contains the preservative benzalkonium chloride (200 ppm), which may be 
absorbed by soft contact lenses. Eye irritation and discolouration of the soft contact lenses may also 



4 

occur because of the presence of benzalkonium chloride. Contact lenses should be removed prior to 
instillation and may be reinserted 15 minutes following administration.  
 
Benzalkonium chloride, which is commonly used as a preservative in ophthalmic products, has been 
reported to cause punctate keratopathy and/or toxic ulcerative keratopathy. Since 
LUMIGAN 0.1 mg/ml contains 200 ppm benzalkonium chloride (four times the concentration in 
bimatoprost 0.3 mg/ml eye drops), it should be used with caution in dry eye patients, in patients where 
the cornea may be compromised and in patients taking multiple BAK-containing eye drops. In 
addition, monitoring is required with prolonged use in such patients.  
 
There have been reports of bacterial keratitis associated with the use of multiple dose containers of 
topical ophthalmic products. These containers had been inadvertently contaminated by patients who, 
in most cases, had a concurrent ocular disease. Patients with a disruption of the ocular epithelial 
surface are at greater risk of developing bacterial keratitis. 
 
Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or 
surrounding structures, to avoid eye injury and contamination of the solution.  
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
No interaction studies have been performed. 
 
No interactions are anticipated in humans, since systemic concentrations of bimatoprost are extremely 
low (less than 0.2 ng/ml) following ocular dosing with bimatoprost 0.3 mg/ml eye drops, solution. 
Bimatoprost is biotransformed by any of multiple enzymes and pathways, and no effects on hepatic 
drug metabolising enzymes were observed in preclinical studies.  
 
In clinical studies, bimatoprost 0.3 mg/ml, eye drops, solution was used concomitantly with a number 
of different ophthalmic beta-blocking agents without evidence of interactions.  
 
Concomitant use of LUMIGAN and antiglaucomatous agents other than topical beta-blockers has not 
been evaluated during adjunctive glaucoma therapy.  
 
There is a potential for the IOP-lowering effect of prostaglandin analogues (e.g. LUMIGAN) to be 
reduced in patients with glaucoma or ocular hypertension when used with other prostaglandin 
analogues (see section 4.4). 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
There are no adequate data from the use of bimatoprost in pregnant women. Animal studies have 
shown reproductive toxicity at high maternotoxic doses (see section 5.3). 
 
LUMIGAN should not be used during pregnancy unless clearly necessary. 
 
Breast-feeding 
It is unknown whether bimatoprost is excreted in human breast milk. Animal studies have shown 
excretion of bimatoprost in breast milk. A decision must be made whether to discontinue 
breast-feeding or to discontinue from LUMIGAN therapy taking into account the benefit of breast-
feeding for the child and the benefit of therapy for the woman. 
 
Fertility 
There are no data on the effects of bimatoprost on human fertility. 
 



5 

4.7 Effects on ability to drive and use machines 
 
LUMIGAN has negligible influence on the ability to drive and use machines. As with any ocular 
treatment, if transient blurred vision occurs at instillation, the patient should wait until the vision clears 
before driving or using machines.  
 
4.8 Undesirable effects  
 
In a 12-month Phase III clinical study approximately 38 % of patients treated with 
LUMIGAN 0.1 mg/ml eye drops, solution experienced adverse reactions. The most frequently 
reported adverse reaction was conjunctival hyperaemia (mostly trace to mild and of a 
non-inflammatory nature) occurring in 29 % of patients. Approximately 4 % of patients discontinued 
due to any adverse event in the 12-month study.  
 
The following adverse reactions were reported during clinical trials with LUMIGAN 0.1 mg/ml eye 
drops, solution or in the post-marketing period. Most were ocular, mild and none was serious. 
 
Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 
to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from available data) adverse 
reactions are presented according to System Organ Class in Table 1 in order of decreased seriousness 
within each frequency grouping.  
 
Table 1. 
 

System Organ class Frequency Adverse reaction 
Nervous system disorders uncommon headache

not known dizziness
Eye disorders 
 

very common conjunctival hyperaemia 
common punctate keratitis, eye irritation, eye 

pruritus, growth of eyelashes,  
eye pain, erythema of eyelid, eyelid 
pruritus

uncommon asthenopia, blurred vision, 
conjunctival disorder, conjunctival 
oedema, iris hyperpigmentation, 
madarosis, eyelid oedema 

not known blepharal pigmentation, macular 
oedema, periorbital and lid changes 
including deepening of the eyelid 
sulcus, dry eye, eye discharge, eye 
oedema, foreign body sensation in 
eyes, lacrimation increased, ocular 
discomfort,  photophobia 

Respiratory, thoracic and 
mediastinal disorders 

not known asthma, asthma exacerbation, COPD 
exacerbation and dyspnoea 

Gastrointestinal disorders uncommon nausea
Skin and subcutaneous tissue 
disorders 

common skin hyperpigmentation, 
hypertrichosis

uncommon dry skin, eyelid margin crusting, 
pruritus

not known skin discoloration (periocular) 
General disorders and 
administration site conditions 

common instillation site irritation 

Immune system disorders not known Hypersensitivity reaction including 
signs and symptoms of eye allergy and 
allergic dermatitis 



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Vascular disorders not known hypertension

In clinical studies, over 1800 patients have been treated with LUMIGAN 0.3 mg/ml. On combining 
the data from phase III monotherapy and adjunctive LUMIGAN 0.3 mg/ml usage, the most frequently 
reported adverse reactions were:  

 growth of eyelashes in up to 45 % in the first year with the incidence of new reports decreasing
to 7 % at 2 years and 2 % at 3 years

 conjunctival hyperaemia (mostly trace to mild and thought to be of a non-inflammatory nature)
in up to 44 % in the first year with the incidence of new reports decreasing to 13 % at 2 years
and 12 % at 3 years  

 ocular pruritus in up to 14 % of patients in the first year with the incidence of new reports
decreasing to 3 % at 2 years and 0 % at 3 years. Less than 9 % of patients discontinued due to
any adverse event in the first year with the incidence of additional patient discontinuations 
being 3 % at both 2 and 3 years. 

Additional adverse reactions reported with LUMIGAN 0.3 mg/ml are presented in Table 2. The table 
also includes those adverse reactions which occurred with both formulations but at a different 
frequency. Most were ocular, mild to moderate, and none was serious: With each frequency grouping, 
adverse reactions are presented in order of decreasing seriousness.  

Table 2. 

System Organ class Frequency  Adverse reaction 
Nervous system disorders common headache

uncommon dizziness
Eye disorders very common ocular pruritus, growth of eyelashes

common corneal erosion, ocular burning, 
allergic conjunctivitis, blepharitis, 
worsening of visual acuity, asthenopia, 
conjunctival oedema, foreign body 
sensation, ocular dryness, eye pain, 
photophobia, tearing, eye discharge, 
visual disturbance/blurred vision, 
increased iris pigmentation, eyelash 
darkening 

uncommon retinal haemorrhage, uveitis, cystoid 
macular oedema, iritis, 
blepharospasm, eyelid retraction, 
periorbital erythema 

Vascular disorders common hypertension
Skin and subcutaneous tissue 
disorders 

uncommon hirsutism 

General disorders and 
administration site conditions 

uncommon asthenia 

Investigations common liver function test abnormal 

Adverse reactions reported in phosphate containing eye drops: 
Cases of corneal calcification have been reported very rarely in association with the use of phosphate 
containing eye drops in some patients with significantly damaged corneas. 

Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 



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4.9 Overdose 

No case of overdose has been reported, and is unlikely to occur after ocular administration. 

If overdose occurs, treatment should be symptomatic and supportive. If LUMIGAN is accidentally 
ingested, the following information may be useful: in two-week oral rat and mouse studies, doses up to 
100 mg/kg/day did not produce any toxicity. This dose expressed as mg/m2 is at least 210 times higher 
than the accidental dose of one bottle of LUMIGAN 0.1 mg/ml eye drops, solution in a 10 kg child.  

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties 

Pharmacotherapeutic group: Ophthalmologicals, prostaglandin analogues, ATC code: S01EE03. 

Mechanism of action 
The mechanism of action by which bimatoprost reduces intraocular pressure in humans is by 
increasing aqueous humour outflow through the trabecular meshwork and enhancing uveoscleral 
outflow. Reduction of the intraocular pressure starts approximately 4 hours after the first 
administration and maximum effect is reached within approximately 8 to 12 hours. The duration of 
effect is maintained for at least 24 hours.  

Bimatoprost is a potent ocular hypotensive agent. It is a synthetic prostamide, structurally related to 
prostaglandin F2 (PGF2), that does not act through any known prostaglandin receptors. Bimatoprost 
selectively mimics the effects of newly discovered biosynthesised substances called prostamides. The 
prostamide receptor, however, has not yet been structurally identified. 

During a 12-month pivotal study in adults with LUMIGAN 0.1 mg/ml eye drops, the mean diurnal 
IOP values measured at any visit over the 12-month study period differed by no more than 1.1 mmHg 
throughout the day and were never greater than 17.7 mmHg.  

