Acular eye drops 0.5%

Composition:

Ketorolac trometamol 5 mg / mL Excipients: 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

Therapeutic indications

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

Contraindications

Hypersensitivity to the active substance or to any of the excipients. 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.

Dosage

Posology: Post-operative inflammation: Instill one drop of eye drops in the affected eye 3 times a day starting 24 hours before the operation 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. 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 upwards.

Warnings and Precautions

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 your vision. Patients presenting with evident corneal epithelial rupture should immediately discontinue the use of topical NSAIDs and the condition 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).

Interactions

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 administration of the two medications.

Side effects

The most frequent adverse events reported with the use of ACULAR are transient stinging and burning pain upon instillation. The frequency of adverse reactions documented during clinical trials is given below and defined as: 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 (frequency cannot be estimated from the available data). Within each frequency class, undesirable effects are presented in decreasing order of severity: Immune system disorders Common: hypersensitivity including localized allergic reactions Nervous system disorders Uncommon: headache Eye disorders Very common: eye irritation (including burning sensation) eye pain (including stinging) Common: superficial (punctate) keratitis, ocular and / or eyelid edema, ocular itching, conjunctival hyperaemia, eye infection, eye inflammation Uncommon: corneal ulcer, corneal infiltrates, clouding / reduction of sight, dry eye, epiphora, iritis Not known: Corneal damage, eg. thinning or erosion, epithelial rupture and corneal perforation * 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 cornea have been received. epithelium and corneal perforation. 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. o non-steroidal anti-inflammatory drugs or a previous medical history of asthma associated with the use of ACULAR which could promote the onset of these 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.

Pregnancy and breastfeeding

Pregnancy There are no or a limited amount of data on the use of ketorolac trometamol in pregnant women. Animal studies are insufficient with respect to reproductive toxicity. ACULAR is not recommended during pregnancy and in women of childbearing potential who are not using any method of contraception. Breastfeeding 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.