Zebinix · 4.4 Special warnings and precautions for use · 1

HOS-095250 · has-adverse-reaction-information · PDF-Seite 62

Summary of the safety profile In clinical studies (adjunctive therapy treatment and monotherapy), 2,434 patients with partial-onset seizures were treated with eslicarbazepine acetate (1,983 adult patients and 451 paediatric patients) and 51% of those patients experienced adverse reactions. Adverse reactions were usually mild to moderate in intensity and occurred predominantly during the first weeks of treatment with eslicarbazepine acetate. The risks that have been identified for Zebinix are mainly class-based, dose-dependent undesirable effects. The most common treatment-emergent adverse reactions reported, in placebo controlled adjunctive therapy studies with adult epileptic patients and in an active controlled monotherapy study 62 comparing eslicarbazepine acetate with carbamazepine controlled release, were dizziness, somnolence, headache, and nausea. The majority of adverse reactions were reported in <3% of subjects in any treatment group. Severe cutaneous adverse reactions (SCARS), including Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in post-marketing experience with Zebinix treatment (see section 4.4). Tabulated list of adverse reactions Adverse reactions associated with eslicarbazepine acetate obtained from clinical studies and post- marketing surveillance are tabulated below. The following convention has been used for the classification of adverse reactions very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100) and not known (frequency cannot be estimated from available data). Within each frequency category, adverse reactions are presented in order of decreasing seriousness. Table 1: Treatment emergent adverse reactions associated with Zebinix obtained from in clinical studies and post-marketing surveillance System Organ Very Common Uncommon Not known Class common Blood and Anaemia Thrombocytopenia, lymphatic leukopenia system disorders Immune system Hypersensitivity disorders Endocrine Hypothyroidism disorders Metabolism and Hyponatraemia, Electrolyte Inappropri

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HOS-095244 · has-adverse-reaction-information · PDF-Seite 44

Summary of the safety profile In clinical studies (adjunctive therapy treatment and monotherapy), 2,434 patients with partial-onset seizures were treated with eslicarbazepine acetate (1,983 adult patients and 451 paediatric patients) and 51% of those patients experienced adverse reactions. Adverse reactions were usually mild to moderate in intensity and occurred predominantly during the first weeks of treatment with eslicarbazepine acetate. The risks that have been identified for Zebinix are mainly class-based, dose-dependent undesirable effects. The most common adverse reactions reported, in placebo controlled adjunctive therapy studies with adult epileptic patients and in an active controlled monotherapy study comparing eslicarbazepine acetate with carbamazepine controlled release, were dizziness, somnolence, headache, 44 and nausea. The majority of adverse reactions were reported in <3% of subjects in any treatment group. Severe cutaneous adverse reactions (SCARS), including Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in post-marketing experience with Zebinix treatment (see section 4.4). Tabulated list of adverse reactions Adverse reactions associated with eslicarbazepine acetate obtained from clinical studies and post- marketing surveillance are tabulated below. The following convention has been used for the classification of adverse reactions very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100) and not known (frequency cannot be estimated from available data). Within each frequency category, adverse reactions are presented in order of decreasing seriousness. Table 1: Treatment emergent adverse reactions associated with Zebinix obtained from clinical studies and post-marketing surveillance System Organ Very Common Uncommon Not known Class common Blood and Anaemia Thrombocytopenia, lymphatic leukopenia system disorders Immune system Hypersensitivity disorders Endocrine Hypothyroidism disorders Metabolism and Hyponatraemia, Electrolyte Inappropriate ADH nutrition

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HOS-095232 · has-adverse-reaction-information · PDF-Seite 8

Summary of the safety profile In clinical studies (adjunctive therapy treatment and monotherapy), 2,434 patients with partial-onset seizures were treated with eslicarbazepine acetate (1,983 adult patients and 451 paediatric patients) and 51% of those patients experienced adverse reactions. Adverse reactions were usually mild to moderate in intensity and occurred predominantly during the first weeks of treatment with eslicarbazepine acetate. The risks that have been identified for Zebinix are mainly class-based, dose-dependent undesirable effects. The most common adverse reactions reported, in placebo controlled adjunctive therapy studies with adult epileptic patients and in an active controlled monotherapy study comparing eslicarbazepine 8 acetate with carbamazepine controlled release, were dizziness, somnolence, headache, and nausea. The majority of adverse reactions were reported in <3% of subjects in any treatment group. Severe cutaneous adverse reactions (SCARS), including Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in post-marketing experience with Zebinix treatment (see section 4.4). Tabulated list of adverse reactions Adverse reactions associated with eslicarbazepine acetate obtained from clinical studies and post- marketing surveillance are tabulated below. The following convention has been used for the classification of adverse reactions very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100) and not known (frequency cannot be estimated from available data). Within each frequency category, adverse reactions are presented in order of decreasing seriousness. Table 1: Treatment emergent adverse reactions associated with Zebinix obtained from clinical studies and post-marketing surveillance System Organ Very Common Uncommon Not known Class common Blood and Anaemia Thrombocytopenia, lymphatic leukopenia system disorders Immune system Hypersensitivity disorders Endocrine Hypothyroidism disorders Metabolism and Hyponatraemia, Electrolyte Inappropriate ADH nutrition

Auszug; vollständigen Abschnitt im Original lesen.