LUMIGAN 0.1 mg/ml eye drops contains BAK in a concentration of 200 ppm. 

Limited experience is available with the use of LUMIGAN in patients with open-angle glaucoma with 
pseudoexfoliative and pigmentary glaucoma, and chronic angle-closure glaucoma with patent 
iridotomy. 

No clinically relevant effects on heart rate and blood pressure have been observed in clinical trials.  

Paediatric population 
The safety and efficacy of LUMIGAN in children aged 0 to less than 18 years has not been 
established. 

5.2 Pharmacokinetic properties 

Absorption 
Bimatoprost penetrates the human cornea and sclera well in vitro. After ocular administration in 
adults, the systemic exposure of bimatoprost is very low with no accumulation over time. After once 
daily ocular administration of one drop of 0.3 mg/ml bimatoprost to both eyes for two weeks, blood 
concentrations peaked within 10 minutes after dosing and declined to below the lower limit of 
detection (0.025 ng/ml) within 1.5 hours after dosing. Mean Cmax and AUC 0-24hrs values were similar 
on days 7 and 14 at approximately 0.08 ng/ml and 0.09 nghr/ml respectively, indicating that a steady 
bimatoprost concentration was reached during the first week of ocular dosing.  



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Distribution 
Bimatoprost is moderately distributed into body tissues and the systemic volume of distribution in 
humans at steady-state was 0.67 l/kg. In human blood, bimatoprost resides mainly in the plasma. The 
plasma protein binding of bimatoprost is approximately 88 %.  

Biotransformation 
Bimatoprost is the major circulating species in the blood once it reaches the systemic circulation 
following ocular dosing. Bimatoprost then undergoes oxidation, N-deethylation and glucuronidation to 
form a diverse variety of metabolites. 

Elimination 
Bimatoprost is eliminated primarily by renal excretion, up to 67 % of an intravenous dose 
administered to healthy adult volunteers was excreted in the urine, 25 % of the dose was excreted via 
the faeces. The elimination half-life, determined after intravenous administration, was approximately 
45 minutes; the total blood clearance was 1.5 l/hr/kg.  
Characteristics in elderly patients 
After twice daily dosing with bimatoprost 0.3 mg/ml eye drops, solution, the mean AUC0-24hr value of 
0.0634 nghr/ml bimatoprost in the elderly (subjects 65 years or older) were significantly higher than 
0.0218 nghr/ml in young healthy adults. However, this finding is not clinically relevant as systemic 
exposure for both elderly and young subjects remained very low from ocular dosing. There was no 
accumulation of bimatoprost in the blood over time and the safety profile was similar in elderly and 
young patients. 

5.3 Preclinical safety data 

Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the 
maximum human exposure indicating little relevance to clinical use. 

Monkeys administered ocular bimatoprost concentrations of 0.3 mg/ml daily for 1 year had an 
increase in iris pigmentation and reversible dose-related periocular effects characterised by a 
prominent upper and/or lower sulcus and widening of the palpebral fissure. The increased iris 
pigmentation appears to be caused by increased stimulation of melanin production in melanocytes and 
not by an increase in melanocyte number. No functional or microscopic changes related to the 
periocular effects have been observed, and the mechanism of action for the periocular changes is 
unknown.  

Bimatoprost was not mutagenic or carcinogenic in a series of in vitro and in vivo studies.  

Bimatoprost did not impair fertility in rats up to doses of 0.6 mg/kg/day (at least 103-times the 
intended human exposure). In embryo/foetal developmental studies abortion, but no developmental 
effects were seen in mice and rats at doses that were at least 860-times or 1700-times higher than the 
dose in humans, respectively. These doses resulted in systemic exposures of at least 33- or 97-times 
higher, respectively, than the intended human exposure. In rat peri/postnatal studies, maternal toxicity 
caused reduced gestation time, foetal death, and decreased pup body weights at  0.3 mg/kg/day (at 
least 41-times the intended human exposure). Neurobehavioural functions of offspring were not 
affected.  

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients 

Benzalkonium chloride 
Sodium chloride 
Sodium phosphate dibasic heptahydrate 



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Citric acid monohydrate 
Hydrochloric acid or sodium hydroxide (to adjust pH) 
Purified water 

6.2 Incompatibilities 

Not applicable.  

6.3 Shelf life 

2 years. 

4 weeks after first opening. 

6.4 Special precautions for storage 

This medicinal product does not require any special storage conditions. 

6.5 Nature and contents of container 

White opaque low density polyethylene bottles with polystyrene screw cap. Each bottle has a fill 
volume of 3 ml. 

The following pack sizes are available: cartons containing 1 or 3 bottles of 3 ml solution. Not all pack 
sizes may be marketed. 

6.6 Special precautions for disposal 

No special requirements for disposal. 

7. MARKETING AUTHORISATION HOLDER

Allergan Pharmaceuticals Ireland 
Castlebar Road 
Westport 
Co. Mayo 
Ireland 

8. MARKETING AUTHORISATION NUMBER
EU/1/02/205/003-004

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
07 January 2010

10. DATE OF REVISION OF THE TEXT

Detailed information on this product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu  



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1. NAME OF THE MEDICINAL PRODUCT 
 
LUMIGAN 0.3 mg/ml eye drops, solution 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
One ml of solution contains 0.3 mg bimatoprost. 
 
Excipient with known effect:  
One ml of solution contains 0.05 mg benzalkonium chloride.  
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Eye drops, solution. 
 
Colourless solution. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Reduction of elevated intraocular pressure in chronic open-angle glaucoma and ocular hypertension in 
adults (as monotherapy or as adjunctive therapy to beta-blockers). 
 
4.2 Posology and method of administration 
 
Posology 
The recommended dose is one drop in the affected eye(s) once daily, administered in the evening. The 
dose should not exceed once daily as more frequent administration may lessen the intraocular pressure 
lowering effect.  
 
Paediatric population: 
The safety and efficacy of LUMIGAN in children aged 0 to 18 years has not yet been established. 
 
Patients with hepatic and renal impairment: 
LUMIGAN has not been studied in patients with renal or moderate to severe hepatic impairment and 
should therefore be used with caution in such patients. In patients with a history of mild liver disease 
or abnormal alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or bilirubin at 
baseline, bimatoprost 0.3 mg/ml eye drops, solution had no adverse effect on liver function over 24 
months. 
 
Method of administration 
If more than one topical ophthalmic medicinal product is being used, each one should be administered 
at least 5 minutes apart.  
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.  
 
LUMIGAN 0.3 mg/ml is contraindicated in patients who have had a suspected previous adverse 
reaction to benzalkonium chloride that has led to discontinuation. 
 



11 

4.4 Special warnings and precautions for use 
 
Ocular 
Before treatment is initiated, patients should be informed of the possibility of eyelash growth, 
darkening of the eyelid skin and increased iris pigmentation, since these have been observed during 
treatment with LUMIGAN. Some of these changes may be permanent, and may lead to differences in 
appearance between the eyes when only one eye is treated. Increased iris pigmentation is likely to be 
permanent. The pigmentation change is due to increased melanin content in the melanocytes rather 
than to an increase in the number of melanocytes. The long term effects of increased iris pigmentation 
are not known. Iris colour changes seen with ophthalmic administration of bimatoprost may not be 
noticeable for several months to years. Typically, the brown pigmentation around the pupil spreads 
concentrically towards the periphery of the iris and the entire iris or parts become more brownish. 
Neither naevi nor freckles of the iris appears to be affected by the treatment. At 12 months, the 
incidence of iris pigmentation with bimatoprost 0.3mg/ml was 1.5% (see section 4.8) and did not 
increase following 3 years treatment. Periorbital tissue pigmentation has been reported to be reversible 
in some patients. 
 
Cystoid macular oedema has been uncommonly reported (≥1/1,000 to <1/100) following treatment 
with bimatoprost 0.3 mg/ml eye drops. Therefore, LUMIGAN should be used with caution in patients 
with known risk factors for macular oedema (e.g. aphakic patients, pseudophakic patients with a torn 
posterior lens capsule). 
 
There have been rare spontaneous reports of reactivation of previous corneal infiltrates or ocular 
infections with bimatoprost 0.3 mg/ml eye drops, solution. LUMIGAN should be used with caution in 
patients with a prior history of significant ocular viral infections (e.g. herpes simplex) or uveitis/iritis. 
 
LUMIGAN has not been studied in patients with inflammatory ocular conditions, neovascular, 
inflammatory, angle-closure glaucoma, congenital glaucoma or narrow-angle glaucoma.  
 
Skin  
There is a potential for hair growth to occur in areas where LUMIGAN solution comes repeatedly in 
contact with the skin surface. Thus, it is important to apply LUMIGAN as instructed and avoid it 
running onto the cheek or other skin areas.  
 
Respiratory 
LUMIGAN has not been studied in patients with compromised respiratory function. While there is 
limited information available on patients with a history of asthma or COPD, there have been reports of 
exacerbation of asthma, dyspnoea and COPD, as well as reports of asthma, in post marketing 
experience. The frequency of these symptoms is not known. Patients with COPD, asthma or 
compromised respiratory function due to other conditions should be treated with caution. 
 
