Please refer to Summary of Product Characteristics before prescribing. Further information about this product can be requested from the Marketing Authorisation Holder or may be found in the Summary of Product Characteristics.
Contains: Clear, colourless, sterile eye drops containing Phenylephrine Hydrochloride Ph. Eur. 2.5% w/v.
Main Indications, Dosage and Administration: Phenylephrine is a directly acting sympathomimetic agent used topically in the eye as a mydriatic. It may be indicated to dilate the pupil for diagnostic or therapeutic procedures. 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 each eye. It is not usually necessary to exceed this dose. Phenylephrine 2.5%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 over dosage. 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. If treatment is medically justified the lowest possible concentration and dose should be used and instillation of more than one drop per eye must be avoided.
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. To minimise cutaneous absorption, excess fluid should be wiped away from the periocular area.
Contraindications, Precautions and Warnings: Infants, children and elderly, because of the increased risk of systemic toxicity. 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. Hypersensitivity to the active substance or to any of the excipients.
Special warnings and precautions for use: Use with caution in elderly or in patients with sympathetic denervation (e.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. The lowest dose necessary to produce the desired effect should always be used. 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.
Fertility, pregnancy and lactation: Safety for use during pregnancy and lactation has not been established. This product should only be used during pregnancy if it is considered by the physician to be essential.
Interactions: Anti-hypertensive Agents: Topical phenylephrine should not be used as it may reverse the action of many anti-hypertensive agents with possibly fatal consequences. Monoamine Oxidase Inhibitors: There is an increased risk of adrenergic reactions when used simultaneously with, or up to three weeks after, the administration of MAOIs. Tricyclic Antidepressants: The pressor response to adrenergic agents and the risk of cardiac arrythmia may be potentiated in patients receiving tricyclic antidepressants (or within several days of their discontinuation). Halothane: Because of the increased risk of ventricular fibrillation, phenylephrine should be used with caution during general anaesthesia with anaesthetic agents which sensitise the myocardium to sympathomimetics. Cardiac Glycosides or Quinidine: There is an increased risk of arrhythmias.
Undesirable effects: 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. arteriospasm coronary, ventricular arrhythmia and myocardial infarction. These sometimes fatal reactions have usually occurred in patients with pre-existing cardiovascular disease. 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.
Legal Category: P
2.5%w/v: PL 03468/0076 Basic NHS Price: £13.08
Marketing Authorisation Holder: Bausch & Lomb UK Limited, Bausch & Lomb House,106 London Road, Kingston-upon-Thames, Surrey KT2 6TN.
Date of Revision: March 2023
Exemption Level: 1
Evocative Code: PHNL 2.5
PIP Code: 037-7192
United Kingdom (UK)