HOS-095238 · has-adverse-reaction-information · PDF-Seite 26

Summary of the safety profile In clinical studies (adjunctive therapy treatment and monotherapy), 2,434 patients with partial-onset seizures were treated with eslicarbazepine acetate (1,983 adult patients and 451 paediatric patients) and 51% of those patients experienced adverse reactions. Adverse reactions were usually mild to moderate in intensity and occurred predominantly during the first weeks of treatment with eslicarbazepine acetate. 26 The risks that have been identified for Zebinix are mainly class-based, dose-dependent undesirable effects. The most common adverse reactions reported, in placebo controlled adjunctive therapy studies with adult epileptic patients and in an active controlled monotherapy study comparing eslicarbazepine acetate with carbamazepine controlled release, were dizziness, somnolence, headache, and nausea. The majority of adverse reactions were reported in <3% of subjects in any treatment group. Severe cutaneous adverse reactions (SCARS), including Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in post-marketing experience with Zebinix treatment (see section 4.4). Tabulated list of adverse reactions Adverse reactions associated with eslicarbazepine acetate obtained from clinical studies and post- marketing surveillance are tabulated below. The following convention has been used for the classification of adverse reactions very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100) and not known (frequency cannot be estimated from available data). Within each frequency category, adverse reactions are presented in order of decreasing seriousness. Table 1: Treatment emergent adverse reactions associated with Zebinix obtained clinical studies and post-marketing surveillance System Organ Very Common Uncommon Not known Class common Blood and Anaemia Thrombocytopenia, lymphatic leukopenia system disorders Immune system Hypersensitivity disorders Endocrine Hypothyroidism disorders Metabolism and Hyponatraemia, Electrolyte Inappropriate ADH nutrition d

Auszug; vollständigen Abschnitt im Original lesen.

HOS-095256 · has-adverse-reaction-information · PDF-Seite 80

Summary of the safety profile In clinical studies (adjunctive therapy treatment and monotherapy), 2,434 patients with partial-onset seizures were treated with eslicarbazepine acetate (1,983 adult patients and 451 paediatric patients) and 51% of those patients experienced adverse reactions. Adverse reactions were usually mild to moderate in intensity and occurred predominantly during the first weeks of treatment with eslicarbazepine acetate. The risks that have been identified for Zebinix are mainly class-based, dose-dependent undesirable effects. The most common adverse reactions reported, in placebo controlled adjunctive therapy studies with adult epileptic patients and in an active controlled monotherapy study comparing eslicarbazepine 80 acetate with carbamazepine controlled release, were dizziness, somnolence, headache, and nausea. The majority of adverse reactions were reported in <3% of subjects in any treatment group. Severe cutaneous adverse reactions (SCARS), including Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in post-marketing experience with Zebinix treatment (see section 4.4). Tabulated list of adverse reactions Adverse reactions associated with eslicarbazepine acetate obtained from clinical studies and post- marketing surveillance are tabulated below. The following convention has been used for the classification of adverse reactions very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100) and not known (frequency cannot be estimated from available data). Within each frequency category, adverse reactions are presented in order of decreasing seriousness. Table 1: Treatment emergent adverse reactions associated with Zebinix obtained from clinical studies and post-marketing surveillance System Organ Very Common Uncommon Not known Class common Blood and Anaemia Thrombocytopenia, lymphatic leukopenia system disorders Immune system Hypersensitivity disorders Endocrine Hypothyroidism disorders Metabolism and Hyponatraemia, Electrolyte Inappropriate ADH nutrition

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HOS-095246 · has-contraindication-information · PDF-Seite 57

Hypersensitivity to the active substance, to other carboxamide derivatives (e.g. carbamazepine, oxcarbazepine) or to any of the excipients listed in section 6.1. Second or third degree atrioventricular (AV) block.

HOS-095240 · has-contraindication-information · PDF-Seite 39

Hypersensitivity to the active substance, to other carboxamide derivatives (e.g. carbamazepine, oxcarbazepine) or to any of the excipients listed in section 6.1. Second or third degree atrioventricular (AV) block.

HOS-095234 · has-contraindication-information · PDF-Seite 21

Hypersensitivity to the active substance, to other carboxamide derivatives (e.g. carbamazepine, oxcarbazepine) or to any of the excipients listed in section 6.1. Second or third degree atrioventricular (AV) block.

HOS-095228 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance, to other carboxamide derivatives (e.g. carbamazepine, oxcarbazepine) or to any of the excipients listed in section 6.1. Second or third degree atrioventricular (AV) block.

HOS-095252 · has-contraindication-information · PDF-Seite 75

Hypersensitivity to the active substance, to other carboxamide derivatives (e.g. carbamazepine, oxcarbazepine) or to any of the excipients listed in section 6.1. Second or third degree atrioventricular (AV) block.

HOS-095251 · has-indication-information · PDF-Seite 74

Zebinix is indicated as: • monotherapy in the treatment of partial-onset seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy; • adjunctive therapy in adults, adolescents and children aged above 6 years, with partial-onset seizures with or without secondary generalisation.