Cardiovascular 
LUMIGAN has not been studied in patients with heart block more severe than first degree or 
uncontrolled congestive heart failure. There have been a limited number of spontaneous reports of 
bradycardia or hypotension with bimatoprost 0.3 mg/ml eye drops, solution. LUMIGAN should be 
used with caution in patients predisposed to low heart rate or low blood pressure. 
 
Other Information 
In studies of bimatoprost 0.3 mg/ml in patients with glaucoma or ocular hypertension, it has been 
shown that the more frequent exposure of the eye to more than one dose of bimatoprost daily may 
decrease the IOP-lowering effect (see section 4.5). Patients using LUMIGAN with other prostaglandin 
analogues should be monitored for changes to their intraocular pressure.  
 
Bimatoprost 0.3 mg/ml eye drops, solution contains the preservative benzalkonium chloride, which 
may be absorbed by soft contact lenses. Eye irritation and discolouration of the soft contact lenses may 
also occur because of the presence of benzalkonium chloride. Contact lenses should be removed prior 
to instillation and may be reinserted 15 minutes following administration.  



12 

 
Benzalkonium chloride, which is commonly used as a preservative in ophthalmic products, has been 
reported to cause punctate keratopathy and/or toxic ulcerative keratopathy. Since LUMIGAN contains 
benzalkonium chloride, monitoring is required with frequent or prolonged use in dry eye patients or 
where the cornea is compromised.  
 
There have been reports of bacterial keratitis associated with the use of multiple dose containers of 
topical ophthalmic products. These containers had been inadvertently contaminated by patients who, 
in most cases, had a concurrent ocular disease. Patients with a disruption of the ocular epithelial 
surface are at greater risk of developing bacterial keratitis. 
 
Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or 
surrounding structures, to avoid eye injury and contamination of the solution.  
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
No interaction studies have been performed. 
 
No interactions are anticipated in humans, since systemic concentrations of bimatoprost are extremely 
low (less than 0.2 ng/ml) following ocular dosing with bimatoprost 0.3 mg/ml eye drops, solution. 
Bimatoprost is biotransformed by any of multiple enzymes and pathways, and no effects on hepatic 
drug metabolising enzymes were observed in preclinical studies.  
 
In clinical studies, LUMIGAN was used concomitantly with a number of different ophthalmic 
beta-blocking agents without evidence of interactions.  
 
Concomitant use of LUMIGAN and antiglaucomatous agents other than topical beta-blockers has not 
been evaluated during adjunctive glaucoma therapy.  
There is a potential for the IOP-lowering effect of prostaglandin analogues (e.g. LUMIGAN) to be 
reduced in patients with glaucoma or ocular hypertension when used with other prostaglandin 
analogues (see section 4.4).  
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
There are no adequate data from the use of bimatoprost in pregnant women. Animal studies have 
shown reproductive toxicity at high maternotoxic doses (see section 5.3). 
 
LUMIGAN should not be used during pregnancy unless clearly necessary. 
 
Breast-feeding 
It is unknown whether bimatoprost is excreted in human breast milk. Animal studies have shown 
excretion of bimatoprost in breast milk. A decision must be made whether to discontinue breast-
feeding or to discontinue from LUMIGAN therapy taking into account the benefit of breast feeding for 
the child and the benefit of therapy for the woman.  
 
Fertility 
There are no data on the effects of bimatoprost on human fertility. 
 
4.7 Effects on ability to drive and use machines 
 
LUMIGAN has negligible influence on the ability to drive and use machines. As with any ocular 
treatment, if transient blurred vision occurs at instillation, the patient should wait until the vision clears 
before driving or using machines.  
 



13 

4.8 Undesirable effects  
 
In clinical studies, over 1800 patients have been treated with LUMIGAN 0.3 mg/ml eye drops, 
solution. On combining the data from phase III monotherapy and adjunctive LUMIGAN 0.3 mg/ml 
eye drops, solution usage, the most frequently reported treatment-related adverse events were: growth 
of eyelashes in up to 45% in the first year with the incidence of new reports decreasing to 7% at 2 
years and 2% at 3 years, conjunctival hyperaemia (mostly trace to mild and thought to be of a non-
inflammatory nature) in up to 44% in the first year with the incidence of new reports decreasing to 
13% at 2 years and 12% at 3 years and ocular pruritus in up to 14% of patients in the first year with the 
incidence of new reports decreasing to 3% at 2 years and 0% at 3 years. Less than 9% of patients 
discontinued due to any adverse event in the first year with the incidence of additional patient 
discontinuations being 3% at both 2 and 3 years.  
 
The following adverse reactions were reported during clinical trials with LUMIGAN 0.3 mg/ml eye 
drops, solution or in the post-marketing period. Most were ocular, mild to moderate, and none was 
serious: 
 
Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 
to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from available data) adverse 
reactions are presented according to System Organ Class in Table 1. Within each frequency grouping, 
undesirable effects are presented in order of decreasing seriousness. 
 

System Organ class Frequency Adverse reaction 
Nervous system disorders common headache

uncommon dizziness
Eye disorders 
 

very common conjunctival hyperaemia, ocular 
pruritus, growth of eyelashes 

common superficial punctate keratitis, corneal 
erosion, ocular burning, ocular 
irritation, allergic conjunctivitis, 
blepharitis, worsening of visual acuity, 
asthenopia, conjunctival oedema, 
foreign body sensation, ocular 
dryness, eye pain, photophobia, 
tearing, eye discharge, visual 
disturbance/blurred vision, increased 
iris pigmentation, eyelash darkening, 
eyelid erythema, eyelid pruritus

uncommon retinal haemorrhage, uveitis, cystoid 
macular oedema, iritis, 
blepharospasm, eyelid retraction, 
periorbital erythema, eyelid oedema

not known periorbital and lid changes including 
deepening of the eyelid sulcus ocular 
discomfort

Vascular disorders common hypertension
Respiratory, thoracic and 
mediastinal disorders 

not known asthma, asthma exacerbation, COPD 
exacerbation and dyspnoea 

Gastrointestinal disorders uncommon nausea
Skin and subcutaneous tissue 
disorders 

common pigmentation of periocular skin 
uncommon hirsutism
not known skin discoloration (periocular) 

General disorders and 
administration site conditions 

uncommon asthenia 

Investigations common liver function test abnormal 
Immune system disorders not known Hypersensitivity reaction including 



14 

signs and symptoms of eye allergy and 
allergic dermatitis 

Adverse reactions reported in phosphate containing eye drops: 
Cases of corneal calcification have been reported very rarely in association with the use of phosphate 
containing eye drops in some patients with significantly damaged corneas. 

Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 

4.9 Overdose 

No case of overdose has been reported, and is unlikely to occur after ocular administration. 

If overdose occurs, treatment should be symptomatic and supportive. If LUMIGAN is accidentally 
ingested, the following information may be useful: in two-week oral rat and mouse studies, doses up to 
100 mg/kg/day did not produce any toxicity. This dose expressed as mg/m2 is at least 70-times higher 
than the accidental dose of one bottle of LUMIGAN 0.3 mg/ml eye drops, solution in a 10 kg child.  

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties 

Pharmacotherapeutic group: Ophthalmologicals, prostaglandin analogues, ATC code: S01EE03. 

Mechanism of action 
The mechanism of action by which bimatoprost reduces intraocular pressure in humans is by 
increasing aqueous humour outflow through the trabecular meshwork and enhancing uveoscleral 
outflow. Reduction of the intraocular pressure starts approximately 4 hours after the first 
administration and maximum effect is reached within approximately 8 to 12 hours. The duration of 
effect is maintained for at least 24 hours.  

Bimatoprost is a potent ocular hypotensive agent. It is a synthetic prostamide, structurally related to 
prostaglandin F2α (PGF2α), that does not act through any known prostaglandin receptors. Bimatoprost 
selectively mimics the effects of newly discovered biosynthesised substances called prostamides. The 
prostamide receptor, however, has not yet been structurally identified. 

During 12 months’ monotherapy treatment with LUMIGAN 0.3 mg/ml in adults, versus timolol, mean 
change from baseline in morning (08:00) intraocular pressure ranged from -7.9 to -8.8 mm Hg. At any 
visit, the mean diurnal IOP values measured over the 12-month study period differed by no more than 
1.3 mmHg throughout the day and were never greater than 18.0 mmHg. 

In a 6-month clinical study with LUMIGAN 0.3 mg/ml, versus latanoprost, a statistically superior 
reduction in morning mean IOP (ranging from -7.6 to -8.2 mmHg for bimatoprost versus –6.0 to 
-7.2 mmHg for latanoprost) was observed at all visits throughout the study. Conjunctival hyperaemia, 
growth of eyelashes, and eye pruritus were statistically significantly higher with bimatoprost than with 
latanoprost, however, the discontinuation rates due to adverse events were low with no statistically 
significant difference.

Compared to treatment with beta-blocker alone, adjunctive therapy with beta-blocker and LUMIGAN 
0.3 mg/ml lowered mean morning (08:00) intraocular pressure by -6.5 to -8.1 mmHg. 



