Ikervis · 4.4 Special warnings and precautions for use · 2

HOS-095808 · has-adverse-reaction-information · PDF-Seite 14

Summary of the safety profile The most common adverse reactions are eye pain (19.0%), eye irritation (17.5%), ocular hyperaemia (5.5%), lacrimation increased (4.9%) and eyelid erythema (1.7%) which are usually transitory and occurred during instillation.These adverse reactions are consistent with those that have been reported during post-marketing experience. Tabulated list of adverse reactions The following adverse reactions listed below were observed in clinical studies or during post- marketing experience. They are ranked according to system organ class and 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). System Organ Class Frequency Adverse reactions Infections and Uncommon Keratitis bacterial, infestations Herpes zoster ophthalmic. Eye disorders Very Eye pain, common Eye irritation Common Erythema of eyelid, Lacrimation increased, Ocular hyperaemia, Vision blurred, Eyelid oedema, Conjunctival hyperaemia, Eye pruritus Uncommon Conjunctival oedema, Lacrimal disorder, Eye discharge, Conjunctival irritation, Conjunctivitis, Foreign body sensation in eyes, Deposit eye, Keratitis, Blepharitis, Chalazion, Corneal infiltrates, Corneal scar, Eyelid pruritus, Iridocyclitis. Ocular discomfort General disorder

Auszug; vollständigen Abschnitt im Original lesen.

HOS-095802 · has-adverse-reaction-information · PDF-Seite 5

Summary of the safety profile The most common adverse reactions are eye pain (19.0%), eye irritation (17.5%), ocular hyperaemia (5.5%), lacrimation increased (4.9%) and eyelid erythema (1.7%) which are usually transitory and occurred during instillation.These adverse reactions are consistent with those that have been reported during post-marketing experience. Tabulated list of adverse reactions The following adverse reactions listed below were observed in clinical studies or during post- marketing experience. They are ranked according to system organ class and 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). System Organ Class Frequency Adverse reactions Infections and Uncommon Keratitis bacterial, infestations Herpes zoster ophthalmic. Eye disorders Very Eye pain, common Eye irritation Common Erythema of eyelid, Lacrimation increased, Ocular hyperaemia, Vision blurred, Eyelid oedema, Conjunctival hyperaemia, Eye pruritus Uncommon Conjunctival oedema, Lacrimal disorder, Eye discharge, Conjunctival irritation, Conjunctivitis, Foreign body sensation in eyes, Deposit eye, Keratitis, Blepharitis, Chalazion, Corneal infiltrates, Corneal scar, Eyelid pruritus, Iridocyclitis. Ocular discomfort General disorder

Auszug; vollständigen Abschnitt im Original lesen.

HOS-095798 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Ocular or peri-ocular malignancies or premalignant conditions. Active or suspected ocular or peri-ocular infection.

HOS-095804 · has-contraindication-information · PDF-Seite 12

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Ocular or peri-ocular malignancies or premalignant conditions. Active or suspected ocular or peri-ocular infection.

HOS-095797 · has-indication-information · PDF-Seite 2

Treatment of severe keratitis in adult patients with dry eye disease, which has not improved despite treatment with tear substitutes (see section 5.1).

HOS-095803 · has-indication-information · PDF-Seite 11

Treatment of severe keratitis in adult patients with dry eye disease, which has not improved despite treatment with tear substitutes (see section 5.1).

HOS-095800 · has-interaction-information · PDF-Seite 4

No interaction studies have been performed with IKERVIS. Combination with other medicinal products that affect the immune system Co-administration of IKERVIS with eye drops containing corticosteroids could potentiate the effects of ciclosporin on the immune system (see section 4.4).

HOS-095806 · has-interaction-information · PDF-Seite 13

No interaction studies have been performed with IKERVIS. Combination with other medicinal products that affect the immune system Co-administration of IKERVIS with eye drops containing corticosteroids could potentiate the effects of ciclosporin on the immune system (see section 4.4).

