Minims Lidocaine & Fluorescein.

Clear, slightly yellow, slightly viscous eye drops containing Lidocaine Hydrochloride PhEur 4% w/v and Fluorescein Sodium PhEur 0.25% w/v.

Single-use, sterile eye drops.

As a diagnostic stain and topical anaesthetic combined Minims Lidocaine & Fluorescein can be used in the measurement of intraocular pressure by Goldmann tonometry.

Adults (including the elderly):

One or more drops, as required.

Children:

As directed by the physician.

Do not use in patients with a known hypersensitivity to fluorescein or lidocaine and other amide-type local anaesthetics.

The anaesthetised eye should be protected from foreign body contamination, particularly in elderly patients in whom the duration of anaesthesia may exceed 30 minutes.

Use with caution in an inflamed eye as hyperaemia greatly increases the rate of systemic absorption through the conjunctiva.

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.)

None known.

This combination has been used for a number of years without apparent ill-consequence.

None known.

ADRs are very rare( <1/10,000),including isolated reports.

Symptoms of allergic-type reactions and anaphylaxis have been reported following topical ophthalmic administration of Fluorescein sodium and may manifest as:

Eye disorders: allergic conjunctivitis, peri-orbital oedema

Immune system disorders: anaphylactic reaction

Skin and subcutaneous tissue disorders: urticaria, rash

Overdose is not expected to cause any adverse effects, however, overuse of local anaesthetics can cause keratitis, with loss of corneal epithelium and stromal opacity.

Lidocaine is an established topical anaesthetic which blocks the sensory nerve endings of the cornea.

The fluorescein moiety does not stain a normal cornea but conjunctival abrasions are stained yellow or orange, corneal abrasions or ulcers are stained a bright green and foreign bodies are surrounded by a green ring.

None relevant.

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

Povidone

Hydrochloric Acid

Purified Water

None known.

15 months.

Store below 25°C. Do not freeze. Protect from light.

A sealed, conical shaped container fitted with a twist and pull-off cap. Each Minims unit is overwrapped in an individual polypropylene/paper pouch. Each container holds approximately 0.5ml of solution.

Each Minims unit should be discarded after a single use.

Chauvin Pharmaceuticals Ltd

106 London Road

Kingston-upon-Thames

Surrey

KT2 6TN

PL 0033/0073

Date of first Authorisation: 14.6.78

June 2007