Protopic · 4.3 Contraindications · 2

HOS-093164 · has-adverse-reaction-information · PDF-Seite 17

In clinical studies approximately 50% of patients experienced some type of skin irritation adverse reaction at the site of application. Burning sensation and pruritus were very common, usually mild to moderate in severity and tended to resolve within one week of starting treatment. Erythema was a common skin irritation adverse reaction. Sensation of warmth, pain, paraesthesia and rash at the site of 17 eDoc-000593873 - Version 19. 0 application were also commonly observed. Alcohol intolerance (facial flushing or skin irritation after consumption of an alcoholic beverage) was common. Patients may be at an increased risk of folliculitis, acne and herpes viral infections. Adverse reactions with suspected relationship to treatment are listed below by system organ class. Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10) and uncommon (≥1/1,000 to <1/100). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. System Organ Very Common Common Uncommon Not known Class ≥1/10 ≥1/100, ≥1/1000, (cannot be <1/10 <1/100 estimated from the available data) Infections and Local skin infection Ophthalmic infestations regardless of specific Herpes aetiology including but not Infection* limited to: Eczema herpeticum, Folliculitis, Herpes simplex, Herpes virus infection, Kaposi’s varicelliform eruption* Metabolism and Alcohol intolera

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HOS-093158 · has-adverse-reaction-information · PDF-Seite 6

In clinical studies approximately 50% of patients experienced some type of skin irritation adverse reaction at the site of application. Burning sensation and pruritus were very common, usually mild to moderate in severity and tended to resolve within one week of starting treatment. Erythema was a common skin irritation adverse reaction. Sensation of warmth, pain, paraesthesia and rash at the site of application were also commonly observed. Alcohol intolerance (facial flushing or skin irritation after consumption of an alcoholic beverage) was common. Patients may be at an increased risk of folliculitis, acne and herpes viral infections. Adverse reactions with suspected relationship to treatment are listed below by system organ class. Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10) and uncommon (≥1/1,000 to <1/100). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. System Organ Very Common Common Uncommon Not known Class ≥1/10 ≥1/100, ≥1/1000, (cannot be <1/10 <1/100 estimated from the available data) Infections and Local skin infection Ophthalmic infestations regardless of specific Herpes aetiology including but not Infection* limited to: Eczema herpeticum, Folliculitis, Herpes simplex, Herpes virus infection, Kaposi’s varicelliform eruption* Metabolism and Alcohol intolerance (facial nutrition flushing or skin irritation disorders after consumption of an

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HOS-093154 · has-contraindication-information · PDF-Seite 4

Hypersensitivity to the active substance, macrolides in general, or to any of the excipients listed in section 6.1.

HOS-093160 · has-contraindication-information · PDF-Seite 15

Hypersensitivity to the active substance, macrolides in general, or to any of the excipients listed in section 6.1.

HOS-093153 · has-indication-information · PDF-Seite 2

Protopic 0.03% ointment is indicated in adults, adolescents and children from the age of 2 years. Flare treatment Adults and adolescents (16 years of age and above) Treatment of moderate to severe atopic dermatitis in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids. Children (2 years of age and above) Treatment of moderate to severe atopic dermatitis in children who failed to respond adequately to conventional therapies such as topical corticosteroids. Maintenance treatment Treatment of moderate to severe atopic dermatitis for the prevention of flares and the prolongation of flare-free intervals in patients experiencing a high frequency of disease exacerbations (i.e. occurring 4 or more times per year) who have had an initial response to a maximum of 6 weeks treatment of twice daily tacrolimus ointment (lesions cleared, almost cleared or mildly affected).