15 

Limited experience is available in patients with open-angle glaucoma with pseudoexfoliative and 
pigmentary glaucoma, and chronic angle-closure glaucoma with patent iridotomy. 

No clinically relevant effects on heart rate and blood pressure have been observed in clinical trials. 

Paediatric population 
The safety and efficacy of LUMIGAN in children aged 0 to less than 18 years has not been 
established.  

5.2 Pharmacokinetic properties 

Absorption 
Bimatoprost penetrates the human cornea and sclera well in vitro. After ocular administration in 
adults, the systemic exposure of bimatoprost is very low with no accumulation over time. After once 
daily ocular administration of one drop of LUMIGAN 0.3 mg/ml to both eyes for two weeks, blood 
concentrations peaked within 10 minutes after dosing and declined to below the lower limit of 
detection (0.025 ng/ml) within 1.5 hours after dosing. Mean Cmax and AUC 0-24hrs values were similar 
on days 7 and 14 at approximately 0.08 ng/ml and 0.09 nghr/ml respectively, indicating that a steady 
bimatoprost concentration was reached during the first week of ocular dosing.  

Distribution 
Bimatoprost is moderately distributed into body tissues and the systemic volume of distribution in 
humans at steady-state was 0.67 l/kg. In human blood, bimatoprost resides mainly in the plasma. The 
plasma protein binding of bimatoprost is approximately 88%.  

Biotransformation 
Bimatoprost is the major circulating species in the blood once it reaches the systemic circulation 
following ocular dosing. Bimatoprost then undergoes oxidation, N-deethylation and glucuronidation to 
form a diverse variety of metabolites. 

Elimination 
Bimatoprost is eliminated primarily by renal excretion, up to 67% of an intravenous dose administered 
to healthy adult volunteers was excreted in the urine, 25% of the dose was excreted via the faeces. The 
elimination half-life, determined after intravenous administration, was approximately 45 minutes; the 
total blood clearance was 1.5 l/hr/kg.  

Characteristics in elderly patients 
After twice daily dosing of LUMIGAN 0.3 mg/ml, the mean AUC0-24hr value of 0.0634 nghr/ml 
bimatoprost in the elderly (subjects 65 years or older) were significantly higher than 0.0218 nghr/ml 
in young healthy adults. However, this finding is not clinically relevant as systemic exposure for both 
elderly and young subjects remained very low from ocular dosing. There was no accumulation of 
bimatoprost in the blood over time and the safety profile was similar in elderly and young patients. 

5.3 Preclinical safety data 

Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the 
maximum human exposure indicating little relevance to clinical use. 

Monkeys administered ocular bimatoprost concentrations of 0.3 mg/ml daily for 1 year had an 
increase in iris pigmentation and reversible dose-related periocular effects characterised by a 
prominent upper and/or lower sulcus and widening of the palpebral fissure. The increased iris 
pigmentation appears to be caused by increased stimulation of melanin production in melanocytes and 
not by an increase in melanocyte number. No functional or microscopic changes related to the 
periocular effects have been observed, and the mechanism of action for the periocular changes is 
unknown.  

Bimatoprost was not mutagenic or carcinogenic in a series of in vitro and in vivo studies.  



16 

Bimatoprost did not impair fertility in rats up to doses of 0.6 mg/kg/day (at least 103-times the 
intended human exposure). In embryo/foetal developmental studies abortion, but no developmental 
effects were seen in mice and rats at doses that were at least 860-times or 1700-times higher than the 
dose in humans, respectively. These doses resulted in systemic exposures of at least 33- or 97-times 
higher, respectively, than the intended human exposure. In rat peri/postnatal studies, maternal toxicity 
caused reduced gestation time, foetal death, and decreased pup body weights at 0.3 mg/kg/day (at 
least 41-times the intended human exposure). Neurobehavioural functions of offspring were not 
affected.  

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients 

Benzalkonium chloride 
Sodium chloride 
Sodium phosphate dibasic heptahydrate 
Citric acid monohydrate 
Hydrochloric acid or sodium hydroxide (to adjust pH) 
Purified water 

6.2 Incompatibilities 

Not applicable.  

6.3 Shelf life 

2 years. 
4 weeks after first opening. 

6.4 Special precautions for storage 

This medicinal product does not require any special storage conditions. 

6.5 Nature and contents of container 

White opaque low density polyethylene bottles with polystyrene screw cap. Each bottle has a fill 
volume of 3 ml. 

The following pack sizes are available: cartons containing 1 or 3 bottles of 3 ml solution. Not all pack 
sizes may be marketed. 

6.6 Special precautions for disposal 

No special requirements for disposal. 

7. MARKETING AUTHORISATION HOLDER

Allergan Pharmaceuticals Ireland 
Castlebar Road 
Westport 
Co. Mayo 
Ireland 



17 

8. MARKETING AUTHORISATION NUMBER

EU/1/02/205/001-002 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

8 March 2002 / 20 February 2007 

10. DATE OF REVISION OF THE TEXT
Detailed information on this product is available on the website of the European Medicines 

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



18 

1. NAME OF THE MEDICINAL PRODUCT

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

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml of solution contains 0.3 mg bimatoprost. 

For the full list of excipients, see section 6.1. 

3. PHARMACEUTICAL FORM

Eye drops, solution, in single-dose container. 

Colourless solution. 

4. CLINICAL PARTICULARS

4.1 Therapeutic indications 

Reduction of elevated intraocular pressure in chronic open-angle glaucoma and ocular hypertension in 
adults (as monotherapy or as adjunctive therapy to beta-blockers).  

4.2 Posology and method of administration 

Posology 
The recommended dose is one drop in the affected eye(s) once daily, administered in the evening. The 
dose should not exceed once daily as more frequent administration may lessen the intraocular pressure 
lowering effect.  

For single use only, one container is sufficient to treat both eyes. Any unused solution should be 
discarded immediately after use. 

Paediatric population: 
The safety and efficacy of LUMIGAN in children aged 0 to 18 years has not yet been established. 

Patients with hepatic and renal impairment: 
LUMIGAN has not been studied in patients with renal or moderate to severe hepatic impairment and 
should therefore be used with caution in such patients. In patients with a history of mild liver disease 
or abnormal alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or bilirubin at 
baseline, bimatoprost 0.3 mg/mL eye drops (multi-dose formulation), solution had no adverse effect 
on liver function over 24 months. 

Method of administration 
If more than one topical ophthalmic medicinal product is being used, each one should be administered 
at least 5 minutes apart. 

4.3 Contraindications 

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.  



19 

4.4 Special warnings and precautions for use 

Ocular 
Before treatment is initiated, patients should be informed of the possibility of eyelash growth, 
darkening of the eyelid skin and increased iris pigmentation, since these have been observed during 
treatment with LUMIGAN. Some of these changes may be permanent, and may lead to differences in 
appearance between the eyes when only one eye is treated. Increased iris pigmentation is likely to be 
permanent. The pigmentation change is due to increased melanin content in the melanocytes rather 
than to an increase in the number of melanocytes. The long term effects of increased iris pigmentation 
are not known. Iris colour changes seen with ophthalmic administration of bimatoprost may not be 
noticeable for several months to years. Typically, the brown pigmentation around the pupil spreads 
concentrically towards the periphery of the iris and the entire iris or parts become more brownish. 
Neither naevi nor freckles of the iris appear to be affected by the treatment. At 3 months, the incidence 
of iris hyperpigmentation with bimatoprost 0.3 mg/mL single dose was 0.3%. At 12 months, the 
incidence of iris pigmentation with bimatoprost 0.3 mg/mL (multi-dose formulation) was 1.5% (see 
section 4.8) and did not increase following 3 years treatment. Periorbital tissue pigmentation has been 
reported to be reversible in some patients. 

Cystoid macular oedema has been uncommonly reported (≥1/1,000 to <1/100) following treatment 
with bimatoprost 0.3 mg/mL eye drops (multi-dose formulation). Therefore, LUMIGAN should be 
used with caution in patients with known risk factors for macular oedema (e.g. aphakic patients, 
pseudophakic patients with a torn posterior lens capsule). 

There have been rare spontaneous reports of reactivation of previous corneal infiltrates or ocular 
infections with bimatoprost 0.3 mg/mL eye drops, solution (multi-dose formulation). LUMIGAN 
should be used with caution in patients with a prior history of significant ocular viral infections (e.g. 
herpes simplex) or uveitis/iritis. 

LUMIGAN has not been studied in patients with inflammatory ocular conditions, neovascular, 
inflammatory, angle-closure glaucoma, congenital glaucoma or narrow-angle glaucoma.  

Skin  
There is a potential for hair growth to occur in areas where LUMIGAN solution comes repeatedly in 
contact with the skin surface. Thus, it is important to apply LUMIGAN as instructed and avoid it 
running onto the cheek or other skin areas. 