HOS-095245 · has-indication-information · PDF-Seite 56

Zebinix is indicated as: • monotherapy in the treatment of partial-onset seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy; • adjunctive therapy in adults, adolescents and children aged above 6 years with partial-onset seizures with or without secondary generalisation.

HOS-095239 · has-indication-information · PDF-Seite 38

Zebinix is indicated as: • monotherapy in the treatment of partial-onset seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy; • adjunctive therapy in adults, adolescents and children aged above 6 years, with partial-onset seizures with or without secondary generalisation.

HOS-095233 · has-indication-information · PDF-Seite 20

Zebinix is indicated as: • monotherapy in the treatment of partial-onset seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy; • adjunctive therapy in adults, adolescents and children aged above 6 years, with partial-onset seizures with or without secondary generalisation.

HOS-095227 · has-indication-information · PDF-Seite 2

Zebinix is indicated as: • monotherapy in the treatment of partial-onset seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy; • adjunctive therapy in adults, adolescents and children aged above 6 years, with partial-onset seizures with or without secondary generalisation.

HOS-095254 · has-interaction-information · PDF-Seite 77

Interaction studies have only been performed in adults. Eslicarbazepine acetate is extensively converted to eslicarbazepine, which is mainly eliminated by glucuronidation. In vitro eslicarbazepine is a weak inducer of CYP3A4 and UDP-glucuronyl transferases. In vivo eslicarbazepine showed an inducing effect on the metabolism of medicinal products that are mainly eliminated by metabolism through CYP3A4 (e.g. Simvastatin). Thus, an increase in the dose of the medicinal products that are mainly metabolised through CYP3A4 may be required, when used concomitantly with eslicarbazepine acetate. Eslicarbazepine in vivo may have an inducing effect on the metabolism of medicinal products that are mainly eliminated by conjugation through the UDP-glucuronyl transferases. When initiating or discontinuing treatment with Zebinix or changing the dose, it may take 2 to 3 weeks to reach the new level of enzyme activity. This time delay must be taken into account when Zebinix is being used just prior to or in combination with other medicinal products that require dose adjustment when co-administered with Zebinix. Eslicarbazepine has inhibiting properties with respect to CYP2C19. Thus, interactions can arise when co-administering high doses of eslicarbazepine acetate with medicinal products that are mainly metabolised by CYP2C19 (e.g. Phenytoin). Interactions with other antiepileptic medicinal products Carbamazepine In a study in healthy subjects, concomitant administration of eslicarbazepine acetate 800 mg once daily and carbamazepine 400 mg twice daily resulted in an average decrease of 32% in exposure to the 77 active metabolite eslicarbazepine, most likely caused by an induction of glucuronidation. No change in exposure to carbamazepine or its metabolite carbamazepine-epoxide was noted. Based on individual response, the dose of eslicarbazepine acetate may need to be increased if used concomitantly with carbamazepine. Results from patient studies showed that concomitant treatment increased the risk of the following adverse reactions: diplopia, abnormal coordination and dizziness. The risk of increase of other specific adverse reactions caused by co-administration of carbamazepine and eslicarbazepine acetate cannot be excluded. Phenytoin In a study in healthy subjects, concomitant administration of eslicarbazepine acetate 1,200 mg once daily and phenytoin resulted in an average decrease of 31-33% in exposure to the acti

Auszug; vollständigen Abschnitt im Original lesen.

HOS-095230 · has-interaction-information · PDF-Seite 5

Interaction studies have only been performed in adults. Eslicarbazepine acetate is extensively converted to eslicarbazepine, which is mainly eliminated by glucuronidation. In vitro eslicarbazepine is a weak inducer of CYP3A4 and UDP-glucuronyl transferases. In vivo eslicarbazepine showed an inducing effect on the metabolism of medicinal products that are mainly eliminated by metabolism through CYP3A4 (e.g. Simvastatin). Thus, an increase in the dose of the medicinal products that are mainly metabolised through CYP3A4 may be required, when used concomitantly with eslicarbazepine acetate. Eslicarbazepine in vivo may have an inducing effect on the metabolism of medicinal products that are mainly eliminated by conjugation through the UDP-glucuronyl transferases. When initiating or discontinuing treatment with Zebinix or changing the dose, it may take 2 to 3 weeks to reach the new level of enzyme activity. This time delay must be taken into account when Zebinix is being used just prior to or in combination with other medicinal products that require dose adjustment when co-administered with Zebinix. Eslicarbazepine has inhibiting properties with respect to CYP2C19. Thus, interactions can arise when co-administering high doses of eslicarbazepine acetate with medicinal products that are mainly metabolised by CYP2C19 (e.g. Phenytoin). Interactions with other antiepileptic medicinal products Carbamazepine In a study in healthy subjects, concomitant administration of eslicarbazepine acetate 800 mg once daily and carbamazepine 400 mg twice daily resulted in an average decrease of 32% in exposure to the active metabolite eslicarbazepine, most likely caused by an induction of glucuronidation. No change in 5 exposure to carbamazepine or its metabolite carbamazepine-epoxide was noted. Based on individual response, the dose of eslicarbazepine acetate may need to be increased if used concomitantly with carbamazepine. Results from patient studies showed that concomitant treatment increased the risk of the following adverse reactions: diplopia, abnormal coordination and dizziness. The risk of increase of other specific adverse reactions caused by co-administration of carbamazepine and eslicarbazepine acetate cannot be excluded. Phenytoin In a study in healthy subjects, concomitant administration of eslicarbazepine acetate 1,200 mg once daily and phenytoin resulted in an average decrease of 31-33% in exposure to the acti

Auszug; vollständigen Abschnitt im Original lesen.

