ACULAR * COLL FL 5ML 0.5%

ACULAR * COLL FL 5ML 0.5%

Therapeutic indications

For prophylaxis and the reduction of inflammation resulting from cataract surgery. ACULAR is indicated in adult patients.

Dosage and method of use

Dosage. Postoperative inflammation:Instill one drop of eye drops in the affected eye 3 times a day starting 24 hours before the surgery and continue for three to four weeks.Pediatric population:There is no relevant use of ACULAR in the pediatric population for the indication: prophylaxis and reduction of postoperative inflammation associated with cataract surgery.Elderly population:Overall, no differences in safety and efficacy were observed between elderly and young patients.Method of administration:Ocular use. Instill a drop of solution into the lower conjunctival sac of the eye to be treated, gently lowering the lower eyelid and looking up. If ACULAR is used concomitantly with other topical ocular medications, there must be an interval of at least 5 minutes between the administration of the two medications.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Cross-hypersensitivity to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs is possible. ACULAR is contraindicated in patients who have shown signs of hypersensitivity to these drugs in the past.

Side effects

The frequency of adverse reactions documented during clinical trials of ketorolac trometamol and through post-marketing experience is reported below and defined as follows: very common (≥ 1/10); common (≥1 / 100 to Immune system disorders. Common: Hypersensitivity including localized allergic reactions.Nervous system disorders.Common: Headache.Eye disorders.Very common: Eye irritation (including burning sensation), Eye pain (including stinging); Common: Superficial (punctate) keratitis, Ocular and / or eyelid edema, Ocular pruritus, Conjunctival hyperaemia, Ocular infection, Ocular inflammation, Iritis, Keratic precipitates, Retinal haemorrhage, Cystoid macular edema, Ocular trauma, Increased intraocular pressure, Clouding / reduction of sight; Uncommon: Corneal ulcer, Corneal infiltrates, Dry eye, Epiphora; Not known: Corneal damage, eg. thinning or erosion, rupture of the epithelium and perforation of the cornea *, ulcerative keratitis, swelling of the eyes, ocular hyperaemia, edema of the face, swelling of the face.Respiratory thoracic and mediastinal disorders.Not known: Bronchospasm or exacerbation of asthma **. * Occasional post-marketing reports of corneal damage including corneal thinning and erosion, rupture of the epithelium and perforation of the cornea have been received. These events have mainly occurred in patients concomitantly using topical corticosteroids and / or with a predisposition to comorbidities (see section 4.4).**There have been post-marketing reports of bronchospasm or exacerbation of asthma in patients with known hypersensitivity to aspirin or non-steroidal anti-inflammatory drugs or a previous medical history of asthma associated with the use of ACULAR which may favor the onset of such symptoms. None of the typical adverse reactions reported with systemic non-steroidal anti-inflammatory agents (including ketorolac trometamol) were observed at doses used in topical ophthalmic therapy.Reporting of suspected adverse reactions.Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

It is recommended that ACULAR be used with caution in patients with a known tendency to bleed or who are under treatment with other drugs that may prolong bleeding time. Like other anti-inflammatory drugs, ACULAR can mask the usual signs of an infection. All non-steroidal anti-inflammatory drugs (NSAIDs) can slow or delay the healing of a wound. Concomitant use of NSAIDs and topical steroids can increase the chance of scarring problems. Concomitant administration of ACULAR and topical corticosteroids should be done with caution in patients predisposed to rupture of the corneal epithelium. The use of topical NSAIDs can cause keratitis. In some patients, prolonged use of topical NSAIDs may cause corneal epithelial rupture, corneal thinning, erosion, ulceration or perforation. Such events could impair visual abilities. Patients presenting with evident corneal epithelial rupture should immediately discontinue the use of topical NSAIDs and the state of the cornea should be carefully monitored. Topical NSAIDs should be used with caution in patients undergoing complicated eye surgery, presenting with corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface disorders (e.g. dry eye syndrome), rheumatoid arthritis, or have repeated eye surgery within a short period of time, as this can increase the risk of corneal adverse events that can impair vision. Post-marketing experience with topical NSAIDs also indicates that use beyond 24 hours prior to surgery or beyond 14 days after surgery may increase the risk of occurrence and severity of corneal adverse events. The preservative in ACULAR, benzalkonium chloride, can cause eye irritation. Remove contact lenses before application and wait at least 15 minutes before reinserting them. Benzalkonium chloride is known to discolour soft contact lenses. Avoid contact with soft contact lenses. There have been post-marketing reports of bronchospasm or exacerbation of asthma in patients with known hypersensitivity to aspirin / non-steroidal anti-inflammatory drugs or a previous medical history of asthma associated with the use of ACULAR, which may favor these events. Caution is advised when using ACULAR in these subjects (see section 4.8). Patients must be instructed to prevent the dropper tip from coming into contact with the eye or surrounding structures to avoid injury and contamination of the eye drops. Undesirable effects can be minimized by using the lowest effective dose for the shortest time needed to control symptoms.

Pregnancy and breastfeeding

Pregnancy:There are no adequate data on the use of ketorolac-containing eye drops in pregnant women. Animal studies have shown reproductive toxicity. Inhibition of prostaglandin synthesis may adversely inhibit pregnancy and / or embryonic / fetal development and / or postnatal development. Although very low systemic exposure is expected following the use of ketorolac eye drops, ACULAR is not recommended during pregnancy.Feeding time:ACULAR should not be used during breastfeeding. Ketorolac trometamol is excreted in breast milk after systemic administration.Fertility:Insufficient data are available regarding the use of ketorolac trometamol on fertility in humans.

Expiration and retention

Store below 25 ° C.

Interactions with other drugs

No interaction studies have been performed. ACULAR has been safely administered concomitantly with systemic and ophthalmic drugs such as antibiotics, sedatives, beta blockers, carbonic anhydrase inhibitors, miotics, mydriatics, local anesthetics and cycloplegics. ACULAR can slow or delay healing. Topical corticosteroids are known to slow or delay the healing process. The concomitant use of NSAIDs and topical corticosteroids may increase scarring problems (see section 4.4). If ACULAR is used concomitantly with other topical ocular medications there must be an interval of at least 5 minutes between the two medications.

Overdose

No cases of overdose have been reported. With the recommended methods of administration it is unlikely to incur an overdose. If accidentally ingested, drink liquids to dilute it.

Active principles

Ketorolac trometamol 5 mg / mL. Excipient with known effect: benzalkonium chloride 0.1 mg / mL For a full list of excipients, see section 6.1

Excipients

Sodium chloride, Benzalkonium chloride, Disodium edetate, Octoxinol 40, Sodium hydroxide or hydrochloric acid (diluted) to adjust the pH to 7.3-7.5, Purified water.