HOS-095801 · has-pregnancy-information · PDF-Seite 4

Women of childbearing potential/contraception in females IKERVIS is not recommended in women of childbearing potential not using effective contraception. Pregnancy There is no data from the use of IKERVIS in pregnant women. Studies in animals have shown reproductive toxicity following systemic administration of ciclosporin at exposure considered sufficiently in excess of the maximum human exposure indicating little relevance to the clinical use of IKERVIS. IKERVIS is not recommended during pregnancy unless the potential benefit to the mother outweighs the potential risk to the foetus. Breast-feeding Following oral administration, ciclosporin is excreted in breast milk. There is insufficient information on the effects of ciclosporin in newborns/infants. However, at therapeutic doses of ciclosporin in eye drops, it is unlikely that sufficient amounts would be present in breast milk. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from IKERVIS therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. Fertility There is no data on the effects of IKERVIS on human fertility. No impairment of fertility has been reported in animals receiving intravenous ciclosporin (see section 5.3).

HOS-095807 · has-pregnancy-information · PDF-Seite 13

Women of childbearing potential/contraception in females IKERVIS is not recommended in women of childbearing potential not using effective contraception. Pregnancy There is no data from the use of IKERVIS in pregnant women. Studies in animals have shown reproductive toxicity following systemic administration of ciclosporin at exposure considered sufficiently in excess of the maximum human exposure indicating little relevance to the clinical use of IKERVIS. IKERVIS is not recommended during pregnancy unless the potential benefit to the mother outweighs the potential risk to the foetus. Breast-feeding Following oral administration, ciclosporin is excreted in breast milk. There is insufficient information on the effects of ciclosporin in newborns/infants. However, at therapeutic doses of ciclosporin in eye drops, it is unlikely that sufficient amounts would be present in breast milk. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from IKERVIS therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. Fertility There is no data on the effects of IKERVIS on human fertility. No impairment of fertility has been reported in animals receiving intravenous ciclosporin (see section 5.3).

HOS-095799 · has-warning-information · PDF-Seite 3

IKERVIS has not been studied in patients with a history of ocular herpes and should therefore be used with caution in such patients. Contact lenses Patients wearing contact lenses have not been studied. Careful monitoring of patients with severe keratitis is recommended. Contact lenses should be removed before instillation of the eye drops at bedtime and may be reinserted at wake-up time. Concomitant therapy There is limited experience with ciclosporin in the treatment of patients with glaucoma. Regular clinical monitoring should be exercised when treating these patients concomitantly with IKERVIS, especially with beta-blockers which are known to decrease tear secretion. Effects on the immune system Ophthalmic medicinal products, which affect the immune system, including ciclosporin, may affect host defences against local infections and malignancies. Therefore, regular examination of the eye(s) is recommended, e.g. at least every 6 months, when IKERVIS is used for years. Cetalkonium chloride content IKERVIS contains cetalkonium chloride. Contact lenses should be removed prior to application and may be reinserted at wake-up time. Cetalkonium chloride may cause eye irritation. Patients should be monitored in case of prolonged use. 3

HOS-095805 · has-warning-information · PDF-Seite 12

IKERVIS has not been studied in patients with a history of ocular herpes and should therefore be used with caution in such patients. Contact lenses Patients wearing contact lenses have not been studied. Careful monitoring of patients with severe keratitis is recommended. Contact lenses should be removed before instillation of the eye drops at bedtime and may be reinserted at wake-up time. Concomitant therapy There is limited experience with ciclosporin in the treatment of patients with glaucoma. Regular clinical monitoring should be exercised when treating these patients concomitantly with IKERVIS, especially with beta-blockers which are known to decrease tear secretion. Effects on the immune system Ophthalmic medicinal products, which affect the immune system, including ciclosporin, may affect host defences against local infections and malignancies. Therefore, regular examination of the eye(s) is recommended, e.g. at least every 6 months, when IKERVIS is used for years. Cetalkonium chloride content IKERVIS contains cetalkonium chloride. Contact lenses should be removed prior to application and may be reinserted at wake-up time. Cetalkonium chloride may cause eye irritation. Patients should be monitored in case of prolonged use. 12