Nevanac · 4.8 Undesirable effects · 1

HOS-154264 · has-adverse-reaction-information · PDF-Seite 14

Summary of the safety profile In clinical studies involving over 1 900 patients receiving NEVANAC 3 mg/ml eye drops, suspension, the most frequently reported adverse reactions were punctate keratitis, keratitis, foreign body sensation in eyes and eye pain which occurred in between 0.4% and 0.1% of patients. Diabetic patients In the two clinical studies involving 594 patients, diabetic patients were exposed to NEVANAC eye drops, suspension treatment for 90 days for the prevention of macular oedema post cataract surgery. The most frequently reported adverse reaction was punctate keratitis which occurred in 1% of patients, resulting in a frequency category of common. The other most frequently reported adverse reactions were keratitis and foreign body sensation in eyes which occurred in 0.5% and 0.3% of patients, respectively both adverse reactions with a frequency category of uncommon. Tabulated list of adverse reactions The following adverse reactions are classified according to the following convention: 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), or not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. The adverse 14 reactions were obtained from clinical trials or post-marketing reports with NEVANAC 3 mg/ml eye drops, suspension and NEVANAC 1 mg/ml eye drops, suspension. System organ classification Adverse reactions Immune system disorders Rare: hypersensitivity Nervous system disorders Rare: dizziness, headache Eye disorders Uncommon: keratitis, punctate keratitis, corneal epithelium defect, foreign body sensation in eyes, eyelid margin crusting Rare: iritis, choroidal effusion, corneal deposits, eye pain, ocular discomfort, dry eye, blepharitis, eye irritation, eye pruritus, eye discharge, allergic conjunctivitis, increased lacrimation, conjunctival hyperaemia

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HOS-154258 · has-adverse-reaction-information · PDF-Seite 5

Summary of the safety profile In clinical studies involving 2 314 patients receiving NEVANAC 1 mg/ml the most common adverse reactions were punctate keratitis, foreign body sensation and eyelid margin crusting which occurred in between 0.4% and 0.2% of patients. Tabulated list of adverse reactions The following adverse reactions are classified according to the following convention: 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), or not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. The adverse reactions were obtained from clinical trials and post-marketing reports. 5  System organ classification Adverse reactions Immune system disorders Rare: hypersensitivity Nervous system disorders Rare: dizziness, headache Eye disorders Uncommon: keratitis, punctate keratitis, corneal epithelium defect, foreign body sensation in eyes, eyelid margin crusting Rare: iritis, choroidal effusion, corneal deposits, eye pain, ocular discomfort, dry eye, blepharitis, eye irritation, eye pruritus, eye discharge, allergic conjunctivitis, increased lacrimation, conjunctival hyperaemia Not known: corneal perforation, impaired healing (cornea), corneal opacity, corneal scar, reduced visual acuity, eye swelling, ulcerative keratitis, corneal thinning, blurred vision Vascular disorders Not known: blood pressure increased Gastrointestinal disorders Rare: nausea Not known: vomiting Skin and subcutaneous tissue disorders Rare: cutis laxa (dermatochalasis), allergic dermatitis Diabetic patients In the two clinical studies

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HOS-154254 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Hypersensitivity to other nonsteroidal anti-inflammatory drugs (NSAIDs). Patients in whom attacks of asthma, urticaria, or acute rhinitis are precipitated by acetylsalicylic acid or other NSAIDs.

HOS-154260 · has-contraindication-information · PDF-Seite 12

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Hypersensitivity to other nonsteroidal anti-inflammatory drugs (NSAIDs). Patients in whom attacks of asthma, urticaria, or acute rhinitis are precipitated by acetylsalicylic acid or other NSAIDs.

HOS-154259 · has-indication-information · PDF-Seite 11

NEVANAC 3 mg/ml eye drops, suspension is indicated in adults for: - Prevention and treatment of postoperative pain and inflammation associated with cataract surgery - Reduction in the risk of postoperative macular oedema associated with cataract surgery in diabetic patients (see section 5.1)

HOS-154253 · has-indication-information · PDF-Seite 2

NEVANAC 1 mg/ml is indicated in adults for: - Prevention and treatment of postoperative pain and inflammation associated with cataract surgery - Reduction in the risk of postoperative macular oedema associated with cataract surgery in diabetic patients (see section 5.1)

HOS-154256 · has-interaction-information · PDF-Seite 4

In vitro studies have demonstrated a very low potential for interaction with other medicinal products and protein binding interactions (see section 5.2). Prostaglandin analogues There are very limited data on the concomitant use of prostaglandin analogues and NEVANAC. Considering their mechanism of action, the concomitant use of these medicinal products is not recommended. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems. Concomitant use of NEVANAC with medications that prolong bleeding time may increase the risk of haemorrhage (see section 4.4). 4

HOS-154262 · has-interaction-information · PDF-Seite 13

In vitro studies have demonstrated a very low potential for interaction with other medicinal products and protein binding interactions (see section 5.2). Prostaglandin analogues There are very limited data on the concomitant use of prostaglandin analogues and NEVANAC. Considering their mechanism of action, the concomitant use of these medicinal products is not recommended. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems. Concomitant use of NEVANAC with medications that prolong bleeding time may increase the risk of haemorrhage (see section 4.4). 13

