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. 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 this medicine in children aged 0 to 18 years has not yet been established.

Patients with hepatic or renal impairment:

This medicine 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 (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.

3 mg/ml single-dose experienced adverse reactions. The most frequently reported adverse reactions were conjunctival hyperaemia (mostly trace to mild and of a non- inflammatory nature) occurring in 24% of patients, and eye pruritus occurring in 4% of patients.

3 mg/ml single-dose group discontinued due to any adverse event in the 3 month study. 3 mg/ml single-dose or in the post-marketing period.

Most were ocular, mild and none was serious:

Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from available data) adverse reactions are presented according to System Organ Class in Table 1.

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. 3 mg/ml (multi-dose formulation). 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. 3 mg/ml (single-dose). Most were ocular, mild to moderate, and none were serious.

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 common corneal erosion, ocular burning, allergic conjunctivitis, blepharitis, worsening of visual acuity, eye discharge, visual disturbance, eyelash darkening Eye disorders uncommon retinal haemorrhage, uveitis, cystoid macular oedema, iritis, blepharospasm, eyelid retraction Vascular disorders common hypertension Gastrointestinal disorders uncommon nausea Skin and subcutaneous tissue disorders not known periorbital erythema 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 Eyreida 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 Eyreida, 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%. 3 mg/ml eye […]

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 this medicine.

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

Respiratory This medicine 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 This medicine 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 (multi-dose formulation). This medicine should be used with caution in patients predisposed to low heart rate or low blood pressure. 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 this medicine with other prostaglandin analogues should be monitored for changes to their intraocular pressure. This medicine 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.

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