Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Synjardy

Synjardy 5 mg/850 mg film-coated tablets Synjardy 5 mg/1 000 mg film-coated tablets Synjardy 12.5 mg/850 mg film-coated tablets Synjardy 12.5 mg/1 000 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 13

HOS-131201 · Präparat HOS-097021

Gastrointestinal Gastrointestinal Constipation disorders symptoms3, 4 Hepatobiliary Liver function disorders tests abnormalities3 Hepatitis3 Skin and Pruritus Urticaria Erythema3 subcutaneous (generalised)2, 3 Angioedema tissue disorders Rash Renal and Increased urination1, Dysuria2 Tubulointerstitial 2 urinary nephritis disorders Investigations Serum lipids Blood increased2, b creatinine increased/ Glomerular filtration rate decreased1 Haematocrit increased2, c 1 See subsections below for additional information 2 Identified adverse reactions of empagliflozin monotherapy 3 Identified adverse reactions of metformin monotherapy 4 Gastrointestinal symptoms such as nausea, vomiting, diarrhoea, abdominal pain and loss of appetite occur most frequently during initiation of therapy and resolve spontaneously in most cases. a See section 4.4 b Mean percent increases from baseline for empagliflozin 10 mg and 25 mg versus placebo, respectively, were total cholesterol 5.0% and 5.2% versus 3.7%; HDL-cholesterol 4.6% and 2.7% versus -0.5%; LDL-cholesterol 9.1% and 8.7% versus 7.8%; triglycerides 5.4% and 10.8% versus 12.1%. c Mean changes from baseline in haematocrit were 3.6% and 4.0% for empagliflozin 10 mg and 25 mg, respectively, compared to 0% for placebo. In the EMPA-REG Outcome study, haematocrit values returned towards baseline values after a follow-up period of 30 days after treatment stop. d Pooled data of empagliflozin trials in patients with heart failure (where half of the patients had type 2 diabetes mellitus) showed a higher frequency of volume depletion (“very common”: 11.4% for empagliflozin versus 9.7% for placebo).

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