HOS-095242 · has-interaction-information · PDF-Seite 41

Interaction studies have only been performed in adults. Eslicarbazepine acetate is extensively converted to eslicarbazepine, which is mainly eliminated by glucuronidation. In vitro eslicarbazepine is a weak inducer of CYP3A4 and UDP-glucuronyl transferases. In vivo eslicarbazepine showed an inducing effect on the metabolism of medicinal products that are mainly eliminated by metabolism through CYP3A4 (e.g. Simvastatin). Thus, an increase in the dose of the medicinal products that are mainly metabolised through CYP3A4 may be required, when used concomitantly with eslicarbazepine acetate. Eslicarbazepine in vivo may have an inducing effect on the metabolism of medicinal products that are mainly eliminated by conjugation through the UDP-glucuronyl transferases. When initiating or discontinuing treatment with Zebinix or changing the dose, it may take 2 to 3 weeks to reach the new level of enzyme activity. This time delay must be taken into account when Zebinix is being used just prior to or in combination with other medicinal products that require dose adjustment when co-administered with Zebinix. Eslicarbazepine has inhibiting properties with respect to CYP2C19. Thus, interactions can arise when co-administering high doses of eslicarbazepine acetate with medicinal products that are mainly metabolised by CYP2C19 (e.g. Phenytoin). Interactions with other antiepileptic medicinal products Carbamazepine In a study in healthy subjects, concomitant administration of eslicarbazepine acetate 800 mg once daily and carbamazepine 400 mg twice daily resulted in an average decrease of 32% in exposure to the active metabolite eslicarbazepine, most likely caused by an induction of glucuronidation. No change in 41 exposure to carbamazepine or its metabolite carbamazepine-epoxide was noted. Based on individual response, the dose of eslicarbazepine acetate may need to be increased if used concomitantly with carbamazepine. Results from patient studies showed that concomitant treatment increased the risk of the following adverse reactions: diplopia, abnormal coordination and dizziness. The risk of increase of other specific adverse reactions caused by co-administration of carbamazepine and eslicarbazepine acetate cannot be excluded. Phenytoin In a study in healthy subjects, concomitant administration of eslicarbazepine acetate 1,200 mg once daily and phenytoin resulted in an average decrease of 31-33% in exposure to the activ

Auszug; vollständigen Abschnitt im Original lesen.

HOS-095248 · has-interaction-information · PDF-Seite 59

Interaction studies have only been performed in adults. Eslicarbazepine acetate is extensively converted to eslicarbazepine, which is mainly eliminated by glucuronidation. In vitro eslicarbazepine is a weak inducer of CYP3A4 and UDP-glucuronyl transferases. In vivo eslicarbazepine showed an inducing effect on the metabolism of medicinal products that are mainly eliminated by metabolism through CYP3A4 (e.g. Simvastatin). Thus, an increase in the dose of the medicinal products that are mainly metabolised through CYP3A4 may be required, when used concomitantly with eslicarbazepine acetate. Eslicarbazepine in vivo may have an inducing effect on the metabolism of medicinal products that are mainly eliminated by conjugation through the UDP-glucuronyl transferases. When initiating or discontinuing treatment with Zebinix or changing the dose, it may take 2 to 3 weeks to reach the new level of enzyme activity. This time delay must be taken into account when Zebinix is being used just prior to or in combination with other medicinal products that require dose adjustment when co-administered with Zebinix. Eslicarbazepine has inhibiting properties with respect to CYP2C19. Thus, interactions can arise when co-administering high doses of eslicarbazepine acetate with medicinal products that are mainly metabolised by CYP2C19 (e.g. Phenytoin). Interactions with other antiepileptic medicinal products Carbamazepine In a study in healthy subjects, concomitant administration of eslicarbazepine acetate 800 mg once daily and carbamazepine 400 mg twice daily resulted in an average decrease of 32% in exposure to the active metabolite eslicarbazepine, most likely caused by an induction of glucuronidation. No change in 59 exposure to carbamazepine or its metabolite carbamazepine-epoxide was noted. Based on individual response, the dose of eslicarbazepine acetate may need to be increased if used concomitantly with carbamazepine. Results from patient studies showed that concomitant treatment increased the risk of the following adverse reactions: diplopia, abnormal coordination and dizziness. The risk of increase of other specific adverse reactions caused by co-administration of carbamazepine and eslicarbazepine acetate cannot be excluded. Phenytoin In a study in healthy subjects, concomitant administration of eslicarbazepine acetate 1,200 mg once daily and phenytoin resulted in an average decrease of 31-33% in exposure to the activ

Auszug; vollständigen Abschnitt im Original lesen.

