Quest for the right Drug
אונג'נטיס 50 מ"ג ONGENTYS 50 MG (OPICAPONE)
תרופה במרשם
תרופה בסל
נרקוטיקה
ציטוטוקסיקה
צורת מתן:
פומי : PER OS
צורת מינון:
קפסולה קשיחה : CAPSULE, HARD
עלון לרופא
מינוניםPosology התוויות
Indications תופעות לוואי
Adverse reactions התוויות נגד
Contraindications אינטראקציות
Interactions מינון יתר
Overdose הריון/הנקה
Pregnancy & Lactation אוכלוסיות מיוחדות
Special populations תכונות פרמקולוגיות
Pharmacological properties מידע רוקחי
Pharmaceutical particulars אזהרת שימוש
Special Warning עלון לרופא
Physicians Leaflet
Adverse reactions : תופעות לוואי
4.8 Undesirable effects Summary of the safety profile The most common adverse reactions reported were nervous system disorders. Dyskinesia was the most frequently reported treatment-emergent adverse reaction (17.7%). Tabulated list of adverse reactions In the table below (Table 1) all adverse reactions are presented by System Organ Class and frequency. Frequency categories are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data). Table 1 – Frequency of adverse reactions (MedDRA) in placebo-controlled Phase 3 studies System Organ Class Very common Common Uncommon Metabolism and Decreased appetite, nutrition disorders Hypertriglyceridaemia Psychiatric disorders Abnormal dreams, Anxiety, Hallucination, Depression, Hallucination visual, Hallucination auditory, Insomnia Nightmare, Sleep disorder Nervous system Dyskinesia Dizziness, Dysgeusia, disorders Headache, Hyperkinesia, Somnolence Syncope Eye disorders Dry eye Ear and labyrinth Ear congestion disorders Cardiac disorders Palpitations Vascular disorders Orthostatic Hypertension, Hypotension Hypotension Respiratory, thoracic Dyspnoea and mediastinal disorders Gastrointestinal Constipation, Abdominal distention, disorders Dry mouth, Abdominal pain, Nausea, Abdominal pain upper, Vomiting Dyspepsia Musculoskeletal and Muscle spasms Muscle twitching, connective tissue Musculoskeletal disorders stiffness, Myalgia, Pain in extremity Renal and urinary Chromaturia, disorders Nocturia Investigations Blood creatine Weight decreased phosphokinase increased Injury, poisoning and Fall procedural complications General disorders and Fatigue administration site conditions Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il
שימוש לפי פנקס קופ''ח כללית 1994
לא צוין
תאריך הכללה מקורי בסל
לא צוין
הגבלות
לא צוין
מידע נוסף