Respiratory 
LUMIGAN has not been studied in patients with compromised respiratory function. While there is 
limited information available on patients with a history of asthma or COPD, there have been reports of 
exacerbation of asthma, dyspnoea and COPD, as well as reports of asthma, in post marketing 
experience. The frequency of these symptoms is not known. Patients with COPD, asthma or 
compromised respiratory function due to other conditions should be treated with caution. 

Cardiovascular 
LUMIGAN has not been studied in patients with heart block more severe than first degree or 
uncontrolled congestive heart failure. There have been a limited number of spontaneous reports of 
bradycardia or hypotension with bimatoprost 0.3 mg/mL eye drops, solution (multi-dose formulation). 
LUMIGAN should be used with caution in patients predisposed to low heart rate or low blood 
pressure. 

Other Information 
In studies of bimatoprost 0.3 mg/ml in patients with glaucoma or ocular hypertension, it has been 
shown that the more frequent exposure of the eye to more than one dose of bimatoprost daily may 
decrease the IOP-lowering effect. Patients using LUMIGAN with other prostaglandin analogues 
should be monitored for changes to their intraocular pressure. 

LUMIGAN 0.3 mg/mL single-dose has not been studied in patients wearing contact lenses. 



20 

Contact lenses should be removed prior to instillation and may be reinserted 15 minutes following 
administration.  

4.5 Interaction with other medicinal products and other forms of interaction 

No interaction studies have been performed. 

No interactions are anticipated in humans, since systemic concentrations of bimatoprost are extremely 
low (less than 0.2 ng/mL) following ocular dosing with bimatoprost 0.3 mg/mL eye drops, solution 
(multi-dose formulation). Bimatoprost is biotransformed by any of multiple enzymes and pathways, 
and no effects on hepatic drug metabolising enzymes were observed in preclinical studies.  

In clinical studies, LUMIGAN 0.3 mg/mL (multi-dose formulation) was used concomitantly with a 
number of different ophthalmic beta-blocking agents without evidence of interactions.  

Concomitant use of LUMIGAN and antiglaucomatous agents other than topical beta-blockers has not 
been evaluated during adjunctive glaucoma therapy. 

There is a potential for the IOP-lowering effect of prostaglandin analogues (e.g. LUMIGAN) to be 
reduced in patients with glaucoma or ocular hypertension when used with other prostaglandin 
analogues (see section 4.4). 

4.6 Fertility, pregnancy and lactation 

Pregnancy 
There are no adequate data from the use of bimatoprost in pregnant women. Animal studies have 
shown reproductive toxicity at high maternotoxic doses (see section 5.3). 

LUMIGAN should not be used during pregnancy unless clearly necessary. 

Breast-feeding 
It is unknown whether bimatoprost is excreted in human breast milk. Animal studies have shown 
excretion of bimatoprost in breast milk. A decision must be made whether to discontinue breast-
feeding or to discontinue from LUMIGAN therapy taking into account the benefit of breast feeding for 
the child and the benefit of therapy for the woman. 

Fertility 
There are no data on the effects of bimatoprost on human fertility. 

4.7 Effects on ability to drive and use machines 

LUMIGAN has negligible influence on the ability to drive and use machines. As with any ocular 
treatment, if transient blurred vision occurs at instillation, the patient should wait until the vision clears 
before driving or using machines.  

4.8 Undesirable effects  

In a 3 month clinical study, approximately 29% of patients treated with LUMIGAN 0.3 mg/mL single-
dose experienced adverse reactions. The most frequently reported adverse reactions were conjuctival 
hyperaemia (mostly trace to mild and of a non-inflammatory nature) occurring in 24% of patients, and 
eye pruritis occurring in 4% of patients. Approximately 0.7% of patients in the LUMIGAN 0.3 mg/mL 
single-dose group discontinued due to any adverse event in the 3 month study.  
The following adverse reactions were reported during clinical trials with LUMIGAN 0.3 mg/mL 
single-dose or in the post-marketing period. Most were ocular, mild and none was serious: 

Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 
to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from available data) adverse 



21 

reactions are presented according to System Organ Class in Table 1. Within each frequency grouping, 
undesirable effects are presented in order of decreasing seriousness. 

Table 1 

System Organ class Frequency Adverse reaction 
Nervous system disorders uncommon headache 

not known dizziness 
Eye disorders very common conjunctival hyperaemia 

common punctate keratitis, eye irritation, 
foreign body sensation, dry eye, 
eye pain, eye pruritus, growth of 
eyelashes, eyelid erythema

uncommon asthenopia, conjunctival 
oedema, photophobia, 
lacrimation increased, iris 
hyperpigmentation, blurred 
vision, eyelid pruritus, eyelid 
oedema

not known eye discharge, ocular discomfort
Respiratory, thoracic and 
mediastinal disorders 

not known asthma, asthma exacerbation, 
COPD exacerbation and 
dyspnoea 

Skin and subcutaneous tissue 
disorders 

common skin hyperpigmentation 
(periocular) 

uncommon hair growth abnormal 
not known skin discoloration (periocular) 

Immune system disorders not known Hypersensitivity reaction 
including signs and symptoms 
of eye allergy and allergic 
dermatitis 

Vascular disorders not known hypertension 

In clinical studies, over 1800 patients have been treated with LUMIGAN 0.3 mg/mL (multi-dose 
formulation). On combining the data from phase III monotherapy and adjunctive 
LUMIGAN 0.3 mg/mL (multi-dose formulation) usage, the most frequently reported adverse reactions 
were:  

 growth of eyelashes in up to 45% in the first year with the incidence of new reports decreasing
to 7% at 2 years and 2% at 3 years

 conjunctival hyperaemia (mostly trace to mild and thought to be of a non-inflammatory nature)
in up to 44% in the first year with the incidence of new reports decreasing to 13% at 2 years and
12% at 3 years

 ocular pruritus in up to 14% of patients in the first year with the incidence of new reports
decreasing to 3% at 2 years and 0% at 3 years.

Less than 9% of patients discontinued due to any adverse event in the first year with the incidence of 
additional patient discontinuations being 3% at both 2 and 3 years. 

Table 2 lists adverse reactions that were seen in a 12 month clinical study with LUMIGAN 0.3 mg/mL 
(multi-dose formulation), but were reported at a higher frequency than with LUMIGAN 0.3 mg/mL 
(single-dose). Most were ocular, mild to moderate, and none were serious. 



22 

Table 2  

System Organ class Frequency Adverse Reaction 
Nervous system disorders common headache 
Eye disorders very common ocular pruritus, growth of 

eyelashes 
common asthenopia, conjunctival 

oedema, photophobia, tearing, 
increased iris pigmentation; 
blurred vision 

Skin and subcutaneous tissue 
disorders 

common eyelid pruritus 

In addition to the adverse reactions seen with LUMIGAN 0.3 mg/mL single-dose, Table 3 lists 
additional adverse reactions that were seen with LUMIGAN 0.3 mg/mL (multi-dose formulation). 
Most were ocular, mild to moderate, and none were serious. 

Table 3 

System Organ class Frequency Adverse Reaction 
Nervous system disorders uncommon dizziness 
Eye disorders common corneal erosion, ocular burning, 

allergic conjunctivitis, 
blepharitis, worsening of visual 
acuity, eye discharge, visual 
disturbance, eyelash darkening 

uncommon retinal haemorrhage, uveitis, 
cystoid macular oedema, iritis, 
blepharospasm, eyelid retraction 

not known periorbital and lid changes 
including deepening of the 
eyelid sulcus 

Vascular disorders common hypertension 
Gastrointestinal disorders uncommon nausea 

Skin and subcutaneous tissue 
disorders 

not known periobital erythema 

General disorders and 
administration site conditions 

uncommon asthenia 

Investigations common liver function test abnormal

Adverse reactions reported in phosphate containing eye drops: 
Cases of corneal calcification have been reported very rarely in association with the use of phosphate 
containing eye drops in some patients with significantly damaged corneas. 

Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 

4.9 Overdose 

No information is available on overdose in humans; overdose is unlikely to occur after ocular 
administration.  



23 

If overdose occurs, treatment should be symptomatic and supportive. If LUMIGAN 0.3 mg/mL single-
dose is accidentally ingested, the following information may be useful: In short term oral (by gavage) 
mouse and rat studies, doses up to 100 mg/kg/day of bimatoprost did not produce any toxicity. This 
dose is at least 22 times higher than an accidental dose of the entire content of a pack of LUMIGAN 
0.3 mg/mL single-dose (30 x 0.4 mL single-dose containers; 12 mL) in a 10 kg child.  

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties 

Pharmacotherapeutic group: Ophthalmologicals, prostaglandin analogues, ATC code: S01EE03. 

Mechanism of action 
The mechanism of action by which bimatoprost reduces intraocular pressure in humans is by 
increasing aqueous humour outflow through the trabecular meshwork and enhancing uveoscleral 
outflow. Reduction of the intraocular pressure starts approximately 4 hours after the first 
administration and maximum effect is reached within approximately 8 to 12 hours. The duration of 
effect is maintained for at least 24 hours.  

