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. 10% 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: 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: Phenylephrine 10% is contraindicated in children aged below 12 years (see section 4.3). There is no data in children aged 12 to 18 years. Phenylephrine is not recommended in these patients.
Elderly population: The use of phenylephrine 10% solution is contraindicated in this group because of the increased risks of systemic toxicity.
Method of administration: The use of a drop of topical anaesthetic a few minutes before instillation of phenylephrine is recommended to prevent stinging.
Contraindications: Patients with cardiac disease, hypertension, aneurysms, thyrotoxicosis, long-standing insulin dependent diabetes mellitus and tachycardia. Children aged below 12 years. The elderly, because of the increased risk of systemic toxicity. 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 Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the SmPC.
Special warnings and precautions for use: Use with caution in the presence of diabetes, 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. 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. Paediatric population: Use in children aged below 12 years is contraindicated, since serious systemic adverse reactions have been reported with ophthalmic products containing phenylephrine. Use in children aged 12 to 18 years is not recommended as adequate clinical experience is missing.
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.
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.
Effects on ability to drive and use machines: May cause stinging and temporarily blurred vision. Warn patients not to drive or operate hazardous machinery until vision is clear.
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, allergic conjunctivitis. 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. Paediatric population: Respiratory, thoracic and mediastinal disorders, Pulmonary oedema.
Legal Category: P
10%w/v: PL 03468/0077 Basic NHS Price: £13.46
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 10
PIP Code: 018-0737
United Kingdom (UK)
