Oxybuprocaine hydrochloride 4 mg/ml eye drops, solution in single-dose container – Summary of Product Characteristics (SmPC) for healthcare professionals

1 NAME OF THE MEDICINAL PRODUCT

Oxybuprocaine hydrochloride 4 mg/ml eye drops, solution in single-dose container

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml of solution contains 4.0 mg of oxybuprocaine hydrochloride. One drop contains approximately 166.4 mcg oxybuprocaine hydrochloride.

Excipient(s) with known effect:

Each ml of solution contains 20.0 mg of boric acid.

One drop contains approximately 0.84 mcg boric acid.

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Eye drops, solution in single-dose container.

Clear solution free of visible particles.

The pH of the solution is between 4.0–5.0; osmolality is about 330–370 mOsmol/kg.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Oxybuprocaine hydrochloride 4 mg/ml eye drops is indicated in adults, adolescents and children as a topical ocular anaesthetic.

4.2 Posology and method of administration

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 unit should be discarded after use.

The medicinal product can only be used for a short period of time.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

Like all local anaesthetics, Oxybuprocaine hydrochloride 4 mg/ml eye drops should only be administered by a doctor or nurse when needed.

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.

The product may cause toxicity if accidentally swallowed or if used for long periods at excessive doses.

This product contains boron which can impair fertility particularly in children under 2 years of age, if it is used more frequently than medically advised.

Contact lenses

Your doctor will ask you to remove your contact lenses prior to the administration of the drops. There is no information on the effect of this product on contact lenses. Therefore, do not wear your contact lenses until the effects of the drops have completely worn off.

4.5 Interaction with other medicinal products and other forms of interaction

Oxybuprocaine hydrochloride 4 mg/ml eye drops is incompatible with silver nitrate, mercury salts and alkaline substances.

Oxybuprocaine is incompatible with chlorhexidine acetate. Avoid co-administration with other ophthalmic agents containing chlorhexidine acetate as a preservative

4.6 Fertility, pregnancy and lactation

This product should not be used in pregnancy or lactation, unless considered essential by the physician.

4.7 Effects on ability to drive and use machines

Patients should be advised not to drive or operate hazardous machinery until normal vision is restored.

4.8 Undesirable effects

The side effects are listed in the following frequencies: Very common (≥ 1/10); Common (≥ 1/100, < 1/10); Uncommon (≥ 1/1,000, < 1/100); Rare (≥ 1/10,000, < 1/1,000); Very rare (< 1/10,000); Not known (cannot be estimated from the current available data).

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).

Table 1.

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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9 Overdose

Overdose following the recommended use is unlikely.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: local anaesthetics, ATC code: S01HA02

Oxybuprocaine hydrochloride is used as a local anaesthetic as it reversibly blocks the propagation and conduction of nerve impulses along nerve axons.

5.2 Pharmacokinetic properties

The rate of loss of local anaesthetics through tearflow is very high as they induce an initial stinging reaction which stimulates reflex lacrimation and leads to dilution of the drugs. It is thought that this is responsible for the very short duration of maximum effect of local anaesthetics. The non-ionised base of oxybuprocaine is rapidly absorbed from the pre-corneal tear film by the lipophilic corneal epithelium. The drug then passes into the corneal stroma and from there into the anterior chamber where it is carried away by the aqueous flow and diffuses into the blood circulation in the anterior uvea. As with other ester type local anaesthetics, oxybuprocaine is probably rapidly metabolised by plasma cholinesterases (and also by esterases in the liver).

5.3 Preclinical safety data

No adverse safety issues were detected during the development of this formulation. The active ingredient is well established in clinical ophthalmology.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Boric acid

Purified water

6.2 Incompatibilities

See section 4.5 Interaction with other medicinal products and other forms of interaction.

6.3 Shelf life

2 years

After the first opening of the sachet: 3 months.

After the first opening of the single-dose container: immediately use.

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions. Do not freeze.

For storage conditions after first opening of the medicinal product, see section 6.3.

6.5 Nature and contents of container

Single-dose container is made of low density polyethylene slightly opaque and thermally sealed.

20 or 30 unit single-dose containers in neutral colour, divided in 2 or 3 strips of 10 containers, are contained in PET/Al/PE pouches (1 strip in each pouch) and then in a suitable box, together with the leaflet.

Each carton box contains 20 or 30 single-dose polyethylene containers containing 0.5 ml of solution. Each single-dose container contains 12 drops.

6.6 Special precautions for disposal

No special requirements.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

Alfa Intes Limited

Second Floor, 150 Fleet Street

London

EC4A 2DQ, UK

8 MARKETING AUTHORISATION NUMBER(S)

PL 54537/0002

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

21/11/2025

10 DATE OF REVISION OF THE TEXT

21/11/2025