Bimatoprost is a potent ocular hypotensive agent. It is a synthetic prostamide, structurally related to 
prostaglandin F2 (PGF2), that does not act through any known prostaglandin receptors. Bimatoprost 
selectively mimics the effects of newly discovered biosynthesised substances called prostamides. The 
prostamide receptor, however, has not yet been structurally identified. 

Clinical efficacy 
A 12 week (double-masked, randomized, parallel group ) clinical study compared the efficacy and 
safety of LUMIGAN 0.3 mg/mL single-dose with LUMIGAN 0.3 mg/mL (multi-dose formulation). 
LUMIGAN 0.3 mg/mL single-dose achieved non-inferior IOP-lowering efficacy to LUMIGAN 0.3 
mg/mL (multi-dose formulation) for worse eye IOP change from baseline in patients with glaucoma or 
ocular hypertension. LUMIGAN 0.3 mg/mL single-dose also achieved equivalent IOP lowering 
efficacy with LUMIGAN 0.3 mg/mL (multi-dose formulation) in average eye IOP at each follow-up 
timepoint at weeks 2, 6 and 12. 

During 12 months’ monotherapy treatment with LUMIGAN 0.3 mg/mL (multi-dose formulation) in 
adults, versus timolol, mean change from baseline in morning (08:00) intraocular pressure ranged from 
-7.9 to -8.8 mmHg. At any visit, the mean diurnal IOP values measured over the 12-month study
period differed by no more than 1.3 mmHg throughout the day and were never greater than 18.0
mmHg.

In a 6-month clinical study with LUMIGAN 0.3 mg/mL (multi-dose formulation), versus latanoprost, 
a statistically superior reduction in morning mean IOP (ranging from -7.6 to -8.2 mmHg for 
bimatoprost versus –6.0 to -7.2 mmHg for latanoprost) was observed at all visits throughout the study. 
Conjunctival hyperaemia, growth of eyelashes, and eye pruritus were statistically significantly higher 
with bimatoprost than with latanoprost, however, the discontinuation rates due to adverse events were 
low with no statistically significant difference. 

Compared to treatment with beta-blocker alone, adjunctive therapy with beta-blocker and 
LUMIGAN 0.3 mg/mL (multi-dose formulation) lowered mean morning (08:00) intraocular pressure 
by -6.5 to -8.1 mmHg.  

Limited experience is available in patients with open-angle glaucoma with pseudoexfoliative and 
pigmentary glaucoma, and chronic angle-closure glaucoma with patent iridotomy. 

No clinically relevant effects on heart rate and blood pressure have been observed in clinical trials. 



24 

Paediatric population 
The safety and efficacy of LUMIGAN in children aged 0 to 18 years has not been established. 

5.2 Pharmacokinetic properties 

Absorption 
Bimatoprost penetrates the human cornea and sclera well in vitro. After ocular administration in 
adults, the systemic exposure of bimatoprost is very low with no accumulation over time. After once 
daily ocular administration of one drop of LUMIGAN 0.3 mg/mL to both eyes for two weeks, blood 
concentrations peaked within 10 minutes after dosing and declined to below the lower limit of 
detection (0.025 ng/ml) within 1.5 hours after dosing. Mean Cmax and AUC 0-24hrs values were similar 
on days 7 and 14 at approximately 0.08 ng/ml and 0.09 nghr/ml respectively, indicating that a steady 
bimatoprost concentration was reached during the first week of ocular dosing.  

Distribution 
Bimatoprost is moderately distributed into body tissues and the systemic volume of distribution in 
humans at steady-state was 0.67 l/kg. In human blood, bimatoprost resides mainly in the plasma. The 
plasma protein binding of bimatoprost is approximately 88%.  

Biotransformation 
Bimatoprost is the major circulating species in the blood once it reaches the systemic circulation 
following ocular dosing. Bimatoprost then undergoes oxidation, N-deethylation and glucuronidation to 
form a diverse variety of metabolites. 

Elimination 
Bimatoprost is eliminated primarily by renal excretion, up to 67% of an intravenous dose administered 
to healthy adult volunteers was excreted in the urine, 25% of the dose was excreted via the faeces. The 
elimination half-life, determined after intravenous administration, was approximately 45 minutes; the 
total blood clearance was 1.5 l/hr/kg.  

Characteristics in elderly patients 
After twice daily dosing of LUMIGAN 0.3 mg/mL, the mean AUC0-24hr value of 0.0634 nghr/ml 
bimatoprost in the elderly (subjects 65 years or older) were significantly higher than 0.0218 nghr/ml 
in young healthy adults. However, this finding is not clinically relevant as systemic exposure for both 
elderly and young subjects remained very low from ocular dosing. There was no accumulation of 
bimatoprost in the blood over time and the safety profile was similar in elderly and young patients. 

5.3 Preclinical safety data 

Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the 
maximum human exposure indicating little relevance to clinical use. 

Monkeys administered ocular bimatoprost concentrations of 0.3 mg/mL daily for 1 year had an 
increase in iris pigmentation and reversible dose-related periocular effects characterised by a 
prominent upper and/or lower sulcus and widening of the palpebral fissure. The increased iris 
pigmentation appears to be caused by increased stimulation of melanin production in melanocytes and 
not by an increase in melanocyte number. No functional or microscopic changes related to the 
periocular effects were observed, and the mechanism of action for the periocular changes is unknown.  

Bimatoprost was not mutagenic or carcinogenic in a series of in vitro and in vivo studies.  

Bimatoprost did not impair fertility in rats up to doses of 0.6 mg/kg/day (at least 103-times the 
intended human exposure). In embryo/foetal developmental studies abortion, but no developmental 
effects were seen in mice and rats at doses that were at least 860-times or 1700-times higher than the 
dose in humans, respectively. These doses resulted in systemic exposures of at least 33- or 97-times 
higher, respectively, than the intended human exposure. In rat peri/postnatal studies, maternal toxicity 



25 

caused reduced gestation time, foetal death, and decreased pup body weights at 0.3 mg/kg/day (at 
least 41-times the intended human exposure). Neurobehavioural functions of offspring were not 
affected.  

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients 

Sodium chloride 
Sodium phosphate dibasic heptahydrate 
Citric acid monohydrate 
Hydrochloric acid or sodium hydroxide (to adjust pH) 
Purified water 

6.2 Incompatibilities 

Not applicable.  

6.3 Shelf life 

5 pack – 12 months 
30 pack – 18 months 
90 pack – 18 months 
Once the pouch is opened, the single dose containers should be used within 30 days. 

Discard the opened single-dose container immediately after use. 

6.4 Special precautions for storage 

5 pack - Do not store above 25°C 
30 pack - No special requirements for storage 
90 pack - No special requirements for storage  

6.5 Nature and contents of container 

Clear, single-dose Low Density Polyethylene (LDPE) containers with a twist-off tab. 

Each single-dose container contains 0.4 ml solution. 

The following pack sizes are available:  
Carton containing 5 single-dose containers,  
Carton containing 30 or 90 single-dose containers in three or nine aluminium foil pouches, 
respectively.  
Each pouch contains 10 single-dose containers. 

Not all pack sizes may be marketed. 

6.6 Special precautions for disposal 

No special requirements for disposal. 

7. MARKETING AUTHORISATION HOLDER

Allergan Pharmaceuticals Ireland 
Castlebar Road 
Westport 



26 

Co. Mayo 
Ireland 

8. MARKETING AUTHORISATION NUMBER

EU/1/02/205/005-007 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

8 March 2002 / 20 February 2007 

10. DATE OF REVISION OF THE TEXT
Detailed information on this product is available on the website of the European Medicines Agency: 

http://www.ema.europa.eu  



27 

ANNEX II 

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH
RELEASE

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY
AND USE

C. OTHER CONDITIONS AND REQUIREMENTS OF THE
MARKETING AUTHORISATION

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO
THE SAFE AND EFFECTIVE USE OF THE MEDICINAL
PRODUCT



28 

A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer responsible for batch release 

Allergan Pharmaceuticals Ireland 
Castlebar Road 
Westport 
County Mayo 
Ireland 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Medicinal product subject to medical prescription. 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
AUTHORISATION

 Periodic safety update reports (PSURs)

The requirements for submission of PSURs for this medicinal product are set out in the list of Union 
reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any 
subsequent updates published on the European medicines web-portal. 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
EFFECTIVE USE OF THE MEDICINAL PRODUCT

Risk management plan (RMP)  
The marketing authorisation holder (MAH) shall perform the required pharmacovigilance 
activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the 
marketing authorisation and any agreed subsequent updates of the RMP.  

An updated RMP should be submitted:  
 At the request of the European Medicines Agency;
 Whenever the risk management system is modified, especially as the result of new

information being received that may lead to a significant change to the benefit/risk profile or
as the result of an important (pharmacovigilance or risk minimisation) milestone being
reached.

If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the 
same time. 