HOS-093159 · has-indication-information · PDF-Seite 14

Protopic 0.1 % ointment is indicated in adults and adolescents (16 years of age and above) Flare treatment Adults and adolescents (16 years of age and above) Treatment of moderate to severe atopic dermatitis in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids. Maintenance treatment Treatment of moderate to severe atopic dermatitis for the prevention of flares and the prolongation of flare-free intervals in patients experiencing a high frequency of disease exacerbations (i.e. occurring 4 or more times per year) who have had an initial response to a maximum of 6 weeks treatment of twice daily tacrolimus ointment (lesions cleared, almost cleared or mildly affected).

HOS-093162 · has-interaction-information · PDF-Seite 17

Formal topical drug interaction studies with tacrolimus ointment have not been conducted. Tacrolimus is not metabolised in human skin, indicating that there is no potential for percutaneous interactions that could affect the metabolism of tacrolimus. Systemically available tacrolimus is metabolised via the hepatic Cytochrome P450 3A4 (CYP3A4). Systemic exposure from topical application of tacrolimus ointment is low (< 1.0 ng/ml) and is unlikely to be affected by concomitant use of substances known to be inhibitors of CYP3A4. However, the possibility of interactions cannot be ruled out and the concomitant systemic administration of known CYP3A4 inhibitors (e.g. erythromycin, itraconazole, ketoconazole and diltiazem) in patients with widespread and/or erythrodermic disease should be done with caution. Paediatric population An interaction study with protein-conjugated vaccine against Neisseria menigitidis serogroup C has been investigated in children aged 2-11 years. No effect on immediate response to vaccination, the generation of immune memory, or humoral and cell-mediated immunity has been observed (see section 5.1).

HOS-093156 · has-interaction-information · PDF-Seite 5

Formal topical drug interaction studies with tacrolimus ointment have not been conducted. Tacrolimus is not metabolised in human skin, indicating that there is no potential for percutaneous interactions that could affect the metabolism of tacrolimus. Systemically available tacrolimus is metabolised via the hepatic Cytochrome P450 3A4 (CYP3A4). Systemic exposure from topical application of tacrolimus ointment is low (<1.0 ng/ml) and is unlikely to be affected by concomitant use of substances known to be inhibitors of CYP3A4. However, the possibility of interactions cannot be ruled out and the concomitant systemic administration of known CYP3A4 inhibitors (e.g. erythromycin, itraconazole, ketoconazole and diltiazem) in patients with widespread and/or erythrodermic disease should be done with caution. Paediatric population An interaction study with protein-conjugated vaccine against Neisseria menigitidis serogroup C has been investigated in children aged 2-11 years. No effect on immediate response to vaccination, the generation of immune memory, or humoral and cell-mediated immunity has been observed (see section 5.1).

HOS-093163 · has-pregnancy-information · PDF-Seite 17

Pregnancy There are no adequate data from the use of tacrolimus ointment in pregnant women. Studies in animals have shown reproductive toxicity following systemic administration (see section 5.3). The potential risk for humans is unknown. Protopic ointment should not be used during pregnancy unless clearly necessary. Breast-feeding Human data demonstrate that, after systemic administration, tacrolimus is excreted into breast milk. Although clinical data have shown that systemic exposure from application of tacrolimus ointment is low, breast-feeding during treatment with Protopic ointment is not recommended. Fertility There are no fertility data available.

HOS-093157 · has-pregnancy-information · PDF-Seite 5

Pregnancy There are no adequate data from the use of tacrolimus ointment in pregnant women. Studies in animals have shown reproductive toxicity following systemic administration (see section 5.3). The potential risk for humans is unknown. Protopic ointment should not be used during pregnancy unless clearly necessary. Breast-feeding Human data demonstrate that, after systemic administration, tacrolimus is excreted into breast milk. Although clinical data have shown that systemic exposure from application of tacrolimus ointment is low, breast-feeding during treatment with Protopic ointment is not recommended. 5 eDoc-000593873 - Version 19. 0 Fertility There are no fertility data available.