HOS-095236 · has-interaction-information · PDF-Seite 23

Interaction studies have only been performed in adults. Eslicarbazepine acetate is extensively converted to eslicarbazepine, which is mainly eliminated by glucuronidation. In vitro eslicarbazepine is a weak inducer of CYP3A4 and UDP-glucuronyl transferases. In vivo eslicarbazepine showed an inducing effect on the metabolism of medicinal products that are mainly eliminated by metabolism through CYP3A4 (e.g. Simvastatin). Thus, an increase in the dose of the medicinal products that are mainly metabolised through CYP3A4 may be required, when used concomitantly with eslicarbazepine acetate. Eslicarbazepine in vivo may have an inducing effect on the metabolism of medicinal products that are mainly eliminated by conjugation through the UDP-glucuronyl transferases.When initiating or discontinuing treatment with Zebinix or changing the dose, it may take 2 to 3 weeks to reach the new level of enzyme activity. This time delay must be taken into account when Zebinix is being used just prior to or in combination with other medicinal products that require dose adjustment when co-administered with Zebinix. Eslicarbazepine has inhibiting properties with respect to CYP2C19. Thus, interactions can arise when co-administering high doses of eslicarbazepine acetate with medicinal products that are mainly metabolised by CYP2C19 (e.g. Phenytoin). Interactions with other antiepileptic medicinal products Carbamazepine 23 In a study in healthy subjects, concomitant administration of eslicarbazepine acetate 800 mg once daily and carbamazepine 400 mg twice daily resulted in an average decrease of 32% in exposure to the active metabolite eslicarbazepine, most likely caused by an induction of glucuronidation. No change in exposure to carbamazepine or its metabolite carbamazepine-epoxide was noted. Based on individual response, the dose of eslicarbazepine acetate may need to be increased if used concomitantly with carbamazepine. Results from patient studies showed that concomitant treatment increased the risk of the following adverse reactions: diplopia, abnormal coordination and dizziness. The risk of increase of other specific adverse reactions caused by co-administration of carbamazepine and eslicarbazepine acetate cannot be excluded. Phenytoin In a study in healthy subjects, concomitant administration of eslicarbazepine acetate 1,200 mg once daily and phenytoin resulted in an average decrease of 31-33% in exposure to the acti

Auszug; vollständigen Abschnitt im Original lesen.

HOS-095249 · has-pregnancy-information · PDF-Seite 61

Pregnancy Risk related to epilepsy and antiepileptic medicinal products in general It has been shown that in the offspring of women with epilepsy using an antiepileptic treatment, the prevalence of malformations is two to three times greater than the rate of approximately 3% in the general population. Most frequently reported are cleft lip, cardiovascular malformations and neural tube defects. Specialist medical advice regarding the potential risk to a foetus caused by both seizures and antiepileptic treatment should be given to all women of child-bearing potential taking antiepileptic treatment, and especially to women planning pregnancy and women who are pregnant. Sudden discontinuation of antiepileptic drug (AED) therapy should be avoided as this may lead to seizures that could have serious consequences for the women and the unborn child. Monotherapy is preferred for treating epilepsy in pregnancy whenever possible because therapy with multiple AEDs could be associated with a higher risk of congenital malformations than monotherapy, depending on the associated AEDs. Neurodevelopmental disorders in children of mothers with epilepsy using an antiepileptic treatment has been observed. There is no data available for eslicarbazepine acetate on this risk. Women of childbearing potential/contraception Women of childbearing potential should use effective contraception during treatment with eslicarbazepine acetate. Eslicarbazepine acetate adversely interacts with oral contraceptives. Therefore, an alternative, effective and safe method of contraception should be used during treatment and up to the end of the current menstrual cycle after treatment has been stopped. Women of childbearing potential should be counselled regarding the use of other effective contraceptive methods. At least one effective method of contraception (such as an intra-uterine device) or two complementary forms of contraception including a barrier method should be used. Individual circumstances should be evaluated in each case, involving the patient in the discussion, when choosing the contraception method. Risk related to eslicarbazepine acetate 61 There is limited amount of data from the use of eslicarbazepine acetate in pregnant women. Studies in animals have shown reproductive toxicity (see Fertility section 5.3). ). A risk in humans (including of major congenital malformations, neurodevelopmental disorders and other reproductive

Auszug; vollständigen Abschnitt im Original lesen.

