RYJUNEA

Ryjunea should only be initiated by an ophthalmologist or a healthcare professional who has myopia within their scope of practice. 1 mg/ml is one drop into each eye once daily. Administration at bedtime is recommended. Treatment should be assessed during regular clinical evaluation.

5 D progression over 2 years) during adolescence. Continue monitoring for one year after cessation of treatment. 4). Missed dose If one dose is missed, treatment should continue with the next dose as normal. Paediatric population The safety and efficacy of Ryjunea in children aged less than 3 years has not been established.

No data are available. Method of administration Ocular use. It is recommended that the lachrymal sac be compressed at the medial canthus (punctal occlusion) for one minute, to reduce possible systemic absorption. This should be performed immediately following the instillation of each drop.

4). If more than one topical ophthalmic medicinal product is being used, the medicinal products must be administered at least fifteen minutes apart. Eye ointments should be used last. To maintain sterility, contact of the container with the eye or eyelids should be avoided.

8%). 1 mg/ml are tabulated below by system organ class and by frequency. 4% of patients using Ryjunea discontinued due to any adverse event in the 24-month study. The frequencies are as follows: 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 the available data).

Table 1. 1 mg/ml System organ class Very common ≥1/10 Common ≥1/100 to <1/10 Uncommon ≥1/1 000 to <1/100 Nervous system disorders Headache Eye disorders Photophobia Vision blurred, Eye irritation, Eye pain, Foreign body sensation in eyes, Mydriasis Accommodation disorder, Conjunctival papillae, Punctate keratitis Description of selected adverse reactions Photophobia Atropine sulfate causes photophobia by dilating the pupil and paralyzing the ciliary muscle, allowing excessive light to enter the eye and impairing its ability to adjust to bright light.

Photophobia was the most commonly reported adverse reaction in clinical trials, typically presenting as mild to moderate in severity. 4). 7). In approximately 69% of patients, it resolves by itself during treatment (range of duration 2 to 734 days, mean duration days 135).

Eye irritation Signs and symptoms of eye irritation associated with atropine sulfate include also eye pruritus and ocular discomfort. These are mostly mild or moderate symptoms occurring intermittently. The duration of these reactions varied from 1 to 758 days in the clinical trial and were comparable in the vehicle group and in the atropine sulfate groups.

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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Photophobia and accommodative dysfunction After using atropine sulfate, accommodative dysfunction and increased sensitivity to bright light can be expected due to mydriasis. The effect could last up to 14 days. Photochromatic lenses may be used as needed to reduce discomfort due to photophobia.

Rebound myopia progression upon discontinuation Discontinuation of atropine sulfate eye drops may lead to rebound myopia progression. Continue monitoring for one year after cessation of treatment. 2). Synechiae Atropine sulfate may increase the risk of adherence of the iris and lens.

Cataract Depending on the type and opacity of the cataract, visual acuity and refraction may not be accurately assessed. Amblyopia and strabismus Atropine sulfate can cause blurred vision which may exacerbate these conditions. Progressive syndromic myopia of childhood Before starting treatment with atropine, it is important to rule out progressive syndromic myopia of childhood, such as glaucoma, retinitis pigmentosa, congenital hemeralopia, and myelinated nerve fiber syndrome.

These conditions do not evolve the same way as typical progressive myopia and should not be treated with atropine. Patients with cardiac disorders Atropine sulfate must be used and dosed with special caution in patients with tachycardia, heart failure, coronary stenosis and hypertension.

Patients who have suffered a recent heart attack may experience tachycardic arrhythmias up to ventricular fibrillation while being administered atropine sulfate. Risk of hyperthermia As the capability for temperature regulation may be affected by inhibition of sweating, atropine sulfate must be used with caution in high ambient temperature and in patients with fever due to the risk of hyperthermia.

Spastic paralysis An increased susceptibility to atropine has been reported in children with spastic paralysis; therefore Atropine sulfate must be used with special caution in these patients. Down’s syndrome An increased susceptibility to atropine has been reported in children with Down’s syndrome; therefore, atropine sulfate must be used with special caution in these patients.

1. Known hypersensitivity to other anticholinergics like ipratropium and tiotropium. Patients with primary glaucoma or angle-closure glaucoma.