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Hetlioz
Eintrag öffnenHetlioz · 4.1 Therapeutic indications · 1
Eintrag öffnenHetlioz · 4.3 Contraindications · 1
Eintrag öffnenHetlioz · 4.3 · Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Eintrag öffnenHetlioz · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenHetlioz · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenHetlioz · 4.5 · Beta blockers The efficacy of tasimelteon may be reduced in patients with concomitant administration of beta a
Eintrag öffnenHetlioz · 4.5 · In a study of 28 healthy volunteers, a single dose of ethanol (0.6 g/kg for women and 0.7 g/kg for men) was co
Eintrag öffnenHetlioz · 4.5 · Potential effect of alcohol on tasimelteon
Eintrag öffnenHetlioz · 4.5 · Potential for other medicinal products to affect tasimelteon CYP1A2 and CYP3A4 are enzymes identified to play
Eintrag öffnenHetlioz · 4.5 · Smoking (moderate CYP1A2 inducer) Tasimelteon exposure decreased by approximately 40% in smokers compared to n
Eintrag öffnenHetlioz · 4.5 · Strong CYP3A4 inducers (e.g. rifampin) Use of tasimelteon should be avoided in combination with rifampin or ot
Eintrag öffnenHetlioz · 4.5 · Strong CYP3A4 inhibitors (e.g. ketoconazole) Tasimelteon exposure was increased by approximately 50% when co-a
Eintrag öffnenHetlioz · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenHetlioz · 4.8 Undesirable effects · 1
Eintrag öffnenHetlioz · 4.8 · 5 Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows c
Eintrag öffnenHetlioz · 4.8 · Adverse reactions leading to discontinuation occurred in 2.3% of tasimelteon-treated patients. The most freque
Eintrag öffnenHetlioz · 4.8 · Reporting of suspected adverse reactions
Eintrag öffnenHetlioz · 4.8 · Summary of the safety profile
Eintrag öffnenHetlioz · 4.8 · Table 1: Summary of Adverse Drug Reactions System Organ Class Very common Common Uncommon Sleep disorder, inso
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