29 

ANNEX III 

LABELLING AND PACKAGE LEAFLET 



30 

A. LABELLING



31 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  

CARTON FOR SINGLE BOTTLE 

1. NAME OF THE MEDICINAL PRODUCT

LUMIGAN 0.1 mg/ml, eye drops, solution 
Bimatoprost 

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One ml of solution contains 0.1 mg bimatoprost 

3. LIST OF EXCIPIENTS

Benzalkonium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate, sodium 
chloride, hydrochloric acid or sodium hydroxide (to adjust pH) and purified water 

4. PHARMACEUTICAL FORM AND CONTENTS

Eye drops, solution 
1 x 3 ml 

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Ocular use.  
Read the package leaflet before use. 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children. 

7. OTHER SPECIAL WARNING(S), IF NECESSARY

Remove contact lenses before use. 

8. EXPIRY DATE

EXP  
Discard four weeks after first opening. 
Opened: 

9. SPECIAL STORAGE CONDITIONS



32 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Allergan Pharmaceuticals Ireland 
Castlebar Road 
Westport 
Co. Mayo 
Ireland 

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/02/205/003 

13. BATCH NUMBER

Batch: 

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription 

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

LUMIGAN 0.1 mg/ml 

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included. 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC: 
SN:  
NN: 



33 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  

CARTON CONTAINING THREE BOTTLES 

1. NAME OF THE MEDICINAL PRODUCT

LUMIGAN 0.1 mg/ml, eye drops, solution 
Bimatoprost 

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One ml of solution contains 0.1 mg bimatoprost 

3. LIST OF EXCIPIENTS

Benzalkonium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate, sodium 
chloride, hydrochloric acid or sodium hydroxide (to adjust pH) and purified water 

4. PHARMACEUTICAL FORM AND CONTENTS

Eye drops, solution 
3 x 3 ml 

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Ocular use.  
Read the package leaflet before use. 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach and children. 

7. OTHER SPECIAL WARNING(S), IF NECESSARY

Remove contact lenses before use. 

8. EXPIRY DATE

EXP 
Discard four weeks after first opening. 
Opened (1): 
Opened (2): 
Opened (3): 

9. SPECIAL STORAGE CONDITIONS



34 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Allergan Pharmaceuticals Ireland 
Castlebar Road 
Westport 
Co. Mayo 
Ireland 

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/02/205/004 

13. BATCH NUMBER

Batch: 

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription 

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

LUMIGAN 0.1 mg/ml 

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included. 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC: 
SN:  
NN: 



35 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

BOTTLE 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

LUMIGAN 0.1 mg/ml, eye drops, solution 
Bimatoprost  
Ocular use 

2. METHOD OF ADMINISTRATION

Read the package leaflet before use. 

3. EXPIRY DATE

Exp: 
Discard 4 weeks after first opening 

4. BATCH NUMBER

Batch:  

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

3 ml 

6. OTHER



36 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

CARTON FOR SINGLE BOTTLE 

1. NAME OF THE MEDICINAL PRODUCT

LUMIGAN 0.3 mg/ml, eye drops, solution 
Bimatoprost 

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One ml of solution contains 0.3 mg bimatoprost 

3. LIST OF EXCIPIENTS

Benzalkonium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate, sodium 
chloride, hydrochloric acid or sodium hydroxide (to adjust pH) and purified water 

4. PHARMACEUTICAL FORM AND CONTENTS

Eye drops, solution 
1 x 3 ml 

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Ocular use.  
Read the package leaflet before use. 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children. 

7. OTHER SPECIAL WARNING(S), IF NECESSARY

Remove contact lenses before use. 

8. EXPIRY DATE

EXP  
Discard four weeks after first opening. 
Opened: 

9. SPECIAL STORAGE CONDITIONS



37 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Allergan Pharmaceuticals Ireland 
Castlebar Road 
Westport 
Co. Mayo 
Ireland 

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/02/205/001 

13. BATCH NUMBER

Batch: 

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription 

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

LUMIGAN 0.3 mg/ml 

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included. 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC: 
SN:  
NN: 



38 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

CARTON CONTAINING THREE BOTTLES 

1. NAME OF THE MEDICINAL PRODUCT

LUMIGAN 0.3 mg/ml, eye drops, solution 
Bimatoprost 

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One ml of solution contains 0.3 mg bimatoprost 

3. LIST OF EXCIPIENTS

Benzalkonium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate, sodium 
chloride, hydrochloric acid or sodium hydroxide (to adjust pH) and purified water 

4. PHARMACEUTICAL FORM AND CONTENTS

Eye drops, solution 
3 x 3 ml 

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Ocular use.  
Read the package leaflet before use. 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children. 

7. OTHER SPECIAL WARNING(S), IF NECESSARY

Remove contact lenses before use. 

8. EXPIRY DATE

EXP 
Discard four weeks after first opening. 
Opened (1): 
Opened (2): 
Opened (3): 

9. SPECIAL STORAGE CONDITIONS



39 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Allergan Pharmaceuticals Ireland 
Castlebar Road 
Westport 
Co. Mayo 
Ireland 

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/02/205/002 

13. BATCH NUMBER

Batch: 

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription 

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

LUMIGAN 0.3 mg/ml 

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included. 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC: 
SN:  
NN: 



40 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

BOTTLE 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

LUMIGAN 0.3 mg/ml, eye drops, solution 
Bimatoprost  
Ocular use 

2. METHOD OF ADMINISTRATION

Read the package leaflet before use. 

3. EXPIRY DATE

Discard 4 weeks after first opening 
Exp: 

4. BATCH NUMBER

Batch:  

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

3 ml 

6. OTHER



41 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

CARTON CONTAINING 5 SINGLE-DOSE CONTAINERS 

1. NAME OF THE MEDICINAL PRODUCT

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

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One ml of solution contains 0.3 mg bimatoprost. 

3. LIST OF EXCIPIENTS

Sodium phosphate dibasic heptahydrate, citric acid monohydrate, sodium chloride, hydrochloric acid 
or sodium hydroxide (to adjust pH) and purified water. 

4. PHARMACEUTICAL FORM AND CONTENTS

Eye drops, solution 
5 x 0.4 ml 

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use. 
Ocular use 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children. 

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP  

9. SPECIAL STORAGE CONDITIONS

Do not store above 25°C. 



42 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE

Discard the opened single-dose container immediately after use. 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Allergan Pharmaceuticals Ireland 
Castlebar Road, 
Westport, 
Co. Mayo, 
Ireland 

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/02/205/005 

13. BATCH NUMBER

Lot 

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription 

15. INSTRUCTIONS ON USE

For single use only 

16. INFORMATION IN BRAILLE

LUMIGAN 0.3 mg/mL single-dose 

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included. 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC: 
SN:  
NN: 



43 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

OUTER CARTON CONTAINING 30 SINGLE-DOSE CONTAINERS 

1. NAME OF THE MEDICINAL PRODUCT

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

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One ml of solution contains 0.3 mg bimatoprost. 

3. LIST OF EXCIPIENTS

Sodium phosphate dibasic heptahydrate, citric acid monohydrate, sodium chloride, hydrochloric acid 
or sodium hydroxide (to adjust pH) and purified water. 

4. PHARMACEUTICAL FORM AND CONTENTS

Eye drops, solution 
30 x 0.4 ml 

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use. 
Ocular use 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children. 

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP 
Once the pouch is opened, the single dose containers should be used within 30 days. 

9. SPECIAL STORAGE CONDITIONS



44 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE

Discard the opened single-dose container immediately after use. 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Allergan Pharmaceuticals Ireland 
Castlebar Road 
Westport 
Co. Mayo 
Ireland 

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/02/205/006 

13. BATCH NUMBER

Lot 

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription 

15. INSTRUCTIONS ON USE

For single use only 

16. INFORMATION IN BRAILLE

LUMIGAN 0.3 mg/mL single-dose 

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included. 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC: 
SN:  
NN: 



45 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  

OUTER CARTON CONTAINING 90 SINGLE-DOSE CONTAINERS 

1. NAME OF THE MEDICINAL PRODUCT

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

2. STATEMENT OF ACTIVE SUBSTANCE(S)

One ml of solution contains 0.3 mg bimatoprost. 

3. LIST OF EXCIPIENTS

Sodium phosphate dibasic heptahydrate, citric acid monohydrate, sodium chloride, hydrochloric acid 
or sodium hydroxide (to adjust pH) and purified water. 

4. PHARMACEUTICAL FORM AND CONTENTS

Eye drops, solution 
90 x 0.4 ml 

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use. 
Ocular use. 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children. 

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP 
Once the pouch is opened, the single dose containers should be used within 30 days. 

9. SPECIAL STORAGE CONDITIONS



46 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE

Discard the opened single-dose container immediately after use. 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Allergan Pharmaceuticals Ireland 
Castlebar Road 
Westport 
Co. Mayo 
Ireland 

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/02/205/007 

13. BATCH NUMBER

Lot 

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription 

15. INSTRUCTIONS ON USE

For single use only 

16. INFORMATION IN BRAILLE

LUMIGAN 0.3 mg/mL single-dose 

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included. 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC: 
SN:  
NN: 



47 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

POUCH CONTAINING 10 SINGLE-DOSE CONTAINERS  

1. NAME OF THE MEDICINAL PRODUCT

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

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Allergan Pharmaceuticals Ireland 

3. EXPIRY DATE

EXP 
Once the pouch is opened, the single dose containers should be used within 30 days. 

