Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Zalasta

Zalasta 5 mg orodispersible tablets Zalasta 7.5 mg orodispersible tablets Zalasta 10 mg orodispersible tablets Zalasta 15 mg orodispersible tablets Zalasta 20 mg orodispersible tablets · Abschnitt 4.8 · PDF-Seite 26–27

HOS-118161 · Präparat HOS-094761

26  (ALT, AST), injury)11 especially in early treatment (see section 4.4) Skin and subcutaneous tissue disorders Rash Photosensitivity Drug Reaction reaction with Eosinophilia Alopecia and Systemic Symptoms (DRESS) Musculoskeletal and connective tissue disorders Arthralgia9 Rhabdomyolysis11 Renal and urinary disorders Urinary incontinence, urinary retention Urinary hesitation11 Pregnancy, puerperium and perinatal conditions Drug withdrawal syndrome neonatal (see section 4.6) Reproductive system and breast disorders Erectile dysfunction in Amenorrhea Priapism12 males Breast enlargement Decreased libido in Galactorrhea in males and females females Gynaecomastia/breast enlargement in males General disorders and administration site conditions Asthenia Fatigue Oedema Pyrexia10 Investigations Elevated plasma Increased alkaline Increased total prolactin levels8 phosphatase10 bilirubin High creatine phosphokinase11 High Gamma Glutamyltransferase10 High uric acid10 1 Clinically significant weight gain was observed across all baseline Body Mass Index (BMI) categories. Following short term treatment (median duration 47 days), weight gain ≥ 7% of baseline body weight was very common (22.2 %), ≥ 15 % was common (4.2 %) and ≥ 25 % was uncommon (0.8 %). Patients gaining ≥ 7 %, ≥ 15 % and ≥ 25 % of their baseline body weight with long-term exposure (at least 48 weeks) were very common (64.4 %, 31.7 % and 12.3 % respectively). 2 Mean increases in fasting lipid values (total cholesterol, LDL cholesterol, and triglycerides) were greater in patients without evidence of lipid dysregulation at baseline. 3 Observed for fasting normal levels at baseline (< 5.17 mmol/l) which increased to high (≥ 6.2 mmol/l). Changes in total fasting cholesterol levels from borderline at baseline (≥ 5.17-< 6.2 mmol/l) to high (≥ 6.2 mmol/l) were very common.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.