HOS-095231 · has-pregnancy-information · PDF-Seite 7

Pregnancy Risk related to epilepsy and antiepileptic medicinal products in general It has been shown that in the offspring of women with epilepsy using an antiepileptic treatment, the prevalence of malformations is two to three times greater than the rate of approximately 3% in the general population. Most frequently reported are cleft lip, cardiovascular malformations and neural tube defects. Specialist medical advice regarding the potential risk to a foetus caused by both seizures and antiepileptic treatment should be given to all women of child-bearing potential taking antiepileptic treatment, and especially to women planning pregnancy and women who are pregnant. Sudden discontinuation of antiepileptic drug (AED) therapy should be avoided as this may lead to seizures that could have serious consequences for the woman and the unborn child. Monotherapy is preferred for treating epilepsy in pregnancy whenever possible because therapy with multiple AEDs could be associated with a higher risk of congenital malformations than monotherapy, depending on the associated AEDs. Neurodevelopmental disorders in children of mothers with epilepsy using an antiepileptic treatment has been observed. There is no data available for eslicarbazepine acetate on this risk. Women of childbearing potential/contraception Women of childbearing potential should use effective contraception during treatment with eslicarbazepine acetate. Eslicarbazepine acetate adversely interacts with oral contraceptives. Therefore, an alternative, effective and safe method of contraception should be used during treatment and up to the end of the current menstrual cycle after treatment has been stopped. Women of childbearing potential should be counselled regarding the use of other effective contraceptive methods. At least one effective method of contraception (such as an intra-uterine device) or two complementary forms of contraception including a barrier method should be used. Individual circumstances should be evaluated in each case, involving the patient in the discussion, when choosing the contraception method. Risk related to eslicarbazepine acetate There is limited amount of data from the use of eslicarbazepine acetate in pregnant women. Studies in 7 animals have shown reproductive toxicity (see Fertility section 5.3). A risk in humans (including of major congenital malformations, neurodevelopmental disorders and other reproductive to

Auszug; vollständigen Abschnitt im Original lesen.

HOS-095243 · has-pregnancy-information · PDF-Seite 43

Pregnancy Risk related to epilepsy and antiepileptic medicinal products in general It has been shown that in the offspring of women with epilepsy using an antiepileptic treatment, the prevalence of malformations is two to three times greater than the rate of approximately 3% in the general population. Most frequently reported are cleft lip, cardiovascular malformations and neural tube defects. Specialist medical advice regarding the potential risk to a foetus caused by both seizures and antiepileptic treatment should be given to all women who are of child-bearing potential taking antiepileptic treatment, and especially to women planning pregnancy and women who are pregnant. Sudden discontinuation of antiepileptic drug (AED) therapy should be avoided as this may lead to seizures that could have serious consequences for the womanand the unborn child. Monotherapy is preferred for treating epilepsy in pregnancy whenever possible because therapy with multiple AEDs could be associated with a higher risk of congenital malformations than monotherapy, depending on the associated AEDs. Neurodevelopmental disorders in children of mothers with epilepsy using an antiepileptic treatment has been observed. There is no data available for eslicarbazepine acetate on this risk. Women of childbearing potential/contraception Women of childbearing potential should use effective contraception during treatment with eslicarbazepine acetate. Eslicarbazepine acetate adversely interacts with oral contraceptives. Therefore, an alternative, effective and safe method of contraception should be used during treatment and up to the end of the current menstrual cycle after treatment has been stopped. Women of childbearing potential should be counselled regarding the use of other effective contraceptive methods. At least one effective method of contraception (such as an intra-uterine device) or two complementary forms of contraception including a barrier method should be used. Individual circumstances should be evaluated in each case, involving the patient in the discussion, when choosing the contraception method. Risk related to eslicarbazepine acetate 43 There is limited amount of data from the use of eslicarbazepine acetate in pregnant women. Studies in animals have shown reproductive toxicity (see Fertility section 5.3). A risk in humans (including of major congenital malformations, neurodevelopmental disorders and other reproduc

Auszug; vollständigen Abschnitt im Original lesen.

HOS-095237 · has-pregnancy-information · PDF-Seite 25

Pregnancy Risk related to epilepsy and antiepileptic medicinal products in general It has been shown that in the offspring of women with epilepsy using an antiepileptic treatment, the prevalence of malformations is two to three times greater than the rate of approximately 3% in the general population. Most frequently reported are cleft lip, cardiovascular malformations and neural tube defects. Specialist medical advice regarding the potential risk to a foetus caused by both seizures and antiepileptic treatment should be given to all women of child-bearing potential taking antiepileptic treatment, and especially to women planning pregnancy and women who are pregnant. Sudden discontinuation of antiepileptic drug (AED) therapy should be avoided as this may lead to seizures that could have serious consequences for the woman and the unborn child. Monotherapy is preferred for treating epilepsy in pregnancy whenever possible because therapy with multiple AEDs could be associated with a higher risk of congenital malformations than monotherapy, depending on the associated AEDs. Neurodevelopmental disorders in children of mothers with epilepsy using an antiepileptic treatment has been observed. There is no data available for eslicarbazepine acetate on this risk. Women of childbearing potential/contraception Women of childbearing potential should use effective contraception during treatment with eslicarbazepine acetate. Eslicarbazepine acetate adversely interacts with oral contraceptives. Therefore, an alternative, effective and safe method of contraception should be used during treatment and up to the end of the current menstrual cycle after treatment has been stopped. Women of childbearing potential should be counselled regarding the use of other effective contraceptive methods. At least one effective method of contraception (such as an intra-uterine device) or two complementary forms of contraception including a barrier method should be used. Individual circumstances should be evaluated in each case, involving the patient in the discussion, when choosing the contraception method. 25 Risk related to eslicarbazepine acetate There is limited amount of data from the use of eslicarbazepine acetate in pregnant women. Studies in animals have shown reproductive toxicity (see Fertility section 5.3). ). A risk in humans (including of major congenital malformations, neurodevelopmental disorders and other reproductive