HOS-093161 · has-warning-information · PDF-Seite 15

Exposure of the skin to sunlight should be minimised and the use of ultraviolet (UV) light from a solarium, therapy with UVB or UVA in combination with psoralens (PUVA) should be avoided during use of Protopic ointment (see section 5.3). Physicians should advise patients on appropriate sun 15 eDoc-000593873 - Version 19. 0 protection methods, such as minimisation of the time in the sun, use of a sunscreen product and covering of the skin with appropriate clothing. Protopic ointment should not be applied to lesions that are considered to be potentially malignant or pre-malignant. The development of any new change different from previous eczema within a treated area should be reviewed by the physician. The use of tacrolimus ointment is not recommended in patients with a skin barrier defect, such as Netherton’s syndrome, lamellar ichthyosis, generalized erythroderma, pyoderma gangrenosum or cutaneous Graft Versus Host Disease. These skin conditions may increase systemic absorption of tacrolimus. Post-marketing cases of increased tacrolimus blood level have been reported in these conditions. Protopic should not be used in patients with congenital or acquired immunodeficiencies or in patients on therapy that cause immunosuppression. Care should be exercised if applying Protopic to patients with extensive skin involvement over an extended period of time, especially in children (see section 4.2). Patients, particularly paediatric patients should be continuously evaluated during treatment with Protopic with respect to the response to treatment and the continuing need for treatment. After 12 months this evaluation should include suspension of Protopic treatment in paediatric patients (see section 4.2). Protopic contains the active substance tacrolimus, a calcineurin inhibitor. In transplant patients, prolonged systemic exposure to intense immunosuppression following systemic administration of calcineurin inhibitors has been associated with an increased risk of developing lymphomas and skin malignancies. Patients with atopic dermatitis treated with Protopic have not been found to have significant systemic tacrolimus levels and the role of local immunosuppression is unknown. Based on the results of long-term studies and experience, a link between Protopic ointment treatment and development of malignancies has not been confirmed, but

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HOS-093155 · has-warning-information · PDF-Seite 4

Exposure of the skin to sunlight should be minimised and the use of ultraviolet (UV) light from a solarium, therapy with UVB or UVA in combination with psoralens (PUVA) should be avoided during use of Protopic ointment (see section 5.3). Physicians should advise patients on appropriate sun protection methods, such as minimisation of the time in the sun, use of a sunscreen product and covering of the skin with appropriate clothing. Protopic ointment should not be applied to lesions that are considered to be potentially malignant or pre-malignant. The development of any new change different from previous eczema within a treated area should be reviewed by the physician. The use of tacrolimus ointment is not recommended in patients with a skin barrier defect, such as Netherton’s syndrome, lamellar ichthyosis, generalized erythroderma, pyoderma gangrenosum or cutaneous Graft Versus Host Disease. These skin conditions may increase systemic absorption of tacrolimus. Post-marketing cases of increased tacrolimus blood level have been reported in these conditions. Protopic should not be used in patients with congenital or acquired immunodeficiencies or in patients on therapy that cause immunosuppression. Care should be exercised if applying Protopic to patients with extensive skin involvement over an extended period of time, especially in children (see section 4.2). Patients, particularly paediatric patients should be continuously evaluated during treatment with Protopic with respect to the response to treatment and the continuing need for treatment. After 12 months this evaluation should include suspension of Protopic treatment in paediatric patients (see section 4.2). The effect of treatment with Protopic ointment on the developing immune system of children aged below 2 years has not been established (see section 4.1). Protopic contains the active substance tacrolimus, a calcineurin inhibitor. In transplant patients, prolonged systemic exposure to intense immunosuppression following systemic administration of calcineurin inhibitors has been associated with an increased risk of developing lymphomas and skin malignancies. Patients with atopic dermatitis treated with Protopic have not been found to have significant systemic tacrolimus levels and the role of local immunosuppression is unknown. Based on the results of long-term studies and experience, a link between Protopic ointment treatment and development of malignancies has not been confirmed, but definitive co

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