4.1. Therapeutic indications

ACULAR is indicated for the prophylaxis and reduction of inflammation and associated symptoms following ocular surgery.

ACULAR is indicated in adults.

4.2. Posology and method of administration

Posology

Post-operative inflammation:

One drop instilled into the eye three times daily starting 24 hours pre-operatively and continuing for up to three weeks post-operatively.

Paediatric population

There is no relevant use of ACULAR in the paediatric population in the indication: For the prophylaxis and reduction of inflammation following cataract surgery.

Method of administration

Ocular use.

Instil one drop of the solution into the inferior conjunctival sac of the eye to be treated, while pulling the lower eyelid gently downwards and looking upwards.

If ACULAR is used concomitantly with other topical eye medications there must be an interval of at least 5 minutes between the two medications.

4.3. Contraindications

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

The potential exists for cross-sensitivity to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs. ACULAR is contraindicated in individuals who have previously exhibited sensitivities to these drugs.

4.4. Special warnings and precautions for use

It is recommended that ACULAR be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time.

In common with other anti-inflammatory drugs, ACULAR may mask the usual signs of infection.

All non-steroidal anti-inflammatory drugs (NSAIDs) may slow down or delay wound healing. Concomitant use of NSAIDs and topical steroids can increase the potential for healing problems.

Concomitant use of ACULAR and topical corticosteroids should be exercised with caution in patients susceptible to corneal epithelial breakdown.

Use of topical NSAIDS may result in keratitis. In some patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration or corneal perforation. These events may be sight threatening. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs and should be closely monitored for corneal health.

Topical NSAIDs should be used with caution in patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g. dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time, as they may be at increased risk for corneal adverse events which may become sight threatening.

Post marketing experience with topical NSAIDs also suggest that use more than 24 hours prior to surgery or use beyond 14 days post surgery may increase patient risk for the occurrence and severity of corneal adverse events.

The preservative in ACULAR, benzalkonium chloride, may cause eye irritation. Contact lenses must be removed prior to application, with at least a 15-minute wait before reinsertion. Benzalkonium chloride is known to discolour soft contact lenses. Contact with soft contact lenses must be avoided.

There have been post-marketing reports of bronchospasm or exacerbation of asthma in patients, who have either a known hypersensitivity to aspirin/non-steroidal anti-inflammatory drugs or a past medical history of asthma associated with the use of ACULAR, which may be contributory. Caution is recommended in the use of ACULAR in these individuals (see section 4.8).

Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures to avoid injury and contamination of eye drops.

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.

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

No interaction studies have been performed.

ACULAR has been safely administered with systemic and ophthalmic medications such as antibiotics, sedatives, beta blockers, carbonic anhydrase inhibitors, miotics, mydriatics, local anaesthetics and cycloplegics.

ACULAR may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical corticosteroids may increase the potential for healing problems (see section 4.4).

4.6. Fertility, pregnancy and lactation

Pregnancy

There are no adequate data from the use of eye drops containing ketorolac trometamol in pregnant women. Studies in animals have shown reproductive toxicity. Inhibition of prostaglandin synthesis may negatively affect pregnancy and/or embryonal/foetal development and/ or postnatal development. Although a very low systemic exposure is expected after the use of ketorolac eye drops, ACULAR is not recommended during pregnancy.

Breast-feeding

ACULAR should not be used during breast-feeding. Ketorolac trometamol is excreted in human milk after systemic administration.

Fertility

There are no adequate data from the use of ketorolac trometamol on fertility in humans.

4.7. Effects on ability to drive and use machines

Transient blurring of vision may occur on instillation of eye drops. Do not drive or use hazardous machinery unless vision is clear.

4.8. Undesirable effects

The most frequent adverse events reported with the use of ACULAR are transient stinging and burning on instillation.

The frequency of adverse reactions documented during clinical trials of ketorolac trometamol and through post-marketing experience is given below and is defined as follows:

Very Common (≥ 1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very Rare (<1/10,000); Not Known (cannot be estimated from available data).

Immune system disorders

Common:

Hypersensitivity including localised allergic reactions

Nervous system disorders

Common:

Headache

Eye Disorders

Very Common:

Eye irritation (including burning sensation)

Eye pain (including stinging)

Common:

Superficial (punctate) keratitis

Eye and/or eyelid oedema

Ocular pruritus

Conjunctival hyperaemia

Eye infection

Eye inflammation

Iritis

Keratic precipitates

Retinal haemorrhage

Cystoid macular oedema

Eye trauma

Increased intraocular pressure

Blurred and/or diminished vision

Uncommon:

Corneal ulcer

Corneal infiltrates

Eye dryness

Epiphora

Not known:

Corneal damage, e.g. thinning, erosion, epithelial breakdown and perforation*

ulcerative keratitis

eye swelling

ocular hyperaemia

Respiratory, thoracic and mediastinal disorders

Not known:

Bronchospasm or exacerbation of asthma**

*Occasional post marketing reports of corneal damage including corneal thinning, corneal erosion, epithelial breakdown and corneal perforation have been received. These occurred mainly in patients using concomitant topical corticosteroids and/or with predisposing co-morbidity (see section 4.4).

**There have been post-marketing reports of bronchospasm or exacerbation of asthma, in patients, who have either a known hypersensitivity to aspirin/non-steroidal anti-inflammatory drugs or a past medical history of asthma, associated with the use of ACULAR which may be contributory.

None of the typical adverse reactions reported with the systemic non-steroidal anti-inflammatory agents (including ketorolac trometamol) have been observed at the doses used in topical ophthalmic therapy.

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:

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

4.9. Overdose

No case of overdose has been reported. Overdose is unlikely to occur via the recommended method of administration.

If accidentally ingested, drink fluids to dilute.