EYREIDA

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. Eyreida eye drops solution is a sterile solution that does not contain a preservative.

Paediatric population:

The safety and efficacy of Eyreida in children aged 0 to 18 years has not yet been established. No data are currently available. Hepatic or renal impairment Eyreida 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 (preserved 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.

Before instillation of the eye drops - Users should be instructed to wash their hands before opening the bottle. - Users should also be instructed to not use this medicine if they notice that the tamper-proof seal on the bottle neck is broken before they first use it.

- When used for the first time, before delivering a drop to the eye, the patient should practise using the dropper bottle by squeezing it slowly to deliver one drop away from the eye. - When the patient is confident they can deliver one drop at a time, the patient should adopt a position that is the most comfortable for the instillation of the drops (the patient can sit down, lie on their back, or stand in front of a mirror).

Instillation 1. The bottle should be held directly below the cap and the cap should be turned to open the bottle. To avoid contamination of the solution, the tip of the bottle must not touch anything. 2. The patient should tilt their head backwards and hold the bottle above their eye.

3. The patient should pull the lower eyelid down and look up. The bottle should be squeezed gently in the middle and a drop should be allowed to fall into the patient’s eye. Please note that there might be a few seconds delay between squeezing and the drop coming out.

The bottle must not be squeezed too hard. Patients should be instructed to seek advice from their doctor, pharmacist or nurse if they are not sure how to administer their medicine. 4. The patient should blink a few times so that the drop spreads over their eye.

3 mg/ml (preservative free formulation) 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 (preservative free formulation) group discontinued due to any adverse event in the 3 month study. 3 mg/ml (preservative free formulation) 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 (preserved formulation). 3 mg/ml (preserved 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 ((preservative free formulation)). Most were ocular, mild to moderate, and none were serious.

3 mg/ml (preserved 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 uncommon retinal haemorrhage, uveitis, cystoid macular oedema, iritis, blepharospasm, eyelid retraction Eye disorders 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.

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 Eyreida. 8). 3 mg/ml eye drops (preserved formulation).

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

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

3 mg/ml eye drops. Eyreida 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 Eyreida with other prostaglandin analogues should be monitored for changes to their intraocular pressure. Eyreida 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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