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: 0.4% w/v solution of Oxybuprocaine Hydrochloride Ph.Eur.
Main Indications, Dosage and Administration: Topical ocular anaesthetic. Adults (including the Elderly) and Children: One drop is sufficient when dropped into the conjunctival sac to anaesthetise the surface of the eye to allow tonometry after one minute. A further drop after 90 seconds provides adequate anaesthesia for the fitting of contact lenses. Three drops at 90 second intervals provides sufficient anaesthesia for a foreign body to be removed from the corneal epithelium or for incision of a meibomian cyst through the conjunctiva. Corneal sensitivity is normal again after about one hour. Instil dropwise into the eye according to the recommended dosage. Each Minims unit should be discarded after use.
Contraindications, Precautions and Warnings: Not to be used in patients with a known hypersensitivity to the product. Transient stinging and blurring of vision may occur on instillation. The anaesthetised eye should be protected from dust and bacterial contamination. When applied to the conjunctiva, oxybuprocaine is less irritant than amethocaine in normal concentrations. The cornea may be damaged by prolonged application of anaesthetic eye drops. Systemic absorption may be reduced by compressing the lacrimal sac at the medial canthus for a minute during and following 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 children).
Pregnancy fertility and lactation: This product should not be used in pregnancy or lactation, unless considered essential by the physician.
Effects on ability to drive and use machines: Patients should be advised not to drive or operate hazardous machinery until normal vision is restored.
Undesirable effects: In very rare cases, uncontrolled use, i.e. long-term and/or too frequent use, may result in keratopathy, hypopyon, or central corneal erosion including central scarring. Corneal perforation may also be possible. Transient irritation, stinging and blurring of vision may occur on instillation. In rare cases, local anaesthetic preparations have been associated with allergic reactions (in the most severe instances, anaphylactic shock).
Eye disorders: Not known: Eye pain, eye irritation, blurred vision, keratopathy, hypopyon, corneal erosion, corneal perforation, eye allergy, allergic blepharitis. Immune system disorders: Not known: Hypersensitivity, anaphylactic reaction/shock.
Legal Category: POM
UK PL No: PL 03468/0053
Basic NHS Price: £ 11.97
Marketing Authorisation Holder: Bausch & Lomb UK Limited Bausch & Lomb House 106 London Road Kingston-Upon-Thames Surrey, UK KT2 6TN
Date of Revision: March 2023
Exemption Level: 1
Evocative Code: BNX 0.4
PIP Code: 018-0497
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