BIMATOPROST ASPIRE

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 bimatoprost in children aged 0 to 18 years have not yet been established.

Patients with hepatic and renal impairment Bimatoprost has not been studied in patients with renal or moderate to severe hepatic impairment and should therefore be used with caution in such patients. 3 mg/mL eye drops, solution had no adverse reaction 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

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.

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.

3 mg/ml. 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. 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 common headacheNervous system disorders uncommon dizziness very common ocular pruritus, growth of eyelashes Eye disorders 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 Description of selected adverse reactions: Prostaglandin analogue periorbitopathy (PAP) Prostaglandin analogues including Bimatoprost Aspire can induce periorbital lipodystrophic changes which can lead to deepening of the eyelid sulcus, ptosis, enophthalmos, eyelid retraction, involution of dermatochalasis and inferior scleral show.

Changes are typically mild, can occur as early as one month after initiation of treatment with Bimatoprost Aspire, and may cause impaired field of vision even in the absence of patient recognition. PAP is also associated with periocular skin hyperpigmentation or discoloration and hypertrichosis.

All changes have been noted to be partially or fully reversible upon discontinuation or switch to alternative treatments. Iris hyperpigmentation 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. 5%. 8 Table 2) and did not increase following 3 years treatment.

Adverse reactions reported in phosphate containing eye drops:

Cases of corneal […]

Ocular Before treatment is initiated, patients should be informed of the possibility of prostaglandin analogue periorbitopathy (PAP) and increased iris pigmentation, since these have been observed during treatment with bimatoprost.

8). 3 mg/ml eye drops, solution. g. aphakic patients, pseudophakic patients with a torn posterior lens capsule). 3 mg/ml eye drops, solution. g. herpes simplex) or uveitis/iritis. Bimatoprost 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 Bimatoprost Aspire solution comes repeatedly in contact with the skin surface. Thus, it is important to apply Bimatoprost Aspire as instructed and avoid it running onto the cheek or other skin areas.

Respiratory Bimatoprost 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 Bimatoprost has not been studied in patients with heart block more severe than first degree or uncontrolled congestive heart failure.

3 mg/ml eye drops, solution. Bimatoprost Aspire should be used with caution in patients predisposed to low heart rate or low blood pressure. 5). Patients using bimatoprost with other prostaglandin analogues should be monitored for changes to their intraocular pressure.

1 mg/ml contains the preservative benzalkonium chloride, which may be absorbed by soft contact lenses and discolour soft contact lenses. Contact lenses should be removed prior to instillation and may be reinserted 15 minutes following administration.

Benzalkonium chloride (BAK), which is commonly used as a preservative in ophthalmic products, has been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy. Benzalkonium chloride has been reported to cause eye irritation, symptoms of dry eyes and may affect the tear film and corneal surface.

Should be used with caution in dry eye patients and in patients where the cornea may be compromised and in patients taking multiple BAK-containing eye drops. Patients should be monitored in case of prolonged use. 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.

1. 1 mg/ml is contraindicated in patients who have had a suspected previous adverse reaction to benzalkonium chloride that has led to discontinuation.