HOS-154257 · has-pregnancy-information · PDF-Seite 5

Women of childbearing potential NEVANAC should not be used by women of child bearing potential not using contraception. Pregnancy There are no adequate data regarding the use of nepafenac in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. Since the systemic exposure in non-pregnant women is negligible after treatment with NEVANAC, the risk during pregnancy could be considered low. Nevertheless, as inhibition of prostaglandin synthesis may negatively affect pregnancy and/or embryonal/foetal development and/or parturition and/or postnatal development. NEVANAC is not recommended during pregnancy. Breast-feeding It is unknown whether nepafenac is excreted in human milk. Animal studies have shown excretion of nepafenac in the milk of rats. However, no effects on the suckling child are anticipated since the systemic exposure of the breast-feeding woman to nepafenac is negligible. NEVANAC can be used during breast-feeding. Fertility There are no data on the effect of NEVANAC on human fertility.

HOS-154263 · has-pregnancy-information · PDF-Seite 14

Women of childbearing potential NEVANAC should not be used by women of child bearing potential not using contraception. Pregnancy There are no adequate data regarding the use of nepafenac in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. Since the systemic exposure in non-pregnant women is negligible after treatment with NEVANAC, the risk during pregnancy could be considered low. Nevertheless, as inhibition of prostaglandin synthesis may negatively affect pregnancy and/or embryonal/foetal development and/or parturition and/or postnatal development, NEVANAC is not recommended during pregnancy. Breast-feeding It is unknown whether nepafenac is excreted in human milk. Animal studies have shown excretion of nepafenac in the milk of rats. However, no effects on the suckling child are anticipated since the systemic exposure of the breast-feeding woman to nepafenac is negligible. NEVANAC can be used during breast-feeding. Fertility There are no data on the effect of NEVANAC on human fertility.

HOS-154255 · has-warning-information · PDF-Seite 3

The product should not be injected. Patients should be instructed not to swallow NEVANAC. Patients should be instructed to avoid sunlight during treatment with NEVANAC. Ocular effects Use of topical NSAIDs may result in keratitis. In some susceptible patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration or corneal perforation (see section 4.8). These events may be sight threatening. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of NEVANAC and should be monitored closely for corneal health. Topical NSAIDs may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems. Therefore, it is recommended that caution should be exercised if NEVANAC is administered concomitantly with corticosteroids, particularly in patients at high risk for corneal adverse reactions described below. 3 Post-marketing experience with topical NSAIDs suggests that 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 may be at increased risk for corneal adverse reactions which may become sight threatening. Topical NSAIDs should be used with caution in these patients. Prolonged use of topical NSAIDs may increase patient risk for occurrence and severity of corneal adverse reactions. There have been reports that ophthalmic NSAIDs may cause increased bleeding of ocular tissues (including hyphaemas) in conjunction with ocular surgery. NEVANAC should be used with caution in patients with known bleeding tendencies or who are receiving other medicinal products which may prolong bleeding time. An acute ocular infection may be masked by the topical use of anti-inflammatory medicinal products. NSAIDs do not have any antimicrobial properties. In case of ocular infection, their use with anti- infectives should be undertaken with care. Contact lenses Contact lens wear is not recommended during the postoperative period following cataract surgery. Therefore, patients should be advised not to wear contact lenses unless clearly indicated by their doctor. Benzalkonium chloride NEVANAC contains benzalkonium c

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HOS-154261 · has-warning-information · PDF-Seite 12

The medicinal product should not be injected. Patients should be instructed not to swallow NEVANAC. Patients should be instructed to avoid sunlight during treatment with NEVANAC. Ocular effects Use of topical NSAIDs may result in keratitis. In some susceptible patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration or corneal perforation (see section 4.8). These events may be sight threatening. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of NEVANAC and should be monitored closely for corneal health. 12 Topical NSAIDs may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems. Therefore, it is recommended that caution should be exercised if NEVANAC is administered concomitantly with corticosteroids, particularly in patients at high risk for corneal adverse reactions described below. Post-marketing experience with topical NSAIDs suggests that 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 may be at increased risk for corneal adverse reactions which may become sight threatening. Topical NSAIDs should be used with caution in these patients. Prolonged use of topical NSAIDs may increase patient risk for occurrence and severity of corneal adverse reactions. There have been reports that ophthalmic NSAIDs may cause increased bleeding of ocular tissues (including hyphaemas) in conjunction with ocular surgery. NEVANAC should be used with caution in patients with known bleeding tendencies or who are receiving other medicinal products which may prolong bleeding time. An acute ocular infection may be masked by the topical use of anti-inflammatory medicinal products. NSAIDs do not have any anti-microbial properties. In case of ocular infection, their use with anti- infectives should be undertaken with care. Contact lenses Contact lens wear is not recommended during the postoperative period following cataract surgery. Therefore, patients should be advised not to wear contact lenses unless clearly indicated by their doctor. Benzalkonium chloride NEVANAC contains be

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