MINIMS PHENYLEPHRINE HYDROCHLORIDE

Posology Adults, including the elderly population Apply one drop topically to each eye. If necessary, this dose may be repeated once only, at least one hour after the first drop. Paediatric population Apply one drop topically to the eye.

It is not usually necessary to exceed this dose. 5%w/v eye drops may be combined with other mydriatics/cycloplegics to produce adequate mydriasis/cycloplegia. Heavily pigmented irides may require larger doses and caution should be exercised to avoid overdosage.

The use in preterm and newborn infants is not recommended unless clearly necessary and only with caution because of safety concerns associated with the risk of systemic adverse reactions including transient increases in blood pressure.

4). Method of administration The use of a drop of topical anaesthetic a few minutes before instillation of phenylephrine is recommended to prevent stinging. Especially in infants, children and the elderly, it is advised to minimise systemic absorption and the risk for systemic adverse reactions by compressing the lacrimal sac at the medial canthus or gently closing the eye for a few minutes after instillation.

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The frequency of the undesirable effects are not known (cannot be estimated from the available data). Immune System Disorders Hypersensitivity Eye Disorders Eye pain, eye irritation, blurred vision, photophobia, conjunctivitis allergic.

Cardiac disorders Palpitations, tachycardia, extrasystoles, arrythmias. Vascular disorders Hypertension Serious cardiovascular reactions including arteriospasm coronary, ventricular arrhythmia and myocardial infarction have occurred following topical use of 10% phenylephrine.

These sometimes fatal reactions have usually occurred in patients with pre-existing cardiovascular disease. Paediatric population Periorbital pallor in preterm patients 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

g. patients with insulin dependent diabetes), orthostatic hypotension, hypertension, hyperthyroidism. Use with caution in patients with cerebral arteriosclerosis or long-standing bronchial asthma. To reduce the risk of precipitating an attack of narrow angle glaucoma, evaluate the anterior chamber angle before use.

Ocular hyperaemia can increase the absorption of phenylephrine given topically. Corneal clouding may occur if phenylephrine 10% is instilled when the corneal epithelium has been denuded or damaged. Use of a drop of topical anaesthetic a few minutes before the instillation of phenylephrine is recommended to avoid eye pain.

Systemic absorption may be minimised by compressing the lacrimal sac at the medial canthus for one minute during and after the instillation of the drops. (This blocks the passage of the drops via the naso-lacrimal duct to the wide absorptive area of the nasal and pharyngeal mucosa.

It is especially advisable in infants, children and the elderly). Paediatric population Use with caution in children. 2). Parents should be warned not to get this preparation in their children's mouth or cheeks and to wash their hands and the child's hands or cheeks following administration.

Both full-term, but especially low birth weight and premature infants may be at an increased risk for systemic adverse reactions including transient increases in blood pressure which potentially increases the risk of intraventricular haemorrhage.

The infant should be monitored after instillation and routines to adequately deal with emergency situations should be in place.

Patients with cardiac disease, hypertension, aneurysms, thyrotoxicosis, long-standing insulin dependent diabetes mellitus and tachycardia. Patients on monoamine oxidase inhibitors, tricyclic antidepressants and anti-hypertensive agents (including beta-blockers).

Patients with closed angle glaucoma (unless previously treated with iridectomy) and patients with a narrow angle prone to glaucoma precipitated by mydriatics. Newborns and infants with cardio- and cerebrovascular disease. Elderly adults with severe arteriosclerotic, cardiovascular or cerebrovascular disease.

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