Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan

Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan 600 mg/200 mg/245 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 37

HOS-225213 · Präparat HOS-217408

Reproductive system and breast disorders: Uncommon gynaecomastia General disorders and administration site conditions: Very common asthenia Common fatigue pain, asthenia 1 Anaemia was common and skin discolouration (increased pigmentation) was very common when emtricitabine was administered to paediatric patients. 2 This adverse reaction may occur as a consequence of proximal renal tubulopathy. It is not considered to be causally associated with tenofovir disoproxil in the absence of this condition. 3 See section 4.8 Description of selected adverse reactions for more details. 4 This adverse reaction was identified through post-marketing surveillance for either efavirenz, emtricitabine or tenofovir disoproxil. The frequency category was estimated from a statistical calculation based on the total number of patients treated with efavirenz in clinical studies (n = 3,969) or exposed to emtricitabine in randomised controlled clinical studies (n = 1,563) or exposed to tenofovir disoproxil in randomised controlled clinical studies and the expanded access programme (n = 7,319). Description of selected adverse reactions

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