ACULAR COLL FL 5ML 0.5%

ACULAR 0.5% P/V COLLECTION

active ingredients

Ketorolac tromethyl 5 mg/mL Excipient with known effects: benzalconio chloride 0.1 mg/mL For the full list of excipients, see paragraph 6.1

Excellent

Sodium chloride, Benzalconio chloride, Detoxed disode, Octoxinol 40, Sodium Hydroxide or hydrochloric acid (diluted) to adjust the pH at 7.3-7.5, Purified water.

Therapeutic indications

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

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. It is possible the existence of acetylsalicylic hypersensitivity and other nonsteroidal anti-inflammatory drugs. ACULAR is contraindicated in patients who have previously shown signs of hypersensitivity to these drugs.

Population

Population Post-operative inflammation: Instill a drop of eye drops 3 times a day from 24 hours before surgery and continue for three to four weeks. Pediatric population There is no relevant use of ACULAR in the pediatric population for indication: prophylaxis and reduction of post-operative inflammation associated with cataract surgery. Senior population Overall, safety and effectiveness differences between older patients and young patients have not been observed. Method of administration I use my eye. Insert one 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.

Conservation

Store below 25°C.

Warnings

It is recommended to use ACULAR with caution in patients with a known tendency to haemorrhage or who are being treated with other drugs that may prolong bleeding time.Like other anti-inflammatory drugs, ACULAR may mask the usual signs of an infection.All nonsteroidal anti-inflammatory drugs (NSAIDs) can slow or delay the healing of a wound.Concomitant use of NSAIDs and topical steroids may increase the possibility of healing problems.Concomitant administration of ACULAR and topical corticosteroids should be used with caution in patients predisposed to corneal epithelial breakdown.The use of topical NSAIDs may cause keratitis.Prolonged use of topical NSAIDs may result in corneal epithelial breakdown, corneal thinning, erosion, ulceration, or perforation in some patients.These events may impair vision.Patients with evidence of corneal epithelial breakdown should discontinue topical NSAIDs immediately and the corneal status should be carefully monitored.Topical NSAIDs should be used with caution in patients undergoing complicated ocular surgery, with corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface disease (e.g. dry eye syndrome), rheumatoid arthritis, or who have undergone multiple ocular surgeries within a short period of time, as this may increase the risk of corneal adverse events which may impair vision.Post-marketing experience with topical NSAIDs also indicates that use more than 24 hours before surgery or more than 14 days after surgery may increase the risk of occurrence and severity of corneal adverse events.The preservative present in ACULAR, benzalkonium chloride, may cause eye irritation.Remove contact lenses prior to application and wait at least 15 minutes before reinsertion.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/nonsteroidal anti-inflammatory drugs or a previous medical history of asthma associated with the use of ACULAR, which could favor such events.Caution is advised when using ACULAR in these subjects (see section 4.8).Patients should be instructed to avoid contact of the dropper tip with the eye or surrounding structures to avoid injury and contamination of the eye drops.Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.

Interactions

No interaction studies have been performed. ACULAR It has been administered without problems in conjunction with systemic and ophthalmic drugs such as antibiotics, sedatives, beta-blockers, carbonic anhydrase inhibitors, miotics, mydriatics, local anaesthetics and cycloplegics. ACULAR may slow down or delay healing.Topical corticosteroids are known to slow down or delay the healing process.Concomitant use of NSAIDs and topical corticosteroids may increase healing problems (see section 4.4).If ACULAR is used in conjunction with other eye medicines there must be a range of at least 5 minutes between the two drugs.

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 (from ?1/100 to Immune system disorders: Common: hypersensitivity including localised allergic reactions. Diseases of the nervous system. Common: cephalea. Pathologies of the eye Very common: eye irritation (including burning sensation) , eye pain (including pungent pain); City: Surface keratin, Eye and/or eyelid Edema, Eye Prurito, Conjunctive Hyperemia, Eye Infection, Eye Inflammation, Irite, Cheratic Precipitates, retinal Hemorrhage, Cistoid Macular Edema, Eye Trauma, Intraocular Pressure Increase, Offuscament. Not common: corneal ulcer, corneal infiltrates, Eye dryness, Epiphora; Not known: corneal damage, e.g. thinning or erosion, rupture of the epithelium and perforation of the cornea*, ulcerative keratin, swelling of the eyes, eye hyperemia, Edema of the face, facial swelling. Thoracic and mediastinic respiratory pathologies. Not known: bronchospasm or exacerbation of asthma**.*Occasional post-marketing reports of corneal damage including corneal thinning and erosion, epithelial breakdown and corneal perforation have been received.These events have occurred primarily in patients using concomitant topical corticosteroids and/or with predisposition to comorbidities (see section 4.4). *There have been post-marketing reports of bronchospasm or asthma exacerbation in patients with hypersensitivity known to aspirin or non-steroidal anti-inflammatory drugs or previous medical history of asthma, associated with the use of ACULAR that could promote the occurrence of such symptoms. None of the typical adverse reactions related to non-steroidal systemic anti-inflammatory agents (including ketorolac tromethylamol) have been observed at the doses used in the topical ophthalmic therapy. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

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

Pregnancy

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

Food

ACULAR should not be used during breastfeeding.Ketorolac trometamol is excreted, after systemic administration, in breast milk.

Fertility

: There are insufficient data available regarding the use of ketorolac trometamol on fertility in humans.

Source: Farmadati