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HOS-095255 · has-pregnancy-information · PDF-Seite 79

Pregnancy Risk related to epilepsy and antiepileptic medicinal products in general It has been shown that in the offspring of women with epilepsy using an antiepileptic treatment, the prevalence of malformations is two to three times greater than the rate of approximately 3% in the general population. Most frequently reported are cleft lip, cardiovascular malformations and neural tube defects. Specialist medical advice regarding the potential risk to a foetus caused by both seizures and antiepileptic treatment should be given to all women of child-bearing potential taking antiepileptic treatment, and especially to women planning pregnancy and women who are pregnant. Sudden discontinuation of antiepileptic drug (AED) therapy should be avoided as this may lead to seizures that could have serious consequences for the woman and the unborn child. Monotherapy is preferred for treating epilepsy in pregnancy whenever possible because therapy with multiple AEDs could be associated with a higher risk of congenital malformations than monotherapy, depending on the associated AEDs. Neurodevelopmental disorders in children of mothers with epilepsy using an antiepileptic treatment has been observed. There is no data available for eslicarbazepine acetate on this risk. Women of childbearing potential/contraception Women of childbearing potential should use effective contraception during treatment with eslicarbazepine acetate. Eslicarbazepine acetate adversely interacts with oral contraceptives. Therefore, an alternative, effective and safe method of contraception should be used during treatment and up to the end of the current menstrual cycle after treatment has been stopped. Women of childbearing potential should be counselled regarding the use of other effective contraceptive methods. At least one effective method of contraception (such as an intra-uterine device) or two complementary forms of contraception including a barrier method should be used. Individual circumstances should be evaluated in each case, involving the patient in the discussion, when choosing the contraception method. Risk related to eslicarbazepine acetate 79 There is limited amount of data from the use of eslicarbazepine acetate in pregnant women. Studies in animals have shown reproductive toxicity (see Fertility section 5.3). A risk in humans (including of major congenital malformations, neurodevelopmental disorders and other reproductive to

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HOS-095235 · has-warning-information · PDF-Seite 21

Suicidal ideation Suicidal ideation and behaviour have been reported in patients treated with antiepileptic active substances in several indications. A meta-analysis of randomised placebo-controlled trials of antiepileptic medicinal products has also shown a small increased risk of suicidal ideation and behaviour. The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for eslicarbazepine acetate. Therefore patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge. Nervous system disorders 21 Eslicarbazepine acetate has been associated with some central nervous system adverse reactions, such as dizziness and somnolence, which could increase the occurrence of accidental injury. Other warnings and precautions If Zebinix is to be discontinued it is recommended to withdraw it gradually to minimise the potential of increased seizure frequency. Cutaneous reactions Rash developed as an adverse reaction in 1.2% of total population treated with Zebinix in clinical studies in epileptic patients. Urticaria and angioedema cases have been reported in patients taking Zebinix. Angioedema in the context of hypersensitivity/anaphylactic reaction associated with laryngeal oedema can be fatal. If signs or symptoms of hypersensitivity develop, eslicarbazepine acetate must be discontinued immediately and alternative treatment should be initiated. Severe cutaneous adverse reactions (SCARS) including Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, have been reported in post-marketing experience with Zebinix treatment. At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions. If signs and symptoms suggestive of these reactions appear, Zebinix should be withdrawn immediately and an alternative treatment considered (as appropriate). If the patients have developed such reactions, treatment with Zebinix must not be restarted in these patients at any time. HLA-B* 1502 allele - in Han Chinese, Thai and other Asian populations HLA-B* 1502 in individuals of Han Chinese and Thai origin has b

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HOS-095229 · has-warning-information · PDF-Seite 3

Suicidal ideation Suicidal ideation and behaviour have been reported in patients treated with antiepileptic active substances in several indications. A meta-analysis of randomised placebo-controlled trials of antiepileptic medicinal products has also shown a small increased risk of suicidal ideation and behaviour. The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for eslicarbazepine acetate. Therefore, patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge. Nervous system disorders Eslicarbazepine acetate has been associated with some central nervous system adverse reactions, such as dizziness and somnolence, which could increase the occurrence of accidental injury. 3 Other warnings and precautions If Zebinix is to be discontinued it is recommended to withdraw it gradually to minimise the potential of increased seizure frequency. Cutaneous reactions Rash developed as an adverse reaction in 1.2% of total population treated with Zebinix in clinical studies in epileptic patients. Urticaria and angioedema cases have been reported in patients taking Zebinix. Angioedema in the context of hypersensitivity/anaphylactic reaction associated with laryngeal oedema can be fatal. If signs or symptoms of hypersensitivity develop, eslicarbazepine acetate must be discontinued immediately and alternative treatment should be initiated. Severe cutaneous adverse reactions (SCARS) including Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, have been reported in post-marketing experience with Zebinix treatment. At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions. If signs and symptoms suggestive of these reactions appear, Zebinix should be withdrawn immediately and an alternative treatment considered (as appropriate). If the patients have developed such reactions, treatment with Zebinix must not be restarted in these patients at any time. HLA-B* 1502 allele - in Han Chinese, Thai and other Asian populations HLA-B* 1502 in individuals of Han Chinese and Thai origin has b