4. BATCH NUMBER

Lot 

5. OTHER

Ocular use 
10 single-dose containers 
Single use only 
Read the package leaflet before use. 
Discard the opened single-dose container immediately after use.



48 

PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

SINGLE-DOSE CONTAINER 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

LUMIGAN 0,3 mg/mL 
Bimatoprost 

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP 

4. BATCH NUMBER

Lot 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

6. OTHER



49 

B. PACKAGE LEAFLET



50 

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 “LUMIGAN 0.1 mg/ml contains benzalkonium chloride”)
- You have or have had low blood pressure or low heart rate
- You have had a viral infection or inflammation of the eye



51 

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 
This medicine contains 0.6 mg benzalkonium chloride in each 3 ml of solution which is equivalent to 
0.2 mg/ml. 
Do not use the drops when you are wearing your lenses. A preservative in LUMIGAN, called 
benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the 
contact lenses.  You should remove contact lenses before using this medicine and wait 15 minutes 
after using the drops before you put your lenses back in. Benzalkonium chloride may also cause eye 
irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the 
eye).  If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to 
your doctor. 

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.  



52 

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 



53 

 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
 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)



54 

 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 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. 



55 

België/Belgique/Belgien 
Luxembourg/Luxemburg/Nederland 
Allergan n.v. 
Tél/Tel: +32 (0)2 351 24 24 

Ísland 
Actavis Pharmaceuticals Iceland ehf. 
Sími: +354 550 3300 

България 
Алерган България ЕООД 
Тел.: +359 (0) 800 20 280 

Italia 
Allergan S.p.A 
Tel: +39 06 509 562 90 

Česká republika 
Allergan CZ s.r.o. 
Tel: +420 800 188 818  

Latvija 
Allergan Baltics UAB 
Tel: +371 676 60 831 

Danmark/Norge/Suomi/Finland/Sverige 
Allergan Norden AB 
Tlf/Puh/Tel: +4580884560 (DK) 
+47 80 01 04 97 (NO)
+358 800 115 003 (FI)
+46 (0)8 594 100 00 (SE)

Lietuva 
Allergan Baltics UAB 
Tel: +37 052 072 777 

Deutschland 
Allergan GmbH 
Tel: +49 69 92038 1050 

Magyarország 
Allergan Hungary Kft. 
Tel: +36 80 100 101  

Eesti 
Allergan Baltics UAB 
Tel: + 37 2634 6109  

Österreich 
Pharm-Allergan GmbH 
Tel: +43 1 99460 6355 

Ελλάδα/Κύπρος 
Allergan Hellas Pharmaceuticals S.A. 
Τηλ: +30 210 74 73 300 

Polska 
Allergan Sp. z o.o. 
Tel: +48 22 256 37 00 

España 
Allergan S.A. 
Tel: +34 91 807 6130 

Portugal 
Profarin Lda. 
Tel: +351 21 425 3242 

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

România 
Allergan S.R.L. 
Tel.: +40 21 301 53 02 

Hrvatska 
Ewopharma d.o.o. 
Tel: +385 1 6646 563 

Slovenija 
Ewopharma d.o.o. 
Tel: +386 (0) 590 848 40 

Ireland/Malta 
Allergan Pharmaceuticals Ireland 
+353 1800 931 787 (IE)
+356 27780331 (MT)

Slovenská republika 
Allergan SK s.r.o. 
Tel: +421 800 221 223 

United Kingdom 
Allergan Ltd 
Tel: +44 (0) 1628 494026 

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. 



56 



57 

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 “LUMIGAN 0.3 mg/ml contains benzalkonium chloride”)
- You have or have had low blood pressure or low heart rate



58 

- 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 
This medicine contains 0.15 mg benzalkonium chloride in each 3 ml of solution which is equivalent to 
0.05 mg/ml. 
Do not use the drops when you are wearing your lenses. A preservative in LUMIGAN, benzalkonium 
chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses.  You 
should remove contact lenses before using this medicine and wait 15 minutes after using the drops 
before you put your lenses back in. Benzalkonium chloride may also cause eye irritation, especially if 
you have dry eyes or disorders of the cornea (the clear layer at the front of the eye).  If you feel 
abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor.. 

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.  



59 

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



60 

 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
 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 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. 



61 

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 
Luxembourg/Luxemburg/Nederland 
Allergan n.v. 
Tél/Tel: +32 (0)2 351 24 24 

Ísland 
Actavis Pharmaceuticals Iceland ehf. 
Sími: +354 550 3300 

България 
Алерган България ЕООД 
Тел.: +359 (0) 800 20 280 

Italia 
Allergan S.p.A 
Tel: +39 06 509 562 90 

Česká republika 
Allergan CZ s.r.o. 
Tel: +420 800 188 818  

Latvija 
Allergan Baltics UAB 
Tel: +371 676 60 831 



62 

Danmark/Norge/Suomi/Finland/Sverige 
Allergan Norden AB 
Tlf/Puh/Tel: +4580884560 (DK) 
+47 80 01 04 97 (NO)
+358 800 115 003 (FI)
+46 (0)8 594 100 00 (SE)

Lietuva 
Allergan Baltics UAB 
Tel: +37 052 072 777 

Deutschland 
Allergan GmbH 
Tel: +49 69 92038 1050 

Magyarország 
Allergan Hungary Kft. 
Tel: +36 80 100 101  

Eesti 
Allergan Baltics UAB 
Tel: + 37 2634 6109  

Österreich 
Pharm-Allergan GmbH 
Tel: +43 1 99460 6355 

Ελλάδα/Κύπρος 
Allergan Hellas Pharmaceuticals S.A. 
Τηλ: +30 210 74 73 300 

Polska 
Allergan Sp. z o.o. 
Tel: +48 22 256 37 00 

España 
Allergan S.A. 
Tel: +34 91 807 6130 

Portugal 
Profarin Lda. 
Tel: +351 21 425 3242 

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

România 
Allergan S.R.L. 
Tel.: +40 21 301 53 02 

Hrvatska 
Ewopharma d.o.o. 
Tel: +385 1 6646 563 

Slovenija 
Ewopharma d.o.o. 
Tel: +386 (0) 590 848 40 

Ireland/Malta 
Allergan Pharmaceuticals Ireland 
Tel: +353 1800 931 787 (IE) 
+356 27780331 (MT)

Slovenská republika 
Allergan SK s.r.o. 
Tel: +421 800 221 223 

United Kingdom 
Allergan Ltd 
Tel: +44 (0) 1628 494026 

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/ 



63 

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



64 

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. 

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  pouch  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. 



65 

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 



66 

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
 Eyes appear sunken
 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. 



67 

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

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. 

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 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 
Luxembourg/Luxemburg/Nederland 
Allergan n.v. 
Tél/Tel: +32 (0)2 351 24 24 

Ísland 
Actavis Pharmaceuticals Iceland ehf. 
Sími: +354 550 3300 

България 
Алерган България ЕООД 
Тел.: +359 (0) 800 20 280 

Italia 
Allergan S.p.A 
Tel: +39 06 509 562 90 

Česká republika 
Allergan CZ s.r.o. 
Tel: +420 800 188 818  

Latvija 
Allergan Baltics UAB 
Tel: +371 676 60 831 



68 

Danmark/Norge/Suomi/Finland/Sverige 
Allergan Norden AB 
Tlf/Puh/Tel: +4580884560 (DK) 
+47 80 01 04 97 (NO)
+358 800 115 003 (FI)
+46 (0)8 594 100 00 (SE)

Lietuva 
Allergan Baltics UAB 
Tel: +37 052 072 777 

Deutschland 
Allergan GmbH 
Tel: +49 69 92038 1050 

Magyarország 
Allergan Hungary Kft. 
Tel: +36 80 100 101  

Eesti 
Allergan Baltics UAB 
Tel: + 37 2634 6109  

Österreich 
Pharm-Allergan GmbH 
Tel: +43 1 99460 6355 

Ελλάδα/Κύπρος 
Allergan Hellas Pharmaceuticals S.A. 
Τηλ: +30 210 74 73 300 

Polska 
Allergan Sp. z o.o. 
Tel: +48 22 256 37 00 

España 
Allergan S.A. 
Tel: +34 91 807 6130 

Portugal 
Profarin Lda. 
Tel: +351 21 425 3242 

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

România 
Allergan S.R.L. 
Tel.: +40 21 301 53 02 

Hrvatska 
Ewopharma d.o.o. 
Tel: +385 1 6646 563 

Slovenija 
Ewopharma d.o.o. 
Tel: +386 (0) 590 848 40 

Ireland/Malta 
Allergan Pharmaceuticals Ireland 
Tel: +353 1800 931 787 (IE) 
+356 27780331 (MT)

Slovenská republika 
Allergan SK s.r.o. 
Tel: +421 800 221 223 

United Kingdom 
Allergan Ltd 
Tel: +44 (0) 1628 494026 

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 we



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	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETINGAUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE ANDEFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET