LUMIGAN 0.1 MG / ML EYE DROPS SOLUTION - patient leaflet, side effects, dosage

Patient leaflet - LUMIGAN 0.1 MG / ML EYE DROPS SOLUTION

ANNEX I

SUMMARY OF PRODUCT CHARACTERISTICS

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.

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 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 breastfeeding 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 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
Nervous system disorders	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

| 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
Nervous system disorders	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.

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 F?^ (PGF2a), 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.

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

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

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:

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.

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).

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

Skin

Respiratory

Cardiovascular

Other Information

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.

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.

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.

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.

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 breastfeeding 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

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 noninflammatory 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
Nervous system disorders	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

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

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

Bimatoprost is a potent ocular hypotensive agent. It is a synthetic prostamide, structurally related to prostaglandin F2a (PGF2a), 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.

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

Biotransformation

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.

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

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/1/02/205/001–002

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

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

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.

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

Respiratory

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.

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.

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 breastfeeding 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

4.8 Undesirable effects

In a 3 month clinical study, approximately 29% of patients treated with LUMIGAN 0.3 mg/mL singledose 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:

Table 1

System Organ class	Frequency	Adverse reaction
Nervous system disorders	uncommon	headache
Nervous system disorders	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.

Table 2

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

4.9 Overdose

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

If overdose occurs, treatment should be symptomatic and supportive. If LUMIGAN 0.3 mg/mL singledose 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 × 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

Bimatoprost is a potent ocular hypotensive agent. It is a synthetic prostamide, structurally related to prostaglandin F2^ (PGF2a), 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.

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

Biotransformation

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 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

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:

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

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.

ANNEX III

LABELLING AND PACKAGE LEAFLET

A. LABELLING

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 × 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:

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:

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 × 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):

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:

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

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 × 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:

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:

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 × 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):

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:

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

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 × 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.

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:

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 × 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.

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:

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 × 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.

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:

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.

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

B. PACKAGE LEAFLET

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

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.

1. Wash your hands. Tilt your head back and look at the ceiling.
2. Gently pull down the lower eyelid until there is a small pocket.
3. Turn the bottle upside down and squeeze it to release one drop into each eye that needs treatment.
4. Let go of the lower lid, and close your eye for 30 seconds.

Wipe off any excess that runs down the cheek.

If a drop misses your eye, try again.

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

If you use more LUMIGAN 0.1 mg/ml than you should

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

If you forget to use LUMIGAN 0.1 mg/ml

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

If you stop using LUMIGAN 0.1 mg/ml

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

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

4. possible side effects

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

Very common side effects

These may affect one or more users in 10

Affecting the eye

Slight redness (up to 29 % of people)

Common side effects

These may affect 1 to 9 users in 100

Affecting the eye

Small breaks in the surface of the eye, with or without inflammation
Irritation
Itchy eyes
Longer eyelashes
Irritation, when drop is put in the eye
Eye pain

Affecting the skin

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

Uncommon side effects

These may affect 1 to 9 users in 1000

Affecting the eye

Darker Iris colour
Tired eye
Swelling of the surface of the eye
Blurred vision
Loss of eye lashes

Affecting the skin

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

Affecting the body

Headache
Feeling of sickness

Side effects where the frequency is not known

Affecting the eye

Macular oedema (swelling of the retina at the back of the eye which may lead to worsening vision)
Darker eyelid colour
Eyes appear sunken
Dryness
Sticky eyes
A feeling that something is in your eye
Swelling of the eye
Increasing tears
Ocular discomfort
Sensitivity to light

Affecting the body

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

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

Ocular burning
An allergic reaction in the eye
Inflamed eyelids
Difficulty in seeing clearly
Worsening of vision
Swelling of the see-through layer that covers the eye
Tears
Darker eyelashes
Retinal bleeding
Inflammation within the eye
Cystoid macular oedema (swelling of the retina within the eye leading to worsening vision)
Eyelid twitching
Eyelid shrinking, moving away from surface of the eye
Skin redness around the eye
Weakness
An increase in blood-test results that show how your liver is working

Other side effects reported with eye drops containing phosphates

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

Reporting 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.

Belgie/Belgique/Belgien

Luxembourg/Luxemburg/Nederland

Allergan n.v.

Island

Actavis Pharmaceuticals Iceland ehf.

Smi: +354 550 3300

Tel/Tel: +32 (0)2 351 24 24

EB^rapun

A.iepraw Etnrapua EOOfl

Ten.: +359 (0) 800 20 280

Italia

Allergan S.p.A

Tel: +39 06 509 562 90

Ceska republika

Allergan CZ s.r.o.

Tel: +420 800 188 818

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)

Latvija

Allergan Baltics UAB

Tel: +371 676 60 831

Lietuva

Allergan Baltics UAB

Tel: +37 052 072 777

Deutschland

Allergan GmbH

Tel: +49 69 92038 1050

Magyarorszag

Allergan Hungary Kft.

Tel: +36 80 100 101

Eesti

Allergan Baltics UAB

Tel: + 37 2634 6109

Osterreich

Pharm-Allergan GmbH

Tel: +43 1 99460 6355

EkXaSa/Knnpog

Allergan Hellas Pharmaceuticals S.A.

Tql: +30 210 74 73 300

Polska

Allergan Sp. z o.o.

Tel: +48 22 256 37 00

Espana

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

Romania

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)

Slovenska 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.

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.

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
– You have had a viral infection or inflammation of the 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.

1. Wash your hands. Tilt your head back and look at the ceiling.
2. Gently pull down the lower eyelid until there is a small pocket.
3. Turn the bottle upside down and squeeze it to release one drop into each eye that needs treatment.

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

Wipe off any excess that runs down the cheek.

If a drop misses your eye, try again.

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

If you use more LUMIGAN 0.3 mg/ml than you should

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

If you forget to use LUMIGAN 0.3 mg/ml

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

If you stop using LUMIGAN 0.3 mg/ml

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

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

4. possible side effects

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

Very common side effects

These may affect one or more users in 10

Affecting the eye

Longer eyelashes (up to 45% of people)
Slight redness (up to 44% of people)
Itchiness (up to 14% of people)

Common side effects

These may affect 1 to 9 users in 100

Affecting the eye

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

Affecting the body

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

Uncommon side effects

These may affect 1 to 9 users in 1000

Affecting the eye

Cystoid macular oedema (swelling of the retina within the eye leading to worsening vision)
Inflammation within the eye
Retinal bleeding
Swollen eyelids
Eyelid twitching
Eyelid shrinking, moving away from surface of the eye
Skin redness around the eye

Affecting the body

Nausea
Dizziness
Weakness
Hair growth around the eye

Side effects where the frequency is not known

Affecting the eye

Eyes appear sunken
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

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

Marketing Authorisation Holder and Manufacturer

Allergan Pharmaceuticals Ireland

Castlebar Road

Westport

Co. Mayo

Ireland.

For any information about this medicine, please authorisation holder.

Belgie/Belgique/Belgien

Luxembourg/Luxemburg/Nederland

Allergan n.v.

Tel/Tel: +32 (0)2 351 24 24

Efcnrapua

A.iepraw Etnrapua EOOfl

Ten.: +359 (0) 800 20 280

Ceska republika

Allergan CZ s.r.o.

Tel: +420 800 188 818

contact the local representative of the marketing

Island

Actavis Pharmaceuticals Iceland ehf.

Smi: +354 550 3300

Italia

Allergan S.p.A

Tel: +39 06 509 562 90

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

Magyarorszag

Allergan Hungary Kft.

Tel: +36 80 100 101

Eesti

Allergan Baltics UAB

Tel: + 37 2634 6109

Osterreich

Pharm-Allergan GmbH

Tel: +43 1 99460 6355

EkXaSa/Knnpog

Allergan Hellas Pharmaceuticals S.A.

Tql: +30 210 74 73 300

Polska

Allergan Sp. z o.o.

Tel: +48 22 256 37 00

Espana

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

Romania

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)

Slovenska 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:

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.

This medicine does not contain a preservative.

2. what you need to know before you use lumigan 0.3 mg/ml single-dose

Do not use this medicine:

- If you are allergic to bimatoprost or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to you doctor or pharmacist before you use LUMIGAN 0.3 mg/mL single-dose.

Please tell your doctor or pharmacist, if:

– You have any breathing problems
– You have liver or kidney problems
– You have had a cataract surgery in the past
– You have or have had low blood pressure or low heart rate
– You have had a viral infection or inflammation of the eye

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

Children and adolescents

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

Other medicines and LUMIGAN 0.3 mg/mL single-dose

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

Pregnancy, breast-feeding and fertility

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

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

Driving and using machines

Your sight may become blurred for a short time just after using LUMIGAN 0.3 mg/mL single-dose.

You should not drive or use machines until your sight is clear again.

3. how to use lumigan 0.3 mg/ml single-dose

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

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

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

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

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.

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

If you use more LUMIGAN 0.3 mg/mL single-dose than you should

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

If you forget to use LUMIGAN 0.3 mg/mL single-dose

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

If you stop using LUMIGAN 0.3 mg/mL single-dose

LUMIGAN 0.3 mg/mL single-dose should be used every day to work properly. If you stop using LUMIGAN 0.3 mg/mL single-dose the pressure inside your eye may go up, therefore talk to your doctor before stopping this treatment.

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

4. possible side effects

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

Very common side effects

These may affect one or more users in 10

Affecting the eye

Slight redness (up to 24% of people)

Common side effects

These may affect 1 to 9 users in 100

Affecting the eye

Small breaks in the surface of the eye, with or without inflammation
Irritation
Itchy eyes
Pain
Dryness
A feeling that something is in your eye
Longer eyelashes
Darker skin colour around the eye
Red eyelids

Uncommon side effects

These may affect 1 to 9 users in 1000

Affecting the eye

Tired eyes
Sensitivity to light
Darker iris colour
Itchy and swollen eyelids
Tears
Swelling of the see-through layer which covers the surface of the eye
Blurred vision

Affecting the body

Headaches
Hair growth around the eye

Side effects where the frequency is not known

Affecting the 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.

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.

Belgie/Belgique/Belgien Luxembourg/Luxemburg/Nederland Allergan n.v. Tel/Tel: +32 (0)2 351 24 24	Island Actavis Pharmaceuticals Iceland ehf. Smi: +354 550 3300
Efcnrapua	Italia
A.iepraw Etnrapua EOOfl	Allergan S.p.A
Ten.: +359 (0) 800 20 280	Tel: +39 06 509 562 90
Ceska republika	Latvija
Allergan CZ s.r.o.	Allergan Baltics UAB
Tel: +420 800 188 818	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

Magyarorszag

Allergan Hungary Kft.

Tel: +36 80 100 101

Eesti

Allergan Baltics UAB

Tel: + 37 2634 6109

Osterreich

Pharm-Allergan GmbH

Tel: +43 1 99460 6355

EkXaSa/Knnpog

Allergan Hellas Pharmaceuticals S.A.

Tql: +30 210 74 73 300

Polska

Allergan Sp. z o.o.

Tel: +48 22 256 37 00

Espana

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

Romania

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)

Slovenska 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:.

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

LUMIGAN 0.1 MG / ML EYE DROPS SOLUTION - patient leaflet, side effects, dosage

Table of contents

Patient leaflet - LUMIGAN 0.1 MG / ML EYE DROPS SOLUTION

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 0.3 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 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