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HOS-095247 · has-warning-information · PDF-Seite 57

Suicidal ideation Suicidal ideation and behaviour have been reported in patients treated with antiepileptic active substances in several indications. A meta-analysis of randomised placebo-controlled trials of antiepileptic medicinal products has also shown a small increased risk of suicidal ideation and behaviour. The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for eslicarbazepine acetate. Therefore patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge. Nervous system disorders Eslicarbazepine acetate has been associated with some central nervous system adverse reactions, such as dizziness and somnolence, which could increase the occurrence of accidental injury. 57 Other warnings and precautions If Zebinix is to be discontinued it is recommended to withdraw it gradually to minimise the potential of increased seizure frequency. Cutaneous reactions Rash developed as an adverse reaction in 1.2% of total population treated with Zebinix in clinical studies in epileptic patients. Urticaria and angioedema cases have been reported in patients taking Zebinix. Angioedema in the context of hypersensitivity/anaphylactic reaction associated with laryngeal oedema can be fatal. If signs or symptoms of hypersensitivity develop, eslicarbazepine acetate must be discontinued immediately and alternative treatment should be initiated. Severe cutaneous adverse reactions (SCARS) including Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, have been reported in post-marketing experience with Zebinix treatment. At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions. If signs and symptoms suggestive of these reactions appear, Zebinix should be withdrawn immediately and an alternative treatment considered (as appropriate). If the patients have developed such reactions, treatment with Zebinix must not be restarted in these patients at any time. HLA-B* 1502 allele - in Han Chinese, Thai and other Asian populations HLA-B* 1502 in individuals of Han Chinese and Thai origin has bee

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HOS-095253 · has-warning-information · PDF-Seite 75

Suicidal ideation Suicidal ideation and behaviour have been reported in patients treated with antiepileptic active substances in several indications. A meta-analysis of randomised placebo-controlled trials of antiepileptic medicinal products has also shown a small increased risk of suicidal ideation and behaviour. The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for eslicarbazepine acetate. Therefore, patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge. Nervous system disorders Eslicarbazepine acetate has been associated with some central nervous system adverse reactions, such as dizziness and somnolence, which could increase the occurrence of accidental injury. Other warnings and precautions 75 If Zebinix is to be discontinued it is recommended to withdraw it gradually to minimise the potential of increased seizure frequency. Cutaneous reactions Rash developed as an adverse reaction in 1.2% of total population treated with Zebinix in clinical studies in epileptic patients. Urticaria and angioedema cases have been reported in patients taking Zebinix. Angioedema in the context of hypersensitivity/anaphylactic reaction associated with laryngeal oedema can be fatal. If signs or symptoms of hypersensitivity develop, eslicarbazepine acetate must be discontinued immediately and alternative treatment should be initiated. Severe cutaneous adverse reactions (SCARS) including Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, have been reported in post-marketing experience with Zebinix treatment. At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions. If signs and symptoms suggestive of these reactions appear, Zebinix should be withdrawn immediately and an alternative treatment considered (as appropriate). If the patients have developed such reactions, treatment with Zebinix must not be restarted in these patients at any time. HLA-B* 1502 allele - in Han Chinese, Thai and other Asian populations HLA-B* 1502 in individuals of Han Chinese and Thai origin has b

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HOS-095241 · has-warning-information · PDF-Seite 39

Suicidal ideation Suicidal ideation and behaviour have been reported in patients treated with antiepileptic active substances in several indications. A meta-analysis of randomised placebo-controlled trials of antiepileptic medicinal products has also shown a small increased risk of suicidal ideation and behaviour. The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for eslicarbazepine acetate. Therefore patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge. Nervous system disorders Eslicarbazepine acetate has been associated with some central nervous system adverse reactions, such as dizziness and somnolence, which could increase the occurrence of accidental injury. 39 Other warnings and precautions If Zebinix is to be discontinued it is recommended to withdraw it gradually to minimise the potential of increased seizure frequency. Cutaneous reactions Rash developed as an adverse reaction in 1.2% of total population treated with Zebinix in clinical studies in epileptic patients. Urticaria and angioedema cases have been reported in patients taking Zebinix. Angioedema in the context of hypersensitivity/anaphylactic reaction associated with laryngeal oedema can be fatal. If signs or symptoms of hypersensitivity develop, eslicarbazepine acetate must be discontinued immediately and alternative treatment should be initiated. Severe cutaneous adverse reactions (SCARS) including Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, have been reported in post-marketing experience with Zebinix treatment. At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions. If signs and symptoms suggestive of these reactions appear, Zebinix should be withdrawn immediately and an alternative treatment considered (as appropriate). If the patients have developed such reactions, treatment with Zebinix must not be restarted in these patients at any time. HLA-B* 1502 allele - in Han Chinese, Thai and other Asian populations HLA-B* 1502 in individuals of Han Chinese and Thai origin has be

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